Flomax

[Tamsulosin]

Warnings

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The signs and symptoms of orthostasis (postural hypotension, dizziness and vertigo) were detected more frequently in FLOMAX capsule treated patients than in placebo recipients. As with other alpha-adrenergic blocking agents there is a potential risk of syncope (see ADVERSE REACTIONS). Patients beginning treatment with FLOMAX capsules should be cautioned to avoid situations where injury could result should syncope occur.

Rarely (probably less than one in fifty thousand patients), tamsulosin, like other alpha1 antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients must be advised about the seriousness of the condition (see Precautions: Information for Patients).

PRECAUTIONS

General

1) Carcinoma of the prostate:

Carcinoma of the prostate and BPH cause many of the same symptoms. These two diseases frequently co-exist. Patients should be evaluated prior to the start of FLOMAX capsules therapy to rule out the presence of carcinoma of the prostate.

2) Drug-Drug Interactions:

The pharmacokinetic and pharmacodynamic interactions between FLOMAX capsules and other alpha-adrenergic blocking agents have not been determined. However, interactions may be expected and FLOMAX capsules should NOT be used in combination with other alpha-adrenergic blocking agents.

The pharmacokinetic interaction between cimetidine and FLOMAX capsules was investigated. The results indicate significant changes in tamsulosin HCI clearance (26% decrease) and AUC (44% increase). Therefore, FLOMAX capsules should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg.

Results from limited in vitro and in vivo drug-drug interaction studies between tamsulosin HCI and warfarin are inconclusive. Therefore, caution should be exercised with concomitant administration of warfarin and FLOMAX capsules.

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