ning a lower dose of that component to achieve similar blood pressure reductions.
2.3 Replacement Therapy
Exforge HCT may be substituted for the individually titrated components.
3 DOSAGE FORMS AND STRENGTHS
5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – White, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VCL” on the other side.
10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – Pale yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VDL” on the other side.
5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VEL” on the other side.
10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VHL” on the other side.
10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets – Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VFL” on the other side.
4 CONTRAINDICATIONS
Because of the hydrochlorothiazide component, Exforge HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
Exforge HCT can cause harm to the fetus 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)].
5.2 Hypotension in Volume- or Salt-Depleted PatientsExcessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Exforge HCT (10/320/25 mg) compared to 1.8% of valsartan/HCTZ (320/25 mg) patients, 0.4% of amlodipine/valsartan (10/320 mg) patients, and 0.2% of HCTZ/amlodipine (25/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension. In patients with an activated renin-angiotensin system, such as volume-or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur in patients receiving angiotensin receptor blockers. Correct this condition prior to administration of Exforge HCT.
Exforge HCT has not been studied in patients with heart failure, recent myocardial infarction, or in patients undergoing surgery or dialysis. Patients with heart failure or post-myocardial infarction patients given valsartan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic hypotension us
