benniacr说明书.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS AND STRENGTHS These highlights do not include all the information needed to use Benicar safely and effectively. See full prescribing Tablets: 5 mg, 20 mg, and 40 mg (3). information for Benicar. CONTRAINDICATIONS Benicar (olmesartan medoxomil) Tablets Initial U.S. Approval: 2002 None (4). WARNING: AVOID USE IN PREGNANCY WARNINGS AND PRECAUTIONS See full prescribing information for complete boxed warning. • Avoid fetal (in utero) exposure (5.1). When pregnancy is detected, discontinue Benicar as soon as • Observe for signs and symptoms of hypotension in volume- possible. Drugs that act directly on the renin-angiotensin or salt-depleted patients with treatment initiation (5.2). system can cause injury and even death to the developing • Monitor for worsening renal function in patients with renal fetus (5.1). impairment (5.3). ADVERSE REACTIONS RECENT MAJOR CHANGES The most common adverse reaction in adults was dizziness (3%) Dosage and Administration, Use in pediatric hypertension (6 to (6.1). 16 years of age) (2.2) 2/2010 To report SUSPECTED ADVERSE REACTIONS, contact INDICATIONS AND USAGE