Daritor-7.5/Daritor-15 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

Darifenacin HBr

Indications/Uses

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

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Dosage/Direction for Use

Initially 7.5 mg daily. May be increased to 15 mg daily based on individual response 2 wk after therapy is initiated. Moderate hepatic impairment (Child-Pugh B) or co-administration w/ potent CYP3A4 inhibitors Max daily dose: Not to exceed 7.5 mg.

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Overdosage

View Daritor-7.5/Daritor-15 overdosage for action to be taken in the event of an overdose.

Administration

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

Contraindications

Hypersensitivity. Urinary/gastric retention & uncontrolled narrow-angle glaucoma.

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Special Precautions

Clinically significant bladder outflow obstruction; GI obstructive disorders & other conditions eg, severe constipation, ulcerative colitis, & myasthenia gravis; narrow-angle glaucoma. Angioedema. May impair ability to drive & use machines. Not recommended for severe hepatic impairment (Child-Pugh C). Impaired renal function. Pregnancy & lactation. Ped patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dry mouth, constipation. Headache, abdominal pain, indigestion, feeling sick, dry eyes, nasal dryness. Angioedema of face, lips, tongue, or larynx.

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Drug Interactions

Increased systemic exposure w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin & nefazodone). Concomitant use w/ drugs predominantly metabolized by CYP2D6 (eg, flecainide, thioridazine & TCAs); warfarin. Increased frequency &/or severity of dry mouth, constipation, blurred vision & other anticholinergic pharmacological effects w/ other anticholinergic agents.

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Storage

View Daritor-7.5/Daritor-15 storage conditions for details to ensure optimal shelf-life.

Description

View Daritor-7.5/Daritor-15 description for details of the chemical structure and excipients (inactive components).

Action

View Daritor-7.5/Daritor-15 mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Drugs for Bladder & Prostate Disorders

ATC Classification

G04BD10 - darifenacin ; Belongs to the class of urinary antispasmodics.

Regulatory Classification

Presentation/Packing

Form

Daritor-15 ER tab 15 mg

Packing/Price

30's (P1,800/box)

Form

Daritor-7.5 ER tab 7.5 mg

Packing/Price

30's (P1,800/box)

Daritor-7.5/Daritor-15

darifenacin

Manufacturer:

Torrent

Distributor:

Torrent