国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Azilsartan kamedoxomil (UNII: WEC6I2K1FC) (AZILSARTAN - UNII:F9NUX55P23), chlorthalidone (UNII: Q0MQD1073Q) (chlorthalidone - UNII:Q0MQD1073Q)
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
Azilsartan kamedoxomil
AZILSARTAN MEDOXOMIL 40 mg
ORAL
PRESCRIPTION DRUG
Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy. Edarbyclor may be used as initial therapy if a patient is 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 thiazide-like diuretics such as chlorthalidone and ARBs such as azilsartan medoxomil. There are no controlled trials demonstrating risk reduction with Edarbyclor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achi
Edarbyclor is supplied as fixed dose combination tablets that are round, biconvex, film-coated, and 9.7 mm in diameter. Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture and light. Do not repackage; dispense and store in original container.
New Drug Application
EDARBYCLOR- AZILSARTAN KAMEDOXOMIL AND CHLORTHALIDONE TABLET AZURITY PHARMACEUTICALS, INC. (FORMERLY ARBOR PHARMACEUTICALS) ---------- 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._ WHEN PREGNANCY IS DETECTED, DISCONTINUE EDARBYCLOR AS SOON AS POSSIBLE (5.1, 8.1) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.1, 8.1) INDICATIONS AND USAGE Edarbyclor is a combination of azilsartan medoxomil, an angiotensin II receptor blocker (ARB) and chlorthalidone, a thiazide-like diuretic combination product 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 help achieve 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 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) DOSAGE FORMS AND STRENGTHS Tablets (azilsartan/chlorthalidone): 40/12.5 mg and 40/25 mg (3) CONTRAINDICATIONS Anuria (4) Do not coadminister aliskiren-containing products with Edarbyclor in patients with diabetes (4) WARNINGS AND PRECAU 完全なドキュメントを読む