Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K)
Marlex Pharmaceuticals Inc
PERINDOPRIL ERBUMINE
PERINDOPRIL ERBUMINE 4 mg
ORAL
PRESCRIPTION DRUG
Perindopril Erbumine Tablets are indicated for the treatment of patients with essential hypertension. Perindopril Erbumine Tablets may be used alone or given with other classes of antihypertensives, especially thiazide diuretics. Perindopril Erbumine Tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. Perindopril Erbumine Tablets can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy. Perindopril Erbumine Tablets are contraindicated in patients known to be hypersensitive (including angioedema) to this product or to any other ACE inhibitor. Perindopril Erbumine Tablets are 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 )] . Pregnancy Category D [see Boxed Warning and
Tablets are oblong with a score on one side. Keep out of the reach of children. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Protect from moisture.
New Drug Application
PERINDOPRIL ERBUMINE- PERINDOPRIL ERBUMINE TABLET MARLEX PHARMACEUTICALS INC ---------- 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 4 AND 8 MG TABLETS INITIAL U.S. APPROVAL: 1993 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE PERINDOPRIL ERBUMINE TABLETS 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) RECENT MAJOR CHANGES • Drug Interaction Dual Blockade of the Renin-Angiotensin System (7.8) 03/2013 INDICATIONS AND USAGE • Perindopril Erbumine Tablets are indicated for the treatment of patients with essential hypertension (1.1) • Perindopril Erbumine Tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction (1.2) DOSAGE AND ADMINISTRATION Hype rte nsion • 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) Stable Coronary Artery Disease • Perindopril Erbumine 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) DOSAGE FORMS AND STRENGTHS • Tablets: 4 and 8 mg (3) CONTRAINDICATIONS • Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema (4.0, 5.1) • Do not co-administer aliskiren with Perindopril Erbumine in patients with diabetes (4.0, 7.8) WARNINGS AND PRECAUTIONS • Watch for anaphylactoid reactions, including angioedema (5.1) • Monitor renal function during therapy (5.8) • Assess for hypotension and hyperkalemia (5.2, 5 Prečítajte si celý dokument