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Fenistae

Fenistae

solifenacin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Solifenacin succinate
Indications/Uses
Symptomatic treatment of urge incontinence &/or increased urinary frequency & urgency in patients w/ overactive bladder syndrome.
Dosage/Direction for Use
Adult including elderly 5 mg once daily. May increase dose to 10 mg once daily if needed. Concomitant use w/ potent CYP3A4 inhibitors eg, ketoconazole, ritonavir, nelfinavir, itraconazole Max: 5 mg. Severe renal (CrCl ≤30 mL/min) & moderate hepatic (Child-Pugh score 7-9) impairment Max: 5 mg once daily.
Administration
May be taken with or without food: Swallow whole w/ liqd.
Contraindications
Hypersensitivity. Patients w/ & at risk of urinary retention, severe GI condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma; undergoing haemodialysis; on treatment w/ potent CYP3A4 inhibitor eg, ketoconazole. Severe renal or moderate & severe hepatic impairment.
Special Precautions
Discontinue treatment if anaphylactic reactions develop; angioedema w/ airway obstruction occur. QT prolongation & Torsades de Pointes in patients w/ risk factors eg, preexisting long QT syndrome & hypokalaemia. Patients w/ significant bladder outflow obstruction; GI obstructive disorders; risk of decreased GI motility; hiatus hernia/gastroesophageal reflux; autonomic neuropathy; neurogenic cause for detrusor overactivity. Assess other causes of frequent urination eg, heart failure or renal disease before treatment. Concomitant use w/ drugs that can cause or exacerbate esophagitis (eg, bisphosphonates); potent CYP3A4 inhibitor eg, ketoconazole. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect the ability to drive or operate machinery. Severe renal (CrCl ≤30 mL/min) & moderate hepatic impairment (Child-Pugh score 7-9). Pregnancy. Avoid use during lactation. Not to be used in childn.
Adverse Reactions
Dry mouth. Blurred vision; constipation, nausea, dyspepsia, abdominal pain. Erythema multiforme.
Drug Interactions
Reduced therapeutic effect w/ cholinergic receptor agonists. Reduced effect of medicinal products that stimulate GIT motility eg, metoclopramide & cisapride. Increased AUC w/ ketoconazole. Possible pharmacokinetic interactions w/ other CYP3A4 substrates w/ higher affinity (eg, verapamil, diltiazem) & CYP3A4 inducers (eg, rifampicin, phenytoin, carbamazepine).
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Fenistae FC tab 10 mg
Packing/Price
3 × 10's
Form
Fenistae FC tab 5 mg
Packing/Price
3 × 10's
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