Medicinal reference book geotar. Detailed instructions for the use of clonazepam

P N012884/01

Trade name of the drug:

Clonazepam (Clonazepam)

International non-proprietary name:

Clonazepam (Clonazepam)

Dosage form:

Tablets 0.5 mg
Tablets 2 mg

Compound:

Composition 1 ml:
active substance: clonazepam 0.5 mg
Excipients: potato starch, gelatin, orange yellow color E-110, talc, magnesium stearate, sodium starch glycolate, lactose.
active substance: clonazepam 2 mg
Excipients: potato starch, gelatin, sodium lauryl sulfate, talc, magnesium stearate, sodium starch glycolate, tween, rice starch, lactose

Description:

Tablets 0.5 mg :
Round biflat tablets with solid edges, without cracks, light orange in color with a cross-shaped risk dividing the tablet into 4 parts.
Tablets 2 mg :
Tablets from white to light cream color, practically odorless, round in shape, bilaterally flat, with solid edges, without cracks, with a cross-shaped risk dividing the tablet into 4 parts.

Pharmacotherapeutic group:

anticonvulsants benzodiazepines.

ATX code:

N03AE01

Indications for use

  • epilepsy in children and adults (mainly akinetic, myoclonic, generalized submaximal seizures, temporal and focal seizures).
  • syndromes of paroxysmal fear, states of fear in phobias, for example. agoraphobia (do not use in patients under 18 years of age).
  • states of psychomotor agitation against the background of reactive psychoses.

Contraindications

  • hypersensitivity to benzodiazepines;
  • respiratory failure of central origin and severe conditions of respiratory failure, regardless of the cause;
  • angle-closure glaucoma;
  • myasthenia gravis;
  • disturbance of consciousness;
  • significant impairment of liver function.

Use during pregnancy and lactation

The use of the drug during pregnancy is allowed only in a situation where its use in the mother has absolute indications, and the use of a safer alternative drug is impossible or contraindicated.
During treatment with clonazepam, breast-feeding should be avoided.

Dosage and administration

Dose and duration of therapy - strictly according to the doctor's prescription.
Treatment should be started with low doses, increasing them gradually until the appropriate therapeutic effect is obtained.
With epilepsy
adults: the initial dose is 1.5 mg / day divided into three doses. The dose should be gradually increased by 0.5-1 mg every 3 days. The maintenance dose is set individually for each patient, depending on the therapeutic effect (usually 4-8 mg / day in 3-4 doses). The maximum daily dose is 20 mg.
Children: initial dose - 1 mg / day (2 times 0.5 mg). The dose can be gradually increased by 0.5 mg every 3 days until a satisfactory therapeutic effect is obtained. The maintenance daily dose is:
in infants up to 1 year - 0.5-1 mg
in children from 1 year to 5 years - 1-3 mg
in children from 5-12 years old -3-6 mg
The maximum daily dose for children is 0.2 mg/kg body weight/day.
With paroxysmal fear syndrome
Adults: The average dose used is 1 mg/day. The maximum daily dose is 4 mg/day.
Children: The safety and efficacy of clonazepam in children under 18 years of age with paroxysmal fear syndrome has not been established.
Elderly patients (over 65 years old): Care must be taken when using clonazepam. A dose reduction is recommended, especially in patients with impaired balance and reduced motor abilities.
Patients with impaired renal and hepatic function: Caution must be exercised when using clonazepam. It may be necessary to reduce the dose of the drug.
Patients with chronic respiratory disease: clonazepam may cause increased saliva secretion. For this reason, and also because of the depressant effect on respiratory function, care must be taken when using the drug.
You can not abruptly cancel the drug, it is always necessary to gradually, controlled by the doctor, reduce the dose. Abrupt withdrawal of the drug can cause sleep disturbance, mood, and even mental disorders. Especially dangerous is the abrupt cessation of long-term therapy or therapy requiring large doses of the drug. Withdrawal symptoms are then more pronounced. Prolonged use leads to a gradual weakening of the effect of the drug as a result of the development of tolerance. During long-term therapy with clonazepam, periodic studies are recommended: blood and liver function tests.
During treatment with clonazepam and 3 days after its completion, you should not drink any alcoholic beverages.

Interaction with other drugs
The inhibitory effect of clonazepam on the central nervous system is enhanced by all drugs with a similar effect: sleeping pills (eg barbiturates), centrally acting blood pressure lowering drugs, antipsychotics, antidepressants, anticonvulsants, narcotic analgesics. Ethyl alcohol has a similar effect. The use of alcohol during treatment with clonazepam, in addition to a summing inhibitory effect on the central nervous system, can provoke paradoxical reactions: psychomotor agitation, aggressive behavior, or a state of pathological intoxication. Pathological intoxication does not depend on the type and amount of alcohol consumed.
The drug potentiates the action of drugs that reduce the tone of skeletal muscles.
Tobacco smoking may reduce the effect of clonazepam.

