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Rivotril - instructions for use, reviews, analogs and formulations (tablets of 0.5 mg and 2 mg, injections in ampoules for injection in solution) for the treatment of epilepsy, seizures and withdrawal symptoms in adults, children and pregnancy

Rivotril - instructions for use, reviews, analogs and formulations (tablets of 0.5 mg and 2 mg, injections in ampoules for injection in solution) for the treatment of epilepsy, seizures and withdrawal symptoms in adults, children and pregnancy

In this article, you can read the instructions for using the drug Rivotril. There are reviews of visitors to the site - consumers of this medication, as well as opinions of specialists on the use of Rivotril in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of rivotril in the presence of existing structural analogs.Use for the treatment of epilepsy, seizures and withdrawal symptoms in adults, children, as well as during pregnancy and lactation.

 

Rivotril antiepileptic agent from the benzodiazepine group. Has pronounced anticonvulsant, as well as central miorelaksiruyuschee, anxiolytic, sedative and hypnotic action.

 

Increases the inhibitory effect of gamma-aminobutyric acid (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 brainstem and intercalary neurons of the lateral horns of the spinal cord. Reduces the excitability of subcortical structures of the brain (limbic system, thalamus, hypothalamus), inhibits postsynaptic spinal reflexes.

 

The anxiolytic effect of rivotril is due to the influence on the amygdala complex of the limbic system and is manifested in a decrease in emotional tension, easing anxiety, fear, anxiety.

 

The sedative effect is due to the effect on the reticular formation of the brainstem and the 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. This suppresses the spread of epileptogenic activity that occurs in epileptogenic foci in the cortex, thalamus, and limbic structures, but the excited state of the focus is not removed.

 

It has been shown that in human Clonazepam (the active substance of the drug Rivotryl) rapidly suppresses paroxysmal activity of various types. Changes in the electroencephalogram (EEG) of the generalized type are suppressed to a greater extent than the focal. In accordance with these data, clonazepam has a beneficial effect in the generalized and focal forms of epilepsy.

 

Central miorelaksiruyuschee effect due to inhibition of the polysynaptic spinal afferent inhibitory pathways (to a lesser extent, monosynaptic). Perhaps a direct inhibition of the motor nerves and muscle functions.

 

Composition

 

Clonazepam + auxiliary substances.

 

Pharmacokinetics

 

When administered, the bioavailability of rivotril is more than 90%. Binding to plasma proteins - more than 80%. It is excreted mainly in the form of metabolites.

 

Indications

  • epilepsy in adults and infants and young children, including typical absences, atypical absences (Lennox-Gastaut syndrome), spasmodic seizures, atonic seizures;
  • infantile spasms (Vest syndrome);
  • tonic-clonic convulsions, simple and complex partial seizures, and secondary generalized tonic-clonic convulsions;
  • status epilepticus;
  • somnambulism (a disorder in which people perform any action while being in a state of sleep);
  • muscular hypertonia;
  • insomnia (especially in patients with organic brain lesions);
  • psychomotor agitation;
  • alcohol withdrawal syndrome (acute agitation, tremor, threatening or acute alcohol delirium and hallucinations);
  • panic disorder.

 

Forms of release

 

Tablets 0.5 mg and 2 mg.

 

Solution for intravenous administration of 1 mg in 1 ml (injections in ampoules for injection).

 

Instructions for use and dosing regimen

 

The dose is set individually.

 

When administered orally, the initial dose for infants and children under 10 years (body weight up to 30 kg) is 0.01-0.03 mg per kg of body weight per day, maintaining a dose of 0.05-0.1 mg per 1 kg of body weight per day.

 

Children older than 10 years and adults with an initial dose of 1-2 mg per day, supporting a dose of children of 10-16 years - 1,5-3 mg, adults - 2-4 mg per day. The maximum daily intake for adults is 20 mg.

 

In the treatment of epileptic status, children are given 1/2 ampoule (0.5 mg) intravenously slowly, adults - 1 ampoule (1 mg) intravenously slowly. If necessary, repeat the introduction. The maximum daily dose for intravenous administration is about 13 mg. The drug is canceled gradually.

 

Side effect

  • pronounced inhibition, fatigue;
  • drowsiness, lethargy;
  • dizziness, headaches;
  • a state of stupor;
  • confusion of consciousness;
  • ataxia (partial or complete loss of coordination of voluntary muscle movements);
  • violation of articulation (speech);
  • Diplopia (visual impairment, in which the image of a visible object doubles);
  • nystagmus (uncontrolled oscillatory movement of eyeballs);
  • paradoxical reactions, including acute excitation conditions;
  • anterograde amnesia (memory impairment of events after the onset of the disease);
  • with prolonged treatment of some forms of epilepsy, an increase in the frequency of seizures is possible;
  • dry mouth;
  • nausea;
  • diarrhea or constipation;
  • nausea, vomiting;
  • decreased appetite;
  • violations of liver function: increased activity of hepatic transaminases and alkaline phosphatase (AF), jaundice;
  • infants and young children may have increased salivation;
  • lowering of blood pressure (BP);
  • tachycardia (increased heart rate);
  • change in libido (sexual desire);
  • dysmenorrhea (pain in the abdomen during menstruation);
  • reversible premature sexual development in children (incomplete premature puberty);
  • with intravenous administration, respiratory depression is possible, especially when treated 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;
  • allergic reactions: urticaria, skin rash, itching, extremely rarely - anaphylactic shock;
  • transient alopecia (baldness);
  • change in skin pigmentation;
  • addiction, drug dependence;
  • with a sharp decrease in dose or discontinuation of reception - withdrawal syndrome.

