LISINOPRIL AND HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide tablets 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:

Solco Healthcare LLC

INN (Tarptautinis Pavadinimas):

LISINOPRIL

Sudėtis:

LISINOPRIL 10 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Lisinopril and hydrochlorothiazide 10-12.5 Tablets, USP, White to off-white, round tablets, imprinted with ‘H150’ on one side and plain on the other side. NDC 43547-420-10 Bottle of 100 tablets NDC 43547-420-50 Bottle of 500 tablets NDC 43547-420-11 Bottle of 1000 tablets Lisinopril and hydrochlorothiazide 20-12.5 Tablets, USP, Yellow, round tablets, imprinted with ‘H151’ on one side and plain on the other side. NDC 43547-421-10 Bottle of 100 tablets NDC 43547-421-50 Bottle of 500 tablets NDC 43547-421-11 Bottle of 1000 tablets Lisinopril and hydrochlorothiazide 20-25 Tablets, USP, Pink mottled, round tablets, imprinted with ‘H152’ on one side and plain on the other side. NDC 43547-422-10 Bottle of 100 tablets NDC 43547-422-50 Bottle of 500 tablets NDC 43547-422-11 Bottle of 1000 tablets Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. Dispense in a well-closed container, if product package is subdivided. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 04/2020 17727-02

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLETS TABLET
SOLCO HEALTHCARE LLC
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, FOR ORAL USE
RX ONLY
WARNING: FETAL TOXICITY
•
•
YOU MAY REPORT SIDE EFFECTS TO SOLCO HEALTHCARE US, LLC AT
1-866-257-2597 OR FDA AT 1-800-
FDA-1088.
DESCRIPTION
Lisinopril and hydrochlorothiazide tablets 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 441.52. 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 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
297.73, 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
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_.
21
31
3
5
2
7
8
3
4
2
of lisinopril with hydrochlorothiazide: lisinopril and
hydrochlorothiazide tablets 10-12.5 containing 10
mg lisinopril and 12.5 mg hydrochlorothiazide; lisinopril and
hydrochlorothiazide tablets 20-12.5
containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide; and,
lisinopril and hydrochlorothiazide
tablets 20-25 containing 20 mg lisinopril and 25 mg
hydrochlorothiazide.
INACT