Darifenacin is the generic equivalent of the brand-name drug Darifenacin. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Darifenacin through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS & USAGE Darifenacin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Darifenacin extended-release tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most frequently reported adverse reactions (greater than 3%) for darifenacin are: constipation, dry mouth, headache, dyspepsia, nausea, urinary tract infection, accidental injury, and flu symptoms ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse react…
Drug Interactions
7 DRUG INTERACTIONS • Caution should be taken when darifenacin is used concomitantly with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine and tricyclic antidepressants ( 7.2 ) • The concomitant use of darifenacin with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects. Anticholinergic agents may pot…
Dosage & Administration
2 DOSAGE & ADMINISTRATION The recommended starting dose of darifenacin is 7.5 mg orally 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 should be taken orally once daily with water. Darifenacin 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…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). Patients should be informed that anticholinergic agents, such as darifenacin, may produce clinically significant adverse effects related to anticholinergic pharmacological activity including constipation, urinary retention and blurred vision. Heat prostration (due to decreased sweating) can occur when anticholinergics such as darifenacin are used in a hot environment. Because anticholinergics, such as darifenacin, may produce dizziness or blurred vision, patients should be advised to exercise caution in…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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