PERINDOPRIL ERBUMINE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

PERINDOPRIL ERBUMINE (UNII: 1964X464OJ) (PERINDOPRILAT - UNII:2UV6ZNQ92K)

Tilgjengelig fra:

Lannett Company, Inc.

INN (International Name):

PERINDOPRIL ERBUMINE

Sammensetning:

PERINDOPRIL ERBUMINE 4 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 Warn

Produkt oppsummering:

Tablets are oblong with a score on one side. Pink, debossed “ACN 4” on unscored side NDC 0527-1919-01 Salmon-colored, debossed “ACN 8” on unscored side NDC 0527-1920-01 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. For further information, please call our medical communications department toll-free at 1-800-325-9994.

Autorisasjon status:

New Drug Application

Preparatomtale

PERINDOPRIL ERBUMINE- PERINDOPRIL ERBUMINE TABLET
LANNETT COMPANY, 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, 5.6)
ADVERSE REACTIONS
HYPERTENSION: Most common a