LISINOPRIL AND HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide tablets tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Exelan Pharmaceuticals, Inc.

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 are available in three combinations of lisinopril with hydrochlorothiazide; 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. The 10 mg/12.5 mg tablets are peach, round, biconvex, bevel-edged tablets debossed IG on one side and 446 on the other side. They are available as follows: NDC-76282-446-90     bottles of 90 tablets NDC-76282-446-01     bottles of 100 tablets NDC-76282-446-05     bottles of 500 tablets NDC-76282-446-10     bottles of 1000 tablets The 20 mg/12.5 mg tablets are white to off-white, round, biconvex, bevel-edged tablets debossed IG on one side and 447 on the other side. They are available as follows: NDC-76282-447-90     bottles of 90 tablets NDC-76282-447-01     bottles of 100 tablets NDC-76282-447-05     bottles of 500 tablets NDC-76282-447-10     bottles of 1000 tablets The 20 mg/25 mg tablets are peach, round, biconvex, bevel-edged tablets debossed IG on one side and 448 on the other side. They are available as follows: NDC-76282-448-90     bottles of 90 tablets NDC-76282-448-01     bottles of 100 tablets NDC-76282-448-05     bottles of 500 tablets NDC-76282-448-10     bottles of 1000 tablets 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: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc. Boca Raton, FL 33432 Rev: 10-2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLETS TABLET
EXELAN PHARMACEUTICALS, INC.
----------
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 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.
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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-[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, USP 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-2H-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide. Its empirical formula is C H ClN O S and its
structural formula
is:
21
31
3
5
2
7
8
3
4 2
Hydrochlorothiazide, USP 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 10 mg/12