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Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. • Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) • Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1)

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 [see Adverse Reactions (6.2) ]. • Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules (4 , 6.2)

• Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur (5.1) • Should not be used in combination with strong inhibitors of CYP3A4. Use with caution in combination with moderate inhibitors of CYP3A4, with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors. (5.2 , 7.1 , 12.3) • Should not be used in combination with other alpha adrenergic blocking agents (5.2 , 7.2 , 12.3) • Exercise caution with concomitant administration of warfarin (5.2 , 7.4 , 12.3) • Advise patients about the possibility and seriousness of priapism (5.3) • Intraoperative Floppy Iris Syndrome has been observed during cataract and glaucoma surgery in some patients. Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken tamsulosin hydrochloride capsules. (5.5) • Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards (5.4) 5.1 Orthostasis The signs and symptoms of orthostasis (postural hypotension, dizziness, and vertigo) were detected more frequently in tamsulosin hydrochloride capsule-treated patients than in placebo recipients. As with other alpha adrenergic blocking agents there is a potential risk of syncope [see Adverse Reactions (6.1) ] . Patients beginning treatment with tamsulosin …

8.1 Pregnancy Risk Summary Tamsulosin hydrochloride is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride in pregnant women. No adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (GD 7 to 17 in the rat and GD 6 to 18 in the rabbit) [ see Data ] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Administration of tamsulosin hydrochloride to pregnant female …