Urocalm Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Solifenacin succinate

Indications/Uses

Overactive bladder w/ symptoms of urinary incontinence, urgency & frequency.

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Dosage/Direction for Use

Adult including the elderly 5 mg once daily. May be increased to 10 mg once daily. Severe renal (CrCl <30 mL/min) & moderate hepatic (Child-Pugh B) impairment &/or concomitant use w/ potent CYP3A4 inhibitors Max: 5 mg once daily.

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Overdosage

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Administration

May be taken with or without food: Swallow whole, do not chew/crush.

Contraindications

Hypersensitivity. Patients w/ urinary retention, severe GI condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma.

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Special Precautions

Patients w/ angioedema & anaphylactic reactions; clinically significant bladder outflow obstruction; decreased GI motility; controlled narrow-angle glaucoma; known history of QT prolongation or taking medications known to prolong QT interval; autonomic neuropathy. Assess other causes of frequent urination prior to treatment. Do not drive or operate heavy machinery. Not recommended in severe hepatic impairment (Child-Pugh C). Pregnancy. Avoid use during lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Blurred vision, dry mouth, eyes, throat & skin, constipation, nausea, dyspepsia, abdominal pain, UTI, cystitis, somnolence, dysgeusia, dizziness, headache, nasal dryness, GERD, colonic obstruction, faecal impaction, vomiting, pruritus, rash, difficulty in micturition, urinary retention, fatigue, peripheral oedema.

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Drug Interactions

Conc may be increased w/ CYP3A4 inhibitors & decreased w/ CYP3A4 inducers. Therapeutic effect may be reduced w/ cholinergic receptor agonists. Reduced effect of medicinal products that stimulate GI tract motility eg, metoclopramide & cisapride. Increased AUC w/ ketoconazole & other potent CYP3A4 inhibitors eg, ritonavir, nelfinavir, itraconazole.

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Storage

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Description

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Action

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MIMS Class

Drugs for Bladder & Prostate Disorders

ATC Classification

G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.

Regulatory Classification

POM

Presentation/Packing

Form

Urocalm FC tab 10 mg

Packing/Price

10 × 10's

Form

Urocalm FC tab 5 mg

Packing/Price

10 × 10's

Urocalm

solifenacin

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House