LISINOPRIL/HCTZ tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Direct_Rx

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

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 bottles of 100 and 500. Lisinopril and hydrochlorothiazide tablets, USP 20 mg/12.5 mg: Light blue, round, unscored, flat-faced, beveled-edge tablets, debossed “WATSON” and “861” on the periphery of one side and plain on the other side are supplied in bottles of 100 and 500. Lisinopril and hydrochlorothiazide tablets, USP 20 mg/25 mg: Pink, round, unscored, flat-faced, beveled-edge tablets, debossed “WATSON” and “862” on the periphery of one side and plain on the other side are supplied in bottles of 100 and 500. 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

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

LISINOPRIL/HCTZ- LISINOPRIL/HCTZ TABLET
DIRECT_RX
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LISINOPRIL
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.
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-[N2-(1-carboxy-3-phenylpropyl)-L-
lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O5•2H2O
and its structural
formula is:
[Structural Formula of Lisinopril]
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-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural
formula is:
[Structural Formula of Hydrochlorothiazide]
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, 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&C Blue #2
Aluminum Lake (20
mg/12.5 mg only), FD&C Red #40 Al