TAMSULOSIN HYDROCHLORIDE capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Proficient Rx LP

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 Hydrochlori

Bidhaa muhtasari:

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 7's:  NDC 71205-217-07 Bottles of 14’s: NDC 71205-217-14 Bottles of 30's:  NDC 71205-217-30 Bottles of 60's:  NDC 71205-217-60 Bottles of 90's:  NDC 71205-217-90 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
PROFICIENT RX LP
----------
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
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
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)
· Intraoperative Floppy Iris Syndrome has been observed during
cataract and glaucoma surgery in some patients. Advise
patients considering cataract or glaucoma surgery to tell their
ophthalmologist that they have taken Tamsulosin
Hydrochloride Capsules. (5.5)
· Advise patients to be screened for the presence of prostate cancer
prior to treatment and at regular intervals afterwards
(5.4)
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASCEND LABORATORIES,
LLC AT 1-877-ASC-RX01 (877-
272-7901) OR FDA AT 1-800-332-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Tamsulosin Hydrochloride Capsules is an alpha adrenoceptor anta