Generic

Indications

Treatment for urge incontinence and/or increased urinary frequency and urgency in patients with overactive bladder syndrome.

Pharmacology

Solifenacin is a muscarinic receptor antagonist that is competitive. It binds to M3, M1, and M2 muscarinic receptors with the greatest affinity. M2 receptors account for 80% of muscarinic receptors in the bladder, while M3 receptors account for 20%. Antagonism of the M3 receptor by solifenacin prevents detrusor muscle contraction, while antagonism of the M2 receptor may prevent bladder smooth muscle contraction.

Dosage & Administration

The recommended dose for adults and the elderly: Solifenacin Succinate 5 mg once daily. If needed, the dose may be increased to Solifenacin Succinate 10 mg once daily.

Use in children: Safety and effectiveness in children have not yet been established. Therefore, Solifenacin Succinate should not be used in children.

Interaction

Concomitant medicine with other restorative items with anticholinergic properties may result in more articulated helpful impacts and undesirable impacts. An interim of roughly one week ought to be permitted after halting treatment with Solifenacin Succinate some time recently commencing other anticholinergic treatment. The restorative impact of Solifenacin may be diminished by concomitant organization of cholinergic receptor agonists. Solifenacin can diminish the impact of restorative items that fortify the motility of the gastrointestinal tract, such as Metoclopramide and Cisapride. In vitro thinks about have illustrated that at helpful concentrations, Solifenacin does not hinder CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 inferred from human liver microsomes.Effect of

Solifenacin on the pharmacokinetics of other restorative products:

• Oral Contraceptives: Admissions of Solifenacin appeared no pharmacokinetic interaction on combined verbal contraceptives (Ethinylestradiol/Levonorgestrel).
• Warfarin: Admissions of Solifenacin did not modify the pharmacokinetics of R-warfarin or S-warfarin or their impact on prothrombin time.
• Digoxin: Admissions of Solifenacin appeared no impact on the pharmacokinetics of digoxin.

Contraindications

Patients allergic to solinacin or any excipient should not use solinacin. Myasthenia gravis, urinary retention, uncontrolled narrow-angle glaucoma, severe gastrointestinal diseases (including toxic megacolon), hemodialysis patients, patients with severe liver damage, patients with severe kidney damage or moderate liver damage, and This product is contraindicated in patients subjected to strong treatment. CYP3A4 inhibitors, such as ketoconazole.

Side Effects

Due to the pharmacological impact of Solifenacin, it may cause anticholinergic undesirable impacts of (in common) mellow or direct seriousness. The recurrence of anticholinergic undesirable impacts is measurements related. The foremost commonly detailed antagonistic reactionwith Solifenacin is dry mouth. It happened in 11% of patients treated with 5 mg once every day, in 22% of patients treated with 10 mg once every day and in 4% of placebo-treated patients. The seriousness of dry mouth was by and large gentle and as it were sometimes driven to cessation of treatment.

• Gastrointestinal clutters: exceptionally common- dry mouth, common-constipation, queasiness, dyspepsia, stomach torment, unprecedented– gastroesophageal reflux maladies, dry throat, uncommon– colonic hindrance, fecal impaction, exceptionally uncommon– vomiting.
• Infections and invasions: uncommonurinary tract contamination, cystitis.
• nervous framework clutters:  exceptional– drowsiness, dysgeusia, exceptionally rare-dizziness, headache. psychiatric clutters: exceptionally uncommon– hallucinations.
• eye clutters: common- obscured vision, exceptional– dry eyes. General clutters and organization location conditions: exceptional– weakness, fringe oedema.
• Respiratory, thoracic and mediastinal clutters: unprecedented nasal dryness.
• skin and subcutaneous tissue clutters: unprecedented– dry skin, exceptionally uncommon– pruritus, hasty, urticaria.
• renal and urinary disarranges: unprecedented– trouble in micturition, uncommon– urinary maintenance.

Pregnancy & Lactation

No clinical information are accessible from ladies who got to be pregnant whereas taking Solifenacin. Creature thinks about don’t show coordinate destructive impacts on ripeness, embryonal / fetal advancement or parturition. The potential chance for people is obscure. Caution ought to be worked out when endorsing to pregnant ladies. No information on the excretion of Solifenacin in human drain are accessible. In mice, Solifenacin and/or its metabolites was excreted in drain, and caused a measurements subordinate disappointment to flourish in neonatal mice. The utilize of Solifenacin ought to in this manner be dodged amid breast-feeding.

Precautions & Warnings

Other causes of visit urination (heart disappointment or renal illness) ought to be evaluated some time recently treatment with Solifenacin Succinate. On the off chance that urinary tract contamination is show, an fitting antibacterial treatment ought to be begun. Solifenacin Succinate ought to be utilized with caution in patients with:clinically critical bladder outpouring obstacle at hazard of urinary maintenance, gastrointestinal obstructive clutters, chance of diminished gastrointestinal motility, serious renal impedance (creatinine clearance 30 ml/min), direct hepatic disability (Child-Pugh score of 7 to 9) and measurements ought to not surpass 5 mg for these patients. Caution ought to be taken in concomitant utilize of a strong CYP3A4 inhibitor e.g. Ketoconazole, rest hernia/ gastroesophageal reflux and/or who are concurrently taking therapeutic items (such as Bisphosphonates) that can cause or worsen oesophagitis, autonomic neuropathy. Security and adequacy have not however been built up in patients with a neurogenic cause for detrus.

Therapeutic Class

Anticholinergics (antimuscarinics)/ Anti-spasmodics, BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children’s reach.

Pharmaceutical Name

ACME Laboratories Ltd.