LISINOPRIL tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)

متاح من:

Aphena Pharma Solutions - Tennessee, LLC

INN (الاسم الدولي):

LISINOPRIL

تركيب:

LISINOPRIL 2.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Lisinopril 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. 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 variety of pharmacologic classes and with differ

ملخص المنتج:

2.5 mg Tablets: White, round, biconvex, bevel-edged tablets debossed with ‘IG’ on one side and “417” on the other side are supplied in bottle of 30 tablets (NDC 76282-417-30), bottle of 45 tablets (NDC 76282-417-45) bottle of 90 tablets (NDC 76282-417-90) bottle of 100 tablets (NDC 76282-417-01), bottle of 180 tablets (NDC 76282-417-18), bottle of 500 tablets (NDC 76282-417-05) and 1000 tablets (NDC 76282-417-10). 5 mg Tablets: Red, round, biconvex, bevel-edged tablets debossed with ‘I’ on the left side of functional score and ‘G’ on the right side of functional score, and “418” on the other side are supplied in bottles of 30 tablets (NDC 76282-418-30), bottle of 45 tablets (NDC 76282-418-45) bottle of 90 tablets (NDC 76282-418-90) bottle of 100 tablets (NDC 76282-418-01), bottle of 180 tablets (NDC 76282-418-18), bottle of 500 tablets (NDC 76282-418-05) and 1000 tablets (NDC 76282-418-10). 10 mg Tablets: Red, round, biconvex, bevel-edged tablets debossed with ‘IG’ on one side and “419” on the other side are supplied in bottles of 30 tablets (NDC 76282-419-30), bottle of 45 tablets (NDC 76282-419-45) bottle of 90 tablets (NDC 76282-419-90) bottle of 100 tablets (NDC 76282-419-01) bottle of 180 tablets (NDC 76282-419-18), bottle of 500 tablets (NDC 76282-419-05), and 1000 tablets (NDC 76282-419-10). 20 mg Tablets: Red, round, biconvex, bevel-edged tablets debossed with ‘IG’ on one side and “420” on the other side are supplied in bottles of 30 tablets (NDC 76282-420-30), bottle of 45 tablets (NDC 76282-420-45) bottle of 90 tablets (NDC 76282-420-90) bottle of 100 tablets (NDC 76282-420-01), bottle of 180 tablets (NDC 76282-420-18), bottle of 500 tablets (NDC 76282-420-05) and 1000 tablets (NDC 76282-420-10). 30 mg Tablets: Red, round, biconvex, bevel-edged tablets debossed with ‘IG’ on one side and “421” on the other side are supplied in bottles of 30 tablets (NDC 76282-421-30), bottle of 45 tablets (NDC 76282-421-45) bottle of 90 tablets (NDC 76282-421-90) bottle of 100 tablets (NDC 76282-421-01), bottle of 180 tablets (NDC 76282-421-18), bottle of 500 tablets (NDC 76282-421-05) and 1000 tablets (NDC 76282-421-10). 40 mg Tablets: Yellow, round, biconvex, bevel-edged tablets debossed with ‘IG’ on one side and “422” on the other side are supplied in bottles of 30 tablets (NDC 76282-422-30), bottle of 45 tablets (NDC 76282-422-45) bottle of 90 tablets (NDC 76282-422-90) bottle of 100 tablets (NDC 76282-422-01), bottle of 180 tablets (NDC 76282-422-18), bottle of 500 tablets (NDC 76282-422-05) and 1000 tablets (NDC 76282-422-10). Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container. *AN69 is a registered trademark of Hospal Ltd All brand names listed are the registered trademarks of their respective owners and are not trademarks of Exelan Pharmaceuticals, Inc. Manufactured for: Exelan Pharmaceuticals, Inc. Lawrenceville, GA 30046 Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Rev: 11/13 Barcode: 422-11-2013

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LISINOPRIL- LISINOPRIL TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
LISINOPRIL TABLETS, USP
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
DESCRIPTION
Lisinopril, USP is an oral long-acting angiotensin converting enzyme
inhibitor. Lisinopril,
USP a synthetic peptide derivative, is chemically described as
(S)-1-[N -(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 and sparingly soluble in methanol and
practically insoluble in
ethanol.
Lisinopril tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30
mg and 40 mg
tablets for oral administration.
Inactive Ingredients:
2.5 mg tablets – lactose monohydrate, maize starch, colloidal
silicon dioxide, magnesium
stearate.
5 mg, 10 mg, 20 mg and 30 mg tablets – lactose monohydrate, maize
starch, colloidal
silicon dioxide, magnesium stearate, iron oxide red.
40 mg tablets - lactose monohydrate, maize starch, colloidal silicon
dioxide, magnesium
stearate, iron oxide yellow.
WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL 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.
2
21
31
3
5
2
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lisinopril inhibits angiotensin-converting enzyme (ACE) in human
subjects and animals.
ACE is a peptidyl dipeptidase that catalyzes the conversion of
angiotensin I to the
vasoconstrictor substance, angiotensin II. Angiotensin II also
stimulates aldosterone
secretion by the adrenal cortex. The beneficial effects of lisinopril
in hypertension and
heart failure appear to result primarily from suppression of the
renin-angiotensin-
aldosterone system. Inhibition of ACE results in decreased plasma
angiotensin II which
leads to decreased vasopressor activity and to decreased aldosteron