LISINOPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

LISINOPRIL

Composition:

LISINOPRIL 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 differe

Product summary:

Lisinopril Tablets, USP are available as: 2.5 mg tablet is a white to off-white, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "2.5" on other side. 5 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with "5" debossed on one side and breakline on other side. 10 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "10" on other side. 20 mg tablet is a pink coloured, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "20" on other side. 30 mg tablet is a red coloured, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "30" on other side. 40 mg tablet is a yellow coloured, round, biconvex, uncoated, tablet with "LUPIN" debossed on one side and "40" on other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage: Store at 20º to 25ºC (68º to 77ºF)[see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LISINOPRIL - LISINOPRIL TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
LISINOPRIL TABLETS USP
2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG AND 40 MG
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 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 - colloidal silicon dioxide, dibasic calcium phosphate,
magnesium stearate, mannitol, pre-
gelatinized starch, starch.
5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide,
dibasic calcium phosphate,
magnesium stearate, mannitol, pre-gelatinized starch, red iron oxide,
starch.
40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate,
magnesium stearate, mannitol, pre-
gelatinized starch, starch, yellow iron oxide.
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