Solifenacin is a competitive muscarinic (acetylcholine) receptor antagonist. The binding of acetylcholine to these receptors, particularly the M3 receptor subtype, plays a critical role in the contraction of smooth muscle. By preventing the binding of acetylcholine to these receptors, solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine and reducing the number of incontinence episodes.
Solifen Tablet: Each film coated tablet contains Solifenacin Succinate INN 5 mg.
Solifen is indicated in the treatment of overactive bladder with symptoms of urge urinary incontinence, urinary frequency and urgency.
The recommended dose of Solifen is 5 mg once daily. If necessary the dose may be increased to 10 mg once daily. Solifen Tablet should be taken orally and swallowed whole with liquids. It can be taken with or without food.
Patients with renal impairment:
No dosage adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg Solifen Tablet once daily.
Patients with hepatic impairment:
No dosage adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment should be treated with caution and receive no more than 5 mg Solifen Tablet once daily.
Patients taking CYP3A4 inhibitors concomitantly:
The maximum dose of Solifen should be limited to 5 mg when treated simultaneously with ketoconazole or other potent CYP3A4 inhibitors e.g. ritonavir, nelfinavir or itraconazole.
Solifenacin is contraindicated in patients with hypersensitivity to solifenacin or to any of the excipients. It is also contraindicated in myasthenia gravis, severe gastro-intestinal conditions (including toxic megacolon), patients undergoing haemodialysis, patients with severe hepatic impairment, patients with severe renal impairment or moderate hepatic impairment and on treatment with a strong CYP3A4 inhibitor, e.g. ketoconazole.
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solifen should be used with caution in patients with clinically significant bladder outflow obstruction at risk of urinary retention, gastrointestinal obstructive disorders, risk of decreased gastrointestinal motility, severe renal impairment (creatinine clearance ≤ 30 ml/min), moderate hepatic impairment, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
The most common side effects are blurred vision, dry mouth, constipation & heat prostration. Other side effects include dizziness, fatigue, edema, palpitation and skin reactions. Disorientation, hallucination and convulsion may occur.
Concomitant medication with other drugs with anticholinergic properties may result in more pronounced therapeutic effects and side effects. The therapeutic effect of solifenacin may be reduced by concomitant administration of cholinergic receptor agonists. Solifenacin can reduce the effect of drugs that stimulate the motility of the gastro-intestinal tract, such as metoclopramide and cisapride. Ketoconazole & other CYP3A4 inhibitors increase the plasma concentration of solifenacin.
Use in pregnancy: There are no adequate data on the use of solifenacin succinate in pregnant women. Caution should be exercised while prescribing solifenacin to pregnant women.
Use in lactating mother: No data concerning the excretion of solifenacin into breast milk are available. The use of Solifenacin is avoided in lactating mother.
Use in children: Safety and efficacy of solifenacin in children have not been established.
Solifen Tablet: Each box contains 30 tablets in blister pack.
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