Valsartan and Hydrochlorothiazide

Pronunciation

(val SAR tan & hye droe klor oh THYE a zide)

U.S. Brand Names

Diovan HCT®

Synonyms

Hydrochlorothiazide and Valsartan

Generic Available

Canadian Brand Names

Diovan HCT®

Use

Treatment of hypertension (not indicated for initial therapy)

Pregnancy Risk Factor

C/D (2nd and 3rd trimester)

Pregnancy Implications

Medications which act on the renin-angiotensin system are reported to have the following fetal/neonatal effects: Hypotension, neonatal skull hypoplasia, anuria, renal failure, and death; oligohydramnios is also reported. These effects are reported to occur with exposure during the 2nd and 3rd trimesters. Valsartan should be discontinued as soon as possible after pregnancy is detected. Hydrochlorothiazide crosses the placenta; adverse (but not teratogenic) effects have been reported in the fetus.

Lactation

Excretion in breast milk unknown/not recommended

Contraindications

Hypersensitivity to valsartan, hydrochlorothiazide, thiazides, sulfonamide-derived drugs, or any component of the formulation; anuria; hypersensitivity to other A-II receptor antagonists; bilateral renal artery stenosis; pregnancy (2nd and 3rd trimesters)

Warnings/Precautions

Avoid use or use a smaller dose in patients who are volume depleted; correct depletion first. Deterioration in renal function can occur with initiation. Use with caution in unilateral renal artery stenosis and pre-existing renal insufficiency; significant aortic/mitral stenosis. Electrolyte disturbances (hypokalemia, hypochloremic alkalosis, hyponatremia) or increases in cholesterol and triglyceride levels can occur. Use caution with diabetes; may see a change in glucose control. Can cause SLE exacerbation or activation. Use caution with renal or hepatic dysfunction.

Chemical similarities are present among sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in patients with sulfonamide allergy is specifically contraindicated in product labeling, however, a risk of cross-reaction exists in patients with allergy to any of these compounds; avoid use when previous reaction has been severe.

Adverse Reactions

Percentages reported with combination product; other reactions have been reported (see individual agents for additional information)

1% to 10%:

Central nervous system: Dizziness (9%; dose related), fatigue (5%)

Gastrointestinal: Diarrhea (3%)

Respiratory: Pharyngitis (3%), cough (3%)

Rhabdomyolysis has been reported (rarely) with angiotensin-receptor antagonists.

Drug Interactions

Valsartan: Inhibits CYP2C8/9 (weak)

Also see individual agents.

Pharmacodynamics/Kinetics

See individual agents.

Dosage

Oral: Adults: Dose is individualized (combination substituted for individual components); dose may be titrated after 3-4 weeks of therapy.

Usual recommended starting dose of valsartan: 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume depleted

Dosage adjustment in renal impairment: Clcr 30 mL/minute: Use of combination not recommended. Contraindicated in patients with anuria.

Dosage adjustment in hepatic impairment: Use with caution

Patient Education

See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause dizziness or drowsiness

Mental Health: Effects on Psychiatric Treatment

May rarely cause neutropenia; use caution with clozapine and carbamazepine; barbiturates and carbamazepine may increase the metabolism of valsartan; may decrease lithium clearance resulting in an increase in serum lithium levels and potential lithium toxicity; monitor serum lithium levels

Dosage Forms

Tablet:

80 mg/12.5 mg: Valsartan 80 mg and hydrochlorothiazide 12.5 mg

160 mg/12.5 mg: Valsartan 160 mg and hydrochlorothiazide 12.5 mg

160 mg/25 mg: Valsartan 160 mg and hydrochlorothiazide 25 mg

International Brand Names

Diovan HCT® (CA)

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