Hyzaar - Side Effects & Drug Interactions

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Post-Marketing Experience

The following additional adverse reactions have been reported in post-marketing experience:

Hypersensitivity:

Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/ or swelling of the face, lips, pharynx, and/ or tongue has been reported rarely in patients treated with losartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported with losartan. Anaphylactic reactions have been reported.

Digestive:

Hepatitis has been reported rarely in patients treated with losartan.

Respiratory:

Dry cough (see above) has been reported with losartan.

Hyperkalemia and hyponatremia have been reported with losartan. Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of HYZAAR.

Creatinine, Blood Urea Nitrogen

Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in 0.6 and 0.8 percent, respectively, of patients with essential hypertension treated with HYZAAR alone. No patient discontinued taking HYZAAR due to increased BUN. One patient discontinued taking HYZAAR due to a minor increase in serum creatinine.

Hemoglobin and Hematocrit:

Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.14 grams percent and 0.72 volume percent, respectively) occurred frequently in patients treated with HYZAAR alone, but were rarely of clinical importance. No patients were discontinued due to anemia.

Liver Function Tests

Occasional elevations of liver enzymes and/ or serum bilirubin have occurred. In patients with essential hypertension treated with HYZAAR alone, no patients were discontinued due to these laboratory adverse experiences.

Drug Interactions

Losartan Potassium

No significant drug-drug pharmacokinetic interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. Rifampin, an inducer of drug metabolism, decreased the concentrations of losartan and its active metabolite. (See CLINICAL PHARMACOLOGY, Drug Interactions.) In humans, two inhibitors of P450 3A4 have been studied. Ketoconazole did not affect the conversion of losartan to the active metabolite after intravenous administration of losartan, and erythromycin had no clinically significant effect after oral administration.