Zestoretic

[Lisinopril/HCTZ]

Special Senses

Visual loss diplopia, photophobia, taste alteration; Urogenital: Acute renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), pyelonephritis, dysuria, breast pain.

Miscellaneous

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A symptom complex has been reported which may include a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/ arthritis, myalgia, fever, vasculitis, eosinophilia and leukocytosis. Rash, photosensitivity or other dermatological manifestations may occur alone or in combination with these symptoms.

Fetal/ Neonatal Morbidity and Mortality
See WARNINGS -Pregnancy, Lisinopril, Fetal/ Neonatal Morbidity and Mortality.

Hydrochlorothiazide

-Body as a Whole

Weakness;

Digestive

Anorexia, gastric irritation, cramping, jaundice (intrahepatic cholestatic jaundice (See WARNINGS, Hepatic Failure), pancreatitis, sialoadenitis, constipation;

Hematologic

Leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia;

Musculoskeletal

Muscle spasm;

Nervous System/ Psychiatric

Restlessness;

Renal

Renal failure, renal dysfunction, interstitial nephritis (see WARNINGS); Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia;

Special Senses

Xanthopsia;

Hypersensitivity

Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions.

Drug Interactions

Lisinopril

Hypotension -Patients on Diuretic Therapy

Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with lisinopril. The possibility of hypotensive effects with lisinopril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with lisinopril.

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