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Uses

Benign Prostatic Hyperplasia (BPH)

Reduction of urinary obstruction and relief of associated manifestations (e.g., hesitancy, terminal dribbling of urine, interrupted or weak stream, impaired size and force of stream, sensation of incomplete bladder emptying or straining) in hypertensive or normotensive patients with symptomatic BPH.

Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.

May consider combined therapy with an α₁-adrenergic blocker and 5α-reductase inhibitor for men with bothersome moderate to severe BPH and demonstrable prostatic enlargement. Has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression. Men at risk for BPH progression are most likely to benefit from combination therapy.

Other Uses

Manufacturer states that tamsulosin should not be used for the treatment of hypertension.

Dosage and Administration

Administration

Oral Administration

Administer orally once daily, 30 minutes after the same meal each day.

Swallow capsules intact; do not open, crush, or chew capsules.

Dosage

Available as tamsulosin hydrochloride; dosage expressed in terms of the salt.

Adults

BPH

Oral

Initially, 0.4 mg once daily. Allow 2–4 weeks to assess response at initial dosage. May increase dosage to 0.8 mg once daily, if necessary, to improve urinary flow rates and reduce symptoms.

If administration is interrupted for several days at either dosage (i.e., 0.4 or 0.8 mg daily), reinitiate therapy at dosage of 0.4 mg once daily.

Special Populations

Hepatic Impairment

Dosage adjustment not necessary in patients with moderate hepatic impairment.

Renal Impairment

Dosage adjustment not necessary in patients with mild to severe renal impairment (Cl_cr 10–70 mL/minute per 1.73 m²).

Not studied in patients with end-stage renal disease (Cl_cr <10 mL/minute per 1.73 m²).

Cautions

Contraindications

• Known hypersensitivity to tamsulosin or any ingredient in the formulation.

Warnings/Precautions

Warnings

Postural Hypotension

Potential for postural hypotension, dizziness, or vertigo; syncope may occur.

Priapism

Priapism reported rarely; treat promptly.

Sensitivity Reactions

Allergic Reactions

Rash, pruritus, urticaria, and angioedema of the tongue, lips, and face reported; positive rechallenge in some patients.

Sulfonamide Sensitivity

Allergic reaction to tamsulosin reported rarely in patients with sulfonamide sensitivity. Use with caution in patients with serious or life-threatening sulfonamide sensitivity.

General Precautions

Prostate Cancer

Exclude possibility of prostate cancer prior to initiation of therapy.

Intraoperative Floppy Iris Syndrome (IFIS)

IFIS observed during phacoemulsification cataract surgery in some patients receiving α₁-blockers, including tamsulosin. Most cases were in patients who continued tamsulosin therapy at the time of cataract surgery.

Specifically question male patients being considered for cataract surgery to ascertain whether they have received tamsulosin or other α₁-blockers. If patient has received tamsulosin, ophthalmologist should be prepared for possible modifications to his/her surgical technique (e.g., use of iris hooks, iris dilator rings, viscoelastic substances) to minimize complications of IFIS.

Benefit of discontinuing α₁-blockers, including tamsulosin, prior to cataract surgery not established.

Specific Populations

Pregnancy

Category B. Not indicated for use in women.

Lactation

Not indicated for use in women.

Pediatric Use

Not indicated for use in children.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

Common Adverse Effects

Headache, infection, asthenia, back pain, chest pain, dizziness, somnolence, insomnia, decreased libido, rhinitis, pharyngitis, increased cough, sinusitis, diarrhea, nausea, tooth disorder, abnormal ejaculation, blurred vision.