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:

NuCare Pharmaceuticals,Inc.

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 hydrochlor

Bidhaa muhtasari:

Tamsulosin hydrochloride capsules, USP are comprising of olive green opaque cap imprinted CL 23, and orange opaque body imprinted 0.4 in black ink. Tamsulosin hydrochloride capsules, USP 0.4 mg are supplied as below: NDC 68071-4872-9 BOTTLES OF 90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tamsulosin hydrochloride capsules and all medicines out of reach of children.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
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 is an alpha1 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
blocki