Country: United States
Language: English
Source: NLM (National Library of Medicine)
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
Tamsulosin hydrochloride capsules USP are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14)]. Tamsulosin hydrochloride capsules USP are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules USP are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules USP. Reactions have included skin rash, urticaria, pruritus, angioedema and respiratory symptoms [see Adverse Reactions (6.2)]. Teratogenic Effects, Pregnancy Category B. Administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. Administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. Tamsulosin hydrochloride capsules USP are not indicated
Tamsulosin hydrochloride capsules USP 0.4 mg are supplied in high density polyethylene bottles containing 100 or 500 hard gelatin capsules with an olive green opaque cap and an orange opaque body. The cap is imprinted with the code “TSL 0.4” in black ink. NDC 68071-4157-1 Bottles of 10 NDC 68071-4157-3 Bottles of 30 NDC 68071-4157-6 Bottles of 60 NDC 68071-4157-9 Bottles of 90 Store at 25°C (77°F). Excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules USP and all medicines out of reach of children.
Abbreviated New Drug Application
TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE NUCARE PHARMACEUTICALS,INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TAMSULOSIN HYDROCHLORIDE CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAMSULOSIN HYDROCHLORIDE CAPSULES USP. TAMSULOSIN HYDROCHLORIDE CAPSULES USP, 0.4 MG INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Dosage and Administration (2) 10/2014 Warnings and Precautions Intraoperative Floppy Iris Syndrome (5.5) 07/2014 INDICATIONS AND USAGE Tamsulosin hydrochloride capsules USP are an alpha adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia ( 1) Tamsulosin hydrochloride capsules USP are not indicated for the treatment of hypertension ( 1) DOSAGE AND ADMINISTRATION 0.4 mg once daily taken approximately one-half hour following the same meal each day. Tamsulosin hydrochloride capsules USP should not be crushed, chewed or opened. ( 2) Can be increased to 0.8 mg once daily for patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing ( 2) If discontinued or interrupted for several days, therapy should start again with the 0.4 mg once-daily dose ( 2) DOSAGE FORMS AND STRENGTHS Capsules: 0.4 mg ( 3) CONTRAINDICATIONS Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules USP ( 4, 6.2) 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 Read the complete document