Lansoprazole
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Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Lansoprazole delayed-release capsules are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. [See Clinical Studies (14)]
Triple Therapy: Lansoprazole delayed-release capsules /amoxicillin /clarithromycin
Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See Clinical Studies (14)]
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin
Dual Therapy: Lansoprazole delayed-release capsules /amoxicillinLansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. [See Clinical Studies (14)]
Please refer to the full prescribing information for amoxicillin.
Lansoprazole delayed-release capsules are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14)]
Lansoprazole delayed-release capsules are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer. [See Clinical Studies (14)]
Lansoprazole delayed-release capsules are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks. [See Clinical Studies (14)]
Lansoprazole delayed-release capsules are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. [See Clinical Studies (14)]
Short-Term Treatment of Symptomatic GERD
Lansoprazole delayed-release capsules is indicated for the treatment of heartburn and other symptoms associated with GERD for upto 8 weeks. [See Clinical Studies (14)]
Short-Term Treatment of Erosive Esophagitis
Lansoprazole delayed-release capsules is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.
For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of lansoprazole delayed-release capsules may be considered. [See Clinical Studies (14)]
Lansoprazole delayed-release capsules are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months. [See Clinical Studies (14)]
Lansoprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. [See Clinical Studies (14)]
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole USP has the following structure:
Lansoprazole USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole USP is freely soluble in dimethylformamideand practically insoluble in water.
Lansoprazole USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0.
Lansoprazole USP is supplied as delayed-release capsules.
The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide.
Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.
Sources
Lansoprazole Manufacturers
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Proficient Rx Lp
![Lansoprazole Capsule, Delayed Release [Proficient Rx Lp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lansoprazole | Proficient Rx Lp
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose FrequencyDuodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERDNonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily#
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
* Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
† Controlled studies did not extend beyond indicated duration.
‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.
§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.
# Controlled studies did not extend beyond 12 months
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: 1. Open capsule. 2. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. 3. Inject through the nasogastric tube into the stomach. 4. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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Remedyrepack Inc.
Lansoprazole | Remedyrepack Inc.
Lansoprazole is available as a capsule, in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
Maintenance of Healed
15 mg
15 mg
Once daily for 4 weeks
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.
§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger- Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
Administration Options
Lansoprazole delayed-release capsules - Oral Administration
· Lansoprazole delayed-release capsules should be swallowed whole.
· Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:
o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
· Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole delayed-release capsules – Nasogastric Tube (≥16 French) Administration
· For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:
o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Direct Rx
Lansoprazole | Direct Rx
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose Frequency *† Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole delayed-release capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks†* Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks†§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily# Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶* Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
† Controlled studies did not extend beyond indicated duration.
‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.
§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.
# Controlled studies did not extend beyond 12 months
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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Prasco Laboratories
Lansoprazole | Taylor James, Ltd.
Directions
· Apply liberally 15 minutes before sun exposure
· Use a water resistant sunscreen if swimming or sweating· Reapply at least every 2 hours
· Children under 6 months: Ask a doctor
· Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses -
Preferred Pharmaceuticals, Inc.
Lansoprazole | Preferred Pharmaceuticals, Inc.
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1Recommended Dose Indication Recommended Dose FrequencyDuodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks
Risk Reduction
15 mg
Once daily for up to 12 weeks
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg
15 mg
Once daily for up to 12 weeks
> 30 kg
30 mg
Once daily for up to 12 weeks
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERDNonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: 1. Open capsule. 2. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. 3. Inject through the nasogastric tube into the stomach. 4. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Preferred Pharmaceuticals, Inc.
Lansoprazole | Preferred Pharmaceuticals, Inc.
Lansoprazole delayed-release capsules are available as capsules in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5% to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.Indication
Recommended
Frequency
Dose
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole Delayed-release Capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole Delayed-release Capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose and should be instructed to take the next dose on time. Patients should be instructed not to take two doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7).]
2.3 Important Administration Information Administration OptionsLansoprazole Delayed-release Capsules -Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact pellets into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-release Capsules -Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Sun Pharmaceutical Industries Limited
Lansoprazole | Sun Pharmaceutical Industries Limited
Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose
Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Controlled studies did not extend beyond 12 months # Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years. Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily¶
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily#
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE* pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact pellets into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules -Oral AdministrationLansoprazole Delayed-Release Capsules -Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Direct Rx
Lansoprazole | Purecore Wellness, Inc
Apply over the affected area once in the evening. Consult a physician for use in children under 12 years of age.
