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Pantoprazole

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Overview

What is Pantoprazole?

The active ingredient in pantoprazole sodium delayed-release tablets USP, a PPI, 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 CHFNNaOS x 1.5 HO, 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, available in two strengths 20 mg pantoprazole (equivalent to 22.6 mg of pantoprazole sodium sesquihydrate) and 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium sesquihydrate). 

Pantoprazole sodium delayed-release tablets USP contains 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.

Pantoprazole sodium delayed-release tablets meets USP



What does Pantoprazole look like?



What are the available doses of Pantoprazole?

Delayed-Release Tablets:

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

How should I use Pantoprazole?

Pantoprazole sodium delayed-release tablets are indicated for:


What interacts with Pantoprazole?

Sorry No Records found


What are the warnings of Pantoprazole?

Sorry No Records found


What are the precautions of Pantoprazole?

Sorry No Records found


What are the side effects of Pantoprazole?

Sorry No records found


What should I look out for while using Pantoprazole?

• Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see ].

• Proton pump inhibitors (PPIs), including pantoprazole sodium delayed-release tablets, are contraindicated with rilpivirine-containing products [see ]. 


What might happen if I take too much Pantoprazole?

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

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

Single oral doses of pantoprazole 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.

If overexposure to pantoprazole sodium occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.


How should I store and handle Pantoprazole?

Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [].How SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 StorageHow SuppliedBottles of 30                                                               NDC 55111-332-30Bottles of 90                                                               NDC 55111-332-90Bottles of 100                                                              NDC 55111-332-01Bottles of 500                                                              NDC 55111-332-05Bottles of 1000                                                           NDC 55111-332-10Unit dose package of 30 (3 x 10)                               NDC 55111-332-81Unit dose package of 100 (10 x 10)                           NDC 55111-332-78   Pantoprazole sodium delayed-release tablets USP 40 mg are yellow, round, biconvex coated tablets printed with “R333” on one side with black ink and plain on the other side. They are supplied in bottles of 30’s, 90’s, 100’s, 500’s, 1000’s, unit dose package of 30 (3 x 10) and unit dosage package of 100 (10 x 10). Bottles of 30                                                               NDC 55111-333-30Bottles of 90                                                               NDC 55111-333-90Bottles of 100                                                              NDC 55111-333-01Bottles of 500                                                             NDC 55111-333-05Bottles of 1000                                                           NDC 55111-333-10Unit dose package of 30 (3 x 10)                               NDC 55111-333-81Unit dose package of 100 (10 x 10)                           NDC 55111-333-78 Storage


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Pantoprazole is a 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. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [see ].

• Proton pump inhibitors (PPIs), including pantoprazole sodium delayed-release tablets, are contraindicated with rilpivirine-containing products [see ]. 

Drugs Metabolized by P450 2D6

The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so-called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA).

In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 206 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interaction may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6,

The plasma concentration of imipramine may increase when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decrease by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), and adjustment of the dosage of imipramine may therefore be necessary.

In occasional susceptible patients or in those receiving anticholinergic drugs (including antiparkinsonism agents) in addition, the atropine-like effects may become more pronounced (e.g., paralytic ileus). Close supervision and careful adjustment of dosage is required when Imipramine Hydrochloride is administered concomitantly with anticholinergic drugs.

Avoid the use of preparations, such as decongestants and local anesthetics, that contain any sympathomimetic amine (e.g., epinephrine, norepinephrine), since it has been reported that tricyclic antidepressants can potentiate the effects of catecholamines.

Caution should be exercised when Imipramine Hydrochloride is used with agents that lower blood pressure. Imipramine Hydrochloride may potentiate the effects of CNS depressant drugs. Patients should be warned that Imipramine Hydrochloride may enhance the CNS depressant effects of alcohol ).

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Interstitial Nephritis [see Warnings and Precautions

• Clostridium difficile-Associated Diarrhea [see Warnings and Precautions

• Bone Fracture [see Warnings and Precautions ]

• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ]

• Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ]

• Hypomagnesemia [see Warnings and Precautions ]

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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

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).