BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- bisoprolol fumarate and hydrochlorothiazide tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), BISOPROLOL FUMARATE (UNII: UR59KN573L) (BISOPROLOL - UNII:Y41JS2NL6U)

제공처:

NuCare Pharmaceuticals, Inc.

INN (국제 이름):

HYDROCHLOROTHIAZIDE

구성:

HYDROCHLOROTHIAZIDE 6.25 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension. Bisoprolol fumarate and hydrochlorothiazide tablets are contraindicated in patients in cardiogenic shock, overt cardiac failure (see WARNINGS), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.

제품 요약:

Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP are supplied as 10 mg/6.25 mg White coloured, biconvex, round, film coated tablets debossed with UL on one side and | | | on other side. Bottles of 30 NDC 68071-2131-3 Store at 20 0 to 25 0 C (68 0 to 77 0 F) [See USP Controlled Room Temperature]. Dispense in a tight container. Please address medical inquiries to Unichem's toll free # 1-866-562-4616.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE- BISOPROLOL FUMARATE AND
HYDROCHLOROTHIAZIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS USP
RX ONLY
DESCRIPTION
Bisoprolol fumarate and hydrochlorothiazide tablets USP are indicated
for the treatment of
hypertension. It combines two antihypertensive agents in a
once–daily dosage: a synthetic beta
-
selective (cardioselective) adrenoceptor blocking agent (bisoprolol
fumarate) and a benzothiadiazine
diuretic (hydrochlorothiazide).
Bisoprolol fumarate is chemically described as
(±)-1-[4-[[-2-(1-methylethoxy)ethoxy]methyl]
phenoxy]-3-[(1-methylethyl)amino]-2-propanol(
_E_)-2-butenedioate(2:1)(salt). It possesses an asymmetric
carbon atom in its structure and is provided as a racemic mixture. The
S(-) enantiomer is responsible for
most of the beta-blocking activity. Its molecular formula is (C
H
NO
)
•C
H
O
and it has a
molecular weight of 766.97. Its structural formula is:
Bisoprolol fumarate is a white crystalline powder, approximately
equally hydrophilic and lipophilic,
and readily soluble in water, methanol, ethanol, and chloroform.
Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-
_2H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide. It is a white, or practically white, practically odorless
crystalline powder. It is slightly soluble
in water, sparingly soluble in dilute sodium hydroxide solution,
freely soluble in n-butylamine and
dimethylformamide, sparingly soluble in methanol, and insoluble in
ether, chloroform, and dilute mineral
acids. Its molecular formula is C
H
ClN
O
S
and it has a molecular weight of 297.73. Its structural
1
18
31
4
2
4
4
4
7
8
3
4
2
formula is:
Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 2.5
mg/6.25 mg for oral administration
contains:
Bisoprolol fumarate USP….. 2.5 mg
Hydrochlorothiazide USP…. 6.25 mg
Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 5 mg/6.25
mg for oral administration
contains:
Bisoprolol fumarate USP….. 5 mg
Hydrochlorothiazide