LISINOPRIL tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

NuCare Pharmaceuticals,Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

20 mg Tablets: Yellow, round, unscored, flat-faced, beveled-edge tablets, debossed WATSON and 408 on the periphery of one side and plain on the other side. NDC 68071-5036-1 BOTTLES OF 1000 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 as defined in the USP.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LISINOPRIL- LISINOPRIL TABLET
NUCARE PHARMACEUTICALS,INC.
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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 TABLETS 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 tablets are 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 tablets in patients
with diabetes ( 4, 7.4)
WARNINGS AND PRECAUTION