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darifenacin

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Overview

What is darifenacin?

Darifenacin  is an extended-release tablet for oral administration which contains 7.5 mg or 15 mg darifenacin as its hydrobromide salt. The active moiety, darifenacin, is a potent muscarinic receptor antagonist.

Chemically, darifenacin hydrobromide is -2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide hydrobromide. The empirical formula of darifenacin hydrobromide is CHNO•HBr.

The structural formula is:

Darifenacin hydrobromide is a white to almost white, crystalline powder, with a molecular weight of 507.5. Freely solouble in dimethylsulfoxide, soluble in methanol.

Darifenacin is a once-a-day extended-release tablet and contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, polyethylene glycol, talc, titanium dioxide. The 15 mg tablet also contains ferric oxide red and ferric oxide yellow. 



What does darifenacin look like?



What are the available doses of darifenacin?

Extended-release tablets 7.5 mg and 15 mg. ()

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

How should I use darifenacin?

Darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

The recommended starting dose of darifenacin extended-release tablets is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy.

Darifenacin extended-release tablets should be taken once daily with water. Darifenacin extended-release tablets may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.

For patients with moderate hepatic impairment (Child-Pugh B) or when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of darifenacin extended-release tablets should not exceed 7.5 mg. Darifenacin extended-release tablets are not recommended for use in patients with severe hepatic impairment (Child-Pugh C) .


What interacts with darifenacin?

Sorry No Records found


What are the warnings of darifenacin?

Sorry No Records found


What are the precautions of darifenacin?

Sorry No Records found


What are the side effects of darifenacin?

Sorry No records found


What should I look out for while using darifenacin?

Darifenacin is contraindicated in patients with, or at risk for, the following conditions:


What might happen if I take too much darifenacin?

Overdosage with antimuscarinic agents, including darifenacin, can result in severe antimuscarinic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended. Darifenacin has been administered in clinical trials at doses up to 75 mg (five times the maximum therapeutic dose) and signs of overdose were limited to abnormal vision.


How should I store and handle darifenacin?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.Darifenacin extended-release tablets 7.5 mg are white to off-white colored, round, biconvex film-coated tablets, with ‘516’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-516-30 Bottle of 90 (child-resistant)               NDC 59746-516-90 Bottle of 100 (child-resistant)             NDC 59746-516-01  Bottle of 1000 (non child-resistant)    NDC 59746-516-10 Darifenacin extended-release tablets 15 mg are peach to pinkish colored, round, biconvex film-coated tablets, with ‘517’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-517-30 Bottle of 90 (child-resistant)               NDC 59746-517-90 Bottle of 100 (child-resistant)             NDC 59746-517-01  Bottle of 1000 (non child-resistant)    NDC 59746-517-10StorageStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from light.  Keep this and all drugs out of the reach of children.Darifenacin extended-release tablets 7.5 mg are white to off-white colored, round, biconvex film-coated tablets, with ‘516’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-516-30 Bottle of 90 (child-resistant)               NDC 59746-516-90 Bottle of 100 (child-resistant)             NDC 59746-516-01  Bottle of 1000 (non child-resistant)    NDC 59746-516-10 Darifenacin extended-release tablets 15 mg are peach to pinkish colored, round, biconvex film-coated tablets, with ‘517’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-517-30 Bottle of 90 (child-resistant)               NDC 59746-517-90 Bottle of 100 (child-resistant)             NDC 59746-517-01  Bottle of 1000 (non child-resistant)    NDC 59746-517-10StorageStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from light.  Keep this and all drugs out of the reach of children.Darifenacin extended-release tablets 7.5 mg are white to off-white colored, round, biconvex film-coated tablets, with ‘516’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-516-30 Bottle of 90 (child-resistant)               NDC 59746-516-90 Bottle of 100 (child-resistant)             NDC 59746-516-01  Bottle of 1000 (non child-resistant)    NDC 59746-516-10 Darifenacin extended-release tablets 15 mg are peach to pinkish colored, round, biconvex film-coated tablets, with ‘517’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-517-30 Bottle of 90 (child-resistant)               NDC 59746-517-90 Bottle of 100 (child-resistant)             NDC 59746-517-01  Bottle of 1000 (non child-resistant)    NDC 59746-517-10StorageStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from light.  Keep this and all drugs out of the reach of children.Darifenacin extended-release tablets 7.5 mg are white to off-white colored, round, biconvex film-coated tablets, with ‘516’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-516-30 Bottle of 90 (child-resistant)               NDC 59746-516-90 Bottle of 100 (child-resistant)             NDC 59746-516-01  Bottle of 1000 (non child-resistant)    NDC 59746-516-10 Darifenacin extended-release tablets 15 mg are peach to pinkish colored, round, biconvex film-coated tablets, with ‘517’ on one side and ‘C’ debossed on the other side. Bottle of 30 (child-resistant)               NDC 59746-517-30 Bottle of 90 (child-resistant)               NDC 59746-517-90 Bottle of 100 (child-resistant)             NDC 59746-517-01  Bottle of 1000 (non child-resistant)    NDC 59746-517-10StorageStore at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].Protect from light.  Keep this and all drugs out of the reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Darifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of the urinary bladder smooth muscle and stimulation of salivary secretion.

In vitro

Non-Clinical Toxicology
Darifenacin is contraindicated in patients with, or at risk for, the following conditions:

See. Misoprostol Tablets has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol Tablets does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprostol Tablets has no clinically significant effect on the kinetics of diclofenac or ibuprofen.

Darifenacin should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

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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

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