LISINOPRIL AND HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide 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:

Preferred Pharmaceuticals, Inc.

INN (International Name):

LISINOPRIL

Composition:

LISINOPRIL 10 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, 10/12.5 mg are available as blue, round, biconvex, unscored tablets debossed “Ivax hourglass logo” 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 30 (NDC 68788-7108-3) Bottles of 60 (NDC 68788-7108-6) Bottles of 90 (NDC 68788-7108-9) Bottles of 100 (NDC 68788-7108-1) 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 brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. M 9/2015 Repackaged By: Preferred Pharmaceuticals, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
5033
5034
5032
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
DESCRIPTION
Lisinopril and Hydrochlorothiazide Tablets USP combine 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:
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.
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 Tablets USP
10/12.5 mg, containing 10 mg lisinopril, USP and 12.5 mg
hydrochlorothiazide, USP; Lisinopril and
Hydrochlorothiazide Tablets USP 20/12.5 mg, containing 20 mg
lisinopril, USP and 12.5 mg
hydrochlorothiazide, USP; and Lisinopril and Hydrochlorothiazide
Tablets USP 20/25 mg, containing
20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. In addition,
each Lisinopr