Perindopril/indapamide

Form and Composition
Each scored tablet contains 2 mg of perindopril tert-butylamine salt and 0.625 mg of indapamide.

Indication
Essential hypertension.

Dosage and Administration
One tablet daily, preferably to be taken in the morning and before a meal.

Pharmacological Action
PRETERAX, a fixed combination of an ACE inhibitor and a chlorosulfamoyl diuretic, leads to additive synergy of the antihypertensive effects of the two constituents. Its pharmacological properties are derived from those of each of the components taken separately, in addition to those due to the additive synergistic action of the two constituents, when combined, on vascular endothelium, arteriolocapillary microcirculation, and the target organs of hypertension. Elderly patients: Normal dosage. Renal failure: Creatinine clearance (CrCl) >30 mL/min: no dosage modification. CrCl <30 ml/min: treatment contraindicated.

Contraindications
Absolute: Known allergy to perindopril, indapamide, or sulfonamides; history of Quincke's edema linked to previous ACE inhibitor therapy; severe renal failure; serious liver disorder; hypokalemia; pregnancy; lactation. Relative: Combination therapy with lithium, potassium salts, potassium-sparing diuretics, and certain medicines which can cause heart rhythm disorders.

Side Effects
Asthenia, dizziness, headache, mood swings and/or sleep disturbances, cramps, hypotension, allergic reactions, skin rashes, gastrointestinal disorders, dry cough, dry mouth, risk of dehydration in the elderly and in patients suffering from heart failure; changes in blood test results may occur.

Warnings
Immunosuppressed patients. Hemodialysis: risk of anaphylactoid reaction during hemodialysis with polyacrylonitrile membranes. Liver impairment.

Precautions
Disorders of electrolyte balance, diabetes, gout, hypotension, or strict sodium-free diets, heart or renal failure, atherosclerosis, renal artery stenosis, elderly.

Drug Interactions
Not recommended: Combinations with lithium, potassium-sparing diuretics, potassium (salts), antiarrhythmic drugs which cause torsade de pointes, anesthetic drugs, cytostatic or immunosuppressive agents.