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PANTOPRAZOLE SODIUM

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Overview

What is PANTOPRAZOLE SODIUM?

The active ingredient in pantoprazole sodium delayed-release tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is CHFNNaOS x 1.5 HO, 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.



What does PANTOPRAZOLE SODIUM look like?



What are the available doses of PANTOPRAZOLE SODIUM?

Delayed-Release Tablets, 20 mg and 40 mg ()

What should I talk to my health care provider before I take PANTOPRAZOLE SODIUM?

How should I use PANTOPRAZOLE SODIUM?

Pantoprazole sodium delayed-release tablets are indicated for:

Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.


What interacts with PANTOPRAZOLE SODIUM?

Sorry No Records found


What are the warnings of PANTOPRAZOLE SODIUM?

Sorry No Records found


What are the precautions of PANTOPRAZOLE SODIUM?

Sorry No Records found


What are the side effects of PANTOPRAZOLE SODIUM?

Sorry No records found


What should I look out for while using PANTOPRAZOLE SODIUM?

Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation [ ] or any substituted benzimidazole.


What might happen if I take too much PANTOPRAZOLE SODIUM?

Experience in patients taking very high doses of pantoprazole sodium (> 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of pantoprazole sodium.

Pantoprazole sodium is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.

Single oral doses of pantoprazole sodium at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.


How should I store and handle PANTOPRAZOLE SODIUM?

StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mgPink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other.Bottles of 100                                  NDC 63481-627-705 mg/325 mgBlue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.Bottles of 100    NDC 63481-623-70Bottles of 500    NDC 63481-623-85Unit dose package of 100 tablets      NDC 63481-623-757.5 mg/325 mgPeach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.Bottles of 100                                  NDC 63481-628-707.5 mg/500 mgPeach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.Bottles of 100                                  NDC 63481-621-7010 mg/325 mgYellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.Bottles of 100                                  NDC 63481-629-7010 mg/650 mgYellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other.Bottles of 100                                  NDC 63481-622-70PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mgPink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other.Bottles of 100                                  NDC 63481-627-705 mg/325 mgBlue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.Bottles of 100    NDC 63481-623-70Bottles of 500    NDC 63481-623-85Unit dose package of 100 tablets      NDC 63481-623-757.5 mg/325 mgPeach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.Bottles of 100                                  NDC 63481-628-707.5 mg/500 mgPeach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.Bottles of 100                                  NDC 63481-621-7010 mg/325 mgYellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.Bottles of 100                                  NDC 63481-629-7010 mg/650 mgYellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other.Bottles of 100                                  NDC 63481-622-70PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mgPink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other.Bottles of 100                                  NDC 63481-627-705 mg/325 mgBlue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.Bottles of 100    NDC 63481-623-70Bottles of 500    NDC 63481-623-85Unit dose package of 100 tablets      NDC 63481-623-757.5 mg/325 mgPeach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.Bottles of 100                                  NDC 63481-628-707.5 mg/500 mgPeach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.Bottles of 100                                  NDC 63481-621-7010 mg/325 mgYellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.Bottles of 100                                  NDC 63481-629-7010 mg/650 mgYellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other.Bottles of 100                                  NDC 63481-622-70PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mgPink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other.Bottles of 100                                  NDC 63481-627-705 mg/325 mgBlue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.Bottles of 100    NDC 63481-623-70Bottles of 500    NDC 63481-623-85Unit dose package of 100 tablets      NDC 63481-623-757.5 mg/325 mgPeach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.Bottles of 100                                  NDC 63481-628-707.5 mg/500 mgPeach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.Bottles of 100                                  NDC 63481-621-7010 mg/325 mgYellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.Bottles of 100                                  NDC 63481-629-7010 mg/650 mgYellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other.Bottles of 100                                  NDC 63481-622-70PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mgPink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other.Bottles of 100                                  NDC 63481-627-705 mg/325 mgBlue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.Bottles of 100    NDC 63481-623-70Bottles of 500    NDC 63481-623-85Unit dose package of 100 tablets      NDC 63481-623-757.5 mg/325 mgPeach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.Bottles of 100                                  NDC 63481-628-707.5 mg/500 mgPeach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.Bottles of 100                                  NDC 63481-621-7010 mg/325 mgYellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.Bottles of 100                                  NDC 63481-629-7010 mg/650 mgYellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other.Bottles of 100                                  NDC 63481-622-70PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mgPink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other.Bottles of 100                                  NDC 63481-627-705 mg/325 mgBlue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.Bottles of 100    NDC 63481-623-70Bottles of 500    NDC 63481-623-85Unit dose package of 100 tablets      NDC 63481-623-757.5 mg/325 mgPeach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.Bottles of 100                                  NDC 63481-628-707.5 mg/500 mgPeach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.Bottles of 100                                  NDC 63481-621-7010 mg/325 mgYellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.Bottles of 100                                  NDC 63481-629-7010 mg/650 mgYellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other.Bottles of 100                                  NDC 63481-622-70PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mgPink, oval, tablet debossed with “PERCOCET” on one side and “2.5” on the other.Bottles of 100                                  NDC 63481-627-705 mg/325 mgBlue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other.Bottles of 100    NDC 63481-623-70Bottles of 500    NDC 63481-623-85Unit dose package of 100 tablets      NDC 63481-623-757.5 mg/325 mgPeach, oval-shaped, tablet debossed with “PERCOCET” on one side and “7.5/325” on the other.Bottles of 100                                  NDC 63481-628-707.5 mg/500 mgPeach, capsule-shaped, tablet debossed with “PERCOCET” on one side and “7.5” on the other.Bottles of 100                                  NDC 63481-621-7010 mg/325 mgYellow, capsule-shaped, tablet debossed with “PERCOCET” on one side and “10/325” on the other.Bottles of 100                                  NDC 63481-629-7010 mg/650 mgYellow, oval, tablet debossed with “PERCOCET” on one side and “10” on the other.Bottles of 100                                  NDC 63481-622-70


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Pantoprazole sodium is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H, K)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H, K)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

Non-Clinical Toxicology
Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation [ ] or any substituted benzimidazole.

Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.

Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.

Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.

Charcoal (activated): Reduces acetaminophen absorption when administered as soon as possible after overdose.

Beta Blockers (Propanolol): Propanolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen Therefore, the pharmacologic effects of acetaminophen may be increased.

Loop diuretics: The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.

Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.

Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.

Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.

Symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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