A-Z Drug Facts > Valsartan/Hydrochlorothiazide

Valsartan / Hydrochlorothiazide

Pronouncation: (VAL-sahr-tan/high-droe-klor-oh-THIGH-uh-zide)
Class: Antihypertensive combination

Trade Names:
Diovan HCT
- Tablets 12.5 mg hydrochlorothiazide and 80 mg valsartan
- Tablets 12.5 mg hydrochlorothiazide and 160 mg valsartan
- Tablets 12.5 mg hydrochlorothiazide and 320 mg valsartan
- Tablets 25 mg hydrochlorothiazide and 160 mg valsartan
- Tablets 25 mg hydrochlorothiazide and 320 mg valsartan

Pharmacology

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Valsartan

Antagonizes the effect of angiotensin II (vasoconstriction and aldosterone secretion) by blocking the angiotensin II receptor (AT ₁ receptor) in vascular smooth muscle and the adrenal gland, producing decreased BP.

Hydrochlorothiazide

Increases chloride, sodium, and water excretion by interfering with transport of sodium ions across renal tubular epithelium.

Indications and Usage

Treatment of hypertension.

Contraindications

Hypersensitivity to any component of this product; anuria; hypersensitivity to sulfonamide-derived drugs (hydrochlorothiazide).

Dosage and Administration

Dosage must be individualized. The fixed combination is not indicated for initial therapy. The combination may be substituted for the titrated components.

Adults

PO Valsartan may be used over a dose range of 80 to 320 mg/day, administered once daily. Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily. There are no studies evaluating doses of valsartan greater than 160 mg in combination with hydrochlorothiazide 25 mg.

Renal Function Impairment (CrCl greater than 30 mL/min)

Loop diuretics are preferred to thiazides.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Protect from moisture.

Drug Interactions

Valsartan Lithium

Plasma concentrations may be elevated by valsartan, increasing the pharmacologic and toxic effects of lithium.

Hydrochlorothiazide Alcohol, barbiturates, narcotics

Increased risk of orthostatic hypotension.

Anticholinergic agents (eg, atropine, biperiden)

May increase bioavailability of thiazide-type diuretics.

Antidiabetic agents (oral agents and insulin)

Dosage adjustment of antidiabetic agent may be necessary.

Antihypertensive agent

Additive or potentiation of effects.

Cholestyramine, colestipol resins

Impaired absorption of hydrochlorothiazide.

Corticosteroids, ACTH

Increased electrolyte depletion, increasing the risk of hypokalemia.

Cyclosporin

Concomitant use may increase risk of hyperuricemia and gout-type complications.

Digoxin

Thiazide-induced electrolyte disturbances may predispose to digitalis-induced arrhythmias.

Lithium

Renal Cl of lithium may be reduced, increasing the risk of lithium toxicity.

Methyldopa

Reports of hemolytic anemia occurring with concomitant use.

Nondepolarizing skeletal muscle relaxants (eg, tubocurarine)

Increased effect of the muscle relaxant.

Nonsteroidal anti-inflammatory agents

The diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics may be reduced.

Potassium supplements

Do not use salt substitutes containing potassium or potassium supplements without consulting the prescribing physician.

Pressor amines (eg, norepinephrine)

Decreased responsiveness to the pressor amine.

Vitamin D/Calcium salts

May potentiate rise in serum calcium.

Laboratory Test Interactions

Valsartan

None well documented.

Hydrochlorothiazide

May decrease serum protein-bound iodine levels without signs of thyroid disturbances. May cause diagnostic interference of serum electrolyte levels, blood and urine glucose levels, serum bilirubin levels, and serum uric acid levels.

Adverse Reactions

Cardiovascular

Palpitations; syncope; tachycardia; hypotension.

CNS

Headache; fatigue; dizziness; increased appetite; anxiety; insomnia; decreased libido; paresthesia; somnolence; asthenia.

Dermatologic

Flushing; rash; increased sweating.

Hydrochlorothiazide

Erythema multiforme (including Stevens-Johnson syndrome); exfoliative dermatitis (including toxic epidermal necrolysis).

