Monopril

Monopril – inhibitor of an angiotensin-converting enzyme (APF).

Form of release and structure

Dosage form – tablets: a round biconvex form with dividing risky on one party and an engraving "609" – on another, can have almost white or white color, without specific smell (on 14 pieces in blisters, in a cardboard pack 2 blisters).

– fozinoprit active ingredient of Monopril sodium, in 1 tablet – 20 mg.

Auxiliary components: кросповидон, cellulose microcrystallic, lactose anhydrous, the sodium stearylfumarating povidone.

Indications to use

• Arterial hypertension;
• Combination therapy of heart failure.

Contraindications

• Age up to 18 years;
• Lactose intolerance, syndrome of glyukozo-galaktozny malabsorption, deficit of lactase;
• Hereditary and idiopathic Quincke's disease in the anamnesis, including against the background of use of other APF inhibitors;
• Period of pregnancy and breastfeeding;
• Hypersensitivity to components of drug and APF inhibitors in the anamnesis.

With care patients need to appoint Monopril with a renal failure, a stenosis of an artery of the only kidney or a bilateral stenosis of renal arteries, a hyponatremia (threat of dehydration, chronic renal failure, arterial hypotension), coronary heart disease, cerebrovascular diseases (including insufficiency of cerebral circulation), chronic heart failure of III and IV functional classes (on NYHA classification), an aortal stenosis; at oppression of a marrowy hemopoiesis, desensitization, a state after transplantation of a kidney, system pathologies of connecting fabric (including a system lupus erythematosus, a scleroderma), a hemodialysis, a diabetes mellitus, gout, a hyperpotassemia, a diet with salt restriction, at the states which are followed by decrease in volume of the circulating blood (including vomiting, diarrhea), the previous treatment by diuretics; at advanced age.

Route of administration and dosage

Pill is taken orally 1 time a day.

The dose is established by the doctor on the basis of clinical indications.

The recommended daily dosing of Monopril:

• Arterial hypertension: an initial dose – 10 mg. The dose is selected individually, considering dynamics of a lowering of arterial pressure (ABP), its size can make 10-40 mg. At insufficiency of hypotensive effect co-administration of diuretics is shown. If use is begun against the background of treatment with diuretics, then the initial dose should not exceed 10 mg and use has to be followed by regular control of the doctor. The maximum dose of drug – 40 mg a day;
• Chronic heart failure (as a part of a combination therapy with diuretic): an initial dose – 10 mg. Within the first week of use it is regularly necessary to control a condition of the patient, his reaction to drug. If he is had well, the dose is recommended to be raised gradually (once a week) to the most admissible – 40 mg. Co-administration of digoxin is optional.

Or to a liver and patients of advanced age (65 years are also more senior) dose adjustment usually is not required to patients with functional disorder of kidneys.

Side effects

• Cardiovascular system: a heart consciousness, strong decrease in the ABP, rushes of blood to face skin, tachycardia, orthostatic hypotension, a syncope, stenocardia, arrhythmia, disturbance of conductivity of heart, peripheral hypostases, a myocardial infarction, increase in the ABP, a cardiac standstill, sudden death;
• Alimentary system: appetite disturbance, nausea, vomiting, meteorism, diarrhea or lock, abdominal pains, intestinal impassability, bleedings, hepatitis, pancreatitis, cholestatic jaundice, stomatitis, dysphagy, glossitis, change of body weight, anorexia, xerostomia;
• Respiratory system: short wind, dry cough, bronchospasm, pneumonia, pulmonary infiltrates, rhinorrhea, dysphonia, laryngitis, sinusitis, pharyngitis, tracheobronchitis, nasal bleedings;
• Urinary system: renal failure, hyperplasia and/or adenoma of a prostate, proteinuria, oliguria, polyuria;
• Sense bodys: sonitus, ear pain, hearing disorder and sight, taste change;
• Nervous system: dizziness, headache, brain ischemia, stroke, balance disturbances, memory disturbance, weakness, sleep disorders, depression, uneasiness, confusion of consciousness, paresthesia, drowsiness;
• Lymphatic system: inflammation of lymph nodes;
• Metabolism: exacerbation of gout;
• Musculoskeletal system: muscular weakness in extremities, a mialgiya, arthritis, musculoskeletal pains;
• Allergic reactions: itch, skin rash, dermatitis, Quincke's disease;
• Laboratory indicators: increase in concentration of urea, giperkreatininemiya, increase in activity of enzymes of a liver, hyperbilirubinemia, hyponatremia, hyperpotassemia, decrease in level of concentration of a hematocrit and hemoglobin, increase in the blood sedimentation rate (BSR), neutropenia, leukopenia, eosinophilia;
• Influence on a fruit: contractures of extremities, hypoplasia of bones of a skull, hypoplasia of lungs, disturbance of development of kidneys of a fruit, renal failure, decrease in the ABP of a fruit and newborns, олигогидрамнион, hyperpotassemia;
• Others: hyperhidrosis, fervescence, disturbance of sexual function.

Special instructions

Treatment is required to be begun after the careful analysis of extent of increase in the ABP, the previous anti-hypertensive therapy, decrease in a diet of content of liquid and/or salt and other clinical factors. Earlier carried out hypotensive treatment, it is desirable to stop some days before the beginning of use of Monopril.

