PERINDOPRIL ERBUMINE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

West-Ward Pharmaceuticals Corp.

INN (Nome Internazionale):

PERINDOPRIL ERBUMINE

Composizione:

PERINDOPRIL ERBUMINE 2 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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).

Dettagli prodotto:

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. 

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PERINDOPRIL ERBUMINE- PERINDOPRIL ERBUMINE TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
_Hypertension_
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_Stable Coronary Artery Disease_
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DOSAGE FORMS AND STRENGTHS
Tablets: 2 mg, 4 mg and 8 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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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