Pantoprazole Sodium Delayed-release
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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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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Pantoprazole Sodium Delayed-Release Tablets are indicated for:
Pantoprazole Sodium Delayed-Release Tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Pantoprazole Sodium Delayed-Release Tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
Pantoprazole Sodium Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in Pantoprazole Sodium Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S × 1.5 H2O, with a molecular weight of 432.4. The structural formula is:
Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole sodium has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.
The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.
Pantoprazole sodium is supplied as a delayed-release tablet, available in two strengths (20 mg and 40 mg).
Each Pantoprazole Sodium Delayed-Release Tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole sodium, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. Pantoprazole Sodium Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.
Sources
Pantoprazole Sodium Delayed-release Manufacturers
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Lake Erie Medical Dba Quality Care Products Llc
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Lake Erie Medical Dba Quality Care Products Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pantoprazole Sodium Delayed-release | Lake Erie Medical Dba Quality Care Products Llc
2.1 Recommended Dosing SchedulePantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. † Controlled studies did not extend beyond 12 months. ‡ Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily† Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily‡ 2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed. Delayed-Release Tablets Oral Swallowed whole, with or without foodPantoprazole Sodium Delayed-Release Tablets
Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
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Contract Pharmacy Services-pa
Pantoprazole Sodium Delayed-release | Contract Pharmacy Services-pa
Treatment of Erosive EsophagitisThe recommended adult oral dose is 40 mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered (see INDICATIONS AND USAGE).
Maintenance of Healing of Erosive EsophagitisThe recommended adult oral dose is one pantoprazole sodium 40 mg delayed-release tablet, taken daily (see CLINICAL PHARMACOLOGY, Clinical Studies).
Pathological Hypersecretory Conditions Including Zollinger-Ellison SyndromeThe dosage of pantoprazole sodium in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult starting dose is 40 mg twice daily. Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Some patients have been treated continuously with pantoprazole sodium for more than 2 years.
No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis.
Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium.
Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed or crushed.
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Cardinal Health
Pantoprazole Sodium Delayed-release | Cardinal Health
Treatment of Erosive EsophagitisThe recommended adult oral dose is 40 mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered (see INDICATIONS AND USAGE).
Maintenance of Healing of Erosive EsophagitisThe recommended adult oral dose is one pantoprazole sodium 40 mg delayed-release tablet, taken daily (see CLINICAL PHARMACOLOGY, Clinical Studies).
Pathological Hypersecretory Conditions Including Zollinger-Ellison SyndromeThe dosage of pantoprazole sodium in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult starting dose is 40 mg twice daily. Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Some patients have been treated continuously with pantoprazole sodium for more than 2 years.
No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis.
Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium.
Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed or crushed.
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Preferred Pharmaceuticals, Inc.
Pantoprazole Sodium Delayed-release | Pharmacosmetic-diafarm
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
Pantoprazole Sodium Delayed-release | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.
2.1 Recommended Dosing SchedulePantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. † Controlled studies did not extend beyond 12 months. ‡ Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily† Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily‡ 2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed. Delayed-Release Tablets Oral Swallowed whole, with or without foodPantoprazole Sodium Delayed-Release Tablets
Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
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Cardinal Health
Pantoprazole Sodium Delayed-release | Cardinal Health
2.1 Recommended Dosing SchedulePantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. † Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily†
2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed.Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole Sodium Delayed-Release Tablets
Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
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Aphena Pharma Solutions – Tennessee, Llc
Pantoprazole Sodium Delayed-release | Aphena Pharma Solutions - Tennessee, Llc
2.1 Recommended Dosing SchedulePantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. † Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered. Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older) ≥ 15 kg to < 40 kg 20 mg Once daily for up to 8 weeks ≥ 40 kg 40 mg Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily† 2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed. Delayed-Release Tablets Oral Swallowed whole, with or without foodPantoprazole Sodium Delayed-Release Tablets
Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
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Proficient Rx
Pantoprazole Sodium Delayed-release | Proficient Rx
2.1 Recommended Dosing SchedulePantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. † Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40 mg
Once daily for up to 8 weeks*
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once daily for up to 8 weeks
≥ 40 kg
40 mg
Maintenance of Healing of Erosive Esophagitis
Adults
40 mg
Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults
40 mg
Twice daily†
2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be split, chewed, or crushed.Delayed-Release Tablets
Oral
Swallowed whole, with or without food
Pantoprazole Sodium Delayed-Release Tablets
Pantoprazole Sodium Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole Sodium Delayed-Release Tablets.
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Contract Pharmacy Services-pa]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7c958802-daad-4c7e-88eb-73be7d2261d8&name=7c958802-daad-4c7e-88eb-73be7d2261d8-03.jpg)
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=903a60c9-d464-4665-8575-553218f97186&name=903a60c9-d464-4665-8575-553218f97186-03.jpg)
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=54b3476b-23fc-4323-b6ef-04362e6dff23&name=46fa8d8e-7a0c-4498-8a95-22823f452f82-01.jpg)
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=742ca9f4-9fba-44d4-29a8-1fe3a04f1af6&name=pantoprazole-02.jpg)
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=15a606c5-e396-4b1f-aec6-0b92080b7e2b&name=15a606c5-e396-4b1f-aec6-0b92080b7e2b-02.jpg)
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Aphena Pharma Solutions – Tennessee, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=03974abc-ad03-44da-b7b6-d8e6c4a06105&name=43353-338.jpg)
![Pantoprazole Sodium Delayed-release (Pantoprazole Sodium) Tablet, Delayed Release [Proficient Rx]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=940c4ba6-80f4-4c9c-831d-1d166ef9a3fe&name=PantoprazoleSod20mg.jpg)
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