Relium

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Relium is a psycholeptic, has a hypnotic, anticonvulsant, sedative, anxiolytic, muscle relaxant effect.

Release form and composition

Dosage forms:

Solution for intravenous (i / v) and intramuscular (i / m) administration: clear or slightly opalescent liquid, from colorless to greenish-yellow color (2 ml each in glass colorless ampoules, 5 ampoules per pallet, in a cardboard box 1, 2 or 10 pallets);
Film-coated tablets (20 pcs. In a blister, 1 blister in a cardboard box).

1 ml of solution for intravenous and intramuscular administration contains:

Active ingredient: diazepam - 5 mg;
Auxiliary components: sodium benzoate, benzyl alcohol, benzoic acid, ethyl alcohol (ethanol 96%), propylene glycol, water for injection.

1 coated tablet contains:

Active ingredient: diazepam - 5 mg;
Auxiliary components: tween 80, potato starch, quinoline yellow (E104), magnesium stearate, lactose, gelatin, talc;
Shell composition: polyethylene glycol 6000, cellulose acetate phthalate.

Indications for use

Sleep disturbances;
Anxiety, neurosis, including against the background of oncological pathologies, arterial hypertension, heart failure, gastric ulcer and duodenal ulcer;
Epilepsy, status epilepticus;
Muscle spasms of central origin;
Skeletal muscle tension in post-traumatic conditions and motor rehabilitation (in order to reduce tension);
Withdrawal symptoms with alcoholism;
Eclampsia;
Tetanus;
Indomitable vomiting;
Premedication in surgical practice and in diagnostic procedures.

Contraindications

Severe respiratory failure of various etiologies, respiratory disorders of central origin;
Impaired consciousness;
Glaucoma;
Myasthenia gravis;
During pregnancy and breastfeeding;
Depressive states with suicidal attempts;
Shock, coma, head trauma;
Acute intoxication with alcohol, narcotic, sleeping pills, psychotropic drugs;
Individual intolerance to the components of the drug.

In addition, intravenous administration of the solution is contraindicated in case of absence or Lennox-Gastaut syndrome, intravenous and intramuscular administration at the age of up to 5 weeks of life.

Do not use tablets in children under 2 years of age.

Care should be taken to prescribe Relium to patients with hepatic and / or renal failure, cerebral and spinal ataxia, hyperkinesis, organic brain diseases, psychosis (risk of paradoxical reactions), hypoproteinemia, established or suspected sleep apnea, in old age, if indicated in anamnesis of epilepsy, epileptic seizures, addiction phenomena.

Method of administration and dosage

Solution for intravenous and intramuscular administration

The solution is intended for intramuscular and intravenous jet or drip administration.

The IM solution is injected deep into large muscles.

For intravenous jet injection, 2 ml of the drug is mixed with 8 ml of 5% glucose solution or physiological solution, the rate of administration is not more than 4 ml per minute.

For intravenous drip injection, 20 ml (10 ampoules) of Relium is diluted in 500 ml of a 5% glucose solution or saline solution, the rate of administration is 40 ml for 60 minutes.

Recommended dosage for intravenous or intramuscular administration in adults:

Acute cases of anxiety and anxiety: 2-5 mg 1 time per day, to achieve a clinical effect - in the same dose again after 180-240 minutes;
Phobic disorders in severe form: 5-10 mg, if necessary, after 180-240 minutes, repeated administration at the same dose is indicated;
Alcohol withdrawal syndrome: 10 mg once, to achieve a clinical effect after 180-240 minutes, you can additionally enter 5-10 mg;
Tetanus, athetosis, muscle spasms: 5-10 mg, dose may be increased if necessary;
Severe cases of recurrent seizures, status epilepticus: the initial dose is 5-10 mg once, then after 10-15 minutes and 120-240 minutes, repeated administration is allowed, but not more than 30 mg in total;
Premedication: i / v slowly - 10 mg, in the absence of simultaneous use of narcotic analgesics - up to 20 mg, or i / m - 5-10 mg 30 minutes before the procedure.

When using the drug in electro-pulse therapy, the patient is injected intravenously 5-10 minutes before the start of the procedure, 5-10 mg.

Patients with impaired liver and / or kidney function need to reduce the dose.

In old age or in a weakened condition of the patient, it is recommended to prescribe 1/2 of the usual dose.

