Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD)
Citron Pharma LLC
LISINOPRIL
LISINOPRIL 2.5 mg
ORAL
PRESCRIPTION DRUG
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
Lisinopril Tablets USP, 2.5 mg - White to off-white, round shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and ‘20’ on the other side. Bottles of 100 NDC 57237-052-00 (Non Child Resistant Closure) Bottles of 500 NDC 57237-052-05 (Non Child Resistant Closure) Lisinopril Tablets USP, 5 mg - Light red colored, round shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘2&1’ on either side of score line. Bottles of 100 NDC 57237-053-00 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-053-99 (Non Child Resistant Closure) Lisinopril Tablets USP, 10 mg - Light yellow colored, round shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘22’. Bottles of 100 NDC 57237-054-00 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-054-99 (Non Child Resistant Closure) Lisinopril Tablets USP, 20 mg - Light yellow colored, capsule shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘23’. Bottles of 100 NDC 57237-055-00 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-055-99 (Non Child Resistant Closure) Lisinopril Tablets USP, 30 mg - Light yellow colored, round shaped, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘24’. Bottles of 100 NDC 57237-056-00 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-056-99 (Non Child Resistant Closure) Lisinopril Tablets USP, 40 mg - Light yellow colored, capsule shaped, biconvex, uncoated tablets, debossed with ‘A’ on one side and on other side with ‘25’. Bottles of 100 NDC 57237-057-00 (Non Child Resistant Closure) Bottles of 1,000 NDC 57237-057-99 (Non Child Resistant Closure) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
LISINOPRIL - LISINOPRIL TABLET CITRON PHARMA LLC ---------- 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 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 in patients with diabetes (4, 7.4) WARNINGS AND PRECAUTIONS Angioedema: Discontinue lisinopril, provide appr Preberite celoten dokument