Side effect

  • Frequent undesirable effects of clonazepam during treatment may be: drowsiness, dizziness, impaired coordination of movements, fatigue, fatigue.
  • May also appear: memory impairment, increased nervous irritability, depression, symptoms of catarrh of the upper respiratory tract, increased secretion of saliva
  • Rarely may occur: speech disturbances, impaired learning ability, emotional lability, decreased libido, disorientation, constipation, abdominal pain, decreased appetite, skin allergic reactions, muscle pain, menstrual irregularities in women, frequent urination, blurred vision, decreased the number of erythrocytes, leukocytes and platelets in the blood, a transient increase in the blood concentration of transaminases (AlAT, AspAT), and alkaline phosphatase; paradoxical reactions: psychomotor agitation, insomnia. In the event of a paradoxical reaction, treatment should be interrupted immediately.

Systematic use of the drug for many weeks can lead to the development of drug dependence and the appearance of withdrawal symptoms in case of abrupt withdrawal of the drug.
During treatment with clonazepam and for 3 days after its completion, you can not drive vehicles and service moving mechanical devices.

Overdose

As a result of an overdose of clonazepam, the following symptoms may occur: drowsiness, disorientation, slurred speech, and in severe cases, loss of consciousness and coma. Life-threatening may be the use of clonazepam along with other drugs that have depressant properties on the central nervous system or alcohol.
In case of acute poisoning, it is necessary to induce vomiting, rinse the stomach. Treatment of clonazepam overdose is primarily symptomatic. It consists primarily in monitoring the basic vital functions of the body (respiration, pulse, blood pressure). The specific antidote is flumazenil (a benzodiazepine receptor antagonist).

Release form

Tablets 0.5 mg:
30 tablets in a blister of orange PVC / Al. One blister, along with instructions for use, is placed in a cardboard box.
Tablets 2 mg:
30 tablets in a blister of PVC film and aluminum foil. The blister, along with instructions for use, is placed in a cardboard box.

Storage conditions

Store at temperatures up to 25°C. Protect from light and moisture.
Keep out of the reach of children.

Best before date

3 years.
After the expiration date, the drug should not be used.

Holiday conditions

By prescription.

Manufacturer

Tarkhominsk Pharmaceutical Plant "POL FA" Joint Stock Company
st. A. Fleming 2 03-176 Warsaw Poland

Claims of consumers should be sent to the address of the Representative Office

Representation in the Russian Federation:

121248, Moscow, Kutuzovsky prospect, 13, office 141.

Which refers to benzodiazepine derivatives. After taking the drug "Clonazepam" reviews are left mostly positive. The drug has a muscle relaxant and hypnotic effect, and also has a sedative effect.

Composition, release form of the drug "Clonazepam"

The drug can be purchased in tablets with different contents of the main component:

  • 0.5 mg. In addition to clonazepam, the composition includes lactose monohydrate. The constituent components of the tablets include sodium carboxymethyl starch. Clonazepam tablets contain gelatin. Auxiliary substances are also talc and potato starch. The color of the tablets is given by the dye E110.
  • 2 mg. Among the auxiliary ingredients are polysorbate 80, lactose monohydrate. The composition of the drug contains sodium carboxymethyl starch and sodium lauryl sulfate. Additional ingredients are also talc, gelatin. Other substances also belong to the auxiliary components - magnesium stearate, rice, potato starch.

Pharmacological action of the drug "Clonazepam"

Clonazepam has a depressing effect on a large number of structures that make up the central nervous system, mainly those that are related to emotional activity. The action of the drug "Clonazepam" instructions for use, reviews are displayed as a sedative, anti-anxiety and hypnotic (the latter is moderately expressed). The drug helps to reduce the tone of skeletal muscles, prevents the appearance of generalized convulsive seizures. There is a positive effect on the course of epileptic seizures (focal, generalized).

Pharmacokinetics

The drug is almost completely absorbed from the gastrointestinal tract, excreted mainly by the kidneys (metabolites), a small part of it (2%) is excreted unchanged. The elimination half-life takes 20 to 40 hours. The bioavailability of the drug taken orally is 90%, the connection with blood proteins is 85%, the highest concentration is reached after an average of 2.5 hours. During treatment with Clonazepam, its components pass into breast milk.

Indications for the use of the drug

Clonazepam tablets are suitable for the treatment of patients of different ages with epilepsy, regardless of its manifestation:

  • partial seizures (local, focal) of any severity;
  • convulsive states (tonic, clonic);
  • seizures are simple of a secondary generalized nature;
  • atypical absences (Lennox-Gastaut syndrome);
  • myoclonic convulsions;
  • typical absences;
  • tonic-clonic seizures of primary and secondary severity.

"Clonazepam" is prescribed to reduce muscle tone, as in the period of treatment of psychomotor crises.

The use of the drug "Clonazepam"

The required dosage is determined taking into account many factors. At the initial stage of therapy, a small dose of Clonazepam (0.5 mg) is used, the dosage is gradually changed until the desired effect is obtained. At the same time, it is forbidden to exceed the permissible dosage. As the reviews show, "Clonazepam" cannot be abruptly canceled, even when the treatment was short-term. A sharp refusal of the drug threatens the development of an epileptic seizure.

