Olmesartan Medoxomil And Amlodipine Besylate And Hydrochlorothiazide

1 INDICATIONS AND USAGE Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets.

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 or FDA at 1-800-332-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations]. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents.

WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets as soon as possible. ( 5.1 , 8.1 ) • Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration ( 5.2 ). • Monitor renal function and potassium in susceptible patients • Increased angina or myocardial infarction with calcium channel blockers may occur upon dosage initiation or increase ( 5.3 ). • Observe for signs of fluid or electrolyte imbalance ( 5.6 ). • Exacerbation or activation of systemic lupus erythematosus ( 5.8 ). • Acute angle-closure glaucoma ( 5.9 ). • Sprue-like enteropathy has been reported. Consider discontinuation of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in cases where no other etiology is found ( 5.10 ). 5.1 Fetal toxicity Olmesartan medoxomil. 4 CONTRAINDICATIONS Because of the hydrochlorothiazide component, olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs.