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:

Legacy Pharmaceutical Packaging, LLC

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 12.5 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 variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION ). In using lisinopril and hydrochlorothiazide tablets USP, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS ). In considering the use of lisinopril and hydrochlorothiazide tablets USP, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients. (See WARNINGS , Lisinopril ). Lisinopril and hydrochlorothiazide is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Lisinopril and hydrochlorothiazide is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril and Hydrochlorothiazide tablets USP within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS ). Do not co-administer aliskiren with lisinopril and hydrochlorothiazide in patients with diabetes (see PRECAUTIONS, Drug Interactions ).

Product summary:

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are blue, hexagonal tablets, with "LL" debossed on one side and "B01" on other side. Unit of Use Bottles of 30: 10 mg/12.5 mg (NDC 68645-556-54) Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are yellow, round tablets, with "LL" debossed on one side and "B02" on other side. Unit of Use Bottles of 30: 20 mg/12.5 mg (NDC 68645-557-54) Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are peach, round tablets, with "LL" debossed on one side and "B03" on other side. Unit of Use Bottles of 30: 20 mg/25 mg (NDC 68645-558-54) 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
LEGACY PHARMACEUTICAL PACKAGING, LLC
----------
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, 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
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
21
31
3
5
2
7
8
3
4
2
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 calcium pho