Treatment for epilepsy:

  • Adults. Initial therapy is performed using no more than 1 mg of the drug. The dose calculated per day is divided into 3 or 4 doses, which should be carried out at the same interval. If it is not possible to use the drug in equal doses, the largest part of Clonazepam is drunk before going to bed. Usually a sufficient daily dose is in the range of 4 to 8 mg of the drug. The maintenance dose should be no more than 20 mg (achieved over a period of 2-4 weeks of therapy). When an effective daily dose has been determined to maintain the normal state of the body, it is allowed to take it once at bedtime.
  • Children (weight not less than 30 kg). As the reviews show, "Clonazepam" is initially prescribed to children at 0.5 mg to determine its optimal dose.

Reception for a syndrome accompanied by paroxysmal fear:

  • Adults. First, patients are prescribed 1-2 doses of the drug per day (0.5 mg at a time). For most patients, a therapeutic dose of 1 mg / day is sufficient. Do not use more than 1 mg of Clonazepam per day. Reviews, however, show that in some cases, doctors may increase the dose to 4 mg. In such cases, the dosage changes gradually (interval - 3 days, adding 0.5 mg is possible). When it is required to reduce the severity of daytime sleepiness, the daily dose can be taken at bedtime.
  • Children. For patients under the age of 18 years, when the syndrome is detected, the drug may be ineffective and unsafe.

To avoid complications, the drug "Clonazepam" reviews of doctors recommend taking strictly according to the recommendations of the specialist who conducts the treatment.

Contraindications to taking the drug "Clonazepam"

Tablets are not used in case of hypersensitivity to the substances of which they are composed. The drug is contraindicated in such conditions:

  • myasthenia gravis;
  • disturbances of consciousness;
  • childbearing, breastfeeding;
  • glaucoma (closed-angle);
  • respiratory disorders of central origin, severe respiratory failure;
  • severe renal and hepatic failure;
  • manifestations of sleep apnea syndrome;
  • alcohol poisoning;
  • acute porphyria.

Side effects of the drug "Clonazepam"

Consider the side effects that Clonazepam can cause. The use of the drug may be accompanied by negative reactions of the body. Perhaps the appearance of apathy, nausea, irritability. With a negative reaction of the body, a person quickly gets tired, he has a violation of coordination of movements. To reduce the strength of the manifestation, you must first apply a small dose, gradually increasing until it becomes optimal.

It is known that during the period of treatment with Clonazepam, its use in violation of the recommendations can cause an overdose. In such cases, there is a stupor, which can lead to confusion, stupor, which can result in coma. Other symptoms include vascular collapse, respiratory failure, and drowsiness. It is necessary to wash the stomach (effectively immediately after taking the tablets), to carry out appropriate therapy. It is important to regularly monitor changes in indicators such as blood pressure, pulse, respiration. In some cases, artificial ventilation is required. There is an antidote - Flumazenil, but it is not suitable for administration to patients who have been treated with Clonazepam for a long time.

You should not combine Clonazepam and alcohol. Reviews make sure that such a combination can be life-threatening. The same applies to all drugs that act on the central nervous system, inhibiting its functioning.

Drug interaction of the drug "Clonazepam"

The effect of the use of the drug is enhanced by anticonvulsants. The same result is observed when it is used together with antidepressants, antipsychotics, barbiturates, as well as when combined with alcohol and substances that reduce the tone of skeletal muscles. The effectiveness of treatment decreases when nicotine enters the body.

Cost, reviews of the drug "Clonazepam"

You can buy Clonazepam tablets in Moscow for 97-150 rubles. (30 pcs.). The drug is effective in epilepsy if the doctor's recommendations are followed. With atonic convulsions, therapy for a duration of two months may be sufficient, during which time it is possible to switch to maintenance treatment. Side effects are sometimes observed, but mostly only at the initial stage of treatment, weakness is often present.

Judging by what information the reviews contain, Clonazepam allows you to get rid of increased muscle tone in about three weeks. Doctors can prescribe medication for anxiety, fear, VVD, which is accompanied by panic attacks. The drug is effective, acts quickly.

Clonazepam tablets instruction

The instructions for Clonazepam tablets are designed to acquaint the patient with all the necessary information on the use of the drug for treatment. Here you can read about the composition of Clonazepam and its pharmacological action, as well as the terms and conditions of storage of the drug. The indications for use are described in detail and recommendations on the dosing regimen are given.

Before starting treatment, you should carefully read this manual, paying particular attention to information about contraindications, side effects and interactions of the drug with other drugs.

Release form and composition

The active substance of the drug is clonazepam. Auxiliary components are substances of potato starch, gelatin, dye orange and yellow E-110, talc, magnesium stearate, sodium starch glycolate and lactose in the required proportions.

The drug Clonazepam is produced in the form of tablets:

  • Round biconvex shape with cruciform risks. The color is light orange. The content of the active substance is 0.5 milligrams. Pack of thirty tablets.
  • Round shapes. White color. Biconvex tablet with a cross-score. The active substance is 2 milligrams. Pack of 30 pieces.

Terms and conditions of storage

You can store the drug for three years in a dry place protected from light, where the air temperature is not higher than 25 degrees.

