Flomax

[Tamsulosin]

(See also drug-drug interaction studies in CLINICAL PHARMACOLOGY, Pharmacokinetics subsection.)

Information for Patients (see Patient Package Insert)

Patients should be told about the possible occurrence of symptoms related to postural hypotension such as dizziness when taking FLOMAX capsules, and they should be cautioned about driving, operating machinery or performing hazardous tasks.

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Patients should be advised not to crush, chew or open the FLOMAX capsules. Patients should be advised about the possibility of priapism as a result of treatment with FLOMAX Capsules and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence).

Laboratory Tests

No laboratory test interactions with FLOMAX capsules are known. Treatment with FLOMAX capsules for up to 12 months had no significant effect on prostate-specific antigen (PSA).

Pregnancy Teratogenic Effects, Pregnancy Category B

Administration of tamsulosin HCI to pregnant female rats at dose levels up to 300 mg/ kg/ day (approximately 50 times the human therapeutic AUC exposure) revealed no evidence of harm to the fetus. Administration of tamsulosin HCI to pregnant rabbits at dose levels up to 50 mg/ kg/ day produced no evidence of fetal harm. FLOMAX capsules are not indicated for use in women.

Nursing Mothers

FLOMAX capsules are not indicated for use in women.

Pediatric Use

FLOMAX capsules are not indicated for use in pediatric populations.

Carcinogenesis, Mutagenesis, and Impairment of Fertility
Rats administered doses up to 43 mg/ kg/ day in males and 52 mg/ kg/ day in females had no increases in tumor incidence with the exception of a modest increase in the frequency of mammary gland fibroadenomas in female rats receiving doses . 5.4 mg/ kg (P < 0.015). The highest doses of tamsulosin HCI evaluated in the rat carcinogenicity study produced systemic exposures (AUC) in rats 3 times the exposures in men receiving the maximum therapeutic dose of 0.8 mg/ day.

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