Enablex

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. Moderate hepatic impairment (Child-Pugh B) Not to exceed 7.5 mg daily.
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 ulcerative colitis; toxic megacolon. Concomitant treatment w/ potent CYP3A4 inhibitors. Severe hepatic impairment (Child-Pugh C).
Special Precautions
Discontinue use if tongue or laropharynx edema or difficulty in breathing occurs. Autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or GI obstructive disorders eg, pyloric stenosis. Patients treated for narrow-angle glaucoma; w/ risk of decreased GI motility, gastroesophageal reflux; neurogenic cause for detrusor overactivity; preexisting cardiac disease. Assess other causes of frequent urination (heart failure & renal disease) before treatment. Concurrent use w/ drugs causing or exacerbating esophagitis. May affect ability to drive & use machines. Hepatic impairment. Pregnancy & lactation. Not recommended for use in childn.
Adverse Reactions
Constipation, dry mouth. Headache; dry eye; nasal dryness; abdominal pain, nausea, dyspepsia.
Drug Interactions
Altered pharmacokinetics w/ CYP2D6 & CYP3A4 inhibitors. Avoid potent P-gp inhibitors eg, ciclosporin, verapamil. Increased in steady-state AUC w/ ketoconazole. Increased exposure in subjects who are poor metabolisers. Increased AUC & Cmax w/ concurrent 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 w/ cimetidine. Drugs w/ narrow therapeutic window eg, flecainide, thioridazine or TCAs eg, imipramine. Modest increased midazolam exposure. Monitor prothrombin time w/ warfarin. Small increased digoxin exposure. Increased 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
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in