Manufacturer:

Daiichi Sankyo

Pharmacological Class:

Antihypertensive (angio­tensin 2 receptor blocker + dihydropyridine calcium channel blocker + thiazide diuretic).

Active Ingredient(s):

Olmesartan medoxomil 20mg, amlodipine (as besylate) 5mg, hydrochlorothiazide (HCTZ) 12.5mg; tabs.

Also:

TRIBENZOR 40/5/12.5mg
Olmesartan medoxomil 40mg, amlodipine (as besylate) 5mg, hydrochlorothiazide (HCTZ) 12.5mg; tabs.

TRIBENZOR 40/5/25mg
Olmesartan medoxomil 40mg, amlodipine (as besylate) 5mg, hydrochlorothiazide (HCTZ) 25mg; tabs.

TRIBENZOR 40/10/12.5mg
Olmesartan medoxomil 40mg, amlodipine (as besylate) 10mg, hydrochlorothiazide (HCTZ) 12.5mg; tabs.

TRIBENZOR 40/10/25mg
Olmesartan medoxomil 40mg, amlodipine (as besylate) 10mg, hydrochlorothiazide (HCTZ) 25mg; tabs.

Indication(s):

Hypertension. Not for initial therapy.

Pharmacology:

Tribenzor combines antihypertensive agents representative of three drug classes: an angio­tensin 2 receptor blocker (ARB), a calcium channel blocker (CCB), and a diuretic. It is ­indicated to treat hypertension that is not ­adequately controlled on opt­imal doses of any two of these drug classes, or it may be substituted for the individually-titrated components.

Olmesartan, an ARB, blocks the binding of angi­o­tensin II to the AT1 receptor in vascular smooth muscle, thereby reducing vasoconstriction mediated by angiotensin II. Amlodipine is a dihydropyridine CCB that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Hydrochlo­rothiazide is a thiazide diuretic that increases the excretion of sodium and chloride ions.

Clinical Trials:

A study was conducted in 2492 ­patients to evaluate the efficacy of Tribenzor in the treatment of hypertension. Patients were randomized to receive one of the three dual therapy combinations for 2–4 weeks, then they were randomized to either continue on the dual therapy or to receive triple therapy. After 8 weeks, triple therapy produced greater reductions in both systolic and ­diastolic blood pressures compared to each of the three dual combination therapies.

Legal Classification:

Rx

Adults:

One tablet daily. Titrate at 2-week intervals; max one 40/10/25mg tablet daily. Replacement ther­apy: may be substituted for individually titrated components. Add-on/switch therapy: may be used to provide additional BP lowering for patients not adequately controlled on max tolerated, labeled or usual doses of any two ­antihypertensive classes: ARBs, calcium channel blockers, and diuretics.

Children:

Not recommended.

Contraindication(s):

Anuria. Sulfonamide allergy.

Warnings/Precautions:

Severe renal impairment (CrCl ≤30mL/min): not recommended. Renal artery stenosis. Suspend if renal dysfunction progresses. Correct salt/volume depletion prior to starting therapy. Severe hepatic dysfunction. Severe CHF or obstructive coronary disease. Severe aortic stenosis. Diabetes. Postsympathec­to­my. SLE. Gout. Monitor electrolytes. Elderly (>75 years). Pregnancy (Cat.C in 1^st trimester; Cat.D in 2^nd and 3^rd trimesters; avoid). Nursing mothers: not recommended.

Interaction(s):

Digitalis, lithium toxicity. Adjust anti­di­abetic, antigout medications. ACTH, ampho­ter­i­cin B, corticosteroids increase hypo­ka­le­mia risk. Orthostatic hypotension potenti­ated by alcohol, CNS depressants. Antagonized by NSAIDs. Poten­tiates other antihypertensives. May potentiate nondepolarizing muscle relaxants. May antagonize norepinephrine. May ­interfere with parathyroid tests.

Adverse Reaction(s):

Dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, GI upset, URI, UTI, joint swelling, hyperuricemia, orthostatic hypotension, electrolyte disturbances.

How Supplied:

Tabs—30, 90