Pantoprazole
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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:
Pantoprazole sodium delayed-release tablets USP 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 delayed-release tablets USP may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Pantoprazole sodium delayed-release tablets USP 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 USP 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 is a white to cream color powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water and ethanol.
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 USP is supplied as a delayed-release tablet for oral administration, available in 2 strengths. Each delayed-release tablet contains 45.1 mg or 22.6 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: ammonium hydroxide, calcium stearate, crospovidone, hydroxypropyl cellulose, hypromellose, iron oxide black, isopropyl alcohol, mannitol, methacrylic acid copolymer, methylated spirit, N-butyl alcohol, polyethylene glycol, propylene glycol, shellac, sodium carbonate anhydrous, synthetic yellow iron oxide, talc, titanium dioxide, triethyl citrate, zein.
USP dissolution test is pending.
Sources
Pantoprazole Manufacturers
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State Of Florida Doh Central Pharmacy
![Pantoprazole Tablet, Delayed Release [State Of Florida Doh Central Pharmacy]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pantoprazole | State Of Florida Doh Central Pharmacy
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 USP
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 Esophagitis Adults 40 mg Once Daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice Daily*** For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets USP 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.
2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions
Formulation Route Instructions* Delayed-Release Tablets Oral Swallowed whole, with or without food* Patients should be cautioned that pantoprazole sodium delayed-release tablets USP should not be split, chewed, or crushed.
Pantoprazole Sodium Delayed-Release Tablets USP
Pantoprazole sodium delayed-release tablets USP 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 USP.
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Legacy Pharmaceutical Packaging
Pantoprazole | Legacy Pharmaceutical Packaging
Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1) Adults 40 mg Once Daily for up to 8 wks Maintenance of Healing of Erosive Esophagitis (2.1) Adults 40 mg Once Daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1) Adults 40 mg Twice DailySee Full Prescribing Information for administration instructions
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 USP
Indication Dose Frequency 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*** For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets USP 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.
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* Delayed-Release Tablets Oral Swallowed whole, with or without food* Patients should be cautioned that pantoprazole sodium delayed-release tablets USP should not be split, chewed, or crushed.
Pantoprazole Sodium Delayed-Release Tablets USP
Pantoprazole sodium delayed-release tablets USP 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 USP.
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Major Pharmaceuticals
Pantoprazole | Major Pharmaceuticals
Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1) Adults 40 mg Once Daily for up to 8 wks Maintenance of Healing of Erosive Esophagitis (2.1) Adults 40 mg Once Daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1) Adults 40 mg Twice DailySee Full Prescribing Information for administration instructions
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 USP
Indication Dose Frequency 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*** For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets USP 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.
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* Delayed-Release Tablets Oral Swallowed whole, with or without food* Patients should be cautioned that pantoprazole sodium delayed-release tablets USP should not be split, chewed, or crushed.
Pantoprazole Sodium Delayed-Release Tablets USP
Pantoprazole sodium delayed-release tablets USP 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 USP.
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Dr.reddy’s Laboratories Limited
Pantoprazole | Dr.reddy's Laboratories Limited
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 USP
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 Esophagitis Adults 40 mg Once Daily*** Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice Daily*** For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets USP 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.
*** Controlled studies did not extend beyond 12 months
2.2 Administration InstructionsDirections for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions
Formulation Route Instructions* Delayed-Release Tablets Oral Swallowed whole, with or without food* Patients should be cautioned that pantoprazole sodium delayed-release tablets USP should not be split, chewed, or crushed.
Pantoprazole Sodium Delayed-Release Tablets USP
Pantoprazole sodium delayed-release tablets USP 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 USP.
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Cardinal Health
Pantoprazole | Cardinal Health
Indication
Dose
Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD (2.1)
Adults
40 mg
Once Daily for up to 8 wks
Maintenance of Healing of Erosive Esophagitis (2.1)
Adults
40 mg
Once Daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (2.1)
Adults
40 mg
Twice Daily
See Full Prescribing Information for administration instructions
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 USP
Indication
Dose
Frequency
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**
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets USP 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.
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*
Delayed-Release Tablets
Oral
Swallowed whole, with or without food
* Patients should be cautioned that pantoprazole sodium delayed-release tablets USP should not be split, chewed, or crushed.
Pantoprazole Sodium Delayed-Release Tablets USP
Pantoprazole sodium delayed-release tablets USP 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 USP.
![Pantoprazole Tablet, Delayed Release [Legacy Pharmaceutical Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eafede1e-b664-464d-90a8-08dd7fb178cb&name=pantoprazole-sodium-delayed-release-tablets-usp-ec-2.jpg)
![Pantoprazole Tablet, Delayed Release [Major Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4c8a0544-5e03-47e3-9236-c9646a841e9b&name=pantoprazole-sodium-delayed-release-tablets-usp-2.jpg)
![Pantoprazole Tablet, Delayed Release [Dr.reddy’s Laboratories Limited]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Pantoprazole Tablet, Delayed Release [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=83c20b13-f3ee-4724-8c8b-18a42460680f&name=image-02.jpg)
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