Label Changes for:

Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets

June 2014

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

June 2014

 

ADVERSE REACTIONS

Post-Marketing Experience
  • Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive. The randomized, placebo-controlled, double-blind ROADMAP trial (Randomized Olmesartan And Diabetes MicroAlbuminuria Prevention trial, n=4447) examined the use of olmesartan, 40 mg daily, vs. placebo in patients with type 2 diabetes mellitus, normoalbuminuria, and at least one additional risk factor for CV disease. The trial met its primary endpoint, decrease in time-to-onset of microalbuminuria, but olmesartan had no beneficial effect on decline in glomerular filtration rate (GFR). There was a finding of increased CV...
  • The epidemiologic study included patients 65 years and older with overall exposure of > 300,000 patient-years. In the sub-group of diabetic patients receiving high-dose olmesartan (40 mg/d) for > 6 months, there appeared to be...
  • Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the credibility of the finding of increased CV risk, notably the observation in the large epidemiologic study for a survival benefit in non-diabetics of a magnitude similar to the adverse finding in diabetics.

DRUG INTERACTIONS

Drug Interactions with Olmesartan Medoxomil
  • Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of olmesartan or thiazide diuretics. Monitor lithium levels in patients receiving Tribenzor and lithium.
Drug Interactions with hydrochlorothiazide
  • Monitor lithium levels

July 2013

WARNINGS AND PRECAUTIONS

Sprue-like Enteropathy
  • Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified

ADVERSE REACTIONS

Post marketing Experience
  • sprue-like enteropathy

 

 

November 2011 

WARNINGS AND PRECAUTIONS

Drug Interactions with Amlodipine
  • Simvastatin: Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

 

June 2011

 

DRUG INTERACTIONS

Olmesartan medoxomil
  • Nonsteroidal anti-inflammatory drugs (NSAIDS): May lead to increased risk of renal impairment and loss of antihypertensive effect

CLINICAL TRIALS

  • There are no trials of Tribenzor demonstrating reductions in cardiovascular risk in patients with hypertension, but at least one pharmacologically similar drug has demonstrated such benefits.

 

March 2011

 

WARNINGS AND PRECAUTIONS

Acute Myopia and Secondary Angle-Closure Glaucoma
  • Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy.

ADVERSE REACTIONS

Post-Marketing Experience
  • anaphylactic reactions, peripheral edema, diarrhea

DRUG INTERACTIONS

Drug Interactions with Olmesartan Medoxomil
  • Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
  • 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, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan and NSAID therapy.
  • The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan may be attenuated by NSAIDs including selective COX-2 inhibitors.

PATIENT LABELING

What are the possible side effects of Tribenzor?
  • Eye problems. One of the medicines in Tribenzor can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Tribenzor. Tell your doctor right away if you have:
  • decrease in vision
  • eye pain

 

 

 

November 2011

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