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contraindicated in patients with anuria or hypersensitivity to
sulfonamide-derived drugs
-- In patients with volume or sodium depletion (eg, patients vigorously
treated with diuretics or on dialysis), such depletion should be
corrected prior to administration of AVAPRO(R) (irbesartan) or
AVALIDE(R) (irbesartan-hydrochlorothiazide), or a lower initial dose of
AVAPRO (75 mg) should be used, to avoid possible symptomatic
hypotension
-- Hypersensitivity reactions to hydrochlorothiazide may occur in patients
with or without a history of allergy or bronchial asthma, but are more
likely in patients with such a history
-- Thiazide diuretics have been reported to cause exacerbation or
activation of systemic lupus erythematosus
-- Lithium generally should not be given with thiazides
-- Thiazides should be used with caution in patients with severe renal
disease and in patients with impaired hepatic function or progressive
liver disease, since minor alterations of fluid and electrolyte balance
may precipitate hepatic coma
-- In placebo-controlled hypertension studies, there were no significant
differences in adverse events (AEs) between AVAPRO and
placebo. Adverse events that occurred in at least 1% of patients
treated with AVAPRO and at a higher incidence vs placebo included
diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%) and fatigue (4% vs
3%)
-- Additionally, in a study of hypertensive type 2 diabetic patients with
renal disease (proteinuria greater than or equal to 900 mg/day), the
reported AEs for AVAPRO were similar to those seen in hypertension
studies, with the exception of an increased incidence of orthostatic
symptoms; AVAPRO compared to placebo (both groups received adjunc
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