Indications
Darifen ER Tablet is used for:
Urge incontinence, Urinary frequency and urgency, Overactive bladder
Adult Dose
Oral
Overactive bladder
Adult: For symptomatic treatment of urge incontinence, urinary frequency and urgency. Initial: 7.5 mg once daily; may increase dose to 15 mg once daily if no adequate response after 2 wk of therapy.
Hepatic impairment: Moderate hepatic impairment (Child Pugh B): Maximum daily dose is 7.5 mg. Severe hepatic impairment (Child Pugh C): Not recommended.
Child Dose
Renal Dose
Administration
May be taken with or without food. Swallow whole, do not chew/crush/divide.
Contra Indications
Patient with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions.
Precautions
Anticholinergic agents including Darifenacin, may cause urinary retention and decreased GI motility. Caution when used in patients with clinically significant bladder outflow obstruction, GI obstructive disorder (e.g. pyloric stenosis), severe constipation, ulcerative colitis, and myasthenia gravis. For patients being treated for narrow-angle glaucoma, caution and only use where potential benefits outweigh the risks. May cause heat prostration when used in a hot environment. May cause dizziness and blurred vision; caution when operating machinery or driving vehicle. Not recommended in severe hepatic impairment. Safety and efficacy have not been established in paediatric patients. Pregnancy and lactation.
Lactation: Excretion in milk unknown; use caution
Pregnancy-Lactation
Pregnancy Category: C
Lactation: Excretion in milk unknown; use caution
Interactions
Concurrent use of CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) or CYP2D6 inhibitors (e.g. quinidine, paroxetine) may increase serum levels of Darifenacin. CYP3A4 inducers (e.g. barbiturates, phenytoin, rifampicin) may likely decrease Darifenacin serum concentrations. Darifenacin may act as a moderate inhibitor of CYP2D6, caution when used concomitantly with CYP2D6 substrates that have narrow therapeutic index (e.g. flecainide, thioridazine, imipramine). Concurrent use of another agent with antimuscarinic properties may potentiate the side effects of Darifenacin.
Side Effects
Side effects of Darifenacin :
>10%
Dry mouth (19-35%), Constipation (15-21%)
1-10%
Abdominal pain (2-4%), Dizziness (2%), Dry eyes (2%), Dyspepsia (3-8%), Nausea (2-4%), UTI (4-5%), Vaginitis (>1%), Back pain (>1%), Rhinitis (>1%), Abnormal vision (>2%), Vomiting (>1%), Weight gain (>1%), Flu-like syndrome (1-3%), Peripheral edema (>1%)
Potentially Fatal: Hypersensitivity reactions, including angioedema.
Mode of Action
Darifenacin is a potent, competitive and selective muscarinic receptor antagonist which has greater binding affinity for muscarinic M3 receptors. M3 receptors are involved in the contraction of the detrusor muscle of the bladder, GI smooth muscle, saliva production, and iris sphincter function. Darifenacin may increase volume threshold in patients with involuntary detrusor contraction, thus increase bladder capacity.
Note
Darifen ER 7.5mg Tablet generic name is Darifenacin. Darifen ER 7.5mg Tablet is manufactured by Acme Laboratories Ltd.Darifen ER is availble in all over Bangladesh.
Mes BD drug index information on Darifen ER Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.