Prestarium

Prestarium – inhibitor of an angiotensin-converting enzyme (APF), has vasodilating, hypotensive effect.

Form of release and structure

Dosage form – tablets: on 2 mg: white color, biconvex round form; on 4 mg: light green color, a rod form, with the rounded edges, with dividing risky from two parties and an engraving of a logo of firm on one of them; on 8 mg: green color, a round biconvex form, with an engraving in the form of heart on one party and a logo of firm – on another (in the blister: on 2 mg and 4 mg – 14 or 30 pieces, on 8 mg – 30 pieces, in a cardboard pack 1 blister).

Active ingredient of Prestarium – was perindoprit by tretbutilaminovy salt, in 1 tablet – 2 mg, 4 mg or 8 mg that is equivalent to the content of 1,669 mg, 3,388 mg or 6,676 mg of a perindopril.

Auxiliary components: lactoses monohydrate, microcellulose, magnesium stearate, silicon dioxide colloid hydrophobic.

Indications to use

• Chronic heart failure;
• Arterial hypertension.

Besides, Prestarium's use is shown to the patients who had a stroke or tranzitorny disturbance of cerebral circulation on ischemic type for prevention of a repeated stroke as a part of a combination therapy with indapamidy.

Contraindications

• Quincke's disease in the anamnesis;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to substances of drug or to medicines of this pharmacological group in the anamnesis.

With care it is recommended to appoint the patient with a reduced volume of the circulating blood (against the background of reception of diuretics, a hemodialysis, vomiting, diarrhea, an electrolyte-deficient diet), with renovascular hypertensia, a hyponatremia, cerebrovascular diseases, stenocardia (because of risk of a sharp lowering of arterial pressure), a bilateral stenosis of renal arteries or existence only of one functioning kidney (development of heavy arterial hypotension, renal failure is possible), a chronic heart or renal failure (risk of a hypopotassemia), at general diseases of connecting fabric (a scleroderma, a system lupus erythematosus), transplantation of the kidney accompanying therapy by immunodepressants (risk of development of a neutropenia and agranulocytosis), a stenosis of the aortal valve, a hypertrophic subaortic stenosis, a hyperpotassemia at a syndrome of glyukozo-galaktozny malabsorption, deficit of lactase, a galactosemia, diabetes mellitus (risk of development of a hypoglycemia against the background of reception of hypoglycemic means), in case of carrying out the general anesthesia at surgery (risk of development of arterial hypotension), when using high-flowing polyacrylonitrile membranes for a hemodialysis, performing the desensibilizing therapy by allergens (the probability of development of allergic reactions increases), up to 18 years and at advanced age.

Route of administration and dosage

Pill is taken orally, 1 time a day (before a breakfast).

The recommended dosing:

• Heart failure (in combination with digoxin and/or nekaliysberegayushchy diuretic): an initial dose – 2 mg, it is necessary to begin Prestarium's use under careful medical control of a condition of the patient. At the normal answer of therapy after 1-2 weeks of administration of drug the dose can be raised to 4 mg;
• Essential hypertensia: an initial dose – 4 mg, for achievement of clinical effect it is possible to raise a dose for a month to 8 mg. Against the background of the accompanying therapy by diuretics perhaps sharp falling of the arterial pressure (AP) therefore patients are followed in 2-3 days prior to APF inhibitor reception by reception of diuretics to stop or lower an initial dose of drug to 2 mg;
• Renovascular arterial hypertension: an initial dose – 2 mg, if necessary it is possible to raise a dose gradually.

Treatment of patients of advanced age it is necessary to begin 2 mg with an initial dose. At good dynamics of therapy its gradual increase to the most admissible dose – 8 mg is shown.

For prevention of a repeated stroke at cerebrovascular pathologies in the anamnesis drug in a dose of 2 mg should begin to be accepted in 2 weeks prior to introduction of an indapamid. After the had stroke use of drug can be begun at any time (from 2 weeks to several years).

The dosing mode for patients with a renal failure depends on potassium concentration level in blood and the clearance of creatinine (CC):

• KK is more than 60 ml/min.: usual dose;
• KK of 30-60 ml/min.: daily – 2 mg;
• KK of 15-30 ml/min.: every other day – 2 mg;
• KK is less than 15 ml/min.: in day of dialysis – 2 mg.

Dose adjustment at a liver failure is not required.

At the accidental admission of the next administration of drug the appointed dose needs to be accepted before the following meal.

Side effects

• Cardiovascular system: often – the expressed decrease in the ABP and the related symptoms; very seldom – stenocardia, arrhythmia, a stroke, a myocardial infarction;
• Alimentary system: often – an abdominal pain, taste disturbance, nausea, vomiting, a lock, diarrhea; seldom – dryness in a mouth; very seldom – pancreatitis, cholestatic jaundice;
• Urinary system: seldom – decrease in function of kidneys; very seldom – an acute renal failure;
• Nervous system: often – a ring in ears, a headache, dizziness, paresthesias, an adynamy, muscular spasms, a vision disorder; seldom – a sleep disorder, decrease in mood; very seldom – confusion of consciousness;
• Allergic reactions: often – a skin itch, rash; seldom – a Quincke's disease, a small tortoiseshell; very seldom – a multiformny erythema;
• Respiratory system: often – breath difficulty, dry cough; seldom – a bronchospasm; very seldom – a rhinorrhea;
• Laboratory indicators: perhaps – slight increase of level of content of creatinine in a blood plasma and urine, after drug withdrawal takes place independently (the risk is increased at a stenosis of renal arteries, reception of diuretic means, a renal failure), increase in concentration of potassium ions (temporary is more often); at a glomerular nephropathy drug can cause development of a proteinuria; anemia (after a hemodialysis, transplantation of a kidney); seldom – decrease in a hematocrit, hemoglobin, thrombocytopenia; very seldom – a pancytopenia, increase in activity of liver enzymes, an agranulocytosis, a hyperbilirubinemia, at deficit glyukozo-6-fosfatdegidrogenazy – development of hemolitic anemia;
• Others: seldom – perspiration, functional disturbance of sexual activity.

At emergence of symptoms of suffocation, puffiness of language and/or the person immediate drug withdrawal and consultation of the doctor is required.

Special instructions

In case of observance of the electrolyte-deficient diet preceding therapy by diuretics patients with arterial hypertension have to report about it to the doctor at Prestarium's appointment.

At emergence of dry cough it is recommended to see a doctor and to resolve an issue of expediency of further therapy.

The patient should be careful as against the background of use of drug development of allergic reactions, a Quincke's disease is possible.

At purpose of drug of the patient has to report to the doctor about all accepted medicines, it will allow to avoid undesirable effect of interaction.

Because of presence at composition of drug of lactose of monohydrate to patients with a lactose intolerance, a syndrome of glyukozo-galaktozny malabsorption or a galactosemia Prestarium's appointment is undesirable.

Medicinal interaction

Co-administration with kaliysberegayushchy diuretics (Triamterenum, Spironolactonum, amiloride), potassium salts is contraindicated.

With care it is necessary to appoint drug for a combination therapy with antidiabetic means, lithium drugs, anesthetics, Allopyrinolum, narcotic analgetics, immunodepressants, procaineamide, system corticosteroids, anti-hypertensive, cytostatic, antipsychotic means.

Terms and storage conditions

To protect from children.

To store at a temperature up to 30 °C.

Period of validity – 2 years.