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The prescribing information for BENICAR HCT also includes the following warnings regarding its hydrochlorothiazide component:
BENICAR HCT is not recommended in patients with severe renal impairment and is contraindicated in patients with anuria or hypersensitivity to other sulfonamide derived drugs.
Fetal/Neonatal Morbidity and Mortality
Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Hepatic Impairment
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Hypersensitivity Reaction
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.
Systemic Lupus Erythematosus
Thiazide diuretics have been reported to cause exacerbation or
activation of systemic lupus erythematosus.
Lithium Interaction
Lithium generally should not be given with thiazides.
Adverse Events
-- The withdrawal rates due to adverse events (AEs) were similar with
BENICAR and BENICAR HCT to placebo: BENICAR (2.4% vs 2.7%); BENICAR HCT
(2.0% vs 2.0%)
-- The incidence of AEs with BENICAR and BENICAR HCT was similar to
placebo
-- The only AE that occurred in > 1% of patients treated with BENICAR and
more frequently than placebo was dizziness (3% vs 1%)
-- AEs reported in > 2% of patients taking BENICAR HCT and more frequently
than placebo included nausea (3
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