LISINOPRIL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

International Laboratories, LLC

INN (International Name):

LISINOPRIL

Composition:

LISINOPRIL 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lisinopril tablet USP is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older 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. 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 variet

Product summary:

Lisinopril tablet USP is available as uncoated biconvex tablets in adherence packages of below mentioned pack size Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Protect from moisture, freezing and excessive heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LISINOPRIL- LISINOPRIL TABLET
INTERNATIONAL LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LISINOPRIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LISINOPRIL TABLETS.
LISINOPRIL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1988
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AS SOON AS
POSSIBLE. (5.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS. (5.1)
INDICATIONS AND USAGE
Lisinopril tablet USP is an angiotensin converting enzyme (ACE)
inhibitor indicated for:
• Treatment of hypertension in adults and pediatric patients 6 years
of age and older (1.1)
• Adjunct therapy for heart failure (1.2)
• Treatment of Acute Myocardial Infarction (1.3)
DOSAGE AND ADMINISTRATION
Hypertension: Initial adult dose is 10 mg once daily. Titrate up to 40
mg daily based on blood pressure response.
Initiate patients on diuretics at 5 mg once daily (2.1)
Pediatric patients with glomerular filtration rate > 30 mL/min/1.73m :
Initial dose in patients 6 years of age and older is
0.07 mg per kg (up to 5 mg total) once daily (2.1)
Heart Failure: Initiate with 5 mg once daily. Increase dose as
tolerated to 40 mg daily (2.2)
Acute Myocardial Infarction (MI): Give 5 mg within 24 hours of MI.
Followed by 5 mg after 24 hours, then 10 mg once
daily (2.3)
Renal Impairment: For patients with creatinine clearance > 10 mL/min
and < 30 mL/min, halve usual initial dose. For
patients with creatinine clearance < 10 mL/min or on hemodialysis, the
recommended initial dose is 2.5 mg (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg (3)
CONTRAINDICATIONS
Angioedema or a history of hereditary or idiopathic angioedema (4)
Hypersensitivity (4)
Co-administration of aliskiren with lisinopril in patients with
diabetes (4, 7.4)
WARNINGS AND PRECAUTIONS
Angioedema: Disc