Mezapam - instructions for use, doses, side effects, contraindications

Active substanceMedazepamMedazepam

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Mezapam

pills inwards

ORGANICS, JSC Russia

Dosage form: & nbsppills

Composition:

In 1 tablet of the drug contains:

active substance: mesazam - 10 mg,

Excipients: lactose monohydrate (sugar milk) - 69, mg, potato starch - 20 mg, calcium stearate (calcium stearic acid) - 1 mg.

Description:Tablets are light yellow in a flat-cylindrical form.

Pharmacotherapeutic group:Anxiolytic agent (tranquilizer)

ATX: & nbsp

N.05.B.A.03 Medazepam

Pharmacodynamics:Mezapam - a "daytime" anxiolytic agent (tranquilizer) from the group, benzodiazepines, has an anxiolytic, miorelaxing and anti-eliptic. has a slightly pronounced timoleptic effect. Interacts with the benzodiazepine receptors of the limbic system and the ascending activating brain stem formation, contributes to the discovery of C1-channels, which leads to an increase in the inhibitory effects of GABA in the central nervous system. Eliminates anxiety, fear, psychoneurotic tension, general motor excitement, excessive fussiness, restores emotional behavior and exerts a stabilizing effect on the autonomic nervous system. He restores a critical assessment of his own disease.Anti-eliptic, central - miorelaksiruyuschee, sedative and hypnotic effect is expressed to a lesser degree than in typical benzodiazepine anxiolytic drugs (tranquilizers).

Pharmacokinetics:After oral administration, it is rapidly absorbed. Absorption - 49-75%. The time required to reach the maximum concentration is 1-2 hours. The connection with plasma proteins is 99.8%. Metabolized by hydroxylation, N-demethylation, oxidation with the formation of active metabolites: desmethylmedazepam (nordiazepam), diazepam, dimethyldiazepam, oxazepam (7.1% of the dose). Nordiazepam has a long half-life (T_1/2), accumulates in the body and has a pronounced sedative effect. Derivation of metabolites associated with glucuronic acid, kidneys (63-85%) and through the intestine (15-37%). T_1/2- 20-176 h. After completing the intake for another 3-14 days, significant concentrations of metabolites in plasma are determined (they have a long T_1/2).

Indications:Neurotic and neurosis-like disorders, psychosomatic and vegetative disorders, alcohol withdrawal syndrome (in complex therapy). Children - mental lability, excessive excitability.

Contraindications:Hypersensitivity, myasthenia gravis, acute liver and kidney disease, "nocturnal" apnea, alcohol and drug addiction, children's age (up to 10 years), lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:Hepatic and / or renal failure, pregnancy, spinal and cerebellar ataxia, intraocular hypertension, organic lesions of the central nervous system, respiratory failure, advanced age, general severity of the condition.

Pregnancy and lactation:The use of Mezapam during pregnancy (I trimester) and during lactation is contraindicated. If it is necessary to use during breastfeeding, you should stop feeding.

Dosing and Administration:

Inside, before meals, doses are selected individually, with neurotic and neurosis-like disorders 2-3 times a day, the initial single dose of 10 mg, the initial daily dose of 20 mg, gradually increasing the dose to 30 mg / day (if necessary, up to 40 mg / day); with psychosomatic and vegetative disorders from 20 to 40 mg per day (an average of 30 mg: 1 tablet 3 times a day). At treatment of an alcoholic abstinent syndrome appoint 30 mg / sut within 1-2 weeks. For adults, the average single dose is 10-20 mg. The average daily dose is 30-40 mg.The maximum daily intake for adults is 40 mg (on an outpatient basis) and 60-70 mg (in a hospital setting). The duration of the course of treatment is set individually, on average no more than 2 months, a second course after a break (at least 3 weeks). The elderly and adolescents are prescribed 10-20 mg / day.

Precautions for use:

Use strictly according to the doctor's prescription to avoid complications.

During the treatment period, it may be difficult to memorize and learn, you should refrain from using ethanol.

In the treatment and prevention of abstinence syndrome, cancellation is gradual.

Assign for a short time, with prolonged use, it is possible to form a drug dependence (with an excessive dose increase - the development of tolerance and mental dependence).

Side effects:

Possible side effects when using the drug:

Mezapam is usually well tolerated.

From the nervous system: Drowsiness, headache (first reaction to the reception, which disappears after reducing the dose), weakness, dizziness, stupor, anterograde amnesia, depression, confusion, dysarthria,ataxia (in elderly patients and patients with mental retardation), paresis of accommodation; in elderly patients and children - loss of orientation in space, disinhibition, aggressiveness.

From the cardiovascular system: tachycardia, lowering blood pressure.

From the digestive system: dry mouth, dyspeptic phenomena, increased activity of "liver" transaminases.

From the respiratory system: depression of the respiratory center (with airway obstruction or brain damage), alveolar hypoventilation (in patients with chronic obstructive pulmonary disease with high doses).

Other: decreased potency and / or libido, dysmenorrhea, urinary retention, spasm of the vocal cords (with a temporary stop of breathing), chest pain, withdrawal syndrome.

Overdose:

Symptoms: feeling of fatigue, catalepsy, ataxia, tachycardia, lowering blood pressure, hypotension of muscles; in severe cases - coma, convulsions, respiratory depression.

Treatment: gastric lavage, intake of activated carbon and laxatives, intravenous fluid infusion, control of respiratory rate, heart rate,blood pressure and body temperature, general measures aimed at maintaining the vital vital functions of the body, and preparing all the conditions necessary to provide emergency assistance in the event of possible development of airway obstruction. Forced diuresis and hemodialysis are ineffective.

Interaction:

With simultaneous application, there is a mutual strengthening of the actions of ethanol, narcotic analgesics, medicines for general anesthesia, central muscle relaxants, barbiturates, hypnotics, antidepressants.

With simultaneous administration of antihypertensive drugs of central action and beta-blockers, excessive strengthening of sedative and hypotensive action is possible.

When combined with anticoagulants, the activity of 1 anticoagulant of indirect action decreases.

Inhibitors of microsomal liver enzymes (cimetidine) enhance and lengthen the effect, inducers (barbiturates and phenytoin) weaken.

Oral contraceptives can delay the metabolism of mesapam, which leads to increased intensity and duration of its action.

Reduces the action of levodopa, enhances the action of phenytoin (inhibition of the latter).

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Tablets, 10 mg.

Packaging:In outline cell packs of 10 tab. or in a bank of light-protective glass or a polymer 50 table. 5 contour mesh packages or 1 jar are placed in a cardboard box.

Storage conditions:

List III of the list of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.

Store in a dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-002377

Date of registration:25.07.2011 / 13.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:ORGANICS, JSC ORGANICS, JSC Russia

Manufacturer: & nbsp

ORGANICS, JSC Russia

Information update date: & nbsp26.04.2018

Illustrated instructions

Instructions

Mezapam (Mezapam)