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warnings and cautions
5 WARNINGS AND PRECAUTIONS · 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 Capsules -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 Hydrochloride Capsules should be cautioned to avoid situations in which injury could result should syncope occur. 5.2 Drug Interactions Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6. Tamsulosin Hydrochloride Capsules 0.4 mg should not be used in combination with strong inhibitors of CYP3A4 (e.g., ketoconazole) [ see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Tamsulosin Hydrochloride Capsules should be used with caution in combination with moderate inhibitors of CYP3A4 (e.g., erythromycin), in combination with strong (e.g., paroxetine) or moderate (e.g., terbinafine) inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers particularly at a dose higher than 0.4 mg (e.g., 0.8 mg) [ see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Tamsulosin Hydrochloride Capsules should be used with caution in combi...
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adverse reactions
6 ADVERSE REACTIONS The most common adverse events (³2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia,back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence,nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-332-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg Tamsulosin Hydrochloride Capsules were used. These studies evaluated safety in 1783 patients treated with Tamsulosin Hydrochloride Capsules and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either Tamsulosin Hydrochloride Capsules 0.4 mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials (US92-03A and US93-01) conducted in 1487 men. Table 1 Treatment-Emergent 1 Adverse Events Occurring in ≥ 2% of Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies. BODY SYSTEM/ADVERSE EVENT TAMSULOSIN HYDROCHLORIDE CAPSULE GROUPS PLACEBO n=493 0.4 mg n=502 0.8 n=492 BODY AS A WHOLE Headache 97 (19.3%) 104 (21.1%) 99 (20.1%) Infection 2 45 (9.0%) 53 (10.8%) 37 (7.5%) Asthenia 39 (7.8%) 42 (8.5%) 27 (5.5%) Back pain 35 (7.0%) 41 (8.3%) 27 (5.5%) Chest pain 20 (4.0%) 20 (4.1%) 18 (3.7%) NERVOUS SYSTEM Dizziness 75 (14.9%) 84(17.1%) 50(10.1%) Somnolence 15 (3.0%) 21 (4.3%) 8 (1.6%) Insomnia 12 (2.4%) 7 (1.4%) 3 (0.6%) Libido decreased 5 (1.0%) 10 (2.0%) 6 (1.2%) RESPIRATORY SYSTEM Rhinitis 3 66(13.1%) 88 (17.9%) 41 (8.3%) Pharyngitis 29 (5.8%) 25 (5.1%) 23 (4.7%) Cough increased 17 (3.4%) 22 (4.5%) 12 (2.4%) Sinusitis 11 (2.2%) 18 (3.7%) 8 (1.6%) DIGESTIVE SYSTEM Diarrhea 31 (6.2%) 21 (4.3%) 22 (4.5%)...
adverse reactions
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg Tamsulosin Hydrochloride Capsules were used. These studies evaluated safety in 1783 patients treated with Tamsulosin Hydrochloride Capsules and 798 patients administered placebo. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving either Tamsulosin Hydrochloride Capsules 0.4 mg or 0.8 mg and at an incidence numerically higher than that in the placebo group during two 13-week U.S. trials (US92-03A and US93-01) conducted in 1487 men. Table 1 Treatment-Emergent 1 Adverse Events Occurring in ≥ 2% of Tamsulosin Hydrochloride Capsules or Placebo Patients in Two U.S. Short-Term Placebo-Controlled Clinical Studies. BODY SYSTEM/ADVERSE EVENT TAMSULOSIN HYDROCHLORIDE CAPSULE GROUPS PLACEBO n=493 0.4 mg n=502 0.8 n=492 BODY AS A WHOLE Headache 97 (19.3%) 104 (21.1%) 99 (20.1%) Infection 2 45 (9.0%) 53 (10.8%) 37 (7.5%) Asthenia 39 (7.8%) 42 (8.5%) 27 (5.5%) Back pain 35 (7.0%) 41 (8.3%) 27 (5.5%) Chest pain 20 (4.0%) 20 (4.1%) 18 (3.7%) NERVOUS SYSTEM Dizziness 75 (14.9%) 84(17.1%) 50(10.1%) Somnolence 15 (3.0%) 21 (4.3%) 8 (1.6%) Insomnia 12 (2.4%) 7 (1.4%) 3 (0.6%) Libido decreased 5 (1.0%) 10 (2.0%) 6 (1.2%) RESPIRATORY SYSTEM Rhinitis 3 66(13.1%) 88 (17.9%) 41 (8.3%) Pharyngitis 29 (5.8%) 25 (5.1%) 23 (4.7%) Cough increased 17 (3.4%) 22 (4.5%) 12 (2.4%) Sinusitis 11 (2.2%) 18 (3.7%) 8 (1.6%) DIGESTIVE SYSTEM Diarrhea 31 (6.2%) 21 (4.3%) 22 (4.5%) Nausea 13 (2.6%) 19 (3.9%) 16 (3.2%) Tooth disorder 6 (1.2%) 10 (2.0%) 7 (1.4%) UROGENITAL SYSTEM Abnormal ejaculation 42 (8.4%) 89 (18.1%) 1 (0.2%) SPECIAL SENSES Blurred vision 1 (0.2%) 10 (2.0%) 2 (0.4%) 1 A treatment-emergent adverse event was defined as any event satisfying one of the following criteria: • The adverse event occurred for the first time after initial dosing with double-blind study medication. • The adverse event was present prior to or at the time of initial dosing with double-bli...