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Darifenacin Hydrobromide

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Overview

What is Darifenacin Hydrobromide?

Darifenacin Hydrobromide Extended-Release Tablets are 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 C H N O ·HBr.

The structural formula is:

Darifenacin hydrobromide is a white to almost white, crystalline powder, with a molecular weight of 507.5.

Darifenacin hydrobromide extended-release tablets are a once-a-day extended-release tablet and contain the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. The 7.5 mg tablet also contains D&C yellow No. 10 aluminum lake and FD&C yellow No. 6/sunset yellow FCF aluminum lake.



What does Darifenacin Hydrobromide look like?



What are the available doses of Darifenacin Hydrobromide?

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

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

How should I use Darifenacin Hydrobromide?

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

The recommended starting dose of Darifenacin Hydrobromide Extended-Release Tablets is 7.5 mg (base) once daily. Based upon individual response, the dose may be increased to 15 mg (base) once daily, as early as two weeks after starting therapy.

Darifenacin hydrobromide extended-release tablets should be taken once daily with water. Darifenacin hydrobromide 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 coadministered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazodone), the daily dose of darifenacin hydrobromide extended-release tablets should not exceed 7.5 mg (base). Darifenacin hydrobromide extended-release tablets are not recommended for use in patients with severe hepatic impairment (Child-Pugh C) .


What interacts with Darifenacin Hydrobromide?

Sorry No Records found


What are the warnings of Darifenacin Hydrobromide?

Sorry No Records found


What are the precautions of Darifenacin Hydrobromide?

Sorry No Records found


What are the side effects of Darifenacin Hydrobromide?

Sorry No records found


What should I look out for while using Darifenacin Hydrobromide?

Darifenacin hydrobromide extended-release tablets are contraindicated in patients with, or at risk for, the following conditions:


What might happen if I take too much Darifenacin Hydrobromide?

Overdosage with antimuscarinic agents, including darifenacin hydrobromide extended-release tablets, can result in severe antimuscarinic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended. Darifenacin hydrobromide extended-release tablets have 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 Hydrobromide?

Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side.Bottle of 90…NDC 42291-206-90Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side.Bottle of 90…NDC 42291-207-90StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Keep this and all drugs out of the reach of children.Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side.Bottle of 90…NDC 42291-206-90Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side.Bottle of 90…NDC 42291-207-90StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Keep this and all drugs out of the reach of children.Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side.Bottle of 90…NDC 42291-206-90Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side.Bottle of 90…NDC 42291-207-90StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Keep this and all drugs out of the reach of children.Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side.Bottle of 90…NDC 42291-206-90Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side.Bottle of 90…NDC 42291-207-90StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Keep this and all drugs out of the reach of children.Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side.Bottle of 90…NDC 42291-206-90Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side.Bottle of 90…NDC 42291-207-90StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Keep this and all drugs out of the reach of children.Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side.Bottle of 90…NDC 42291-206-90Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side.Bottle of 90…NDC 42291-207-90StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.Keep this and all drugs out of the reach of children.Darifenacin Hydrobromide Extended-Release Tablets, 7.5 mg (base) are yellow round shaped film-coated tablets engraved with “C170” on one side and plain on the other side.Bottle of 90…NDC 42291-206-90Darifenacin Hydrobromide Extended-Release Tablets 15 mg (base) are white to off-white round shaped film-coated tablets engraved with “C171” on one side and plain on the other side.Bottle of 90…NDC 42291-207-90StorageStore at 20° to 25°C (68° to 77°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 hydrobromide extended-release tablets are contraindicated in patients with, or at risk for, the following conditions:

The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

Darifenacin hydrobromide extended-release tablets 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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