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Prescribing Information

Valzodec-HCT ® (Valsartan and Hydrochlorothiazide)

INDICATIONS AND USAGE: Treatment of hypertension: In patients not adequately controlled on
monotherapy, and as initial therapy in patients likely to need multiple drugs to achieve their blood
pressure goals. May be substituted for titrated components. DOSAGE AND ADMINISTRATION: Once
daily. Titrate as needed to a maximum dose of 320/25mg. May be used as add-on/switch therapy for
patients not adequately controlled on any of the components (Valsartan or HCT). DOSAGE FORMS
AND STRENGTHS: Tablets (Valsartan/HCT): 80/12.5, 160/12.5, 160/25 mg. CONTRAINDICATIONS:
Anuria; hypersensitivity to any sulfonamide-derived drugs or any component; co-administration
with Aliskiren in patients with diabetes. WARNINGS AND PRECAUTIONS:Correct volume depletion
prior to initiation. Observe for signs of fluid or electrolyte imbalance. Monitor renal function and
potassium in susceptible patients. In systemic lupus erythematosus, exacerbation or activation of
disease can occur, and be cautious in acute angle-closure glaucoma. ADVERSE REACTIONS:The
only adverse experience that occurred in 2% of patients treated with this combination and at a
higher incidence than placebo was nasopharyngitis (2.4% vs. 1.9%). DRUG INTERACTIONS: Dosage
adjustment of Antidiabetic drugs may be required. Cholestyramine and Colestipol can reduce
absorption of Thiazides. Risk of Lithium toxicity increases and serum Lithium concentrations need to
be monitored during concurrent use. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may increase
risk of renal impairment and can reduce diuretic, natriuretic and antihypertensive effects of Diuretics.
Dual inhibition of the renin-angiotensin system increases the risk of renal impairment, hypotension,
and hyperkalemia. USE IN SPECIAL POPULATIONS: Lactation: Breastfeeding is not recommended.

FDA label, Reference ID: 4659158.
See FDA approved labeling for more information.