LISINOPRIL- lisinopril tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Mylan Institutional Inc.

INN (mednarodno ime):

LISINOPRIL

Sestava:

LISINOPRIL 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Lisinopril Tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of lisinopril, USP. The 5 mg tablet is a peach, round, scored tablet debossed with M over L23 on one side of the tablet and scored on the other side. They are available as follows: NDC 51079-981-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-981-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each). The 10 mg tablet is a white, round, unscored tablet debossed with L over 24 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-982-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-982-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each). The 20 mg tablet is a yellow, round, unscored tablet debossed with L over 25 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-983-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). NDC 51079-983-56 – Unit dose punch cards of 300 (10 punch cards of 30 tablets each). The 40 mg tablet is a green, round, unscored tablet debossed with L over 26 on one side of the tablet and M on the other side. They are available as follows: NDC 51079-984-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture, freezing and excessive heat.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

LISINOPRIL- LISINOPRIL TABLET
MYLAN INSTITUTIONAL INC.
----------
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 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/1.73 m
: 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 PRECAUTIONS
Angioedema: Disc