EENT

Pharyngitis; sinusitis; tinnitus; vertigo; abnormal vision; rhinitis; epistaxis.

Hydrochlorothiazide

Transient blurred vision; xanthopsia.

GI

Diarrhea; constipation; dyspepsia; flatulence; dry mouth; nausea; abdominal pain; vomiting.

Hydrochlorothiazide

Pancreatitis; sialadenitis; cramping; gastric irritation.

Genitourinary

Dysuria; impotence; micturition frequency; UTI.

Hydrochlorothiazide

Renal failure; renal function impairment; interstitial nephritis.

Hematologic

Hydrochlorothiazide

Aplastic anemia; leukopenia; thrombocytopenia; microcytic anemia; neutropenia.

Hepatic

Elevated liver enzymes; jaundice (intrahepatic cholestatic); hepatitis.

Metabolic

Dehydration; gout; edema.

Hydrochlorothiazide

Hyperglycemia; glycosuria; hyperuricemia.

Respiratory

Cough; upper respiratory tract infection; dyspnea; epistaxis; bronchitis.

Miscellaneous

Viral infection; back pain; chest pain; allergic reaction; anaphylaxis; asthenia; dependent edema; arthralgia; muscle cramps; muscle weakness; arm pain; leg pain; angioedema.

Hydrochlorothiazide

Hypersensitivity (including purpura, photosensitivity, urticaria, necrotizing angiitis, fever, respiratory distress, anaphylactic reactions).

Precautions

Warnings When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.

Pregnancy

Category D (second and third trimester); Category C (first trimester). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Lactation

Valsartan

Undetermined.

Hydrochlorothiazide

Excreted in breast milk.

Children

Safety and efficacy not established.

Hypersensitivity

May occur in patients with or without history of allergy or bronchial asthma; cross-sensitivity with sulfonamides may also occur.

Renal Function

Decreases in renal function may occur in patients whose renal function is dependent on the renin-angiotensin system; patients with renal artery stenosis may experience acute renal failure. Use caution in treating patients whose renal function may depend on the activity of renin-angiotensin-aldosterone system (eg, severe CHF). In addition, hydrochlorothiazide may precipitate azotemia and cumulative effects of the drug may develop in patients with impaired renal function.

Hepatic disease

Use with caution. Minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hyperuricemia

May occur, or acute gout may be precipitated in thiazide therapy.

Hypotension/Volume-depleted patients

Symptomatic hypotension may occur after initiation of valsartan therapy in patients who are intravascularly volume depleted (eg, those treated with diuretics). Correct these conditions prior to administration of valsartan or start treatment under close medical supervision. Lightheadedness can occur, especially during the first days of therapy.

Systemic lupus erythematosus

Exacerbation or activation may occur.

Valvular stenosis

May increase the risk of decreased coronary perfusion when treated with vasodilators.

Overdosage

Symptoms

Hypotension, tachycardia, bradycardia, electrolyte depletion (eg, hypokalemia, hypochloremia, hyponatremia), dehydration.

Patient Information

• Advise patient to take once daily as prescribed, without regard to meals but to take with food if GI upset occurs.
• Advise patient to try to take each dose at about the same time each day.
• Inform patient that drug controls but does not cure hypertension and to continue taking drug as prescribed even when BP is not elevated.
• Caution patient not to change the dose or stop taking unless advised by health care provider.
• Instruct patient to continue taking other BP medications as prescribed by health care provider.
• Instruct patient in BP and pulse measurement skills.
• Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted. Advise patient to take record of BP and pulse to each follow-up visit.
• Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
• Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
• Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP, resulting in lightheadedness or fainting.
• Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
• Caution patient to avoid unnecessary exposure to UV light (sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light to avoid photosensitivity reaction.
• Emphasize to hypertensive patient importance of the following modalities on BP: weight control, regular exercise, smoking cessation, moderate intake of alcohol and salt.
• Instruct patient to stop taking drug and immediately report any of the following symptoms to health care provider: fainting, swelling of the face, lips, eyelids, or tongue.
• Caution patient not to take any prescription or OTC medications, salt substitutes, or dietary supplements unless advised by health care provider.

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