valsartan/hydrochlorothiazide (Rx)

Brand and Other Names:Diovan HCT
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

valsartan/hydrochlorothiazide

tablet

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

Hypertension

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

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Interactions

Interaction Checker

and valsartan/hydrochlorothiazide

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            Adverse Effects

            1-10%

            Valsartan

            • Hyperkalemia (4-10%)
            • Dizziness (2-8%)
            • Hypotension (1-7%)
            • Fatigue (3%)

            Frequency Not Defined

            Hydrochlorothiazide

            • Anaphylaxis
            • Anemia
            • Anorexia
            • Confusion
            • Dizziness
            • Epigastric distress
            • Erythema multiforme
            • Exfoliative dermatitis, including toxic epidermal necrolysis
            • Headache
            • Hyperuricemia
            • Hypokalemia or hypomagnesemia
            • Orthostatic hypotension
            • Photosensitivity
            • Stevens-Johnson syndrome

            Postmarketing Reports

            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)

            Vascular: Vasculitis

            Musculoskeletal: Rhabdomyolysis

            Hydrochlorothiazide

            • Non-melanoma skin cancer
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            Warnings

            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

            Contraindications

            Hypersensitivity to valsartan, hydrochlorothiazide, or sulfonamides

            Anuria

            Coadministration with aliskiren in patients with diabetes

            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 <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 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 sun and undergo regular skin cancer screening

            Renal function

            • Avoid in 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 activity of the renin-angiotensin system (eg,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 on 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 prior to 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 (eg, muscular weakness, paresis, or ECG alterations); therapy should be discontinued
            • Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to 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 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 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
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            Pregnancy & Lactation

            Pregnancy

            Angiotensin system during 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 maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, and post-partum hemorrhage); hypertension increases 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 intra-amniotic environment; fetal testing may be appropriate, based on week of gestation; however, oligohydramnios may not appear until after fetus has sustained irreversible injury; if oligohydramnios is observed, consider alternative drug treatment
            • Closely observe neonates with histories of in utero exposure to 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 renal function

            Hydrochlorothiazide

            • Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma; hydrochlorothiazidecan cause placental hypoperfusion; accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in 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 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 presence of drug in human milk, effects on breastfed infant, or on 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 potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with this drug combination

            Pregnancy Categories

            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.

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            Pharmacology

            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

            Absorption

            Valsartan

            • Bioavailability: 25%
            • Onset: 2 hr
            • Duration: 24 hr
            • Peak plasma time: 2-4 hr
            • Peak response: 4-6 hr

            Hydrochlorothiazide

            • Onset: Diuresis, ~2 hr; hypertension, 3-4 days
            • Peak plasma time: 1-2.5 hr
            • Peak effect: Diuresis, 4-6 hr

            Distribution

            Valsartan

            • Protein bound: 94-95%
            • Vd: 17 L

            Hydrochlorothiazide

            • Protein bound: 68%
            • Vd: 3.6-7.8 L/kg

            Metabolism

            Valsartan

            • Minimally metabolized in liver
            • Metabolites: Valeryl-4-hydroxyvalsartan (inactive)

            Hydrochlorothiazide

            • Minimally metabolized

            Elimination

            Valsartan

            • Half-life: 6-9 hr
            • Renal clearance: 0.62 L/hr
            • Total body clearance: 2.2 L/hr
            • Excretion: Feces (83%), urine (13%)

            Hydrochlorothiazide

            • Half-life: 5/6-14.8 hr
            • Excretion: Urine
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            Formulary

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            Tier Description
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