PROSTA-TAB 0.4MG 30TAB

Indications

Approved Uses

Benign prostatic hyperplasia (BPH) - relief of lower urinary tract symptoms (LUTS) including urinary hesitancy, weak stream, nocturia, and incomplete bladder emptying

Off-Label Uses

Medical expulsive therapy for distal ureteral stones (selected patients); other uses are not routinely recommended without specialist direction.

Dosage & Administration

Dosing by Condition

BPH/LUTS: 0.4 mg orally once daily after the same meal; if response is inadequate after 2-4 weeks, may increase to 0.8 mg once daily (where an appropriate strength/formulation is available).

Initial Dose

0.4 mg once daily

Maintenance Dose

0.4mg to 0.8mg once daily

Maximum Dose

0.8 mg once daily (after 0.4 mg once daily if response is inadequate).

Children's Dosage

Not approved for children.

Dose Adjustment Notes

No routine dose adjustment for mild-moderate renal impairment; use caution in severe renal impairment (CrCl <10 mL/min) due to limited data; avoid/use with caution in severe hepatic impairment; if therapy is interrupted for several days, restart at 0.4 mg once daily.

How to Take

Take 0.4 mg orally once daily after the same meal each day; swallow the prolonged‑release tablet whole with water-do not crush, chew, or split.

Side Effects

Common Side Effects

Dizziness/orthostatic hypotension, abnormal ejaculation (including retrograde ejaculation/ejaculation failure), headache, rhinitis/nasal congestion, asthenia (weakness).

Side Effect Frequency

Common (≥1% to <10%): dizziness, abnormal ejaculation/ejaculation disorders, rhinitis; Uncommon (≥0.1% to <1%): orthostatic hypotension; Rare/very rare: syncope, angioedema, priapism; IFIS reported (frequency not known)

Safety & Warnings

Contraindications

Hypersensitivity to tamsulosin (or excipients) and history of orthostatic hypotension; severe hepatic impairment is a contraindication/should not be used.

Warnings & Precautions

Warn about orthostatic hypotension/syncope (especially at initiation/restart), exclude prostate cancer before treatment, inform ophthalmologist about current/past tamsulosin before cataract surgery (IFIS risk), caution with severe renal impairment (CrCl <10) and with concomitant antihypertensives/PDE5 inhibitors; sulfonamide allergy: use caution.

Age Restriction

Not indicated/approved for use in children and adolescents (<18 years).

Driving Warning

Dizziness can occur; caution patients about risks of syncope, especially at initiation

Drug Interactions

Drug Interactions

Clinically important interactions include strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole), strong CYP2D6 inhibitors (e.g., paroxetine/fluoxetine), other alpha-blockers, PDE5 inhibitors, and other antihypertensives (additive hypotension); warfarin interaction is possible-monitor.

Interaction Severity

MAJOR: Other alpha-1 blockers (additive hypotension/syncope-avoid); strong CYP3A4 inhibitors (e.g., ketoconazole) especially in CYP2D6 poor metabolizers or with strong CYP2D6 inhibitors (markedly increased exposure-avoid/contraindicated per labeling in some regions). MODERATE: PDE5 inhibitors and other antihypertensives (additive hypotension-caution); strong CYP2D6 inhibitors (e.g., paroxetine) (increased exposure-caution). MINOR/monitor: Warfarin (possible interaction-monitor INR/bleeding).

Food Interaction

Take after the same meal each day (commonly after breakfast) to keep exposure consistent; avoid taking on an empty stomach.

Special Populations

Children

Not approved for children.

Elderly

Standard adult dosing (0.4 mg once daily); exercise caution regarding orthostatic hypotension risk, which is higher in elderly patients

Kidney Impairment

No dose adjustment for CrCl ≥10 mL/min; CrCl <10 mL/min: not studied-use with caution.

Liver Impairment

Mild-to-moderate hepatic impairment: No adjustment needed. Severe hepatic impairment: Contraindicated

Storage & Patient Advice

Missed Dose

If a dose is missed, take it when remembered the same day; if it is close to the next dose, skip the missed dose-do not double; if therapy has been stopped for several days, restart at 0.4 mg once daily.

Stopping the Medicine

Can be stopped without taper; if therapy is interrupted for several days, restart at 0.4 mg once daily (and reassess).

Overdose

Expected toxicity is marked hypotension (± dizziness/syncope/reflex tachycardia); manage with supportive care (supine/legs elevated, IV fluids, vasopressors if needed) and consider GI decontamination if recent; dialysis is unlikely to help.

Patient Counseling

Take once daily after the same meal; swallow the prolonged‑release tablet whole (do not crush/chew/split). Rise slowly to reduce dizziness/fainting risk; avoid driving/operating machinery until effects are known. Tell your eye surgeon before cataract/glaucoma surgery (risk of intraoperative floppy iris syndrome). Seek care for severe dizziness/syncope or priapism; continue therapy as prescribed for symptom control.

Monitoring Requirements

Monitor blood pressure (especially at initiation and after dose increases) and assess for orthostatic symptoms; monitor BPH response and periodically evaluate for prostate cancer as clinically indicated (e.g., PSA/DRE per urology practice).

Pharmacology

Mechanism of Action

Blocks alpha-1 (predominantly alpha-1A) adrenergic receptors in prostate/bladder neck/urethral smooth muscle, relaxing smooth muscle and improving urinary flow and LUTS.

Onset of Action

Symptom improvement may begin within days to 1 week; maximal benefit is typically assessed over ~2-4 weeks.

Duration of Effect

Approximately 24 hours per dose (supports once-daily dosing); clinical symptom benefit is maintained with continued daily use and is typically evaluated over 2-4 weeks.

Half-Life

Approximately 9-13 hours (can be ~10-15 hours depending on formulation/feeding conditions)

Bioavailability

Approximately 100% (high oral bioavailability; not meaningfully reduced by first-pass metabolism)

Metabolism

Hepatic metabolism mainly via CYP3A4 and CYP2D6 (with additional minor pathways); not typically described as having clinically significant extensive first-pass loss

Excretion

Primarily renal excretion of metabolites (about 76% in urine; ~9-10% unchanged) with the remainder in feces (about 21%)

Protein Binding

High protein binding: approximately 94-99%

Product Information

Available Dosage Forms

Prolonged-release tablet (this product).

Composition per Dose

Each prolonged-release tablet: 0.4 mg tamsulosin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

BPH

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