TAMSULOSIN HYDROCHLORIDE- tamsulosin hydrochloride capsule

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I)

থেকে পাওয়া:

REMEDYREPACK INC.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Tamsulosin Hydrochloride Capsules 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) ]. 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 are not indicated for use in women. Tamsulosin Hydrochlo

পণ্য সারাংশ:

Tamsulosin Hydrochloride Capsules, USP 0.4 mg are supplied in high density polyethylene bottles containing 30, 60,100,500 and 1000 hard gelatin capsules and Alu-Alu blisters containing 100 hard gelatin capsules with olive green opaque cap and orange opaque body. The capsules are imprinted on one side with “TAM” on cap & “0.4 mg” on body in black ink. Tamsulosin Hydrochloride Capsules, USP 0.4 mg, Bottles of 30's:  NDC 67877-450-30 Bottles of 60's:  NDC 67877-450-60 Bottles of 100's:  NDC 67877-450-01 Bottles of 500's:  NDC 67877-450-05 Bottles of 1000's:  NDC 67877-450-10 Carton  of Blister pack (10 x 10's): NDC 67877-450-38 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep Tamsulosin Hydrochloride Capsules, USP and all medicines out of reach of children.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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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, 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)
07/2014
INDICATIONS AND USAGE
Tamsulosin Hydrochloride Capsules 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 caut