LISINOPRIL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

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Ladda ner Produktens egenskaper (SPC)
20-06-2014

Aktiva substanser:

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

Tillgänglig från:

ReadyMeds

INN (International namn):

LISINOPRIL

Sammansättning:

LISINOPRIL 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Lisinopril tablet is 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 different mec

Produktsammanfattning:

Lisinopril Tablets 2.5 mg are white, oval shaped, convex tablets, debossed “4209” on one side and “V” on the reverse side; and supplied as follows: Lisinopril Tablets 5 mg are white, capsule shaped, convex, bisected tablets, debossed “42/10” on one side and “V” on the reverse side; and supplied as follows: Lisinopril Tablets 10 mg are white, round, convex tablets, debossed “3972” on one side and “V” on the reverse side; and supplied as follows: Lisinopril Tablets 20 mg are white, round, convex tablets, debossed “3973” on one side and “V” on the reverse side; and supplied as follows: Lisinopril Tablets 30 mg are white, round, convex tablets, debossed “3974” on one side and “V” on the reverse side; and supplied as follows: Lisinopril Tablets 40 mg are white, round, convex tablets, debossed “4214” on one side and “V” on the reverse side; and supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

                                LISINOPRIL- LISINOPRIL TABLET
READYMEDS
----------
LISINOPRIL TABLETS, USP
RX ONLY
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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.
DESCRIPTION
Lisinopril is an oral long-acting angiotensin converting enzyme
inhibitor. Lisinopril, a synthetic peptide
derivative, is chemically described as (S)-1-[_N_
-(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 is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg
tablets for oral administration.
Lisinopril Tablets 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg contain
the following inactive
ingredients: corn starch, dibasic calcium phosphate dihydrate,
magnesium stearate, mannitol and talc.
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
decrease may result in a small increase of serum potassium. In
hypertensive patients with normal renal
function treated with lisinopril alone for up to 24 weeks, the mean
increase in serum potassium was
2
21
31
3
5
2
approximately 0.
                                
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