valsartan/hydrochlorothiazide (Rx)

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Brand and Other Names:Diovan HCT

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

valsartan/hydrochlorothiazide

tablet

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

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        Significant - Monitor Closely

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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

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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

            Do not coadminister with aliskiren in patients with diabetes

            Not for initial treatment

            Cautions

            Orthostatic hypotension risk: Initiate combination therapy with 2 antihypertensive drugs cautiously in patients with diabetes or autonomic dysfunction and in geriatric patients

            Acute transient myopia and acute angle-closure glaucoma have been reported, particularly with a history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

            Avoid in severe renal impairment (ineffective)

            Use with caution in severe hepatic impairment

            Use with caution in renal artery stenosis; avoid in bilateral renal artery stenosis

            CrCl <30 mL/min: Use loop diuretic instead of hydrochlorothiazide

            Hyperkalemia, particularly when coadministered with potassium-sparing diuretics, potassium supplements, or salt substitutes; concurrent therapy with hydrochlorothiazide may reduce the frequency of this effect

            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

            Hydrochlorothiazide can cause hypokalemia and hyponatremia; hypomagnesemia can result in hypokalemia that appears difficult to treat despite potassium repletion

            Drugs that inhibit the renin-angiotensin system can cause hyperkalemia; monitor serum electrolytes periodically

            In certain patients receiving thiazide therapy, hyperuricemia may occur, or frank gout may be precipitated

            Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides

            Thiazides may decrease urinary calcium excretion

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            Pregnancy & Lactation

            Pregnancy category: 1st trimester, C; 2nd and 3rd trimesters, D

            Lactation: Discontinue drug, or do not nurse

            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

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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