Pharmacology

The active substance of the drug is capable of providing a central muscle relaxant, anticonvulsant, anxiolytic, hypnotic and sedative action, which will help ease fear, anxiety and anxiety, as well as relieve emotional stress.

This drug is considered one of the strongest in terms of anticonvulsant effect, therefore, in patients suffering from epilepsy, treatment with Clonazepam provides a stable therapeutic effect: the intensity of seizures decreases and their occurrence is much less common.

Often Clonazepam is considered as an effective sleeping pill, especially in cases where the brain has organic damage.

The action of the drug occurs quite quickly and is distinguished by its duration.

Pharmacokinetics

The drug has a rapid and complete absorption in the gastrointestinal tract. Its bioavailability is 90%. Plasma protein binding is more than 80%. Excretion occurs in the urine mainly by metabolites.

Clonazepam indications for use

The drug Clonazepam is prescribed for the treatment of those patients who suffer from epilepsy with the manifestation of nodding spasms, typical absences and atonic seizures. Also, its use is indicated in the presence of paroxysmal fear syndrome, various states of fear associated with phobias (only from the age of 18) and psychomotor arousal, which has developed against the background of reactive psychosis.

In addition, the drug clonazepam can be prescribed when the patient has the following conditions:

  • Muscular hypertonicity;
  • Somnambulism;
  • Psychomotor agitation;
  • Alcohol withdrawal syndrome (tremor, acute agitation, delirium and hallucinations);
  • Insomnia (with organic damage to the brain);
  • panic disorder.

Contraindications

Clonazepam has a number of contraindications that should be taken into account when prescribing it. You should not take the drug:

  • In acute respiratory failure, which may progress;
  • With oppression of the respiratory center;
  • In shock conditions;
  • In acute poisoning with sleeping pills or narcotic analgesics;
  • With hypersensitivity to clonazepam;
  • With angle-closure glaucoma;
  • With myasthenia;
  • in a state of coma;
  • In a state of acute intoxication of an alcoholic nature, when vital functions are weakened;
  • For pregnant and lactating women;
  • In severe depressive states, due to the possible development of suicidal tendencies, a connection with which Clonazepam is not released without a doctor's prescription.

The drug requires careful use when a patient has a severe liver disease, as well as severe chronic respiratory failure.

The combination of Clonazepam with alcoholic beverages is contraindicated.

Clonazepam use

The dosage regimen of this drug provides an individual approach to the patient.

The daily dose of the drug is divided into 3 or 4 equal doses. Maintenance doses are usually prescribed after 14 or 21 days of therapy.

Clonazepam during pregnancy

The use of the drug during pregnancy and breastfeeding is not allowed, since Clonazepam has the property of penetrating into breast milk and through the placental barrier.

Clonazepam for children

For infants and from 1 to 5 years of age, the drug is prescribed at an initial dosage of 250 micrograms per day and no more;

Children from 5 to 12 years old - 500 micrograms;

Maintenance doses: from birth to a year - 0.5-1 milligram;

From 1 to 5 years - 1-3 milligrams;

From 5 to 12 years - 3-6 milligrams.

Long-term use of the drug by children may lead to the occurrence of side effects that will affect the development of the physical and mental nature. These effects can manifest themselves many years later.

Clonazepam tablets for the elderly

When an elderly patient is diagnosed with cardiopulmonary insufficiency, Clonazepam should be administered to them with caution. In addition, the delayed elimination of the drug and the decrease in tolerance in this category of patients also require careful use.

Side effects

When prescribing the drug, special attention should be paid to possible side effects that may be caused by the use of Clonazepam, since their list is quite impressive.

central nervous system

  • In the form of severe inhibition;
  • In the form of a feeling of fatigue, drowsiness and lethargy;
  • In the form of dizziness;
  • In the form of a state of stupor;
  • In the form of recurring headaches;
  • In rare cases, the occurrence of confusion, ataxia;
  • When taking high doses and long-term therapy, articulation may be disturbed, diplopia, nystagmus may occur;
  • In the form of reactions of a paradoxical nature, such as an acute state of arousal;
  • In the form of anterograde amnesia;
  • In rare cases, the occurrence of hyperergic reactions, muscle weakness and depression;
  • With long-term therapy of epilepsy in some forms, the frequency of seizures may increase.

Digestive system

  • In rare cases, the occurrence of dry mouth;
  • In the form of attacks of nausea and vomiting;
  • In the form of diarrhea or constipation;
  • In the form of heartburn;
  • In the form of a decrease in appetite;
  • In the form of violations of the functionality of the liver;
  • In the form of increased activity of hepatic transaminase;
  • The occurrence of jaundice;
  • In the form of increased salivation (in infants).

The cardiovascular system

  • In the form of a drop in blood pressure;
  • in the form of tachycardia.

Endocrine system

  • In the form of a change in libido;
  • In the form of dysmenorrhea;
  • In the form of premature sexual development in children of a reversible nature.

