Tri-Alzor

Per 20 mg/5 mg/12.5 mg FC tab Olmesartan medoxomil 20 mg, amlodipine besilate 5 mg, hydrochlorothiazide 12.5 mg. Per 40 mg/5 mg/12.5 mg FC tab Olmesartan medoxomil 40 mg, amlodipine besilate 5 mg, hydrochlorothiazide 12.5 mg. Per 40 mg/10 mg/12.5 mg FC tab Olmesartan medoxomil 40 mg, amlodipine besilate 10 mg, hydrochlorothiazide 12.5 mg

HTN.

Individualized dosage. May be increased in 2-wk interval as needed. Max: 40 mg/10 mg/25 mg once daily. Moderate hepatic impairment Max dose: Not to exceed 20 mg/5 mg/12.5 mg once daily.

May be taken with or without food: Swallow whole, do not chew/crush.

Hypersensitivity to olmesartan medoxomil, amlodipine besilate, hydrochlorothiazide or other sulfonamide-derived drugs. Patients w/ anuria. Not to be co-administered w/ aliskiren in patients w/ diabetes.

Not indicated for initial therapy. Patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system eg, patients w/ CHF. Electrolyte & metabolic imbalances. Antihypertensive effects may be enhanced in postsympathectomy patients. Hepatic impairment. Contraindicated in severe hepatic impairment, cholestasis or biliary obstruction. Renal impairment. Avoid use in severe renal impairment (CrCl <30 mL/min). Discontinue use when pregnancy is detected. Lactation. Childn. Elderly (frequent monitoring of BP). Olmesartan: Long-term use in patients w/ unilateral or bilateral renal artery stenosis. Sprue-like enteropathy. Amlodipine: Increased angina &/or MI in patients particularly those w/ severe obstructive CAD. Hydrochlorothiazide: May alter glucose tolerance & raise serum levels of cholesterol & triglycerides. Hyperuricemia may occur or frank gout may be precipitated. Decreases Ca excretion & may cause elevations of serum Ca. Monitor Ca levels. Discontinue use if acute myopia & secondary angle-closure glaucoma occur. Exacerbation or activation of SLE. Increased risk of non-melanoma skin cancer (basal & squamous cell carcinoma). Limit exposure to sunlight & UV rays. May precipitate azotemia in patients w/ renal disease. Olmesartan & amlodipine: Hypotension in vol- or salt-depleted patients.

Dizziness. Peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, URTI, diarrhea, UTI, joint swelling.

Olmesartan: May result in deterioration of renal function including possible acute renal failure w/ NSAIDs including selective COX-2 inhibitors. Antihypertensive effect may be attenuated w/ NSAIDs including selective COX-2 inhibitors. Increased risks of hypotension, hyperkalemia & changes in renal function (including acute renal failure) w/ dual blockade of the renin-angiotensin system w/ ARBs, ACE inhibitors or aliskiren. Reduced systemic exposure & peak plasma conc w/ colesevelam HCl. Increased serum lithium conc & toxicity. Amlodipine: Increased systemic exposure of simvastatin. May increase systemic exposure of cyclosporine or tacrolimus. Increased systemic exposure w/ moderate & strong CYP3A inhibitors. Closely monitor BP in co-administration w/ CYP3A inducers. Hydrochlorothiazide: Adjust dose of concomitant antidiabetic drugs (oral agents & insulin). Reduced absorption w/ cholestyramine or colestipol resins. Intensified electrolyte depletion particularly hypokalemia w/ corticosteroids, ACTH. Reduced diuretic, natriuretic & antihypertensive effects w/ NSAIDs.

Angiotensin II Antagonists / Calcium Antagonists / Diuretics

C09DX03 - olmesartan medoxomil, amlodipine and hydrochlorothiazide ; Belongs to the class of angiotensin II receptor blockers (ARBs), other combinations. Used in the treatment of cardiovascular disease.

Rx