País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)
Blenheim Pharmacal, 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. Tamsulosin hydrochloride capsules USP, 100 capsules (NDC 0228-2996-11). Tamsulosin hydrochloride capsules USP, 500 capsules (NDC 0228-2996-50). Store at 25° C (77° F). Excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature]. WARNING: As with all medications, keep out of the reach of children. Dispense in containers with child-resistant closures. USUAL DOSAGE: See package insert.
Abbreviated New Drug Application
TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE BLENHEIM PHARMACAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION TAMSULOSIN HYDROCHLORIDE CAPSULES USP, 0.4 MG THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TAMSULOSIN HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAMSULOSIN HYDROCHLORIDE. TAMSULOSIN HYDROCHLORIDE (TAMSULOSIN HYDROCHLORIDE) CAPSULE FOR ORAL USE. INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Warnings and Precautions Intraoperative Floppy Iris Syndrome ( 5.5) 7/2011 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 ( 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 ( 5.2, 7.2, 12.3) Exercise caution with concomitant administration of war Llegiu el document complet