Hematopoietic system

  • In the form of leukopenia;
  • In the form of neutropenia;
  • In the form of agranulocytosis;
  • in the form of anemia;
  • in the form of thrombocytopenia.

urinary system

  • In the form of urinary incontinence;
  • In the form of urinary retention;
  • In the form of impaired renal function.

Allergy

  • In the form of urticaria;
  • In the form of a skin rash;
  • In the form of itching;
  • In extremely rare cases, anaphylactic shock may occur.

Dermatological reactions

  • In the form of transient alopecia;
  • As a change in pigmentation.

Miscellaneous

  • In the form of addiction or drug dependence;
  • In the form of a withdrawal syndrome (sharp dose reduction or discontinuation).

Overdose

Symptoms of an overdose of the drug may be a state of depression of the central nervous system, which can be expressed to varying degrees:

  • In the form of severe drowsiness,
  • In the form of prolonged confusion of consciousness,
  • In the form of oppression of reflexes,
  • In the form of a state of coma;
  • In the form of possible respiratory depression.

Therapy is carried out by inducing vomiting and subsequent administration of activated charcoal for those patients who are conscious. If the patient is in a coma, he should wash the stomach through a tube and carry out symptomatic therapy. It is advisable to monitor the pulse, respiration, blood pressure, as well as increased diuresis through intravenous fluids.

The specific antidote is the benzodiazepine receptor antagonist flumazenil, the use of which is possible only under medical supervision. In order to avoid the provocation of epileptic seizures, its use in patients diagnosed with epilepsy is not recommended.

Drug Interactions

Strengthening the action of the drug Clonazepam occurs with its simultaneous use with barbiturates, neuroleptics, antidepressants, anticonvulsants, narcotic analgesics, alcohol, as well as drugs that help reduce skeletal muscle tone.

The weakening of the action of the drug Clonazepam occurs under the influence of nicotine. In addition, alcohol can provoke reactions of a paradoxical nature: strong psychomotor agitation with aggression in behavior or the onset of pathological intoxication.

Additional instructions

The drug should be prescribed carefully when the patient has impaired liver or kidney function, as well as in chronic respiratory diseases. No less cautious appointment should be carried out for elderly patients (over 65 years).

If the drug is used for a long time, its effect may weaken. During treatment, the use of alcohol is strictly prohibited, as well as after the end of the treatment course for three days. Cancellation of the drug should be gradual in order to avoid the occurrence of withdrawal symptoms and dependence of a psychophysical nature.

Treatment with the drug instructs the patient to refrain from driving and operating machinery.

Clonazepam analogues

Structural analogues of the drug (according to the active substance) are the drugs Rivotril and Clonotril. Also, Clonazepam has a very long list of analogues for pharmacological action. Here are some of these drugs:

  • Adaptol;
  • bromidem;
  • Valium Roche;
  • Hydroxyzine;
  • diazepam;
  • Zolomax;
  • Ipronal;
  • Cassadan;
  • Lexotan;
  • Mebicar;
  • Napoton;
  • Seduxen;
  • Tazepam;
  • Phenazipam;
  • Helex;
  • Elenium and others.

Clonazepam price

The cost of the drug is low. Its average price in pharmacies does not exceed 100 rubles.

Clonazepam reviews

Many patients who have been treated with Clonazepam find it to be an effective and serious drug. Many agree that the drug should not be dispensed without a doctor's prescription and approve of its affordable price, since if there is a prescription, you still have to buy it.

This page contains detailed instructions for use. Clonazepam. The available dosage forms of the drug (0.5 mg and 2 mg tablets), as well as its analogues, are listed. Information is provided on the side effects that Clonazepam can cause, on interactions with other drugs. In addition to information about the diseases for the treatment and prevention of which the drug is prescribed (convulsions, epilepsy, seizures, insomnia), the algorithms for admission, possible dosages for adults and children are described in detail, the possibility of using during pregnancy and lactation is specified. The annotation for Clonazepam is supplemented by reviews of patients and doctors. The composition and interaction of the drug with alcohol. Manifestations of withdrawal syndrome.

Instructions for use and dosage

Individual. For oral administration, adults are recommended an initial dose of not more than 1 mg per day. Maintenance dose - 4-8 mg per day.

For infants and children aged 1-5 years, the initial dose should be no more than 250 mcg per day, for children aged 5-12 years - 500 mcg per day. Maintenance daily doses for children under the age of 1 year - 0.5-1 mg, 1-5 years - 1-3 mg, 5-12 years - 3-6 mg.

The daily dose should be divided into 3-4 equal doses. Maintenance doses are prescribed after 2-3 weeks of treatment.

Intravenously (slowly) for adults - 1 mg, for children under the age of 12 - 500 mcg.

Compound

Clonazepam + excipients.

Release forms

Tablets 0.5 mg and 2 mg.

Clonazepam- an antiepileptic drug from the group of benzodiazepine derivatives. It has a pronounced anticonvulsant, as well as central muscle relaxant, anxiolytic, sedative and hypnotic effect.

Enhances the inhibitory effect of GABA on the transmission of nerve impulses. Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors of the ascending activating reticular formation of the brain stem and intercalary neurons of the lateral horns of the spinal cord. Reduces the excitability of the subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits postsynaptic spinal reflexes.

