Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)
Preferred Pharmaceuticals, Inc
TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE 0.4 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE PREFERRED PHARMACEUTICALS, INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION 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 CAPSULES USP*, 0.4 MG INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Dosage and Administration (2) 4/2009 Contraindications (4) 12/2009 Warnings and Precautions Drug Interactions (5.2) 12/2009 Screening for Prostate Cancer (5.4) 12/2009 INDICATIONS AND USAGE • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS • Tamsulosin hydrochloride is an alpha adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) 1 Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension (1) 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) Capsules: 0.4 mg (3) 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 (5.2, 7.1). 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 blo read_full_document