LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NuCarePharmaceuticals, Inc.

INN (mednarodno ime):

LISINOPRIL

Sestava:

LISINOPRIL 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Lisinopril and hydrochlorothiazide tablets, USP 10 mg/12.5 mg: Pink, round, unscored, flat-faced, beveled-edge tablets, debossed “ WATSON ” and “ 860 ” on the periphery of one side and plain on the other side are supplied in bottles of 30 NDC 68071-3008-3 bottles of 60 NDC 68071-3008-6 bottles of 90 NDC 68071-3008-9 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 according to USP/NF. *AN69 is a registered trademark of Hospal Ltd. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: February 2016

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
NUCAREPHARMACEUTICALS, INC.
----------
LISINOPRIL AND
HYDROCHLOROTHIAZIDE
TABLETS, USP
REVISED: FEBRUARY 2016
RX ONLY
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 RENNIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY
AND DEATH TO THE DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY.
DESCRIPTION
Lisinopril and hydrochlorothiazide, 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-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its empirical formula is C
H
CIN
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: 10 mg lisinopril and 12.5 mg hydrochlorothiazide USP, 20
mg lisinopril and
12.5 mg hydrochlorothiazide USP, and 20 mg lisinopril and 25 mg
hydrochlorothiazide
USP.
INACTIVE INGREDIENTS: In addition, each tablet contains the following
inactive
ingredients: colloidal silicon dioxide, dibasic calcium phosphate,
FD&C Blue #2 Aluminum
Lake (20 mg/12.5 mg only), FD&C Red #40 Aluminum Lake (10 mg/12.5 mg,
and 20
mg/25 mg), magnesium ste