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Safeway
Lansoprazole | Safeway
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25°C (68-77°F) • keep product out of high heat and humidity • protect product from moisture -
Rebel Distributors Corp
Lansoprazole | Rebel Distributors Corp
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years. Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks NSAID-associated Gastric Ulcer
Healing
Risk Reduction
30 mg
15 mg
Once daily for 8 weeks†
Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶ 2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7)]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
Lansoprazole Delayed-Release Capsules - Nasogastric Tube Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube. -
Physicians Total Care, Inc.
Lansoprazole | Physicians Total Care, Inc.
Lansoprazole is available as a delayed-release orally disintegrating tablet in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release orally disintegrating tablets should be taken before eating. Lansoprazole delayed-release orally disintegrating tablets SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Controlled studies did not extend beyond indicated duration. † The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole Delayed-
Release Orally
Disintegrating Tablets 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole Delayed-
Release Orally
Disintegrating Tablets 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks* Risk Reduction 15 mg Once daily for up to 12 weeks* Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of
Erosive Esophagitis 30 mg Once daily for up to 8 weeks Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks† > 30 kg 30 mg Once daily for up to 12 weeks† (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison syndrome 60 mg Once daily 2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration Information Administration Options Lansoprazole delayed-release orally disintegrating tablets Lansoprazole delayed-release orally disintegrating tablets should not be broken or cut. Lansoprazole delayed-release orally disintegrating tablets should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. The tablet typically disintegrates in less than 1 minute. Alternatively, for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be delivered in two different ways.Lansoprazole delayed-release orally disintegrating tablets – Oral Syringe
For administration via oral syringe, lansoprazole delayed-release orally disintegrating tablets can be administered as follows:
Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, administer the contents within 15 minutes. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.Lansoprazole delayed-release orally disintegrating tablets – Nasogastric Tube (≥ 8 French)Administration
For administration via a nasogastric tube, lansoprazole delayed-release orally disintegrating tablets can be administered as follows:
Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes. Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube. -
Stat Rx Usa Llc
Lansoprazole | Stat Rx Usa Llc
Lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets should be taken before eating. Lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets.
2.1 Recommended Dose Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years. Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks NSAID-associated Gastric Ulcer
Healing
Risk Reduction
30 mg
15 mg
Once daily for 8 weeks†
Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶ 2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Lansoprazole delayed-release orally disintegrating tablets should not be broken or cut. Lansoprazole delayed-release orally disintegrating tablets should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. The tablet typically disintegrates in less than 1 minute. Alternatively, for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be delivered in two different ways.Lansoprazole Delayed-Release Orally Disintegrating Tablets – Oral Syringe
For administration via oral syringe, lansoprazole delayed-release orally disintegrating tablets can be administered as follows: Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, administer the contents within 15 minutes. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.Lansoprazole Delayed-Release Orally Disintegrating Tablets – Nasogastric Tube (≥ 8 French) Administration
For administration via a nasogastric tube, lansoprazole delayed-release orally disintegrating tablets can be administered as follows: Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes. Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube. -
Physicians Total Care, Inc.
Lansoprazole | Physicians Total Care, Inc.
Lansoprazole delayed-release capsules USP are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules USP should be taken before eating. Lansoprazole delayed-release capsules USP SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Controlled studies did not extend beyond indicated duration. † The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole Delayed-
Release Capsules USP 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole Delayed-
Release Capsules USP 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks* Risk Reduction 15 mg Once daily for up to 12 weeks* Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of
Erosive Esophagitis 30 mg Once daily for up to 8 weeks Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks† > 30 kg 30 mg Once daily for up to 12 weeks† (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison syndrome 60 mg Once dailyPatients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules USP - Oral Administration Lansoprazole delayed-release capsules USP should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules USP can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules USP may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately. Lansoprazole Delayed-Release Capsules USP - Nasogastric Tube (≥ 16 French) Administration For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules USP can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Wockhardt Usa Llc.
