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
Feedback for Valsartan/Hydrochlorothiazide
Compare with other drugs. |
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.
HydrochlorothiazideIncreases 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.
AdultsPO 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 LithiumPlasma concentrations may be elevated by valsartan, increasing the pharmacologic and toxic effects of lithium.
Hydrochlorothiazide Alcohol, barbiturates, narcoticsIncreased 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 agentAdditive or potentiation of effects.
Cholestyramine, colestipol resinsImpaired absorption of hydrochlorothiazide.
Corticosteroids, ACTHIncreased electrolyte depletion, increasing the risk of hypokalemia.
CyclosporinConcomitant use may increase risk of hyperuricemia and gout-type complications.
DigoxinThiazide-induced electrolyte disturbances may predispose to digitalis-induced arrhythmias.
LithiumRenal Cl of lithium may be reduced, increasing the risk of lithium toxicity.
MethyldopaReports of hemolytic anemia occurring with concomitant use.
Nondepolarizing skeletal muscle relaxants (eg, tubocurarine)Increased effect of the muscle relaxant.
Nonsteroidal anti-inflammatory agentsThe diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing, and thiazide diuretics may be reduced.
Potassium supplementsDo 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 saltsMay potentiate rise in serum calcium.
Laboratory Test Interactions
ValsartanNone well documented.
HydrochlorothiazideMay 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.
HydrochlorothiazideErythema multiforme (including Stevens-Johnson syndrome); exfoliative dermatitis (including toxic epidermal necrolysis).
EENT
Pharyngitis; sinusitis; tinnitus; vertigo; abnormal vision; rhinitis; epistaxis.
HydrochlorothiazideTransient blurred vision; xanthopsia.
GI
Diarrhea; constipation; dyspepsia; flatulence; dry mouth; nausea; abdominal pain; vomiting.
HydrochlorothiazidePancreatitis; sialadenitis; cramping; gastric irritation.
Genitourinary
Dysuria; impotence; micturition frequency; UTI.
HydrochlorothiazideRenal failure; renal function impairment; interstitial nephritis.
Hematologic
HydrochlorothiazideAplastic anemia; leukopenia; thrombocytopenia; microcytic anemia; neutropenia.
Hepatic
Elevated liver enzymes; jaundice (intrahepatic cholestatic); hepatitis.
Metabolic
Dehydration; gout; edema.
HydrochlorothiazideHyperglycemia; 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.
HydrochlorothiazideHypersensitivity (including purpura, photosensitivity, urticaria, necrotizing angiitis, fever, respiratory distress, anaphylactic reactions).
Precautions
WarningsWhen 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
ValsartanUndetermined.
HydrochlorothiazideExcreted 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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