 

Contraindications

  • depression of the respiratory center;
  • severe chronic obstructive pulmonary disease (COPD);
  • acute respiratory failure;
  • myasthenia gravis (pathologically fatigue of the striated muscles;
  • coma, shock;
  • closed angle glaucoma (acute attack or predisposition);
  • acute alcohol intoxication with impaired vital functions;
  • acute poisoning with narcotic analgesics and hypnotics;
  • severe depression (suicidal tendencies may occur);
  • pregnancy, lactation (breastfeeding);
  • increased sensitivity to clonazepam;
  • the period of newborns and the state of prematurity in children.

 

Application in pregnancy and lactation

 

Ribotril is contraindicated in pregnancy and lactation. Clonazepam penetrates the placental barrier, can be excreted in breast milk.

 

Use in children

 

With prolonged use of clonazepam in children, one should keep in mind the possibility of side effects on physical and mental development, which may not manifest itself for many years.

 

Ribotril should not be given to newborns and premature infants.

 

Application in elderly patients

 

They are used with caution in elderly patients, since they can slow down the withdrawal of clonazepam and reduce tolerance, especially in the presence of cardiopulmonary insufficiency.

 

special instructions

 

With extreme caution apply in patients with ataxia, severe liver disease, severe chronic respiratory failure, especially in the acute deterioration phase, with episodes of nocturnal apnea.

 

With prolonged use, it is possible to develop drug dependence. With the abrupt withdrawal of clonazepam after prolonged treatment, the development of the withdrawal syndrome is possible.

 

During the treatment with rivotril, do not allow the use of ethanol (alcohol).

 

Impact on the ability to drive vehicles and manage mechanisms

 

During the treatment period, the speed of psychomotor reactions slows down. This should be taken into account by persons engaged in potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

 

Drug Interactions

 

When used simultaneously with drugs that exert a depressing effect on the central nervous system (CNS), ethanol (alcohol), ethanol-containing drugs, an increase in the inhibitory effect on the central nervous system is possible.

 

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

 

With simultaneous application, the case of decreasing the concentration of desipramine in the blood plasma was 2 times and its increase after the withdrawal of clonazepam.

 

When used simultaneously with carbamazepine, which causes the induction of microsomal enzymes of the liver, 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 half-life.

 

With simultaneous application 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; with lithium carbonate - the development of neurotoxicity.

 

With the simultaneous use of rivotril with primidon, the concentration of primidone in the blood plasma increases; with tiapridom - possible development of malignant neuroleptic syndrome (ZNS).

 

With simultaneous use with toremifene, a significant decrease in the half-life of toremifene in connection with the induction of microsomal liver enzymes under the influence of clonazepam, which leads to an acceleration of the metabolism of toremifene.

 

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

 

With simultaneous use, an increase in 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 is possible.

 

With simultaneous application of rivotril with cimetidine, side effects from the CNS are increased, however, the frequency of convulsive seizures in some patients decreased.

 

Analogues of rivotril

 

Structural analogs for the active substance:

  • Clonazepam;
  • Clonotril.

 

Analogues of the drug Rivotril for the pharmacological group (antiepileptic drugs):

  • Actinerval;
  • Algerian;
  • Acetazolamide;
  • Benzobarbital;
  • Benzon;
  • Valopixime;
  • Valparin;
  • Gabagamma;
  • Gabapentin;
  • Habitryl;
  • Halodiff;
  • Gapentec;
  • Depakin;
  • Depamid;
  • Dipromal;
  • Zagreton;
  • Zenicetam;
  • Zeptol;
  • Inovevelon;
  • Carbamazepine;
  • Carbapine;
  • Caten;
  • Clonazepam;
  • Convalis;
  • Convilept;
  • Convulex;
  • Lameptil;
  • Lamitor;
  • Lamotrigine;
  • Levetinol;
  • Lethiram;
  • Mazepine;
  • Maliazine;
  • Mysolin;
  • Neuronthin;
  • Paglyuferal;
  • Prabiegin;
  • Primidone;
  • Relium;
  • Ropimat;
  • Seizar;
  • Sibazon;
  • Storilate;
  • Suxilep;
  • Tebantin;
  • Topalepsin;
  • Topamax;
  • Topiramate;
  • Torapimat;
  • Trileptal;
  • Ficomp;
  • Phenobarbital;
  • Finlepsin;
  • Chloracon;
  • Exalieff;
  • Eltator;
  • Enkorat;
  • Epimax;
  • Epitera;
  • Epitropil.

 

Response of a pediatric neurologist

 

Some children suffering from epilepsy and undergoing treatment in our department receive rivotril in tablets. Both the initial and maintenance doses we select strictly individually for each patient, taking into account his body weight. Dosage of the drug is convenient, since there are tablets of 0.5 mg and 2 mg. The children are taken with rivotril therapy in different ways: someone is easy, and someone develops side reactions. Most often, unwanted reactions appear in the form of drowsiness, rapid fatigue, episodes of sudden arousal and irritability. But usually these symptoms are noted at the initial stage of treatment, then gradually disappear.

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