LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

International Laboratories, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Lisinopril and hydrochlorothiazide tablets USP are 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

Resumen del producto:

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with "LL" debossed on one side and "B01" on other side. They are supplied as follows: NDC 54458-886-10  Adherence packages of 30’s Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from excessive light and humidity. *AN69 is a registered trademark of Hospal Ltd. Manufactured by:     Lupin Limited Goa 403 722 INDIA or Lupin Limited Pithampur (M.P.) 454 775 INDIA Packaged by: International Laboratories, LLC St. Petersburg, FL 33710 Distributed by: Walmart Bentonville, AR 72716 Rev. 04/17                                                                                                                                                                                        LI0003

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
INTERNATIONAL LABORATORIES, LLC
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE AND LISINOPRIL
TABLET
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND
HYDROCHLOROTHIAZIDE AS SOON AS
POS S IBLE.
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 tablet 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 C
H N O •2H O and its structural formula is:
LISINOPRIL CHEM STRUCTURE
Lisinopril is a white to off-white, crystalline powder, with a
molecular weight of 441.53. 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:
HCTZ CHEM STRUCTURE
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.72, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
Lisinopril and hydrochlorothiazide tablets USP are available for oral
use in three tablet combinations of
lisinopril with hydrochlorothiazide: lisinopril and
hydrochlorothiazide tablets USP, 10 mg/12.5 mg,
containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide;
lisinopril and hydrochlorothiazide tablets
USP, 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg
hydrochlorothiazide; and lisinopril and
hydrochlorothiazide tablets USP, 20 mg/2