LISINOPRIL AND HYDROCHLOROTHIAZIDE- 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:

REMEDYREPACK INC.

INN (Tarptautinis Pavadinimas):

LISINOPRIL

Sudėtis:

LISINOPRIL 20 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Lisinopril and hydrochlorothiazide t ablets 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 var

Produkto santrauka:

Lisinopril and Hydrochlorothiazide Tablets, for oral administration, are available as: 10 mg/12.5 mg Light pink, round, biconvex tablets, debossed " E " over "71" on one side and plain on the other and supplied as: NDC 0185-7100-01 bottles of 100 NDC 0185-7100-10 bottles of 1000 20 mg/12.5 mg White, round, biconvex tablets, debossed " E " over "152" on one side and plain on the other and supplied as: NDC 0185-0152-01 bottles of 100 NDC 0185-0152-10 bottles of 1000 20 mg/25 mg Light pink, round, biconvex tablets, debossed " E " over "173" on one side and plain on the other and supplied as: NDC 0185-0173-01 bottles of 100 NDC 0185-0173-10 bottles of 1000 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. *AN69 is a registered trademark of Hospal Ltd. Manufactured by Sandoz Inc. Princeton, NJ 08540 46192944 Rev. September 2018 MF7100REV09/18 7459

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
REMEDYREPACK INC.
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND
HYDROCHLOROTHIAZIDE AS SOON AS
POS S IBLE.
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 combines an angiotensin converting
enzyme inhibitor, lisinopril, and
a diuretic, hydrochlorothiazide.
Lisinopril, USP, 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 441.52. It is
soluble in water, sparingly soluble in methanol, and practically
insoluble in ethanol.
Hydrochlorothiazide, USP 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 297.73, 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, 10 mg/12.5 mg, 20
mg/12.5 mg, and 20 mg/25 mg.
Inactive ingredients are: calcium phosphate, colloidal silicon
dioxide, crospovidone, magnesium
stearate, mannitol, and pregelatinized starch (corn). Lisinopril and
hydrochlorothiazide Tablets, 10
mg/12.5 mg, and 20 mg/25 mg also contain iron oxides.
CLINICAL PHARMACOLOGY
LISINOPRIL AND HYDROCHLOROTHIAZIDE
As a result of i