LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
18-10-2019

유효 성분:

LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

제공처:

Preferred Pharmaceuticals Inc.

INN (International Name):

LISINOPRIL

구성:

LISINOPRIL 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Lisinopril and Hydrochlorothiazide Tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous  antihypertensive  drugs,  from  a  

제품 요약:

Lisinopril and hydrochlorothiazide tablets, USP 10 mg/12.5 mg: Pink, round, unscored, flat-faced, beveled-edge tablets, debossed “WATSON ” and “860 ” on the periphery of one side and plain on the other side are supplied in; Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive light and humidity. Dispense in a tight, light-resistant container according to USP/NF. Brands listed are trademarks of their respective owners. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: October 2017 Repackaged By: Preferred Pharmaceuticals Inc.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

                                LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
PREFERRED PHARMACEUTICALS INC.
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
• WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLETS AS
SOON AS POSSIBLE.
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO
THE DEVELOPING FETUS. SEE WARNINGS, _FETAL TOXICITY_.
DESCRIPTION
Lisinopril and Hydrochlorothiazide Tablets, USP combines an
angiotensin converting enzyme
inhibitor, lisinopril, and a diuretic, hydrochlorothiazide.
Lisinopril, a synthetic peptide derivative, is an oral long-acting
angiotensin converting enzyme inhibitor.
It is chemically described as
(_S_)-1-[_N_2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate.
Its
empirical formula is C
H N O •2H O and its structural formula is:
Lisinopril is a white to off-white, crystalline powder, with a
molecular weight of 441.52. It is soluble
in water, sparingly soluble in methanol, and practically insoluble in
ethanol.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its empirical formula is C H ClN O S and its structural formula is:
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.73, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
Lisinopril and Hydrochlorothiazide Tablets, USP is available for oral
use in three tablet combinations
of lisinopril with hydrochlorothiazide: Lisinopril and
Hydrochlorothiazide Tablets, USP 10-12.5,
21
31
3
5
2
7
8
3
4
2
containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide USP and
Lisinopril and
Hydrochlorothiazide Tablets, USP 20-12.5, containing 20 mg lisinopril
and 12.5 mg
hydrochlorothiazide USP and Lisinopril and Hydrochlorothiazide Tablets
20-25, containing 20 mg
lisinopril and 25 mg hydrochlorothiazide USP. Inactive ingredients are
colloidal silicon dioxide,
dibasic calcium phosphate, FD
                                
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