FDA Approves First Generic Formulation of Tamsulosin for BPH
By Yael Waknine
Medscape Medical News
March 3, 2010 — The US Food and Drug Administration (FDA) has approved the first generic version of tamsulosin HCl 0.4 mg capsules (Impax Laboratories, Inc; Flomax, Astellas Pharma, Inc, marketed by Boehringer Ingelheim Pharmaceuticals, Inc).
The alpha1a–selective blocker is indicated for the treatment of benign prostatic hyperplasia, a condition that affects up to 90% of men aged 70 years or older. Symptoms are generally obstructive (hesitancy/straining, weak stream/intermittency) and irritative (frequent urination, nocturia, urinary urgency).
"The approval of generic tamsulosin offers greater access to a widely used treatment for [benign prostatic hyperplasia]," said Gary Buehler, director of the FDA's Office of Generic Drugs, in an agency news release. "FDA is committed to making generic drugs available to patients and these drugs meet the same rigid standards as the brand name drugs."
Tamsulosin should be administered once daily as a 0.4- to 0.8-mg dose, approximately 30 minutes after a meal.
Adverse events may include headache, dizziness, rhinitis, infection, and abnormal ejaculation. Patients should be cautioned regarding the risk for orthostasis (postural hypotension, dizziness, and vertigo), particularly after the first dose or when changing doses.
Other adverse events observed in some patients have included intraoperative floppy iris syndrome during cataract surgery and priapism.
