Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K)
West-Ward Pharmaceuticals Corp.
PERINDOPRIL ERBUMINE
PERINDOPRIL ERBUMINE 2 mg
ORAL
PRESCRIPTION DRUG
Perindopril erbumine is indicated for the treatment of patients with essential hypertension. Perindopril erbumine may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. Perindopril erbumine is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Perindopril erbumine can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. Perindopril erbumine is contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor. Perindopril erbumine is also contraindicated in patients with hereditary or idiopathic angioedema. Do not co-administer aliskiren with perindopril erbumine in patients with diabetes [see Drug Interactions (7.8) ]. Perindopril erbumine is contraindicated in combination with neprilysin inhibitor (e.g., sacubitril).
Perindopril Erbumine Tablets USP 2 mg tablets are supplied as a white to off-white, round, biconvex tablet, debossed with product identification “54” over “551” on one side and scored on the other side. NDC 0054-0110-25: Bottle of 100 Tablets 4 mg tablets are supplied as a white to off-white, round, biconvex tablet, debossed with product identification “54” over “327” on one side and scored on the other side. NDC 0054-0111-25: Bottle of 100 Tablets 8 mg tablets are supplied as a white to off-white, round, biconvex tablet, debossed with product identification “54” over “715” on one side and scored on the other side. NDC 0054-0112-25: Bottle of 100 Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.
Abbreviated New Drug Application
PERINDOPRIL ERBUMINE- PERINDOPRIL ERBUMINE TABLET WEST-WARD PHARMACEUTICALS CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PERINDOPRIL ERBUMINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PERINDOPRIL ERBUMINE TABLETS. PERINDOPRIL ERBUMINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1993 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE • • DOSAGE AND ADMINISTRATION _Hypertension_ • _Stable Coronary Artery Disease_ • DOSAGE FORMS AND STRENGTHS Tablets: 2 mg, 4 mg and 8 mg (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD PHARMACEUTICALS CORP. AT 1-800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. WHEN PREGNANCY IS DETECTED, DISCONTINUE PERINDOPRIL ERBUMINE AS SOON AS POSSIBLE. (5.4) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.4) Perindopril erbumine is indicated for the treatment of patients with essential hypertension. (1.1) Perindopril erbumine is indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. (1.2) The recommended initial dose is 4 mg once a day. The dosage may be titrated upward until blood pressure, when measured just before the next dose, is controlled or to a maximum of 16 mg per day. (2.1) Perindopril should be given at an initial dose of 4 mg once daily for 2 weeks, and then increased, as tolerated, to a maintenance dose of 8 mg once daily. (2.2) Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema. (4, 5.1) Do not co-administer aliskiren with perindopril in patients with diabetes. (4, 7.8) Do not take a neprilysin inhibitor with perindopril. (4) Do not administer perindopril within Прочитайте повний документ