as needed to control blood pressure [see Clinical Studies (14.2)]. DiovanHCT is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions(5.2)].
3 DOSAGE FORMS AND STRENGTHS
80/12.5mg tablets, imprinted CG/HGH (Side 1/Side 2)
160/12.5mg tablets, imprinted CG/HHH
160/25mg tablets, imprinted NVR/HXH
320/12.5mg tablets, imprinted NVR/HIL
320/25mg tablets, imprinted NVR/CTI
4 CONTRAINDICATIONS
DiovanHCT (valsartan and hydrochlorothiazide, USP) is contraindicated in patients who are hypersensitive to any component of this product.
Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
DiovanHCT can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Drugs that act on the renin-angiotensin system can cause fetal and neonatal morbidity and mortality when used in pregnancy. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death [see Use in Specific Populations (8.1)].
Intrauterine exposure to thiazide diuretics is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
5.2 Hypotension in Volume- and/or Salt-Depleted Patients
Excessive reduction of blood pressure was rarely seen (0.7%) in patients with uncomplicated hypertension treated with DiovanHCT in controlled trials. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur. This condition should be corrected prior to administration of DiovanHCT, or the treatment should start under close medical supervision.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
5.3Impaired Hepatic Function
Hydrochlorothiazide: Thiazide diuretics 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.
Valsartan: As the majority of valsartan is eliminated in the bile, patients with mild-to-moderate hepatic impairment, including patients with biliary obstructive disorders, showed lower valsartan clearance (higher AUCs). Care should be exercised in administering Diovan (valsartan) to these patients.
5.4 Hypersensitivity Reaction
Hydrochlorothiazide: 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.
5.5 Systemic Lupus Erythematosus
Hydrochlorothiazide: Thiazide diuretics have been reported to cause exacerbati |