Lansoprazole | Wockhardt Usa Llc.
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Wockhardt Limited
Lansoprazole | Wockhardt Limited
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Wockhardt Usa Llc.
Lansoprazole | Wockhardt Usa Llc.
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for
4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to
Reduce the Risk of
Duodenal Ulcer
Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h)
for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h)
for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h)
for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily
(q8h) for 14 days
Amoxicillin
1 gram
Three times daily
(q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for
up to 8 weeks
NSAID-associated
Gastric Ulcer
Healing
30 mg
Once daily for
8 weeks†
Risk Reduction
15 mg
Once daily for
up to 12 weeks†
Gastroesophageal Reflux
Disease (GERD)
Short-Term Treatment of
Symptomatic GERD
15 mg
Once daily for
up to 8 weeks
Short-Term Treatment
of Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment
of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for
up to 12 weeks§
> 30 kg
30 mg
Once daily for
up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for
up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks
Maintenance of Healing
of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory
Conditions Including
Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Wockhardt Limited
Lansoprazole | Wockhardt Limited
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for
4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to
Reduce the Risk of
Duodenal Ulcer
Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h)
for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h)
for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h)
for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily
(q8h) for 14 days
Amoxicillin
1 gram
Three times daily
(q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for
up to 8 weeks
NSAID-associated
Gastric Ulcer
Healing
30 mg
Once daily for
8 weeks†
Risk Reduction
15 mg
Once daily for
up to 12 weeks†
Gastroesophageal Reflux
Disease (GERD)
Short-Term Treatment of
Symptomatic GERD
15 mg
Once daily for
up to 8 weeks
Short-Term Treatment
of Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment
of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for
up to 12 weeks§
> 30 kg
30 mg
Once daily for
up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for
up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks
Maintenance of Healing
of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory
Conditions Including
Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Lansoprazole | Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose Frequency * † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years. Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole delayed-release capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Bryant Ranch Prepack
Lansoprazole | Bryant Ranch Prepack
Lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets should be taken before eating. Lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules and lansoprazole delayed-release orally disintegrating tablets.
2.1 Recommended Dose Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years. Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks NSAID-associated Gastric Ulcer
Healing
Risk Reduction
30 mg
15 mg
Once daily for 8 weeks†
Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶ 2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
Lansoprazole Delayed-Release Orally Disintegrating Tablets
Lansoprazole delayed-release orally disintegrating tablets should not be broken or cut. Lansoprazole delayed-release orally disintegrating tablets should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. The tablet typically disintegrates in less than 1 minute. Alternatively, for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be delivered in two different ways.Lansoprazole Delayed-Release Orally Disintegrating Tablets – Oral Syringe
For administration via oral syringe, lansoprazole delayed-release orally disintegrating tablets can be administered as follows: Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, administer the contents within 15 minutes. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.Lansoprazole Delayed-Release Orally Disintegrating Tablets – Nasogastric Tube (≥ 8 French) Administration
For administration via a nasogastric tube, lansoprazole delayed-release orally disintegrating tablets can be administered as follows: Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes. Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube. -
Dr. Reddy’s Laboratories Limited
Lansoprazole | Dr. Reddy's Laboratories Limited
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a days swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Dr.reddy’s Laboratories Ltd.
Lansoprazole | Dr.reddy's Laboratories Ltd.
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose Frequency * † Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole delayed-release capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks†* Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks†§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily# Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶* Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
† Controlled studies did not extend beyond indicated duration.
‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.
§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.
# Controlled studies did not extend beyond 12 months
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Breckenridge Pharmaceutical, Inc.
Lansoprazole | Apotheca Company
10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
-
Actavis Inc
Lansoprazole | Actavis Inc
Lansoprazole is available as a capsule, in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose
*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.
§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger- Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
Maintenance of Healed
15 mg
15 mg
Once daily for 4 weeks
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole delayed-release capsules - Oral Administration
· Lansoprazole delayed-release capsules should be swallowed whole.
· Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:
o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
· Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole delayed-release capsules – Nasogastric Tube (≥16 French) Administration· For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:
o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Unit Dose Services
Lansoprazole | Unit Dose Services
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than 4 years. Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily Eradication to Reduce the Risk of Duodenal Ulcer Recurrence H. pylori* Triple Therapy: Lansoprazole Delayed-Release Capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole Delayed-Release Capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks † Risk Reduction 15 mg Once daily for up to 12 weeks † Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks ‡ Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks § > 30 kg 30 mg Once daily for up to 12 weeks § (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily ¶Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [ ]. see Use in Specific Populations ( , and ) 8.58.68.7
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. ® Swallow immediately. Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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Bryant Ranch Prepack
Lansoprazole | Bryant Ranch Prepack
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Rebel Distributors Corp
Lansoprazole | Rebel Distributors Corp
Lansoprazole delayed-release capsules USP are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules USP should be taken before eating. Lansoprazole delayed-release capsules USP SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules USP for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules USP may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than 4 years. Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole Delayed-Release Capsules USP 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole Delayed-Release Capsules USP 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison syndrome 60 mg Once daily¶Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules USP - Oral Administration
Lansoprazole delayed-release capsules USP should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules USP can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules USP may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules USP - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules USP can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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Rebel Distributors Corp
Lansoprazole | Rebel Distributors Corp
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose Frequency * † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years. Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole delayed-release capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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Remedyrepack Inc.
Lansoprazole | Remedyrepack Inc.
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole delayed-release capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks2 Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks4 (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
Administration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
1 2 Controlled studies did not extend beyond indicated duration. 3 For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. 4 The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see 5 Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years. -
Best Choice (Valu Merchandisers Company)
Lansoprazole | Best Choice (valu Merchandisers Company)
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Rugby Laboratories Inc
Lansoprazole | Rugby Laboratories Inc
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Simply Right (Sam’s West, Inc.)
Lansoprazole | Simply Right (sam's West, Inc.)
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Preferred Pharmaceuticals, Inc.
Lansoprazole | Preferred Pharmaceuticals, Inc.
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for
4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to
Reduce the Risk of
Duodenal Ulcer
Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h)
for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h)
for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h)
for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily
(q8h) for 14 days
Amoxicillin
1 gram
Three times daily
(q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for
up to 8 weeks
NSAID-associated
Gastric Ulcer
Healing
30 mg
Once daily for
8 weeks†
Risk Reduction
15 mg
Once daily for
up to 12 weeks†
Gastroesophageal Reflux
Disease (GERD)
Short-Term Treatment of
Symptomatic GERD
15 mg
Once daily for
up to 8 weeks
Short-Term Treatment
of Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment
of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for
up to 12 weeks§
> 30 kg
30 mg
Once daily for
up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for
up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks
Maintenance of Healing
of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory
Conditions Including
Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Preferred Pharmaceuticals, Inc.
Lansoprazole | Preferred Pharmaceuticals, Inc.
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than 4 years.Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole Delayed-Release Capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole Delayed-Release Capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Avkare, Inc.
Lansoprazole | Avkare, Inc.
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Controlled studies did not extend beyond 12 months. # Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than 4 years. Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole Delayed-Release Capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole Delayed-Release Capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily¶ Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily#Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Shopko Stores Operating Co., Llc
Lansoprazole | Shopko Stores Operating Co., Llc
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25°C (68-77°F) • keep product out of high heat and humidity • protect product from moisture -
Zydus Pharmaceuticals (Usa) Inc.
Lansoprazole | Zydus Pharmaceuticals (usa) Inc.
Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Direction for use specific to the route and available methods of administration of this dosage form is presented below. Lansoprazole should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
† Controlled studies did not extend beyond indicated duration.
‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
#Controlled studies did not extend beyond 12 months.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to
Reduce the Risk of
Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term
Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 year of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see USE IN SPECIFIC POPULATIONS (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Option
Lansoprazole Delayed-release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:о Open capsule.
о Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
о Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:о Open capsule.
о Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
о Mix briefly.
о Swallow immediately.
о To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole delayed-release capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:о Open capsule.
о Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
о Inject through the nasogastric tube into the stomach.
о Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Cadila Healthcare Limited
Lansoprazole | Cadila Healthcare Limited
Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Direction for use specific to the route and available methods of administration of this dosage form is presented below. Lansoprazole should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years. Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to
Reduce the Risk of
Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term
Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 year of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see USE IN SPECIFIC POPULATIONS (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Option
Lansoprazole Delayed-release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:о Open capsule.
о Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
о Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:о Open capsule.
о Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
о Mix briefly.
о Swallow immediately.
о To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole delayed-release capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:о Open capsule.
о Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
о Inject through the nasogastric tube into the stomach.
о Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Remedyrepack Inc.
Lansoprazole | Remedyrepack Inc.
Indication
Dose
Frequency
Duodenal Ulcers (1.1, 1.3) Short-Term Treatment
15 mg
Once daily for 4 wks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce Recurrence of Duodenal Ulcer (1.2) Triple Therapy: Lansoprazole
30 mg
Amoxicillin
1 gram
Twice daily for 10 or 14 days
Clarithromycin
500 mg
Dual Therapy: Lansoprazole
30 mg
Three times daily for 14 days
Amoxicillin
1 gram
Benign Gastric Ulcer (1.4) Short-Term Treatment
30 mg
Once daily up to 8 wks
NSAID-associated Gastric Ulcer (1.6) Healing
30 mg
Once daily for 8 wks
Risk Reduction
15 mg
Once daily up to 12 wks
GERD (1.7) Short-Term Treatment of Symptomatic GERD
15 mg
Once daily up to 8 wks
Short-Term Treatment of EE
30 mg
Once daily up to 8 wks
Pediatric (8.4) (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of EE
≤ 30 kg
15 mg
Once daily up to 12 wks
> 30 kg
30 mg
Once daily up to 12 wks
(12 to 17 years of age) Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily up to 8 wks
EE
30 mg
Once daily up to 8 wks
Maintenance of Healing of EE (1.8) 15 mg
Once daily
Pathological Hypersecretory Conditions (i.e., ZES) (1.9) 60 mg
Once daily
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for
4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to
Reduce the Risk of
Duodenal Ulcer
Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h)
for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h)
for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h)
for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily
(q8h) for 14 days
Amoxicillin
1 gram
Three times daily
(q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for
up to 8 weeks
NSAID-associated
Gastric Ulcer
Healing
30 mg
Once daily for
8 weeks†
Risk Reduction
15 mg
Once daily for
up to 12 weeks†
Gastroesophageal Reflux
Disease (GERD)
Short-Term Treatment of
Symptomatic GERD
15 mg
Once daily for
up to 8 weeks
Short-Term Treatment
of Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment
of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for
up to 12 weeks§
> 30 kg
30 mg
Once daily for
up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for
up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for
up to 8 weeks
Maintenance of Healing
of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory
Conditions Including
Zollinger-Ellison Syndrome
60 mg
Once daily¶
*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
Administration Options
Lansoprazole Delayed-Release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.
USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Sun Pharma Global Fze
Lansoprazole | Sun Pharma Global Fze
Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose
Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years. Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE* pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact pellets into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules -Oral AdministrationLansoprazole Delayed-Release Capsules -Nasogastric Tube (≥16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Premier Value (Chain Drug Consortium, Llc)
Lansoprazole | Premier Value (chain Drug Consortium, Llc)
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
P And L Development Of New York Corporation
Lansoprazole | P And L Development Of New York Corporation
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Western Family Foods, Inc.
Lansoprazole | Western Family Foods, Inc.
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Major Pharmaceuticals
Lansoprazole | Major Pharmaceuticals
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Freds Inc
Lansoprazole | Freds Inc
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Teva Pharmaceuticals Usa Inc
Lansoprazole | Aloe Vera Of America, Inc.
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Mylan Pharmaceuticals Inc.
Lansoprazole | Mylan Pharmaceuticals Inc.
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form are presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5% to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole delayed-release capsule dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Controlled studies did not extend beyond 12 months. # Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-Associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 Years of Age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 Years of Age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily¶
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily#
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take two doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration Information Administration Options Lansoprazole Delayed-release Capsules – Oral Administration • Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: o Open capsule. o Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. o Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: o Open capsule. o Sprinkle intact pellets into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). o Mix briefly. o Swallow immediately. o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately. Lansoprazole Delayed-release Capsules – Nasogastric Tube (≥ 16 French) Administration • For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: o Open capsule. o Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. o Inject through the nasogastric tube into the stomach. o Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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Cvs Pharmacy
Lansoprazole | American Health Packaging
Carbidopa and levodopa extended-release tablet contains carbidopa and levodopa in a 1:4 ratio as either the 50 mg/200 mg tablet or the 25 mg/100 mg tablet. The daily dosage of carbidopa and levodopa extended-release tablets must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of involuntary movements, dyskinesias or nausea. Carbidopa and levodopa extended-release tablets should not be chewed or crushed.
Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while carbidopa and levodopa extended-release tablet is being administered, although their dosage may have to be adjusted.
Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, carbidopa and levodopa extended-release tablets can be given to patients receiving supplemental pyridoxine (vitamin B6).
Initial DosagePatients currently treated with conventional carbidopa and levodopa preparations:
Table 2. Approximate Bioavailabilities at Steady State† Tablet Amount of Levodopa (mg)
Studies show that peripheral dopa-decarboxylase is saturated by the bioavailable carbidopa at doses of 70 mg a day and greater. Because the bioavailabilities of carbidopa and levodopa in carbidopa and levodopa tablets and carbidopa and levodopa extended-release tablets are different, appropriate adjustments should be made, as shown in Table 2.
in Each Tablet Approximate
Bioavailability Approximate
Amount of
Bioavailable
Levodopa (mg) in
Each Tablet † This table is only a guide to bioavailabilities since other factors such as food, drugs, and inter-patient variabilities may affect the bioavailability of carbidopa and levodopa.
†† The extent of availability of levodopa from carbidopa and levodopa extended-release tablets was about 70 to 75% relative to intravenous levodopa or standard carbidopa and levodopa tablets in the elderly.
††† The extent of availability of levodopa from carbidopa and levodopa tablets was 99% relative to intravenous levodopa in the healthy elderly.Carbidopa and levodopa extended-release tablets
50 mg/200 mg200
0.7 to 0.75
140 to 150
Carbidopa and levodopa tablets
25 mg/100 mg100
0.99
99
Table 3. Guidelines for Initial Conversion from Carbidopa and Levodopa Tablets to Carbidopa and Levodopa Extended-Release Tablets Carbidopa and levodopa
Dosage with carbidopa and levodopa extended-release tablets should be substituted at an amount that provides approximately 10% more levodopa per day, although this may need to be increased to a dosage that provides up to 30% more levodopa per day depending on clinical response (see DOSAGE AND ADMINISTRATION, Titration with carbidopa and levodopa extended-release tablets). The interval between doses of carbidopa and levodopa extended-release tablets should be 4 to 8 hours during the waking day. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.)
A guideline for initiation of carbidopa and levodopa extended-release tablets is shown in Table 3.
tablets Carbidopa and levodopa
extended-release tablets * For dosing ranges not shown in the table see DOSAGE AND ADMINISTRATION, Initial Dosage-Patients currently treated with conventional carbidopa and levodopa preparations.Total Daily Dose*
Suggested
Levodopa (mg)
Dosage Regimen
300 to 400
200 mg b.i.d.
500 to 600
300 mg b.i.d.
or 200 mg t.i.d.700 to 800
A total of 800 mg in 3 or more divided doses (e.g., 300 mg a.m., 300 mg early p.m., and 200 mg later p.m.)
900 to 1,000
A total of 1,000 mg in 3 or more divided doses (e.g., 400 mg a.m., 400 mg early p.m., and 200 mg later p.m.)
Patients currently treated with levodopa without a decarboxylase inhibitor: Levodopa must be discontinued at least twelve hours before therapy with carbidopa and levodopa extended-release tablets is started. Carbidopa and levodopa extended-release tablets should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage. In patients with mild to moderate disease, the initial dose is usually 1 tablet of carbidopa and levodopa extended-release tablets 50 mg/200 mg b.i.d.
Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of carbidopa and levodopa extended-release tablets 50 mg/200 mg b.i.d. Initial dosage should not be given at intervals of less than 6 hours.
Titration with Carbidopa and Levodopa Extended-Release TabletsFollowing initiation of therapy, doses and dosing intervals may be increased or decreased depending upon therapeutic response. Most patients have been adequately treated with doses of carbidopa and levodopa extended-release tablets that provide 400 to 1,600 mg of levodopa per day, administered as divided doses at intervals ranging from 4 to 8 hours during the waking day. Higher doses of carbidopa and levodopa extended-release tablets (2,400 mg or more of levodopa per day) and shorter intervals (less than 4 hours) have been used, but are not usually recommended.
