PRESTALIA- perindopril arginine and amlodipine besylate tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

perindopril arginine (UNII: TFT5IM1KGB) (perindoprilat - UNII:2UV6ZNQ92K), amlodipine besylate (UNII: 864V2Q084H) (amlodipine - UNII:1J444QC288)

Tilgængelig fra:

Adhera Therapeutics, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

PRESTALIA contains perindopril arginine, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, and is indicated for the treatment of hypertension, to lower blood pressure. PRESTALIA may be used in patients whose blood pressure is not adequately controlled on monotherapy. PRESTALIA may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal 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, including amlodipine and the ACE inhibitor class to which perindopril principally belongs. There are no controlled trials demonstrating risk reduction with PRESTALIA. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithr

Produkt oversigt:

PRESTALIA is available as white, uncoated tablets containing perindopril arginine 3.5 mg, 7 mg, or 14 mg and amlodipine 2.5 mg, 5 mg, or 10 mg for the following three combinations of perindopril arginine/amlodipine: 3.5/2.5 mg, 7/5 mg, and 14/10 mg. All three strengths are packaged in bottles of 90 tablets. Each tablet is debossed with the tablet strength. Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).

Autorisation status:

New Drug Application

Produktets egenskaber

PRESTALIA- PERINDOPRIL ARGININE AND AMLODIPINE BESYLATE TABLET
ADHERA THERAPEUTICS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRESTALIA TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR PRESTALIA.
PRESTALIA (PERINDOPRIL ARGININE AND AMLODIPINE) TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 2015
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE PRESTALIA 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
Prestalia is a combination of perindopril, an angiotensin converting
enzyme inhibitor, and amlodipine, a dihydropyridine
calcium channel blocker, indicated for the treatment of hypertension
to lower blood pressure:
In patients not adequately controlled with monotherapy (1).
As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals (1).
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and myocardial
infarctions (1).
DOSAGE AND ADMINISTRATION
Initiate treatment at 3.5/2.5 mg, once daily. Adjust dose according to
blood pressure goals waiting 1 to 2 weeks between
titration steps (2.1).
DOSAGE FORMS AND STRENGTHS
Tablets (perindopril arginine/amlodipine): 3.5/2.5 mg, 7/5 mg and
14/10 mg (3).
CONTRAINDICATIONS
History of angioedema, or hypersensitivity to any ACE-inhibitor or to
amlodipine (4).
Do not use aliskiren with PRESTALIA in patients with diabetes (4).
Do not take a neprilysin inhibitor with PRESTALIA (4).
Do not administer PRESTALIA within 36 hours of switching to or from
sacubitril/valsartan (4).
WARNINGS AND PRECAUTIONS
Anaphylactoid reactions, including angioedema (head, neck, or
intestinal) (5.2).
Myocardial infarction: Worsening angina and acute myocardial
infarction can develop after starting or increasing the
dose of PRESTALIA, p