Urotex 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

Bladder outlet obstruction associated w/ benign prostatic hyperplasia.

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Dosage/Direction for Use

Adult 4 mg bid after breakfast & evening meals. Elderly & renal impairment Start at 2 mg.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity.

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Special Precautions

Consider dose reduction or treatment discontinuation if decrease in BP occurs. Abnormal ejaculation (eg, retrograde ejaculation); orthostatic hypotension. Intraoperative floppy iris syndrome. Patients treated w/ phosphodiesterase-5 inhibitors. Consider therapeutic measures (eg, surgery) if no result in expected effect. Examine patients for presence of prostate carcinoma prior to therapy. Perform digital rectal exam & determination of PSA before treatment & at regular intervals afterwards. Concomitant use w/ hypotensive drugs. Elevated plasma drug conc in patients w/ hepatic & renal impairment. Not recommended in severe hepatic impairment. May affect ability to drive & use machines. Not intended for female patients. Temporary effect in male fertility. Elderly (reduced physiological, renal & hepatic function).

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Use In Pregnancy & Lactation

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Adverse Reactions

Abnormal ejaculation (eg, retrograde ejaculation); thirst; increased triglycerides. Impotence, urinary incontinence; stomach discomfort, diarrhea, loose stools, constipation; dizziness, dizziness on standing up, light-headed feeling, headache; epistaxis, nasal congestion; increased AST (GOT), ALT (GPT), γ-glutamyl transferase, total bilirubin, alkaline phosphatase & LDH; decreased WBC, RBC, Hb & hematocrit; malaise, increased C-reactive protein, total cholesterol, urine sugar & urinary sediment.

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Drug Interactions

Diminished ability to regulate BP on standing w/ hypotensive agents. Elevated plasma drug conc w/ potent CYP3A4 inhibitors; azole antifungal agents (itraconazole). Enhanced hypotensive effect w/ phosphodiesterase-5 inhibitors (sildenafil citrate, vardenafil HCl hydrate). Increased C_max & AUC_0-∞ w/ ketoconazole.

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Caution For Usage

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

Storage

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Description

View Urotex description for details of the chemical structure and excipients (inactive components).

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

Urotex FC tab 4 mg

Packing/Price

3 × 10's

Urotex

silodosin

Manufacturer:

Sriprasit Pharma

Distributor:

SPS Medical

Marketer:

SPS Medical