Mezapamum

Mezapamum – the drug having anxiolytic and sedative effect.

Form of release and structure

Mezapamum is released in the form of tablets (in blister strip packagings on 10 pieces, on 5 packagings in a cardboard pack; in dark glass jars on 50 pieces, after 1 bank in a cardboard pack).

Is a part of 1 tablet:

• Active agent: Medazepamum – 10 mg;
• Auxiliary components: potato starch – 20 mg, monohydrate of lactose (milk sugar) – 69 mg, calcium stearate (stearate calcium) – 1 mg.

Indications to use

• Disorders of psychosomatic and psychovegetative character, including vegeto-vascular dystonia, functional disorders of digestive tract and cardiovascular system, a sleep disorder, a menopausal syndrome, migraine (for the purpose of prevention of attacks);
• The psychopathies, neurosises, psychopatholike and neurosis-like states which are followed by irritability, hypererethism, decrease in mood, emotional lability, tension, alarm, fear;
• "School" neurosises, hyperexcitability and mental lability at children;
• Alcoholic abstinence syndrome (at an uncomplicated current);
• The delayed neurotic frustration developing in structure of remission of drug addiction and alcoholism (along with other drugs).

Contraindications

• Drug and alcohol addiction;
• Apnoea syndrome during sleep;
• Heavy myasthenia;
• Closed-angle glaucoma;
• Diseases of kidneys and a liver (at an acute current);
• Renal and/or liver failure (at a heavy current);
• First trimester of pregnancy and period of a lactation;
• Hypersensitivity to drug components, and also to other benzodiazepines.

In the II-III trimesters of pregnancy use of Mezapamum is possible in cases when the advantage of therapy is higher than estimated harm for health of a fruit (it is necessary to avoid use of drug in high doses or it is long).

Route of administration and dosage

Mezapamum is accepted inside, it is more preferable – before meal.

The initial adult dose makes 5 mg 2-3 times a day, gradually daily dose is increased to 30 mg (in need cases – to 40 mg). In out-patient conditions usually appoint 5 mg in the morning and at noon, in the evening – 10 mg. An average single dose – 10-20 mg, daily – 30-40 mg. The maximum daily dose in out-patient conditions makes 40 mg, in a hospital – 60-70 mg. Therapy duration – up to 60 days. Carrying out a repeated course with a break is possible not less than 21 day.

To elderly patients and teenagers Mezapamum appoint 10-20 mg in a daily dose.

The single/daily dose for children is defined by age:

• 1-2 years: 1/2-3 mg;
• 3-6 years: 1-2/3-6 mg;
• 7-10 years: 4-8/6-24 mg;
• 10 years are more senior: 6-10/20-60 mg.

At alcoholism for 7-14 days usually appoint 30 mg a day.

Side effects

• Cardiovascular system and blood (hemostasis, hemopoiesis): lowering of arterial pressure, bradycardia, tachycardia;
• Nervous system and sense bodys: drowsiness, dizziness, a headache (as a rule, arises as the first reaction to reception, after a dose decline usually takes place), slackness, weakness, pains in a thorax, the suppressed mood, confusion of consciousness, bystry fatigue (including at patients with depressive diseases in the anamnesis), double indistinct vision, an oglushennost, an ecmnesia, accommodation paresis, a dysarthtia, twitching of an eyeglobe, an ataxy (at the elderly and weakened patients), paradoxical reactions (in the form of the increased aggression, sleep disorders, spasms of various groups of muscles; – is more often than strong excitement, sensation of fear, suicide thoughts at elderly patients and children);
• Digestive tract: pain in epigastriums, dryness in a mouth, vomiting, nausea, jaundice, a lock, the dispepsichesky phenomena, increase in activity of hepatic transaminases;
• Respiratory system: a laryngospasm, oppression of a respiratory center (at injuries of a brain or obstruction of airways), an asthma, alveolar hypoventilation (at patients with a chronic obstructive pulmonary disease at reception in high doses);
• Others: thorax pain, myasthenia, ischuria, skin and allergic reactions (itch, reddening, rash, dieback), dysmenorrhea, decrease in a libido; at long use – dependence development (mental and physical), accustomings, a withdrawal.

Special instructions

To the patients accepting it is long beta adrenoblockers, hypotensive medicines of the central action, hypoglycemic drugs, contraceptive peroral means, cardiac glycosides and anticoagulants it is necessary to appoint Mezapamum with care (precisely it is impossible to predict the nature of interaction of these medicines with Medazepamum).

Therapy should be interrupted in cases of development of the increased aggression, excitement, sensation of fear, thoughts of suicide, hallucinations, muscular spasms.

At daily reception of Mezapamum for several weeks there can be a danger of development of mental and physical dependence (this disturbance can be observed both at reception of high doses of drug, and at its use in usual medical doses) in this connection continuation of therapy is possible only according to vital indications and only after a careful ratio of advantage of drug with risk of emergence of dependence on it. The risk of development of medicinal dependence increases at patients who abused ethanol or medicines earlier, and also at use of high doses, increase in duration of therapy.

Long use of Mezapamum by pregnant women can cause development of a withdrawal in the newborn. Reception of high doses of drug just before or at the time of delivery can cause a lowering of arterial pressure, respiratory depression, suction difficulty ("a syndrome of the sluggish child") and a hypothermia in the newborn.

In cases of the admission of reception of the next dose of Mezapamum, it needs to be accepted at once as soon as it was noticed, however it is impossible to double a single dose.

The use of alcoholic beverages during therapy is inadmissible.

During treatment and prevention of an abstinence syndrome it is necessary to cancel Mezapamum gradually.

In the period of an after-effect there can be serious conditions of excitement.

It is necessary to consider that tension or alarm connected with a daily stress, indications to purpose of anxiolytics usually are not.

Drivers of vehicles and patients, whose profession is connected with the increased concentration of attention, Mezapamum need to take with caution (in the first days of therapy it is recommended to refuse completely control of vehicles and the performance of work demanding bystry mental and physical reactions).

Medicinal interaction

At simultaneous use of Mezapamum with some medicines the following effects can develop:

• The means oppressing the central nervous system (including somnolent medicines, narcotic analgetics, neuroleptics, anesthetics, antihistaminic drugs with a sedative component), muscle relaxants, alcohol and etanolsoderzhashchy drugs: strengthening of their action;
• Alcohol: development of paradoxical reaction;
• Levodopa: oppression of its action;
• Theophylline (low doses): decrease in the calming action of Medazepamum;
• Estrogensoderzhashchy oral contraceptives, Cimetidinum, Disulfiramum, омепразол: strengthening and prolongation of action of Medazepamum;
• Nicotine: acceleration of removal of Medazepamum from an organism.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C.

Period of validity – 5 years.