País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)
McKesson Corporation dba SKY Packaging
TAMSULOSIN HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE 0.4 mg
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 are not indicated for the treatment of hypertension. 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)]. Risk Summary Tamsulosin hydrochloride capsules are not indicated for use in women. There are no adequate data on the developmental risk associated with the use of Tamsulosin hydrochloride capsules 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.
Tamsulosin Hydrochloride Capsules USP, 0.4 mg are white to off-white free flowing pellets filled in size '2' empty hard gelatin capsules with green colored cap printed with "ZA-18" in black ink and peach colored body printed with "0.4 mg" in black ink and are supplied as follows: Boxes of 10x10 UD 100 NDC 63739-567-10 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.
Abbreviated New Drug Application
TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE MCKESSON CORPORATION DBA SKY PACKAGING ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TAMSULOSIN HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TAMSULOSIN HYDROCHLORIDE CAPSULES. TAMSULOSIN HYDROCHLORIDE CAPSULES USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Dosage and Administration (2) 10/2014 Warnings and Precautions Intraoperative Floppy Iris Syndrome (5.5) 7/2014 INDICATIONS AND USAGE Tamsulosin hydrochloride capsules are an alpha 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) DOSAGE AND ADMINISTRATION 0.4 mg once daily taken approximately one-half hour following the same meal each day. Tamsulosin capsules 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 ( 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) Exerc Leer el documento completo