Indications for: ZESTORETIC

Hypertension. Not for initial therapy.

Adult Dosage:

Switching from monotherapy with either component: start with Zestoretic 10/12.5 or 20/12.5 once daily, then adjust. Allow 2–3 weeks for titration of HCTZ component. If on diuretic: if possible, suspend diuretic for 2–3 days, then adjust. Or, substitute for individually titrated components.

Children Dosage:

Not established.

ZESTORETIC Contraindications:

History of ACEI-associated or other angioedema. Anuria. Sulfonamide allergy. Concomitant neprilysin inhibitors (eg, sacubitril); do not administer lisinopril within 36hrs of switching to or from sacubitril/valsartan. Concomitant aliskiren in patients with diabetes.

Boxed Warning:

Fetal toxicity.

ZESTORETIC Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Severe CHF. Ischemic heart disease. Cerebrovascular disease. Arrhythmias. Salt/volume depletion. Hypertrophic cardiomyopathy. Postsympathectomy. Dialysis (esp. high-flux membrane). Renal or hepatic impairment. Severe renal impairment (CrCl ≤30mL/min): not recommended. Diabetes. Gout. Asthma. SLE. Renal artery stenosis. Surgery. Acute myopia. Secondary angle-closure glaucoma. Monitor BP, electrolytes, renal and hepatic function. Monitor serum potassium in diabetics. Monitor WBC in renal or collagen vascular disease. Discontinue if angioedema or laryngeal edema (SC epinephrine should be available), jaundice or marked elevations of liver enzymes occur. Black patients may have higher rate of angioedema than non-Black patients. Elderly. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

ZESTORETIC Classification:

ACE inhibitor + diuretic (thiazide).

ZESTORETIC Interactions:

See Contraindications. May cause hypotension or increased BUN with diuretics. May cause hyperkalemia with K+ sparing diuretics, K+ supplements, or K+ -containing salt substitutes. May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. 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 diabetics or renal impairment (GFR <60mL/min): not recommended. May increase lithium levels; monitor frequently. Increased risk of angioedema with concomitant mTOR inhibitors (eg, temsirolimus, sirolimus, everolimus) or neprilysin inhibitors. Orthostatic hypotension may be increased by alcohol, CNS depressants. Risk of hypoglycemia with concomitant antidiabetic agents; adjust doses. Hypokalemia with ACTH, corticosteroids. May antagonize pressor amines (eg, norepinephrine). May potentiate tubocurarine, neuromuscular blocking agents. Reduced absorption with bile acid resins (eg, cholestyramine, colestipol). May interfere with parathyroid test. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare.

Adverse Reactions:

Dizziness, headache, cough, fatigue, orthostatic hypotension, upper respiratory infection, muscle cramps, asthenia, paresthesia, vomiting, dyspepsia, rash, impotence, electrolyte disturbances (hypo- or hyperkalemia, hypomagnesemia, hyponatremia), hyperuricemia, angioedema; liver dysfunction, blood dyscrasias (rare); HCTZ: increased risk for non-melanoma skin cancer.

Generic Drug Availability:


How Supplied:

Tabs—90, 100