The anxiolytic effect is due to the effect on the amygdala complex of the limbic system and manifests itself in a decrease in emotional stress, weakening anxiety, fear, anxiety.

The sedative effect is due to the effect on the reticular formation of the brain stem and nonspecific nuclei of the thalamus and is manifested by a decrease in neurotic symptoms (anxiety, fear).

Anticonvulsant action is realized due to increased presynaptic inhibition. In this case, the spread of epileptogenic activity that occurs in epileptogenic foci in the cortex, thalamus and limbic structures is suppressed, but the excited state of the focus is not removed.

In humans, clonazepam has been shown to rapidly suppress various types of paroxysmal activity, incl. spike-wave complexes in absences (petit mal), slow and generalized spike-wave complexes, spikes of temporal and other localization, as well as irregular spikes and waves.

EEG changes of the generalized type are suppressed to a greater extent than those of the focal type. In accordance with these data, clonazepam has a beneficial effect in generalized and focal forms of epilepsy.

The central muscle relaxant effect is due to the inhibition of polysynaptic spinal afferent inhibitory pathways (to a lesser extent, monosynaptic ones). Direct inhibition of motor nerves and muscle function is also possible.

Pharmacokinetics

When taken orally, bioavailability is more than 90%. Plasma protein binding - more than 80%. It is excreted mainly as metabolites.

Indications

  • epilepsy (adults, infants and young children): typical absence seizures (petit mal), atypical absence seizures (Lennox-Gastaut syndrome), nodding spasms, atonic seizures ("fall" or "drop-attack" syndrome);
  • infantile spasms (West syndrome);
  • tonic-clonic convulsions (grand mal), simple and complex partial seizures and secondary generalized tonic-clonic convulsions;
  • status epilepticus (intravenous administration);
  • somnambulism;
  • muscle hypertonicity;
  • insomnia (especially in patients with organic brain lesions);
  • psychomotor agitation;
  • alcohol withdrawal syndrome (acute agitation, tremor, threatening or acute alcoholic delirium and hallucinations);
  • panic disorder.

Contraindications

  • depression of the respiratory center;
  • severe COPD (progression of the degree of respiratory failure);
  • acute respiratory failure;
  • myasthenia gravis;
  • coma;
  • angle-closure glaucoma (acute attack or predisposition);
  • acute alcohol intoxication with weakening of vital functions;
  • acute poisoning with narcotic analgesics and hypnotics;
  • severe depression (suicidal tendencies may be noted);
  • pregnancy;
  • lactation period;
  • hypersensitivity to clonazepam.

special instructions

Use with extreme caution in patients with ataxia, severe liver disease, severe chronic respiratory failure, especially in the stage of acute deterioration, with episodes of sleep apnea.

With prolonged use, the development of drug dependence is possible. Abrupt withdrawal of clonazepam after long-term treatment may lead to withdrawal symptoms.

Released by prescription.

Avoid drinking alcohol during treatment.

Influence on the ability to drive vehicles and control mechanisms

During the treatment period, a slowdown in the speed of psychomotor reactions is observed. This must be taken into account by persons engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Side effect

  • severe lethargy;
  • feeling tired;
  • drowsiness;
  • lethargy;
  • dizziness;
  • a state of stupor;
  • headache;
  • confusion;
  • nystagmus;
  • paradoxical reactions (including acute states of arousal);
  • anterograde amnesia;
  • muscle weakness;
  • depression;
  • dry mouth;
  • nausea, vomiting;
  • heartburn;
  • loss of appetite;
  • constipation or diarrhea;
  • increased salivation;
  • decrease in blood pressure;
  • tachycardia;
  • change in libido;
  • dysmenorrhea;
  • reversible premature sexual development in children (incomplete premature puberty);
  • with intravenous administration, respiratory depression is possible, especially during treatment with other drugs that cause respiratory depression;
  • in infants and young children, bronchial hypersecretion is possible;
  • leukopenia, neutropenia, agranulocytosis, anemia, thrombocytopenia;
  • urinary incontinence;
  • urinary retention;
  • impaired renal function;
  • hives;
  • skin rash;
  • anaphylactic shock;
  • transient alopecia;
  • change in pigmentation;
  • addictive;
  • withdrawal syndrome.

drug interaction

With simultaneous use with drugs that have a depressant effect on the central nervous system, ethanol (alcohol), ethanol-containing drugs may increase the inhibitory effect on the central nervous system.

With the simultaneous use of clonazepam enhances the effect of muscle relaxants; with sodium valproate - weakening of the action of sodium valproate and provocation of convulsive seizures.

With simultaneous use, a case of a decrease in the concentration of desipramine in the blood plasma by 2 times and its increase after the abolition of clonazepam is described.

With simultaneous use with carbamazepine, which causes the induction of microsomal liver enzymes, it is possible to increase metabolism and, as a result, a decrease in the concentration of clonazepam in the blood plasma, a decrease in its T1 / 2.

With simultaneous use with caffeine, a decrease in the sedative and anxiolytic effect of clonazepam is possible; with lamotrigine - a decrease in the concentration of clonazepam in the blood plasma is possible; with lithium carbonate - the development of neurotoxicity.

