Classes
DEA Class; Rx
Common Brand Names; Diovan HCT
- ARB/HCTZ Combos
Description
Angiotensin II blocker and thiazide diuretic once-daily product
Used for hypertension
Additive efficacy; less potassium loss than with hydrochlorothiazide alone.
Indications
Indicated for the treatment of hypertension.
Contraindications
Hypersensitivity to valsartan, hydrochlorothiazide, or sulfonamides
Anuria
Coadministration with aliskiren in patients with diabetes
Adverse Effects
Valsartan
- Hyperkalemia (4-10%)
- Dizziness (2-8%)
- Hypotension (1-7%)
- Fatigue (3%)
Hydrochlorothiazide
- Anaphylaxis
- Anemia
- Anorexia
- Confusion
- Dizziness
- Epigastric distress
- Erythema multiforme
- Exfoliative dermatitis, including toxic epidermal necrolysis
- Headache
- Hyperuricemia
- Hypokalemia or hypomagnesemia
- Orthostatic hypotension
- Photosensitivity
- Stevens-Johnson syndrome
Warnings
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
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus
Orthostatic hypotension risk: Initiate combination therapy with 2 antihypertensive drugs cautiously in patients with diabetes or autonomic dysfunction and in geriatric patients
Use with caution in severe hepatic impairment
With CrCl <30 mL/min use loop diuretic instead of hydrochlorothiazide
Dual blockade of the renin-angiotensin system with ARBs, angiotensin-converting enzyme (ACE) inhibitors, or aliskiren is associated with increased risk of hypotension, hyperkalemia, and altered renal function (including acute renal failure) in comparison with monotherapy
Phototoxicity may occur; instruct patients to protect skin from sun and undergo regular skin cancer screening
Pregnancy and Lactation
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; valsartan is present in rat milk; hydrochlorothiazide is present in human breast milk
Maximum Dosage
320 mg/day PO valsartan and 25 mg/day PO hydrochlorothiazide.
320 mg/day PO valsartan and 25 mg/day PO hydrochlorothiazide.
Safety and efficacy have not been established.
Safety and efficacy have not been established
How supplied
Valsartan/hydrochlorothiazide
tablet
- 80mg/12.5mg
- 160mg/12.5mg
- 320mg/12.5mg
- 160mg/25mg
- 320mg/25mg