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:

Preferred Pharmaceuticals Inc.

INN (International Nazwa):

HYDROCHLOROTHIAZIDE

Skład:

HYDROCHLOROTHIAZIDE 25 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 a

Podsumowanie produktu:

Lisinopril and Hydrochlorothiazide Tablets, USP 20/25 mg are Peach-Red with White Mottling, Round, Unscored Tablet, Debossed "WW 64" and are available in: Storage 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 as defined in the USP using a child-resistant closure. *AN69 is a registered trademark of Hospal Ltd. Manufactured By: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 Revised September 2015 Repackaged By: Preferred Pharmaceuticals Inc .

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LISINOPRIL WITH HYDROCHLOROTHIAZIDE- LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
PREFERRED PHARMACEUTICALS INC.
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLETS,
USP 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 combine 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 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.
21
31
3
5
2
7
8
3
4
2
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: