Pantoprazole Sodium Dr
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Questions & Answers
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
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FDA Labeling Changes
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Uses
Pantoprazole sodium delayed-release tablets, USP are indicated for:
Pediatric indication and usage information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.'s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Pediatric indication and usage information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.'s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Maintenance of Healing of Erosive Esophagitis 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.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 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, USP 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 x 1.5 H2O, with a molecular weight of 432.4. The structural formula is: 
Pantoprazole sodium sesquihydrate, USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water and practically insoluble in 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 for oral administration, available in 2 strengths (40 mg and 20 mg).
Each delayed-release tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: aerosil 200, calcium stearate, colloidal silicon dioxide, mannitol, pregelatinized starch, shellac glaze, sodium carbonate anhydrous, sodium starch glycolate and talc. Each delayed-release tablet contains ammonium hydroxide, eudragit L 100-55, FD and C Blue #2, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, propylene glycol, sodium hydroxide, titanium dioxide and triethyl citrate as the coating ingredients.
Pantoprazole sodium delayed-release tablets USP, 20 mg and 40 mg, meet USP Dissolution Test 3.
Sources
Pantoprazole Sodium Dr Manufacturers
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Lake Erie Medical Dba Quality Care Products Llc
![Pantoprazole Sodium Dr (Pantoprazole Sodium) Tablet, Delayed Release [Lake Erie Medical Dba Quality Care Products Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pantoprazole Sodium Dr | 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 delayed-release tablets 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* Maintenance of Healing of Erosive Esophagitis
Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults 40 mg Twice daily** Pediatric dosing information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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, USP
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. 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 delayed-release tablets 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* Maintenance of Healing of Erosive Esophagitis
Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults 40 mg Twice daily** Pediatric dosing information in pediatric patients ages five years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 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, USP
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. -
Northwind Pharmaceuticals, Llc
Pantoprazole Sodium Dr | Northwind Pharmaceuticals, Llc
Pantoprazole 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
*For adult patients who have not healed after 8 weeks of treatment, an additional 8 week course of pantoprazole sodium delayed-release tablets 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.Indication Dose Frequency
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 wks
≥ 40 kg 40 mg
Maintenance of Healing of Erosive EsophagitisAdults 40 mg Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Adults 40 mg Twice daily†Administration Instructions
Directions for method of administration are presented in Table 2.
Table 2: Administration Instructions*Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.
Formulation Route Instructions*
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.
![Pantoprazole Sodium Dr (Pantoprazole Sodium) Tablet, Delayed Release [Northwind Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=25a1efd6-b6e1-4367-8f74-0f4b8087ae99&name=PantoprazoleSodiumDR40MG51655-501.jpg)
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