For decrease in risk of development of arterial hypotension, reception of diuretics is cancelled in 2-3 days prior to therapy.

Use of drug has to be followed by regular control of the ABP, function of kidneys, level of concentration of creatinine, potassium ions, urea, contents of electrolytes and activity of liver enzymes in blood serum.

At development of a Quincke's disease of lips, persons, language, throats or drinks, mucous membranes, extremities against the background of administration of drug, it is necessary to cancel Monopril. Often the termination of treatment provides normalization of a condition of the patient if hypostasis does not pass it is necessary to appoint the corresponding therapy, including hypodermic administration of solution of Epinephrinum (adrenaline) (1:1000). The untimely help can lead to obstruction of respiratory tracts with risk of a lethal outcome.

In rare instances reception of APF inhibitors can cause the hypostasis of a mucous membrane of intestines which is followed by abdominal pains. As it can proceed without symptoms of a face edema, at normal activity of C1 esterase and absence at the patient of nausea or vomiting, it needs to be included in differential diagnosis of patients with complaints to abdominal pains. Symptoms of hypostasis pass after drug withdrawal.

Patients with anaphylactic reactions against the background of dialysis with use of high-permeability membranes or an afereza of lipoproteids of low density with adsorption need to appoint hypotensive drugs of other class or use of dialysis membranes of other type to sulfate of a dextran.

Because of risk of development of anaphylactic reactions when performing desensitization of patients it is necessary to observe extra care.

Not to allow development of suppression of function of marrow and an agranulocytosis before use of APF inhibitors and in the course of therapy follows regularly (within the first 3-6 months once a month) to carry out definition of leukocytes and a leukocytic formula. At patients with the increased risk (a renal failure, general diseases of connecting fabric) researches continue to be conducted for the first year of therapy.

Against the background of carrying out dialysis, an intensive care diuretics, the diet limiting consumption of table salt, development of symptomatic arterial hypotension happens more often. At tranzitorny arterial hypotension use of drug is continued after recovery of volume of the circulating blood.

Use of APF inhibitors is shown to patients with chronic heart failure, but it can cause the excess anti-hypertensive action exponentiating development of an azotemia and oliguria, in rare instances – an acute renal failure with a lethal outcome. Therefore each increase in a dose of Monopril or diuretic demands careful observation of their state from patients of this category, especially within the first two weeks of therapy. To the normal or low ABP who were earlier accepting diuretic means the diuretic dose decline can be necessary for patients with a hyponatremia.

Insignificant decrease in the system ABP in an initiation of treatment of patients with chronic heart failure is the typical and desired effect. The maximum decrease in the ABP is observed at early stages of therapy and stabilized within 1-2 weeks without decrease in therapeutic effect.

In rare instances reception of APF inhibitors can cause the syndrome beginning with cholestatic jaundice which approach of a fulminant necrosis of a liver follows (with risk of a lethal outcome). As the nature of this syndrome is not established, at significant increase in activity of enzymes of a liver and emergence in the patient of noticeable yellowness drug it is necessary to cancel and appoint the corresponding therapy.

At an abnormal liver function the increased maintenance of a fozinopril can be noted in a blood plasma. At cirrhosis the general clearance of a fozinoprilat seeming to normal is reduced, and approximately AUC, in comparison with patients with normal function of a liver is twice higher.

At arterial hypertension with a stenosis of an artery of the only kidney or about one - or a bilateral stenosis of renal arteries use of APF inhibitors can cause reversible processes of increase in concentration of creatinine of blood serum and an urea nitrogen of blood in patients (in this case drug withdrawal is required). This category of patients needs regular control of function of kidneys in the first weeks of therapy. Increase in concentration of creatinine of blood serum and an urea nitrogen of blood (usually insignificant and passing) with normal function of kidneys can be caused in patients by a concomitant use of Monopril and diuretics (in this case the drug dose decline is required).

At the expressed chronic heart failure use of APF inhibitors can be followed by the progressing azotemia and/or an oliguria, in rare instances – risk of development of an acute renal failure with a lethal outcome.

The patients with a diabetes mellitus of 1 type, a renal failure and also accepting the kaliysoderzhashchy nutritional supplements, kaliysberegayushchy diuretics and other means promoting increase in level of maintenance of potassium ions in blood serum are subject to big risk of development of a hyperpotassemia against the background of administration of drug.

In case of cough it is necessary to consider administration of drug as the possible reason when carrying out the differential diagnosis.

By preparation for carrying out surgery it is necessary to warn the anesthesiologist about Monopril's reception.

Patients are recommended to carry out with care exercise stresses, including in hot weather.

Because of possible developing of dizziness, it is necessary to be careful at control of vehicles and mechanisms.

Medicinal interaction

During treatment by Monopril simultaneous use of other medicines can be begun only after consultation with the attending physician who can estimate interaction of drugs that will allow to avoid development of undesirable effects.

Terms and storage conditions

To store in the place, dry, unavailable to children, at a temperature of 15-25 °C.

Period of validity – 2 years.