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Severe Hypertension In a clinical study in patients with severe hypertension (SiDBP 110 mmHg), the overall pattern of adverse events reported through six weeks of follow-up was similar in patients treated with HYZAAR as initial therapy and in patients treated with losartan as initial therapy. There were no reported cases of syncope in either treatment group. There were 2 (0. 6%) and 0 (0. 0%) cases of hypotension reported in the group treated with HYZAAR and the group treated with losartan, respectively. There were 3 (0. 8%) and 2 (1. 2%) cases of increased serum creatinine (> 0.5 mg/ dL) in the group treated with HYZAAR and the group treated with losartan, respectively, during the same time period. (See CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Severe Hypertension.) Post-Marketing Experience Text Continues Below
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. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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