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:

Mylan Pharmaceuticals Inc.

INN (International Name):

LISINOPRIL

Composition:

LISINOPRIL 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lisinopril and hydrochlorothiazide tablets 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 vari

Product summary:

Lisinopril and Hydrochlorothiazide Tablets, USP are available containing lisinopril, USP 10 mg and hydrochlorothiazide, USP 12.5 mg, lisinopril, USP 20 mg and hydrochlorothiazide, USP 12.5 mg or lisinopril, USP 20 mg and hydrochlorothiazide, USP 25 mg. The 10 mg/12.5 mg tablets are white, round, unscored tablets debossed with LH1 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-1012-01 bottles of 100 tablets The 20 mg/12.5 mg tablets are yellow, round, unscored tablets debossed with LH2 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-2012-01 bottles of 100 tablets The 20 mg/25 mg tablets are green, round, unscored tablets debossed with LH3 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-2025-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from excessive light and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 10/2017 LSHCTZ:R18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
MYLAN PHARMACEUTICALS INC.
----------
WARNING: FETAL TOXICITY
•
•
DESCRIPTION
Lisinopril and hydrochlorothiazide tablets, USP combine 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 1-[_N_
-[(_S_)-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline dihydrate. Its
molecular 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 441.52. 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 molecular formula is C H ClN O S and its structural formula is:
Hydrochlorothiazide, USP is a white, or practically white, crystalline
powder with a molecular weight
of 297.75, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
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.
2
21
31
3
5
2
7
8
3
4
2
Lisinopril and hydrochlorothiazide tablets are available for oral use
in three tablet combinations of
lisinopril with hydrochlorothiazide: lisinopril and
hydrochlorothiazide tablets 10 mg/12.5 mg,
containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide,
lisinopril and hydrochlorothiazide tablets
20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg
hydrochlorothiazide, and lisinopril and
hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril
and 25 mg hydrochlorothiazide.
Inactive ingredients are colloidal silicon dioxide, croscarmellose
sodium, dibasic calcium phosphate
(dihydrate), magnesium stearate, mannitol