LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with "LL" debossed on one side and "B03" on other side. They are supplied as follows: Bottles of 20 NDC 68071-1945-2 Bottles of 30 NDC 68071-1945-3 Bottles of 60 NDC 68071-1945-6 Bottles of 90 NDC 68071-1945-9 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
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 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 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 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:
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular
21
31
3
5
2
7
8
3
4
2
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/25 mg, containing 20 mg
lisinopril and 25 mg
hydrochlorothiazide.
Inactive ingredients are dibasic calciu