When doses of carbidopa and levodopa extended-release tablets are given at intervals of less than 4 hours, and/or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day.
An interval of at least 3 days between dosage adjustments is recommended.
MaintenanceBecause Parkinson's disease is progressive, periodic clinical evaluations are recommended; adjustment of the dosage regimen of carbidopa and levodopa extended-release tablets may be required.
Addition of Other Antiparkinson MedicationsAnticholinergic agents, dopamine agonists, and amantadine can be given with carbidopa and levodopa extended-release tablets. Dosage adjustment of carbidopa and levodopa extended-release tablets may be necessary when these agents are added.
A dose of carbidopa and levodopa tablets 25 mg/100 mg or 10 mg/100 mg (one half or a whole tablet) can be added to the dosage regimen of carbidopa and levodopa extended-release tablets in selected patients with advanced disease who need additional immediate-release levodopa for a brief time during daytime hours.
Interruption of TherapySporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa and levodopa tablets or carbidopa and levodopa extended-release tablets.
Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa and levodopa extended-release tablets is required, especially if the patient is receiving neuroleptics. (See WARNINGS).
If general anesthesia is required, carbidopa and levodopa extended-release tablets may be continued as long as the patient is permitted to take oral medication. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual dosage should be administered as soon as the patient is able to take oral medication.
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Bluepoint Laboratoires
Lansoprazole | Bluepoint Laboratories
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1Recommended Dose Indication Recommended Dose FrequencyDuodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERDNonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily#
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
* Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
† Controlled studies did not extend beyond indicated duration.
‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.
§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.
# Controlled studies did not extend beyond 12 months
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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The Kroger Co.
Lansoprazole | The Kroger Co.
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Safeway, Inc.
Lansoprazole | Safeway, Inc.
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor. Patients should use the lowest dose and shortest duration of this therapy. children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Aidarex Pharmaceuticals Llc
Lansoprazole | Aidarex Pharmaceuticals Llc
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose Frequency * † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years. Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole delayed-release capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole delayed-release capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks† Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short -Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks§ > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE® pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
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Walgreen Co
Lansoprazole | Walgreen Co
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a days swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Wal-mart Stores Inc
Lansoprazole | Wal-mart Stores Inc
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a days swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
American Health Packaging
Lansoprazole | American Health Packaging
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose FrequencyDuodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks
Risk Reduction
15 mg
Once daily for up to 12 weeks
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg
15 mg
Once daily for up to 12 weeks
> 30 kg
30 mg
Once daily for up to 12 weeks
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERDNonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: 1. Open capsule. 2. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. 3. Inject through the nasogastric tube into the stomach. 4. Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Gericare Pharmaceuticals
Lansoprazole | Gericare Pharmaceuticals
adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a days swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. -
Sandoz Inc
Lansoprazole | Sandoz Inc
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole should be taken before eating. Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended DoseIndication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERDNonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily#
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.
§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.
# Controlled studies did not extend beyond 12 months
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see USE IN SPECIFIC POPULATIONS(8.5, 8.6, 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole delayed-release capsules-Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: o Open capsule. o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. o Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: o Open capsule. o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). o Mix briefly. o Swallow immediately. o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole delayed-release capsules- Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Sandoz Inc
Lansoprazole | Sandoz Inc
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceThe recommended adult oral dose is 30 mg lansoprazole, 1 g amoxicillin, and 500 mg clarithromycin administered together twice daily (morning and evening) for 10 or 14 days (see INDICATIONS AND USAGE.)
Lansoprazole Delayed-Release Capsules USP, 30 mg, Amoxicillin Capsules USP, 500 mg, and Clarithromycin Tablets USP, 500 mg is not recommended in patients with creatinine clearance less than 30 mL/min.
