LISINOPRIL tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Hikma Pharmaceutical

INN (mednarodno ime):

LISINOPRIL

Sestava:

LISINOPRIL 2.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Lisinopril Tablets, USP 2.5 mg: White, Capsule Shape Tablet; Debossed “WW 65” Bottles of 100 tablets Bottles of 1000 tablets Lisinopril Tablets, USP 5 mg: Red, Capsule Shape, Bisected Tablet; Debossed “WW 66” Bottles of 100 tablets Bottles of 1000 tablets Lisinopril Tablets, USP 10 mg: Pink, Round Tablet; Debossed “WW” on one side and “267” on the other side. Bottles of 100 tablets Bottles of 1000 tablets Lisinopril Tablets, USP 20 mg: Red, Round, Unscored Tablet; Debossed “WW 268” Bottles of 100 tablets Bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F) [ See USP Controlled Room Temperture]. Protect from moisture, freezing and execcive heat. Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure. Manufactured by: Hikma Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724 USA Revised January 2013

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

LISINOPRIL- LISINOPRIL TABLET
HIKMA PHARMACEUTICAL
----------
LISINOPRIL TABLETS, USP
LISINOPRIL TABLETS, USP
Rev. 01/13
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
· WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL 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.
DESCRIPTION
Lisinopril is an oral long-acting angiotensin converting enzyme
inhibitor. Lisinopril, a synthetic peptide
derivative, is chemically described as (S)-1-[_N_2-(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 and sparingly soluble in methanol and practically insoluble
in ethanol.
Lisinopril Tablets, USP are supplied as 2.5 mg, 5 mg, 10 mg and 20 mg
tablets for oral administration.
Inactive ingredients:
2.5 MG: Corn Starch, Colloidal Silicon Dioxide, Dibasic Calcium
Phosphate, Magnesium Stearate,
Mannitol, and Sodium Starch Glycolate.
5 MG, 10 MG AND 20 MG: Corn Starch, Colloidal Silicon Dioxide, Dibasic
Calcium Phosphate,
Magnesium Stearate, Mannitol, Red Iron Oxide, and Sodium Starch
Glycolate.
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
aldosterone secretion. The latter
21
31
3
5
2
decrease may result in a small increa