Valsartan/Amlodipine/Hydrochlorothiazide

DEA Class; Rx

Common Brand Names; Exforge HCT

• ARB/CCB/Diuretic Combos

Combination thiazide diuretic and angiotensin II antagonist
Used for hypertension
Hyperuricemia compared to diuretic monotherapy; additive efficacy; less potassium loss

Indicated for the treatment of hypertension.

Hypersensitivity to valsartan, amlodipine, sulfonamide drugs, or other ingredients

Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality

Anuria

Coadministration with aliskiren in patients with diabetes

Amlodipine

• Edema (1.8-10.8%)
• Headache (7.3%)
• Fatigue (4.5%)
• Palpitation (0.7-4.5%)
• Dizziness (1.1-3.4%)
• Flushing (0.7-2.6%)
• Nausea (2.9%)
• Abdominal pain (1.6%)
• Somnolence (1.4%)

Valsartan

• Hyperkalemia (4-10%)
• Dizziness (2-8%)
• Hypotension (1-7%)
• Fatigue (3%)

Hydrochlorothiazide

• Anorexia
• Epigastric distress
• Hypokalemia
• Hypotension
• Phototoxicity

Avoid with severe hepatic impairment or renal impairment (ie, CrCl <30 mL/min)

Excessive hypotension may occur (rare); caution if volume/salt depleted, initiate cautiously in patients with heart failure, recent MI, or those undergoing surgery or dialysis

Worsening angina and acute MI may occur after starting or increasing amlodipine dose, particularly with severe obstructive CAD

Patients whose renal function may depend in part on the activity of the renin angiotensin system (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion); correct volume depletion prior to initiation

Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy; closely monitor blood pressure; monitor renal function and potassium in susceptible patients

Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

Hydrochlorothiazide may exacerbate systemic lupus erythematosus

Instruct patients to protect skin from sun and undergo regular skin cancer screening

Hydrochlorothiazide may alter glucose tolerance and raise cholesterol and triglycerides

Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium; monitor calcium levels in patients with hypercalcemia receiving therapy

Angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

There is limited information regarding presence of drug in human milk, effects on breastfed infant, or on milk production