Generic name: olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Dosage form: tablet, film coated
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Dose once daily.
Dosage may be increased after 2 weeks. The full blood pressure lowering effects are attained within 2 weeks after a change in dose. The maximum recommended dose of Tribenzor is 40/10/25 mg. Tribenzor may be taken with or without food.
The usual regimens of therapy with Tribenzor may be followed if the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Tribenzor [see Warnings and Precautions (5.4)].
Patients ≥ 75 years of age should start amlodipine at 2.5 mg, which is not available with Tribenzor.
Patients with severe hepatic impairment should start amlodipine at 2.5 mg, which is not available with Tribenzor [see Warnings and Precautions (5.5)].
Tribenzor may be substituted for its individually titrated components.
Tribenzor may be used to provide additional blood pressure lowering for patients not adequately controlled on maximally tolerated, labeled, or usual doses of any two of the following antihypertensive classes: angiotensin receptor blockers (ARB), calcium channel blockers (CCB), and diuretics.
A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Tribenzor may be switched to Tribenzor containing a lower dose of that component to achieve similar blood pressure reductions.