Generic Name and Formulations:
Valsartan, hydrochlorothiazide; 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, 320mg/25mg; tabs.

Company:
Novartis Pharmaceuticals Corp
Indications for DIOVAN HCT:
Hypertension.

Adult Dose for DIOVAN HCT:
Take once daily. Add-on or initial therapy and not volume-depleted: Initially 160mg/12.5mg; may increase after 1–2 weeks up to max 320mg/25mg. Replacement therapy: may be substituted for the titrated components. Maximum effects within 2–4 weeks after dose change. CrCl ≤30mL/min: not recommended.

Children's Dose for DIOVAN HCT:
Not recommended.

Pharmacological Class:
Angiotensin II receptor blocker + diuretic.

Contraindications:
Anuria. Sulfonamide allergy. Concomitant aliskiren in diabetics.

Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy detected. Intravascular volume depletion; do not use as initial therapy. Correct salt/volume depletion before starting, or monitor closely. Hepatic or severe renal impairment. Diabetes. Gout. Asthma. Hypercalcemia. Severe CHF. Renal artery stenosis. SLE. Acute myopia. Secondary angle-closure glaucoma. Monitor electrolytes. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:
See Contraindiactions. Monitor for hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt substitutes. Antagonized by cholestyramine, colestipol resins. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. May be antagonized by, and renal toxicity potentiated by NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume-depleted). Orthostatic hypotension may be potentiated by alcohol, barbiturates, narcotics, antihypertensives. May be potentiated by inhibitors of OATP1B1 (eg, rifampin, cyclosporine) or MRP2 (eg, ritonavir). Potentiates nondepolarizing muscle relaxants. Adjust antidiabetic, antigout medications. Hyperuricemia may be potentiated by cyclosporine. Avoid lithium. May increase toxicity of digitalis, lithium. Possible symptomatic hyponatremia with carbamazepine.

Adverse Reactions:
Headache, dizziness, nasopharyngitis, viral infection, fatigue, cough, diarrhea, orthostatic hypotension, electrolyte disturbances (eg, hypokalemia, hyponatremia, hypomagnesemia), hyperuricemia, increased serum cholesterol or triglycerides; rare: rhabdomyolysis.

Metabolism:
Valsartan: Hepatic (CYP2C9); 95% protein bound. HCTZ: not metabolized.

Elimination:
Valsartan: fecal, renal. HCTZ: renal.

Generic Availability:
YES

How Supplied:
Tabs—90