Sodez 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 Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Silodosin

Indications/Uses

Relief of bladder outlet obstruction associated w/ benign prostatic hyperplasia.

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Dosage/Direction for Use

Adult 4 mg bid. May be reduced according to patient's response. Moderate renal impairment (CrCl 30 to <50 mL/min) Initially 4 mg once daily. May be increased to 8 mg once daily after 1 wk, depending on patient's response.

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Overdosage

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Administration

Should be taken with food: Take after breakfast & evening meals.

Contraindications

Hypersensitivity.

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Special Precautions

Discontinue treatment 1-2 wk prior to cataract surgery. Not recommended in patients for whom cataract surgery is scheduled; w/ orthostatic hypotension. Intraoperative floppy iris syndrome. Examine patients to rule out presence of prostate carcinoma prior to therapy. Perform digital rectal exam & determination of PSA before treatment & at regular intervals afterwards. May affect ability to drive & use machines. Not recommended in severe renal (CrCl <30 mL/min) or hepatic impairment. Temporary effect on male fertility. Not intended for female patients. Paed patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Ejaculatory disorders including retrograde ejaculation, anejaculation. Dizziness; orthostatic hypotension; nasal congestion; diarrhoea.

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Drug Interactions

Increased plasma conc & exposure w/ potent CYP3A4 inhibitor ketoconazole. Not recommended in concomitant use w/ α-adrenoreceptor antagonists; potent CYP3A4 inhibitors eg, itraconazole, ritonavir or cyclosporine. Concomitant use w/ PDE-5 inhibitors; antihypertensives.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Sodez detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Drugs for Bladder & Prostate Disorders

ATC Classification

G04CA04 - silodosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

Thai FDA Category

Presentation/Packing

Form

Sodez FC tab 4 mg

Packing/Price

3 × 10's

Sodez

silodosin

Manufacturer:

Siam Pharmaceutical

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical