Indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. This fixed combination drug is not indicated for the initial therapy of hypertension.

Do not co-administer aliskiren with Tribenzor in patients with diabetes.

Avoid use of aliskiren with Tribenzor in patients with renal impairment (GFR <60 ml/min).

Because of the hydrochlorothiazide component, Tribenzor is contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs.

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics) symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil. Initiate treatment with Tribenzor under close medical supervision.

Patients with heart failure have decreased clearance of amlodipine with a resulting increase in AUC of approximately 40% to 60%.

Amlodipine: Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction upon starting calcium channel blocker therapy or at the time of dosage increase.

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with Tribenzor because of the olmesartan medoxomil component.

If progressive renal impairment becomes evident consider withholding or discontinuing Tribenzor.

Thiazides may precipitate azotemia in patients with renal disease.

Tribenzor contains hydrochlorothiazide which can cause hypokalemia, hyponatremia and hypomagnesemia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Tribenzor also contains olmesartan, a drug that affects the RAS. Drugs that inhibit the RAS can also cause hyperkalemia.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. 

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.

Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation.

Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine. Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure.

In general, avoid combined use of RAS inhibitors.

Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan.

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of olmesartan or thiazide diuretics.

Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin.

Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered.

Co-administration of amlodipine with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction.

Co-administration of hydrochlorothiazide with corticosteroids and ACTH intensified electrolyte depletion, particularly hypokalemia.

Alcohol, Barbiturates, or Narcotics: Potentiation of orthostatic hypotension may occur.

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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.

When pregnancy is detected, discontinue Tribenzor as soon as possible.

It is not known whether amlodipine or olmesartan are excreted in human milk, but thiazides appear in human milk and olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Initial therapy of hypertension. GoToSource

Urinary tract infection, upper respiratory tract infection, bronchitis, peripheral edema, fatigue, joint swelling, muscle spasms, hypokalemia (low potassium level) and cough. GoToSource

Increased risk of gout (a form of inflammatory arthritis). GoToSource

Systemic lupus erythematosus (autoimmune disorder). GoToSource

Acute angle closure glaucoma (sudden increase in eye pressure). GoToSource

Acute cholestatic hepatitis, impaired glucose tolerance, pancreatitis (inflammation of pancreas) and increased plasma levels of low-density lipoprotein cholesterol, total cholesterol and total triglycerides. GoToSource

Hypotension (low blood pressure), aplastic anemia (bone marrow not producing blood cells), sialadenitis (inflammation of salivary glands), agranulocytosis (low number of granulocytes, a type of white blood cell), leukopenia (low white blood cell count), thrombocytopenia (low blood platelet count), urticaria (hives) erythema multiforme, exfoliative dermatitis (severe skin reactions), azotemia (elevated BUN indicating kidney damage), hyponatremia (low blood sodium level) and hypomagnesemia ( low blood magnesium level). GoToSource

Vertigo and tachycardia (fast or irregular heart rate). GoToSource

Sprue-like enteropathy (condition characterized by severe diarrhea and weight loss). GoToSource

Lawsuits filed for gastrointestinal injuries (sprue-like enteropathy).