LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Aurobindo Pharma Limited

INN (Tarptautinis Pavadinimas):

LISINOPRIL

Sudėtis:

LISINOPRIL 10 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 (e.g., 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 use of Lisinopril and Hydrochlorothiazide Tablets, USP it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS ,  Head and Neck Angioedema ). Lisinopril and Hydrochlorothiazide Tablets are contraindicated in patients who are hypersensitive to any component of 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 Tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril and Hydrochlorothiazide Tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS ). Do not coadminister aliskiren with Lisinopril and Hydrochlorothiazide Tablets in patients with diabetes.

Produkto santrauka:

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are light pink colored, round shaped, biconvex, uncoated tablets debossed with ‘A’ on one side and ‘26’ on the other side. Each tablet contains 10 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:             Bottles of 30                                    NDC 65862-043-30 (Child Resistant Closure)             Bottles of 100                                  NDC 65862-043-01 (Child Resistant Closure)             Bottles of 100                                  NDC 65862-043-00 (Non Child Resistant Closure)             Bottles of 500                                  NDC 65862-043-05 (Non Child Resistant Closure)             Bottles of 1,000                                NDC 65862-043-99 (Non Child Resistant Closure) Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are light yellow colored, round shaped, biconvex, uncoated tablets debossed with ‘A’ on one side and ‘28’ on the other side. Each tablet contains 20 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:             Bottles of 30                                    NDC 65862-044-30 (Child Resistant Closure)             Bottles of 100                                  NDC 65862-044-01 (Child Resistant Closure)             Bottles of 100                                  NDC 65862-044-00 (Non Child Resistant Closure)             Bottles of 500                                  NDC 65862-044-05 (Non Child Resistant Closure)             Bottles of 1,000                                NDC 65862-044-99 (Non Child Resistant Closure) Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 mg are light pink colored, round shaped, biconvex, uncoated tablets debossed with ‘A’ on one side and ‘27’ on the other side. Each tablet contains 20 mg of lisinopril and 25 mg of hydrochlorothiazide. They are supplied as follows:             Bottles of 30                                    NDC 65862-045-30 (Child Resistant Closure)             Bottles of 100                                  NDC 65862-045-01 (Child Resistant Closure)             Bottles of 100                                  NDC 65862-045-00 (Non Child Resistant Closure)             Bottles of 500                                  NDC 65862-045-05 (Non Child Resistant Closure)             Bottles of 1,000                                NDC 65862-045-99 (Non Child Resistant Closure) Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 01/2022

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

LISINOPRIL AND HYDROCHLOROTHIAZIDE - LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
AUROBINDO PHARMA LIMITED
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
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 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-[_N_
-(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-_2H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its molecular formula is C H ClN O S and its structural
formula is:
2
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 297.73, which is slightly soluble in water, but
freely soluble in sodium
hydroxide solution.
Lisinopril and Hydrochlorothiazide Tablets 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 USP and 12.5 mg
hydrochlorothiazide USP; Lisinopril and Hydrochlorothiazide Tablets
USP, 20 mg/12.5 mg
containing 20 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP;
and, Lisinopril and
Hydrochlorothiazide Tablets USP, 20 mg/25 mg containing 20 mg
lisinopril USP and 25
mg hydrochlorothiazide USP.
Inactive ingredients are dibasic calcium phosphate, magnes