LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Bryant Ranch Prepack

INN (International namn):

LISINOPRIL

Sammansättning:

LISINOPRIL 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Lisinopril and Hydrochlorothiazide Tablets USP, 10/12.5 mg are available as blue, round, biconvex, unscored tablets debossed and “5033” on one side and “10/12.5” on the other side containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP, packaged in bottles of 100 and 500 tablets. Lisinopril and Hydrochlorothiazide Tablets USP, 20/12.5 mg are available as yellow, round, flat-faced, beveled edge, unscored tablets debossed and “5034” on one side and “20/12.5” on the other side containing 20 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP, packaged in bottles of 100 and 500 tablets. Lisinopril and Hydrochlorothiazide Tablets USP, 20/25 mg are available as peach, round, flat-faced, beveled edge, unscored tablets debossed and “5032” on one side and “20/25” on the other side containing 20 mg lisinopril USP and 25 mg hydrochlorothiazide USP, packaged in bottles of 100 and 500 tablets. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM EXCESSIVE LIGHT AND HUMIDITY KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All trademarks are the property of their respective owners. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. I 11/2012

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
BRYANT RANCH PREPACK
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND
HYDROCHLOROTHIAZIDE 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 USP combines an
angiotensin-converting enzyme inhibitor,
lisinopril USP, and a diuretic, hydrochlorothiazide USP.
Lisinopril USP, a synthetic peptide derivative, is an oral long-acting
angiotensin-converting enzyme
inhibitor. It is chemically described as 1-[_N _
-[_(S)_-1-carboxy-3-phenylpropyl]-L-lysyl]-L-proline
dihydrate and has the following structural formula:
C
H N O •2H O M.W. 441.52
Lisinopril USP is a white to off-white, crystalline powder. It is
soluble in water, sparingly soluble in
methanol, and practically insoluble in ethanol.
Hydrochlorothiazide USP is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide and has the following structural formula:
2
21
31
3
5
2
C H ClN O S M.W. 297.74
Hydrochlorothiazide USP is a white, or practically white, crystalline
powder, which is slightly soluble
in water, but freely soluble in sodium hydroxide solution.
Lisinopril and hydrochlorothiazide tablets USP, for oral
administration, are available in three tablet
combinations of lisinopril with hydrochlorothiazide: lisinopril and
hydrochlorothiazide 10/12.5 mg,
containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP;
lisinopril and
hydrochlorothiazide 20/12.5 mg, containing 20 mg lisinopril USP and
12.5 mg hydrochlorothiazide USP
and lisinopril and hydrochlorothiazide 20/25 mg, containing 20 mg
lisinopril USP and 25 mg
hydrochlorothiazide USP. In addition, each lisinopril and
hydrochlorothiazide tablet USP contains the
following inactive ingredients: dibasic