Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
OLMESARTAN MEDOXOMIL
OLMESARTAN MEDOXOMIL 20 mg
PRESCRIPTION DRUG
New Drug Application
BENICAR - OLMESARTAN MEDOXOMIL TABLET, FILM COATED LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BENICAR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BENICAR. BENICAR (OLMESARTAN MEDOXOMIL) TABLETS INITIAL U.S. APPROVAL: 2002 WARNING: AVOID USE IN PREGNANCY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ When pregnancy is detected, discontinue Benicar as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus (5.1). RECENT MAJOR CHANGES Dosage and Administration, Use in pediatric hypertension (6 to 16 years of age) (2.2) 2/2010 INDICATIONS AND USAGE Benicar is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension, alone or with other antihypertensive agents (1). DOSAGE AND ADMINISTRATION INDIC ATIO N STARTING DOSE DOSE RANGE Adult Hypertension (2.1) 20 mg once daily 20 - 40 mg once daily Pediatric Hypertension (6 - 16 years) (2.2) 20 to <35 kg 10 mg once daily ≥35 kg 20 mg once daily 20 to <35 kg 10 - 20 mg once daily ≥35 kg 20 - 40 mg once daily Benicar may be administered with or without food. If blood pressure is not controlled by Benicar alone, a diuretic may be added. Benicar may be administered with other antihypertensive agents. DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 20 mg, and 40 mg (3). CONTRAINDICATIONS None (4). WARNINGS AND PRECAUTIONS Avoid fetal (in utero) exposure (5.1). Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation (5.2). Monitor for worsening renal function in patients with renal impairment (5.3). ADVERSE REACTIONS The most common adverse reaction in adults was dizziness (3%) (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DAIICHI SANKYO, INC. AT 1-877-437-7763 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH USE IN SPECIFIC POPULATIONS Nursing mothers: C Perskaitykite visą dokumentą