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darifenacin

Manufacturer:

Aspen Pharmacare Asia

Distributor:

Primal
Concise Prescribing Info
Contents
Darifenacin (as HBr)
Indications/Uses
Symptomatic treatment of urge incontinence &/or increased urinary frequency & urgency in patients w/ overactive bladder syndrome.
Dosage/Direction for Use
Adult ≥18 yr & elderly ≥65 yr Initially 7.5 mg daily, may be increased to 15 mg daily after 2 wk of starting therapy, based on individual response.
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contraindications
Hypersensitivity. Urinary retention. Gastric retention. Uncontrolled narrow-angle glaucoma. Myasthenia gravis. Severe ulcerative colitis. Toxic megacolon. Concomitant treatment w/ potent CYP3A4 inhibitors. Severe hepatic impairment (Child Pugh C).
Special Precautions
Caution in patients w/ autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or GI obstructive disorders eg, pyloric stenosis; patients being treated for narrow-angle glaucoma; patients w/ risk of decreased GI motility, gastro-oesophageal reflux &/or who are concurrently taking medicinal products (eg, oral bisphosphonates) that can cause or exacerbate oesophagitis. Assess other causes of frequent urination (heart failure or renal disease) before treatment. Start an appropriate antibacterial therapy if UTI is present. No established safety & efficacy in patients w/ a neurogenic cause for detrusor overactivity. May impair ability to drive or operate machinery. Patients w/ renal impairment; mild or moderate hepatic impairment (Child Pugh A or B). Lactation. Not recommended during pregnancy. Not recommended in childn.
Adverse Reactions
Dry mouth, constipation. Headache, abdominal pain; dyspepsia, nausea; dry eyes.
Drug Interactions
Increased exposure w/ potent CYP2D6 inhibitors eg, paroxetine, terbinafine, cimetidine, quinidine; potent CYP3A4 inhibitors eg, PIs, ketoconazole, itraconazole; potent P-gp inhibitors eg, cyclosporine, verapamil; moderate CYP3A4 inhibitors eg, erythromycin, clarithromycin, telithromycin, fluconazole, grapefruit juice. Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin, carbamazepine, barbiturates, St. John's wort. Increased exposure of CYP2D6 substrates eg, flecainide, thioridazine, TCAs (eg, imipramine). Modest increase in midazolam (CYP3A4 substrate) exposure. Small increase in digoxin exposure. More pronounced therapeutic & side effects w/ medicinal products that possess antimuscarinic properties eg, oxybutynin, tolterodine, flavoxate. Potentiation of anticholinergic effects w/ anti-parkinson agents & TCAs.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04BD10 - darifenacin ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Enablex PR tab 7.5 mg
Packing/Price
28's
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