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Enablex

darifenacin

Manufacturer:

Aspen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Darifenacin HBr
Indications/Uses
Overactive bladder including symptoms eg, urgency, urinary incontinence & frequency.
Dosage/Direction for Use
Adult Initially 7.5 mg daily, may be increased to 15 mg daily as early as 2 wk after starting therapy.
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contraindications
Hypersensitivity. Urinary & gastric retention. Uncontrolled narrow-angle glaucoma. Myasthenia gravis. Severe hepatic impairment (Child-Pugh C) & ulcerative colitis. Toxic megacolon. Concomitant treatment w/ potent CYP3A4 inhibitors.
Special Precautions
Autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or GI obstructive disorders eg, pyloric stenosis. Assess other causes of frequent urination (heart failure & renal disease) before treatment. Risk of decreased GI motility, gastroesophageal reflux &/or currently taking drugs causing or exacerbating esophagitis. Neurogenic cause for detrusor overactivity. Preexisting cardiac disease. Discontinue if tongue edema or laropharynx or difficulty in breathing occurs. May affect ability to drive or operate machinery. Hepatic impairment. Pregnancy & lactation. Childn.
Adverse Reactions
Constipation & dry mouth. Headache; dry eye; nasal dryness; abdominal pain, nausea, dyspepsia.
Drug Interactions
May alter pharmacokinetics w/ CYP2D6 & CYP3A4 inhibitors. Avoid potent p-glycoprotein inhibitors eg, ciclosporin & verapamil. Increased in steady-state AUC by ketoconazole. Increased exposure in subjects who are poor metabolisers. Increased AUC & Cmax when administered concurrently w/ erythromycin in subjects who are extensive metabolisers. Decreased plasma conc w/ CYP3A4 inducers eg, rifampicin, carbamazepine, barbiturates & St. John's wort. Higher mean Cmax & AUC in the presence of cimetidine. Caution when used concomitantly w/ drugs that have narrow therapeutic window eg, flecainide, thioridazine or TCAs eg, imipramine. Modest increase in midazolam exposure. Monitor prothrombin time w/ warfarin. Small increase in digoxin exposure. May increase frequency & severity of antimuscarinic pharmacological effects.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04BD10 - darifenacin ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Enablex PR tab 15 mg
Packing/Price
28's
Form
Enablex PR tab 7.5 mg
Packing/Price
28's
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