Fetal/Neonatal Morbidity and Mortality: Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women.
Valsartan must not be given to pregnant women or woman of child-bearing age with no intention to use contraception.
Hypotension in volume- and/or salt-depleted patients: Excessive reduction of blood pressure was seen (0.5%) in patients with uncomplicated hypertension treated with valsartan and hydrochlorothiazide. In a patient with an activated renin-angiotensin system, such as a volume- and/or salt-depleted patient receiving high dose of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of (Valsartan + hydrochlorothiazide) Duoval, or the treatment should start under close medical supervision.
Hydrochlorothiazide: Impaired Hepatic Function: Thiazide diuretics should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alteration of fluid and electrolyte balance may precipitate hepatic coma.
Hypersensitivity Reaction: Hypersensitivity reaction 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.
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