Valsartan-Hydrochlorothiazide

Valsartan-Hydrochlorothiazide is a combination of prescription medication used for the treatment of hypertension. 

• Valsartan-Hydrochlorothiazide is available under the following different brand names: Diovan HCT

Adult dosage

Tablet

• 80 mg/12.5 mg
• 160 mg/12.5 mg
• 320 mg/12.5 mg
• 160 mg/25 mg
• 320 mg/25 mg

Hypertension

Adult dosage

• 1 tablet/day orally (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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Valsartan-Hydrochlorothiazide include:

• dizziness, and
• headache

Serious side effects of Valsartan-Hydrochlorothiazide include:

• lightheadedness,
• swelling in your hands or feet,
• rapid weight gain,
• eye pain,
• vision problems,
• skin rash,
• pounding heartbeats,
• fluttering in your chest,
• yellowing of the skin or eyes (jaundice)
• dry mouth,
• increased thirst,
• drowsiness,
• confusion,
• feeling restless,
• vomiting,
• muscle pain,
• lack of energy,
• fast heartbeats,
• little or no urine, and
• convulsions (seizures).

Rare side effects of Valsartan-Hydrochlorothiazide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Valsartan-Hydrochlorothiazide has severe interactions with the following drug:
  • aliskiren
• Valsartan-Hydrochlorothiazide has serious interactions with at least 25 other drugs.
• Valsartan-Hydrochlorothiazide has moderate interactions with at least 250 other drugs.
• Valsartan-Hydrochlorothiazide has minor interactions with at least 157 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to valsartan, hydrochlorothiazide, or sulfonamides
• Anuria
• Coadministration with aliskiren in patients with diabetes

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Valsartan-Hydrochlorothiazide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Valsartan-Hydrochlorothiazide?”

Cautions

• 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 less than 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 an 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 the sun and undergo regular skin cancer screening
• Renal function
  • Avoid severe renal impairment (ineffective)
  • Use with caution in renal artery stenosis; avoid in bilateral renal artery stenosis
  • Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics
  • Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure in patients receiving therapy
  • Monitor renal function periodically in these patients; consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on patients receiving the combination drug
• Hypotension
  • In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur; this condition should be corrected before administration of therapy, or the treatment should start under close medical supervision
  • If hypotension occurs, place the patient in the supine position and, if necessary, give intravenous normal saline; a transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized
• Potassium abnormalities
  • Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion
  • Drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically
  • Hyperkalemia, particularly when coadministered with potassium-sparing diuretics, potassium supplements, or salt substitutes; concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect
  • Drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically; if hypokalemia is accompanied by clinical signs (e.g., muscular weakness, paresis, or ECG alterations); therapy should be discontinued
  • Correction of hypokalemia and any coexisting hypomagnesemia is recommended before the initiation of thiazides; some patients with heart failure have developed increases in potassium with therapy
  • Effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment; dosage reduction and/or discontinuation of the diuretic and/or drug combination may be required
  • Acute myopia and secondary angle-closure glaucoma
  • Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma
  • Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation; untreated acute angle-closure glaucoma can lead to permanent vision loss; the primary treatment is to discontinue hydrochlorothiazide as rapidly as possible
  • Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled; risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy
• Metabolic disturbances
  • Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides; hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients
  • Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium; monitor calcium levels in patients with hypercalcemia receiving therapy

Pregnancy & Lactation

• Angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death; most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents; published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan; when pregnancy is detected discontinue therapy as soon as possible
• Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, and post-partum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly
• Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death
• Valsartan
  • Perform serial ultrasound examinations to assess the intra-amniotic environment; fetal testing may be appropriate, based on the week of gestation; however, oligohydramnios may not appear until after the fetus has sustained an irreversible injury; if oligohydramnios is observed, consider alternative drug treatment
  • Closely observe neonates with histories of in utero exposure to the drug for hypotension, oliguria, and hyperkalemia; in neonates with a history of in utero exposure to Diovan HCT, if oliguria or hypotension occurs, support blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing the renal function
• Hydrochlorothiazide
  • Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma; hydrochlorothiazide can cause placental hypoperfusion; accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in the umbilical vein plasma; use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia; since they do not prevent or alter the course of EPH (Edema, proteinuria, hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women; use of hydrochlorothiazide for other indications (eg, heart disease) in pregnancy should be avoided
• Lactation
  • There is limited information regarding the presence of the drug in human milk, effects on the breastfed infant, or milk production; valsartan is present in rat milk; hydrochlorothiazide is present in human breast milk
  • Valsartan is present in rat milk. Hydrochlorothiazide is present in human breast milk
  • Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with this drug combination