Flomax (Tamsulosin Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Flomax^® (tamsulosin hydrochloride) capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX capsules are not indicated for the treatment of hypertension.

DOSAGE AND ADMINISTRATION

FLOMAX 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.

For those patients who fail to respond to the 0.4 mg dose after two to four weeks of dosing, the dose of FLOMAX capsules can be increased to 0.8 mg once daily. The 0.8 mg dose should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) (see WARNINGS).

If FLOMAX 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.

HOW SUPPLIED

FLOMAX capsules 0.4 mg are supplied in high density polyethylene bottles containing 100 hard gelatin capsules with olive green opaque cap and orange opaque body. The capsules are imprinted on one side with “Flomax 0.4 mg” and on the other side with “BI 58.”

FLOMAX capsules 0.4 mg, 100 capsules (NDC 0597-0058-01)

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Keep FLOMAX capsules and all medicines out of reach of children.

Patients should be reminded to read and follow the accompanying “PATIENT INFORMATION”, which should be dispensed with the product.