LISINOPRIL WITH HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

HYDROCHLOROTHIAZIDE

Skład:

HYDROCHLOROTHIAZIDE 12.5 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Lisinopril and hydrochlorothiazide tablets, USP 10/12.5 mg are Blue with White Mottling, Round, Unscored Tablets, Debossed “WW 62” and are available in: Bottles of 100 tablets                                                      NDC 0143-1262-01 Bottles of 1000 tablets                                                    NDC 0143-1262-10 Lisinopril and hydrochlorothiazide tablets, USP 20/12.5 mg are Yellow with White Mottling, Round, Unscored Tablets, Debossed “WW 63” and are available in: Bottles of 100 tablets                                                      NDC 0143-1263-01 Bottles of 1000 tablets                                                    NDC 0143-1263-10 Lisinopril and hydrochlorothiazide tablets, USP 20/25 mg are Peach-Red with White Mottling, Round, Unscored Tablets, Debossed “WW 64” and are available in: Bottles of 100 tablets                                                      NDC 0143-1264-01 Bottles of 1000 tablets                                                    NDC 0143-1264-10 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. Manufactured By: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 Revised April 2020

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LISINOPRIL WITH HYDROCHLOROTHIAZIDE- LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
HIKMA PHARMACEUTICALS USA INC.
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
REV. 04/2020
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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, 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 to off-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:
21
31
3
5
2
7
8
3
4 2
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 and Hydrochlorothiazide Tablets, USP
10/12.5 containing 10
mg lisinopril and 12.5 mg hydrochlorothiazide; Lisinopril and
Hydrochlorothiazide tablets,
USP 20/12.5 containing 20 mg lisinopril and 12.5 mg
hydrochlorothiazide; and Lisinopril
and Hydrochlorothiazide Tablets, USP 20/25 containing 20 mg lisinopril
and 25 mg
hydrochlorothiazide.
INACTIVE INGREDIENTS:
10/12.5 mg: Calcium Phosphate Dibasic, Collo