Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)
Sun Pharmaceutical Industries, Inc.
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 capsule is 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. general
Tamsulosin hydrochloride capsules USP, 0.4 mg are supplied in high density polyethylene bottles as follows: Hard gelatin capsules, size ‘2’ Olive Green colored cap and Light Yellow colored body with “160” imprinted in black ink on cap and body, containing white to off white pellets. Bottles of 30’s with Child Resistant Cap……………NDC 62756-160-83 Bottles of 90’s with Child Resistant Cap……………NDC 62756-160-81 Bottles of 100’s with Child Resistant Cap…………..NDC 62756-160-88 Bottles of 100’s with Non Child Resistant Cap……..NDC 62756-160-08 Bottles of 500’s with Non Child Resistant Cap……..NDC 62756-160-13 Bottles of 1000’s with Non Child Resistant Cap…....NDC 62756-160-18 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.
Abbreviated New Drug Application
TAMSULOSIN HYDROCHLORIDE - TAMSULOSIN HYDROCHLORIDE CAPSULE SUN PHARMACEUTICAL INDUSTRIES, 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 CAPSULES. TAMSULOSIN HYDROCHLORIDE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE Tamsulosin hydrochloride is 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 hydrochloride 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) Exercise caution with concomitant administration of warfarin (5.2, 7.4, 12.3) Advise patients about the possibility and seriousness of priapism (5.3) Intraope Prečítajte si celý dokument