LISINOPRIL- lisinopril tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BluePoint Laboratories

INN (International Name):

LISINOPRIL

Composition:

LISINOPRIL 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lisinopril tablets are 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 variety

Product summary:

Lisinopril Tablets, USP, for oral administration, are available as 2.5 mg White, round, biconvex, uncoated tablets debossed “E 25” on one side and plain on the other side and supplied as: NDC 68001-272-00 bottles of 100 NDC 68001-272-08 bottles of 1000 5 mg Pink, capsule shaped, uncoated tablets, scored and debossed “E54 ” on one side and scored on the other side and supplied as: NDC 68001-267-00 bottles of 100 NDC 68001-267-08 bottles of 1000 10 mg Pink, round, biconvex, uncoated tablets debossed “E 101” on one side and plain on the other side and supplied as: NDC 68001-268-00 bottles of 100 NDC 68001-268-08 bottles of 1000 20 mg Peach, round, biconvex, uncoated tablets debossed “E 102” on one side and plain on the other side and supplied as: NDC 68001-269-00 bottles of 100 NDC 68001-269-08 bottles of 1000 30 mg Red, round, biconvex, uncoated tablets debossed “E 103” on one side and plain on the other side and supplied as: NDC 68001-270-00 bottles of 100 40 mg Yellow, round, biconvex, uncoated tablets debossed “E 104” on one side and plain on the other side and supplied as: NDC 68001-271-00 bottles of 100 NDC 68001-271-08 bottles of 1000 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LISINOPRIL- LISINOPRIL TABLET
BLUEPOINT LABORATORIES
----------
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._
•
•
INDICATIONS AND USAGE
Lisinopril tablets are an angiotensin converting enzyme (ACE)
inhibitor indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5mg, 10 mg, 20 mg, 30 mg, 40 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Common adverse reactions (events 2% greater than placebo) by use.
•
•
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)
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)
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 greater than 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)
2
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 greater than
or equal to 10 mL/min and less than or equal to
30 mL/min, halve usual initial dose. For patients with creatinine
clearance less than 10 mL/min or on hemodialysis, the
recommended initial dos