LISINOPRIL AND HYDROCHLOROTHIAZIDE - lisinopril and hydrochlorothiazide tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Citron Pharma LLC

INN (الاسم الدولي):

LISINOPRIL

تركيب:

LISINOPRIL 10 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg are light pink colored, round shaped, biconvex, uncoated tablets debossed with ‘A’ on one side and ‘26’ on the other side. Each tablet contains 10 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:             Bottles of 100                                  NDC 57237-242-01 (Non Child Resistant Closure)             Bottles of 500                                  NDC 57237-242-05 (Non Child Resistant Closure)              Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg are light yellow colored, round shaped, biconvex, uncoated tablets debossed with ‘A’ on one side and ‘28’ on the other side. Each tablet contains 20 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows:             Bottles of 100                                  NDC 57237-243-01 (Non Child Resistant Closure)             Bottles of 500                                  NDC 57237-243-05 (Non Child Resistant Closure)             Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/25 m g are light pink colored, round shaped, biconvex, uncoated tablets debossed with ‘A’ on one side and ‘27’ on the other side. Each tablet contains 20 mg of lisinopril and 25 mg of hydrochlorothiazide. They are supplied as follows:                         Bottles of 100                                  NDC 57237-244-01 (Non Child Resistant Closure)             Bottles of 500                                  NDC 57237-244-05 (Non Child Resistant Closure)           Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. *AN69 is a registered trademark of Hospal Ltd. Distributed by: Citron Pharma LLC Suite -1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: TS/DRUGS/19/1993 Made in India Issued: 04/2016

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LISINOPRIL AND HYDROCHLOROTHIAZIDE - LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
CITRON PHARMA LLC
----------
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 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, 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
molecular 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 441.53. 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 molecular formula is C H ClN O S and its structural formula is:
Hydrochlorothiazide USP 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 is available for oral use in three
tablet combinations of lisinopril
with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets
USP, 10 mg/12.5 mg containing 10
mg lisinopril USP and 12.5 mg hydrochlorothiazide USP; lisinopril and
hydrochlorothiazide tablets
USP, 20 mg/12.5 mg containing 20 mg lisinopril USP and 12.5 mg
hydrochlorothiazide USP; and,
lisinopril and hydrochlorothiazide tablets USP, 20 mg/25 mg containing
20 mg lisinopril USP and 25 mg
hydrochlorothiazide USP.
Inactive ingredients are dibasic ca