TAMSULOSIN HYDROCHLORIDE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

RedPharm Drug, Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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)]. Risk Summary Tamsulosin hydrochloride is not indicated for use in women. There are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride 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

Tóm tắt sản phẩm:

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:  Bottle of 30 capsules          NDC 33342-159-07 Bottle of 100 capsules       NDC 33342-159-11 Bottle of 500 capsules       NDC 33342-159-15 Bottle of 1000 capsules    NDC 33342-159-44  Unit dose package of 100 capsules     NDC 33342-159-12 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.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

TAMSULOSIN HYDROCHLORIDE- TAMSULOSIN HYDROCHLORIDE CAPSULE
REDPHARM DRUG, INC.
----------
TAMSULOSIN 0.4MG
1 INDICATIONS & USAGE
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.
2 DOSAGE & ADMINISTRATION
Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as
the dose for
the treatment of the signs and symptoms of BPH. It should be
administered
approximately one-half hour following the same meal each day.
Tamsulosin
hydrochloride capsules should not be crushed, chewed or opened.
For those patients who fail to respond to the 0.4 mg dose after 2 to 4
weeks of dosing,
the dose of Tamsulosin hydrochloride capsules can be increased to 0.8
mg once daily.
Tamsulosin hydrochloride capsules 0.4 mg should not be used in
combination with
strong inhibitors of CYP3A4 (e.g., ketoconazole) _[see Warnings and
Precautions ( 5.2)]. _
If tamsulosin hydrochloride capsules administration is discontinued or
interrupted for
several days at either the 0.4 mg or 0.8 mg dose, therapy should be
started again with
the 0.4 mg once-daily dose.
3 DOSAGE FORMS & STRENGTHS
Tamsulosin hydrochloride capsule, USP: 0.4 mg, olive green opaque cap
imprinted “CL
23” and orange opaque body imprinted "0.4" in black ink.
4 CONTRAINDICATIONS
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)]._
5 WARNINGS AND PRECAUTIONS
5.1 ORTHOSTASIS
The signs and symptoms of orthostasis (postural hypotension,
dizziness, and vertigo)
were detected more frequently in tamsulosin hydrochloride
capsule-treated patients
than in placebo recipients. As with other alpha adrenergic blocking
agents there is a
potential ri