TRIBENZOR

Tribenzor Generic Name & Formulations

Legal Class

General Description

Olmesartan medoxomil, amlodipine (as besylate), hydrochlorothiazide; 20mg/5mg/12.5mg, 40mg/5mg/12.5mg, 40mg/5mg/25mg, 40mg/10mg/12.5mg, 40mg/10mg/25mg; tabs.

Pharmacological Class

Angiotensin II receptor blocker (ARB) + dihydropyridine calcium channel blocker (CCB) + thiazide diuretic.

How Supplied

Tabs—30, 90

Manufacturer

Cosette Pharmaceuticals, Inc.

Generic Availability

Mechanism of Action

Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium.

Tribenzor Indications

Indications

Hypertension. Not for initial therapy.

Tribenzor Dosage and Administration

Adult

Individualize. 1 tab once daily. May titrate at 2-week intervals; max one 40/10/25mg tab daily. ≥75yrs or severe hepatic impairment: use individual components (amlodipine 2.5mg).

Children

Not established.

Administration

May be given with other antihypertensive agents.

Nursing Considerations

Full BP lowering effects attained within 2 weeks after change in dose. May be given with other antihypertensive agents. Inform patients to report pregnancies as soon as possible. Caution patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in BP.

Tribenzor Contraindications

Contraindications

Anuria. Sulfonamide allergy. Concomitant aliskiren in patients with diabetes.

Tribenzor Boxed Warnings

Boxed Warning

Fetal toxicity.

Tribenzor Warnings/Precautions

Warnings/Precautions

Fetal toxicity may develop; discontinue if pregnancy is detected. Severe renal impairment (CrCl ≤30mL/min): avoid. Renal artery stenosis. Suspend if renal dysfunction progresses. Correct salt/volume depletion prior to starting therapy. Severe hepatic impairment. Severe CHF or obstructive coronary artery disease. Severe aortic stenosis. Diabetes. Postsympathectomy. SLE. Gout. Acute myopia and secondary angle-closure glaucoma. Monitor electrolytes. Neonates. Pregnancy: monitor. Nursing mothers: not recommended.

Tribenzor Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal, fecal.

Tribenzor Interactions

Interactions

See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). Take 4hrs before colesevelam HCl dose. Concomitant simvastatin: max simvastatin dose 20mg/day. May potentiate cyclosporine, tacrolimus, lithium; monitor levels. Potentiated by CYP3A4 inhibitors; may need dose reduction. Adjust antidiabetic, antigout medications. ACTH, corticosteroids increase hypokalemia risk. Orthostatic hypotension potentiated by alcohol, barbiturates, narcotics. May be antagonized by, and renal toxicity potentiated by NSAIDs, including COX-2 inhibitors; monitor renal function in elderly and/or volume-depleted. Reduced absorption with bile acid resins (eg, cholestyramine, colestipol). Potentiates other antihypertensives. May potentiate nondepolarizing muscle relaxants. May antagonize norepinephrine. Monitor BP with CYP3A4 inducers. May interfere with parathyroid tests.

Tribenzor Adverse Reactions

Adverse Reactions

Dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, diarrhea, URI, UTI, joint swelling; hyperuricemia, orthostatic hypotension, electrolyte disturbances, possible sprue-like enteropathy; HCTZ: increased risk for non-melanoma skin cancer.

Tribenzor Clinical Trials

See Literature

Tribenzor Note

Not Applicable

Tribenzor Patient Counseling