Prostulax 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 Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Tamsulosin HCl

Indications/Uses

Functional symptoms of benign prostatic hyperplasia (BPH).

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Dosage/Direction for Use

1 cap daily after breakfast or the 1st meal of the day.

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Overdosage

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Administration

Should be taken with food: Swallow whole. Do not crunch or chew.

Contraindications

Hypersensitivity to tamsulosin, including drug-induced angioedema. History of orthostatic hypotension. Severe hepatic insufficiency.

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Special Precautions

Discontinue use if angioedema occurs. Not to be initiated in patients for cataract surgery. Rarely, syncope may occur. Patient should sit or lie down at 1st signs of orthostatic hypotension (dizziness, weakness) until the symptoms disappear. Examine patient to exclude the presence of other conditions which have the same symptoms as BPH. Perform digital rectal exam & when necessary determination of PSA prior to treatment & at regular intervals afterwards. Intraoperative floppy iris syndrome has been observed during cataract surgery in some patients on or previously treated w/ tamsulosin. Severe renal impairment (CrCl <10 mL/min). Not indicated for women. Events of ejaculation disorder & failure, & retrograde ejaculation. Safety & efficacy in childn <18 yr have not been established.

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Use In Pregnancy & Lactation

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Drug Interactions

Rise in plasma levels w/ cimetidine. Decrease plasma levels w/ furosemide. Elimination rate may be increased w/ diclofenac & warfarin. Concomitant use w/ strong CYP3A4 inhibitors in poor CYP2D6 metabolizers; strong & moderate CYP3A4 inhibitors. Increased C_max & AUC w/ paroxetine. May lead to hypotensive effects w/ α-adrenoceptor antagonist.

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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

G04CA02 - tamsulosin ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

Regulatory Classification

Presentation/Packing

Form

Prostulax PR cap 400 mcg

Packing/Price

30's

Prostulax

tamsulosin

Manufacturer:

Sydler Remedies

Distributor:

Trumed