Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
AZILSARTAN KAMEDOXOMIL (UNII: WEC6I2K1FC) (AZILSARTAN - UNII:F9NUX55P23)
Takeda Pharmaceuticals America, Inc.
AZILSARTAN KAMEDOXOMIL
AZILSARTAN MEDOXOMIL 40 mg
PRESCRIPTION DRUG
New Drug Application
EDARBYCLOR- AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE TABLET TAKEDA PHARMACEUTICALS AMERICA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE EDARBYCLOR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EDARBYCLOR. EDARBYCLOR (AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2011 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • RECENT MAJOR CHANGES Contraindications (4) 10/2012 INDICATIONS AND USAGE Edarbyclor is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension, to lower blood pressure: • • Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1) DOSAGE AND ADMINISTRATION • • • • • • • DOSAGE FORMS AND STRENGTHS Tablets (azilsartan/chlorthalidone): 40/12.5 mg and 40/25 mg (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • WHEN PREGNANCY IS DETECTED, DISCONTINUE EDARBYCLOR 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) In patients not adequately controlled with monotherapy (1) As initial therapy in patients likely to need multiple drugs to help achieve blood pressure goals (1) Starting dose is 40/12.5 mg once daily (2.1) Edarbyclor may be used to provide additional blood pressure lowering for patients not adequately controlled on azilsartan medoxomil 80 mg or chlorthalidone 25 mg (2.1) Dose may be increased to 40/25 mg after 2 to 4 weeks as needed to achieve blood pressure goals (2.1) Maximal dose is 40/25 mg (2.1) May be administered with other antihypertensive agents (2.1) Edarbyclor may be administered with or without food (2.1) Replace volume in volume-depleted patients prior to use (2.2) Anuria (4) Do not coadminister aliskiren with Edarbyclor in patients with diabe Prečítajte si celý dokument