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:

Direct_Rx

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)]. 8.1 Pregnancy 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 the U.S. gene

Tóm tắt sản phẩm:

Tamsulosin Hydrochloride Capsules USP, 0.4 mg are olive green opaque/orange opaque size ‘0’ hard gelatin capsules imprinted with ‘D’ on cap and ‘53’ on body with black edible ink filled with white to off-white beadlets. Bottles of 100 Bottles of 500 3 x 10 Unit-dose Capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in tight container. Avoid excessive moisture. 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
DIRECT_RX
----------
TAMSULOSIN HYDROCHLORIDE
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 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.
Capsule: 0.4 mg are olive green opaque/orange opaque size ‘0’ hard
gelatin capsules
imprinted with ‘D’ on cap and ‘53’ on body with black edible
ink filled with white to off-
white beadlets.
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)].
5.1 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 risk of syncope [see Adverse Reactions (6.1)]. Patients
beginning treatment
with tamsulosin hydrochloride capsules should be cautioned to avoid
situations in which
injury could result should syncope occur.
5.2 Drug Interactions
Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6.
Tamsulosin
hydrochloride capsules 0.4 mg should not be used in combination with
strong inhibitors
of CYP3A4 (e.g., ketoconazole) [see Drug Interactions (7.1) and
Clinical Pharmacology
(12.3)]. Tamsulosin hydrochloride capsules should be used with caution
in combination
with moderate inhibitors of CYP3A4 (e.g., erythromycin), in
combination with strong
(e.g., paroxetine)