-
Hyvee Inc
Lansoprazole | Hyvee Inc
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other Information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Rite Aid Corporation
Lansoprazole | Rite Aid Corporation
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other Information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Meijer Distribution Inc
Lansoprazole | Meijer Distribution Inc
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Kroger Company
Lansoprazole | Kroger Company
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
H E B
Lansoprazole | H E B
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Western Family Foods Inc
Lansoprazole | Western Family Foods Inc
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Publix Super Markets Inc
Lansoprazole | Publix Super Markets Inc
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Perrigo New York Inc
Lansoprazole | Perrigo New York Inc
• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment
• swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctorRepeated 14-Day Courses (if needed)
• you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. Other information • read the directions, warnings and package insert before use • keep the carton and package insert. They contain important information. • store at 20-25˚C (68-77˚F) • keep product out of high heat and humidity • protect product from moisture -
Preferred Pharmaceuticals, Inc.
Lansoprazole | Preferred Pharmaceuticals, Inc.
Lansoprazole is available as a capsule, in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose *Please refer to amoxicillin and clarithromycin full prescribing information forCONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5–10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.
§The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years.
Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
Maintenance of Healed
15 mg
15 mg
Once daily for 4 weeks
Once dailyH. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERDNonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
2.2 Special Populations
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole delayed-release capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:o Open capsule.
o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
o Swallow immediately.
• Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:o Open capsule.
o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
o Mix briefly.
o Swallow immediately.
o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lanlansoprazole delayed-release capsules – Nasogastric Tube (≥16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:
o Open capsule.
o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
o Inject through the nasogastric tube into the stomach.
o Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Mylan Institutional Inc.
Lansoprazole | Mylan Institutional Inc.
Lansoprazole delayed-release capsules are available as capsules in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for 8 weeks (5% to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years.Indication
Recommended
Frequency
Dose
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole Delayed-release Capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole Delayed-release Capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose and should be instructed to take the next dose on time. Patients should be instructed not to take two doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7).]
2.3 Important Administration Information Administration OptionsLansoprazole Delayed-release Capsules -Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact pellets into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-release Capsules -Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Proficient Rx Lp
Lansoprazole | Proficient Rx Lp
Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.
2.1 Recommended Dose * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than 4 years.Indication
Recommended Dose
Frequency
Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole Delayed-Release Capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole Delayed-Release Capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short-Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
American Health Packaging
Lansoprazole | American Health Packaging
Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration is presented below. Lansoprazole delayed-release capsules should be taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole delayed-release capsules.
2.1 Recommended Dose Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered. § The lansoprazole delayed-release capsules dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole delayed-release capsules for more than 4 years. # Controlled studies did not extend beyond 12 monthsDuodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks
Maintenance of Healed
15 mg
Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release capsules
30 mg
Twice daily (q12h) for 10 or 14 days
Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days
Clarithromycin
500 mg
Twice daily (q12h) for 10 or 14 days
Dual Therapy:
Lansoprazole delayed-release capsules
30 mg
Three times daily (q8h) for 14 days
Amoxicillin
1 gram
Three times daily (q8h) for 14 days
Benign Gastric Ulcer
Short-Term Treatment
30 mg
Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
Healing
30 mg
Once daily for 8 weeks†
Risk Reduction
15 mg
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
15 mg
Once daily for up to 8 weeks
Short -Term Treatment of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks‡
Pediatric
(1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis≤ 30 kg
15 mg
Once daily for up to 12 weeks§
> 30 kg
30 mg
Once daily for up to 12 weeks§
(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERDNonerosive GERD
15 mg
Once daily for up to 8 weeks
Erosive Esophagitis
30 mg
Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily¶
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
60 mg
Once daily#
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
2.2 Special PopulationsRenal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment. [See Use in Specific Populations (8.5, 8.6 and 8.7)]
2.3 Important Administration InformationAdministration Options
Lansoprazole Delayed-Release Capsules - Oral Administration
• Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: o Open capsule. o Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. o Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: o Open capsule. o Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). o Mix briefly. o Swallow immediately. o To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.Lansoprazole Delayed-Release Capsules - Nasogastric Tube (≥ 16 French) Administration
• For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: o Open capsule. o Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. o Inject through the nasogastric tube into the stomach. o Flush with additional apple juice to clear the tube.USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
-
Preferred Pharmaceuticals Inc.
Lansoprazole | Oculus Innovative Sciences
There is currently no dosage information available for this product. We apologize for any inconvenience.
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