Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
perindopril arginine (UNII: TFT5IM1KGB) (perindoprilat - UNII:2UV6ZNQ92K), amlodipine besylate (UNII: 864V2Q084H) (amlodipine - UNII:1J444QC288)
Marina BioTech
perindopril arginine
perindopril arginine 3.5 mg
ORAL
PRESCRIPTION DRUG
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
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).
New Drug Application
PRESTALIA- PERINDOPRIL ARGININE, AMLODIPINE BESYLATE TABLET MARINA BIOTECH ---------- 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, particularly in Izlasiet visu dokumentu