With simultaneous use with primidone, the concentration of primidone in the blood plasma increases; with tiapride - the development of NMS is possible.

A case of the development of headache with localization in the occipital region is described with simultaneous use with phenelzine.

With simultaneous use, it is possible to increase the concentration of phenytoin in the blood plasma and the development of toxic reactions, a decrease in its concentration or the absence of these changes.

With simultaneous use with cimetidine, side effects from the central nervous system increase, but the frequency of convulsive seizures in some patients decreased.

Analogues of the drug Clonazepam

Structural analogues for the active substance:

  • Clonotril;
  • Rivotril.

Analogues by pharmacological group (anxiolytics):

  • Adaptol;
  • Alzolam;
  • Alprazolam;
  • Alprox;
  • Anvifen;
  • Apaurin;
  • Atarax;
  • Afobazole;
  • bromidem;
  • Valium Roche;
  • Hydroxyzine;
  • Grandaxin;
  • diazepam;
  • Diazepex;
  • diapam;
  • Zolomax;
  • Ipronal;
  • Cassadan;
  • Xanax;
  • Xanax retard;
  • Lexotan;
  • Librax;
  • Loram;
  • Lorafen;
  • Mebicar;
  • Mebix;
  • Mexiprim;
  • Mexifin;
  • Napoton;
  • Neurol;
  • Nozepam;
  • Noofen;
  • Relanium;
  • Relium;
  • Seduxen;
  • Sibazon;
  • Tazepam;
  • Tenoten;
  • Tenoten for children;
  • Tofisopam;
  • Tranxen;
  • Phenazepam;
  • Phenibut;
  • Helex;
  • Elenium;
  • Elzepam.

Use in elderly patients

Use with caution in elderly patients, tk. they may have delayed elimination of clonazepam and reduced tolerance, especially in the presence of cardiopulmonary insufficiency.

Use in children

With prolonged use of clonazepam in children, the possibility of side effects on physical and mental development should be borne in mind, which may not appear for many years.

Use during pregnancy and lactation

Use during pregnancy and lactation is contraindicated. Clonazepam crosses the placental barrier. May be excreted in breast milk.

An antiepileptic drug from the group of benzodiazepine derivatives. It has a pronounced anticonvulsant, as well as central muscle relaxant, anxiolytic, sedative and hypnotic effect.

Enhances the inhibitory effect of GABA on the transmission of nerve impulses. Stimulates benzodiazepine receptors located in the allosteric center of postsynaptic GABA receptors of the ascending activating reticular formation of the brain stem and intercalary neurons of the lateral horns of the spinal cord. Reduces the excitability of the subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits postsynaptic spinal reflexes.

The anxiolytic effect is due to the effect on the amygdala complex of the limbic system and manifests itself in a decrease in emotional stress, weakening anxiety, fear, anxiety.

The sedative effect is due to the effect on the reticular formation of the brain stem and nonspecific nuclei of the thalamus and is manifested by a decrease in neurotic symptoms (anxiety, fear).

Anticonvulsant action is realized due to increased presynaptic inhibition. In this case, the spread of epileptogenic activity that occurs in epileptogenic foci in the cortex, thalamus and limbic structures is suppressed, but the excited state of the focus is not removed.

In humans, clonazepam has been shown to rapidly suppress various types of paroxysmal activity, incl. spike-wave complexes in absences (petit mal), slow and generalized spike-wave complexes, spikes of temporal and other localization, as well as irregular spikes and waves.

EEG changes of the generalized type are suppressed to a greater extent than those of the focal type. In accordance with these data, clonazepam has a beneficial effect in generalized and focal forms of epilepsy.

The central muscle relaxant effect is due to the inhibition of polysynaptic spinal afferent inhibitory pathways (to a lesser extent, monosynaptic ones). Direct inhibition of motor nerves and muscle function is also possible.

Pharmacokinetics

When taken orally, bioavailability is more than 90%. Plasma protein binding - more than 80%. V d - 3.2 l / kg. T 1/2 - 23 hours. Excreted mainly as metabolites.

Release form

30 pcs. - cellular contour packings (1) - packs of cardboard.

Dosage

Individual. For oral administration, adults are recommended an initial dose of not more than 1 mg / day. Maintenance dose - 4-8 mg / day.

For infants and children aged 1-5 years, the initial dose should be no more than 250 mcg / day, for children aged 5-12 years - 500 mcg / day. Maintenance daily doses for children under the age of 1 year - 0.5-1 mg, 1-5 years - 1-3 mg, 5-12 years - 3-6 mg.

The daily dose should be divided into 3-4 equal doses. Maintenance doses are prescribed after 2-3 weeks of treatment.

In / in (slowly) adults - 1 mg, children under the age of 12 years - 500 mcg.

Interaction

With simultaneous use with drugs that have a depressant effect on the central nervous system, ethanol, ethanol-containing drugs may increase the inhibitory effect on the central nervous system.

With the simultaneous use of clonazepam enhances the effect of muscle relaxants; with sodium valproate - weakening of the action of sodium valproate and provocation of convulsive seizures.

