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Drugs reference index «Valsartan/Hydrochlorothiazide»

Valsartan/Hydrochlorothiazide
Valsartan/Hydrochlorothiazide
Valsartan/Hydrochlorothiazide


Valsartan / Hydrochlorothiazide

Pronunciation: (val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)Class: Antihypertensive combination

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

Pharmacology

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.

Dosage and Administration

Adults

PO Dosage must be individualized. The usual starting dosage is 160 mg/12.5 mg once daily. Increase after 1 to 2 wk to a max dosage of 320 mg/25 mg once daily.

Renal Function Impairment (CrCl 30 mL/min or less)

Use is not recommended.

Hepatic Function Impairment

Start with a low dose and titrate slowly.

General Advice

  • May be taken with or without food.
  • May be administered with other antihypertensives.
  • The fixed combination is not indicated for initial therapy in patients with volume depletion.
  • The combination may be substituted for the titrated components.

Storage/Stability

Store at 59° to 86°F. Protect from moisture.

Drug Interactions

Adrenocorticotropic hormone, corticosteroids

Increased electrolyte depletion, increasing the risk of hypokalemia.

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.

Cyclosporine

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

Digoxin

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

Lithium

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

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

May lead to increases in serum potassium. Monitor potassium levels and renal function regularly.

Pressor amines (eg, norepinephrine)

Decreased responsiveness to the pressor amine.

Vitamin D/calcium salts

May potentiate rise in serum calcium.

Laboratory Test Interactions

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

Hypotension (1%); palpitations, syncope, tachycardia.

CNS

Dizziness (6%); anxiety, asthenia, decreased libido, depression, fatigue, increased appetite, insomnia, paresthesia, somnolence.

Dermatologic

Flushing, hyperhidrosis, pruritus, rash, sunburn.

EENT

Sinus congestion, nasal congestion, nasopharyngitis (2%); abnormal vision, epistaxis, pharyngolaryngeal pain, pharyngitis, sinusitis, tinnitus, vertigo.

GI

Abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastritis, nausea, vomiting.

Genitourinary

Dysuria, erectile dysfunction, pollakiuria, UTI.

Hepatic

Elevated liver enzymes.

Metabolic

Dehydration, gout, peripheral edema.

Musculoskeletal

Arthralgia, back pain, muscle cramps, muscle weakness, myalgia, pain in extremity.

Respiratory

Bronchospasm, bronchitis, cough, dyspnea, upper respiratory tract infection.

Miscellaneous

Increased BUN (15%); increased creatinine (2%); anaphylaxis, asthenia, chest pain, influenza, pyrexia, viral infection.

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.

Monitor

Monitor BP and electrolytes at regular intervals.

Pregnancy

Category D .

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 renal function impairment.

Fluid/Electrolyte imbalance

May occur.

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.

Hypoglycemia

May occur.

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. Light-headedness can occur, especially during the first days of therapy.

Lipids

Increases in cholesterol and triglycerides may occur.

Systemic lupus erythematosus

Exacerbation or activation may occur.

Valvular stenosis

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

Overdosage

Symptoms

Bradycardia, circulatory collapse, depressed consciousness, dehydration, electrolyte depletion (eg, hypochloremia, hypokalemia, hyponatremia), hypotension, tachycardia, shock.

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.
  • Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted.
  • Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
  • Instruct patient to lie or sit down if experiencing dizziness or light-headedness when standing.
  • Caution patient that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to excessive fall in BP, resulting in light-headedness or fainting.
  • Instruct patient with diabetes 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.
  • 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.
  • Advise patient not to use salt substitutes containing potassium or potassium supplements without consulting the prescribing health care provider.
  • Caution patient not to take any prescription or OTC medications, or dietary supplements unless advised by health care provider.
  • Inform women of childbearing age to report pregnancy to health care provider as soon as possible.
  • Advise women who are breast-feeding not to breast-feed while taking this medication.

Copyright © 2009 Wolters Kluwer Health.