Indications And Usage

Tamsulosin hydrochloride capsules  are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Tamsulosin hydrochloride capsules  are not indicated for the treatment of hypertension.

Administration

Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules should not be crushed, chewed, or opened.

For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg once daily. Tamsulosin hydrochloride capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4

If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose.

Contraindications

Tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. Reactions have included skin rash, urticaria, pruritus, angioedema and respiratory symptoms

Precautions

Orthostasis, Drug Interactions, Priapism, Screening for Prostate Cancer, Intraoperative Floppy Iris Syndrome, Sulfa Allergy

Adverse Reactions

Headache 19%, Dizziness 14%, Rhinitis 13%

Pregnancy and lactation

Pregnancy Category B.

Tamsulosin hydrochloride capsules are not indicated for use in women.

Renal and liver Impairment

Patients with renal impairment do not require an adjustment in tamsulosin hydrochloride capsules dosing. However, patients with end-stage renal disease (CLcr<10 mL/min/1.73 m2) have not been studied.

Patients with moderate hepatic impairment do not require an adjustment in tamsulosin hydrochloride capsules dosage. Tamsulosin hydrochloride capsules have not been studied in patients with severe hepatic impairment

Laboratory Tests