With simultaneous use, a case of a decrease in the concentration of desipramine in the blood plasma by 2 times and its increase after the abolition of clonazepam is described.

With simultaneous use with carbamazepine, which causes the induction of microsomal liver enzymes, it is possible to increase metabolism and, as a result, a decrease in the concentration of clonazepam in the blood plasma, a decrease in its T 1/2.

With simultaneous use with caffeine, a decrease in the sedative and anxiolytic effect of clonazepam is possible; with lamotrigine - a decrease in the concentration of clonazepam in the blood plasma is possible; with lithium carbonate - the development of neurotoxicity.

With simultaneous use with primidone, the concentration of primidone in the blood plasma increases; with tiapride - the development of NMS is possible.

With simultaneous use with toremifene, a significant decrease in the AUC and T 1/2 of toremifene is possible due to the induction of microsomal liver enzymes under the influence of clonazepam, which leads to an acceleration of the metabolism of toremifene.

A case of the development of headache with localization in the occipital region is described with simultaneous use with phenelzine.

With simultaneous use, it is possible to increase the concentration of phenytoin in the blood plasma and the development of toxic reactions, a decrease in its concentration or the absence of these changes.

With simultaneous use with cimetidine, side effects from the central nervous system increase, but the frequency of convulsive seizures in some patients decreased.

Side effects

From the side of the central nervous system: at the beginning of treatment - severe lethargy, fatigue, drowsiness, lethargy, dizziness, stupor, headaches; rarely - confusion, ataxia. When used in high doses, especially with long-term treatment - articulation disorders, diplopia, nystagmus; paradoxical reactions (including acute states of arousal); anterograde amnesia. Rarely - hyperergic reactions, muscle weakness - depression. With long-term treatment of some forms of epilepsy, an increase in the frequency of seizures is possible.

On the part of the digestive system: rarely - dry mouth, nausea, diarrhea, heartburn, nausea, vomiting, loss of appetite, constipation or diarrhea, abnormal liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice. In infants and young children, increased salivation is possible.

From the cardiovascular system: lowering blood pressure, tachycardia.

From the endocrine system: changes in libido, dysmenorrhea, reversible premature sexual development in children (incomplete premature puberty).

On the part of the respiratory system: with intravenous administration, respiratory depression is possible, especially during treatment with other drugs that cause respiratory depression; in infants and young children, bronchial hypersecretion is possible.

From the hemopoietic system: leukopenia, neutropenia, agranulocytosis, anemia, thrombocytopenia.

From the urinary system: urinary incontinence, urinary retention, impaired renal function.

Allergic reactions: urticaria, skin rash, itching, extremely rarely - anaphylactic shock.

Dermatological reactions: transient alopecia, pigmentation changes.

Others: addiction, drug dependence; with a sharp decrease in dose or discontinuation - withdrawal syndrome.

Indications

Means of the first row - epilepsy (adults, infants and young children): typical absence seizures (petit mal), atypical absence seizures (Lennox-Gastaut syndrome), nodding spasms, atonic seizures ("fall" or "drop-attack" syndrome).

The remedy of the second row is infantile spasms (West's syndrome).

Means of the III row - tonic-clonic convulsions (grand mal), simple and complex partial seizures and secondary generalized tonic-clonic convulsions.

Epileptic status (in / in the introduction).

Somnambulism, muscle hypertonicity, insomnia (especially in patients with organic brain lesions), psychomotor agitation, alcohol withdrawal syndrome (acute agitation, tremor, threatening or acute alcoholic delirium and hallucinations), panic disorders.

Contraindications

Respiratory center depression, severe COPD (progression of the degree of respiratory failure), acute respiratory failure, myasthenia gravis, coma, shock, angle-closure glaucoma (acute attack or predisposition), acute alcohol intoxication with weakening of vital functions, acute poisoning with narcotic analgesics and hypnotics, severe depression (suicidal tendencies may occur), pregnancy, lactation, hypersensitivity to clonazepam.

Application features

Use during pregnancy and lactation

Use during pregnancy and lactation is contraindicated. Clonazepam crosses the placental barrier. Clonazepam may be excreted in breast milk.

Application for violations of liver function

Use with extreme caution in patients with severe liver disease.

Use in children

Use in elderly patients

special instructions

Use with extreme caution in patients with ataxia, severe liver disease, severe chronic respiratory failure, especially in the stage of acute deterioration, with episodes of sleep apnea.

Use with caution in elderly patients, tk. they may have delayed elimination of clonazepam and reduced tolerance, especially in the presence of cardiopulmonary insufficiency.

With prolonged use, the development of drug dependence is possible. Abrupt withdrawal of clonazepam after long-term treatment may lead to withdrawal symptoms.

With prolonged use of clonazepam in children, the possibility of side effects on physical and mental development should be borne in mind, which may not appear for many years.

Avoid drinking alcohol during treatment.

Influence on the ability to drive vehicles and control mechanisms

During the treatment period, a slowdown in the speed of psychomotor reactions is observed. This must be taken into account by persons engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.

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