Dosing & Uses
Dosage Forms & Strengths
1 tablet/day PO (80-160 mg valsartan/12.5-25 mg hydrochlorothiazide); may be titrated after 1-2 weeks of therapy; not to exceed 320 mg valsartan/25 mg hydrochlorothiazide daily
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
- Hyperkalemia (4-10%)
- Dizziness (2-8%)
- Hypotension (1-7%)
- Fatigue (3%)
Frequency Not Defined
- Epigastric distress
- Erythema multiforme
- Exfoliative dermatitis, including toxic epidermal necrolysis
- Hypokalemia or hypomagnesemia
- Orthostatic hypotension
- Stevens-Johnson syndrome
Hypersensitivity: Angioedema (rare), urticaria
Digestive: Elevated liver enzymes, hepatitis (rare)
Renal: Impaired renal function, renal failure
Clinical laboratory tests: Hyperkalemia
Dermatologic: Alopecia, bullous dermatitis
Blood and lymphatic: Thrombocytopenia (rare)
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death
Hypersensitivity to valsartan, hydrochlorothiazide, or sulfonamides
Do not coadminister with aliskiren in patients with diabetes
Not for initial treatment
Orthostatic hypotension risk: Initiate combination therapy with 2 antihypertensive drugs cautiously in patients with diabetes or autonomic dysfunction and in geriatric patients
Acute transient myopia and acute angle-closure glaucoma have been reported, particularly with a history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)
Avoid in severe renal impairment (ineffective)
Use with caution in severe hepatic impairment
Use with caution in renal artery stenosis; avoid in bilateral renal artery stenosis
CrCl <30 mL/min: Use loop diuretic instead of hydrochlorothiazide
Hyperkalemia, particularly when coadministered with potassium-sparing diuretics, potassium supplements, or salt substitutes; concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect
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
Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can result in hypokalemia that appears difficult to treat despite potassium repletion
Drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically
In certain patients receiving thiazide therapy, hyperuricemia may occur, or frank gout may be precipitated
Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides
Thiazides may decrease urinary calcium excretion
Pregnancy & Lactation
Pregnancy category: 1st trimester, C; 2nd and 3rd trimesters, D
Lactation: Discontinue drug, or do not nurse
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Valsartan: Blocks binding of angiotensin II to type 1 angiotensin II receptors; blocks vasoconstrictor and aldosterone-secreting effects of angiotensin II
Hydrochlorothiazide: Thiazide diuretic that inhibits sodium reabsorption in distal renal tubules; results in increased excretion of sodium ions and water, as well as potassium and hydrogen ions
- Bioavailability: 25%
- Onset: 2 hr
- Duration: 24 hr
- Peak plasma time: 2-4 hr
- Peak response: 4-6 hr
- Onset: Diuresis, ~2 hr; hypertension, 3-4 days
- Peak plasma time: 1-2.5 hr
- Peak effect: Diuresis, 4-6 hr
- Protein bound: 94-95%
- Vd: 17 L
- Protein bound: 68%
- Vd: 3.6-7.8 L/kg
- Minimally metabolized in liver
- Metabolites: Valeryl-4-hydroxyvalsartan (inactive)
- Minimally metabolized
- Half-life: 6-9 hr
- Renal clearance: 0.62 L/hr
- Total body clearance: 2.2 L/hr
- Excretion: Feces (83%), urine (13%)
- Half-life: 5/6-14.8 hr
- Excretion: Urine
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.