Recommended dosage in pediatrics:

Tetanus: at the age from 5 weeks of life to 5 years - 1-2 mg, from 5 years and older - 5-10 mg; the drug is administered intramuscularly or slowly intravenously; to achieve the desired effect, it can be re-administered after 180-240 minutes;
Status epilepticus, severe recurrent seizures: under the control of respiratory function IV slowly - infants from 5 weeks of life to 5 years (at a rate of 0.2-0.5 mg for 2-5 minutes) - no more than 5 mg, from 5 years and older (at a rate of administration of 1 mg for 2-5 minutes) - no more than 10 mg. To achieve a clinical effect, the procedure is repeated after 120-240 minutes.

Film-coated

tablets Tablets are taken orally.

The dose and period of use is prescribed by the doctor based on clinical indications.

Recommended dosage for adults:

Insomnia: short-term, 5-10 mg 30 minutes before bedtime;
Alcohol withdrawal syndrome: 10 mg 3 times a day, the maximum daily dose is 60 mg;
Muscle spasticity: 5 mg 1-3 times a day, if necessary, you can increase the daily dose to 60 mg.

Recommended daily dosage for children:

2-3 years: 2-5 mg;
4-7 years: 4-6 mg
8-18 years: 5-8 mg.

The daily dose for children is proportionally divided into 2-3 doses.

Side effects

Nervous system: at the beginning of use (especially in elderly patients) - lethargy, increased fatigue, dullness of emotions, impaired concentration, slowing down of motor and mental reactions, antegrade amnesia; headache, drowsiness, dizziness, confusion, delayed reaction, ataxia, disorientation; rarely - depression of mood, euphoria, numbness, uncontrolled movements of the body and eyes, dysarthria, hyporeflexia; paradoxical reactions - outbursts of aggression, fear, psychomotor agitation, muscle spasm, suicidal tendencies, hallucinations, confusion, acute agitation, anxiety, insomnia, irritability, depression;
Cardiovascular system: lowering blood pressure, palpitations, tachycardia;
Hematopoietic organs: anemia, neutropenia, leukopenia, thrombocytopenia, agranulocytosis (weakness, hyperthermia, chills, sore throat, feeling of fatigue);
Digestive system: heartburn, dry mouth, vomiting, hiccups, gastralgia, anorexia, increased activity of liver enzymes, liver dysfunction, jaundice;
Allergic reactions: very rarely - itching, rash, urticaria, anaphylactic reactions;
Genitourinary system: libido disorders, dysmenorrhea, renal dysfunction;
Influence on the fetus: depression of the central nervous system, teratogenicity (especially in the first trimester of pregnancy), respiratory failure, violation of the sucking reflex;
When used in obstetrics: hypothermia, muscle hypotension, dyspnea;
Others: drug dependence, addiction; rarely - impaired function of external respiration, depression of the respiratory center, weight loss, impaired vision, diplopia, bulimia; against the background of a sharp dose reduction or drug withdrawal - withdrawal syndrome; with a rapid on / in the introduction - oppression of respiration and blood circulation;
Local reactions: (with intramuscular injection) sometimes - phlebitis; often - pain, erythema at the injection site.

special instructions

With organic changes in the brain (it is recommended to avoid parenteral administration), respiratory and heart failure, myasthenia gravis, angle-closure glaucoma or a predisposition to it, diazepam should be used with extreme caution.

Under the supervision of a physician, especially at the beginning of therapy, it is necessary to prescribe the drug against the background of prolonged use of beta-blockers, centrally acting antihypertensive drugs, anticoagulants, cardiac glycosides.

A gradual dose reduction is required when Relium is canceled, since a sudden cessation can cause agitation, anxiety, convulsions, tremors.

Drinking alcohol during the treatment period is categorically contraindicated.

If paradoxical reactions appear, diazepam should be canceled.

With i / m administration of the drug, it is possible to increase the activity of creatine phosphokinase in the blood plasma.

Intra-arterial injection is not allowed.

For the period of treatment, you should refuse to drive vehicles and mechanisms.

Drug interactions

With the simultaneous use of Relium:

Antipsychotics, opioid analgesics, sedatives and hypnotics, drugs for anesthesia and other drugs that depress the central nervous system (CNS) - increase the depressing effect on the respiratory center and central nervous system, contribute to the appearance of severe arterial hypotension;
Muscle relaxants - enhance their effect, increasing the risk of apnea;
Tricyclic antidepressants (including amitriptyline) - increase the cholinergic effect, the depressant effect on the central nervous system, the level of concentration of antidepressants;
Oral contraceptives - the activity of diazepam increases, the risk of developing breakthrough bleeding increases;
Caffeine - reduces the sedative, anxiolytic effect of diazepam;
Antiepileptic drugs (phenytoin, carbamazepine) and other drugs that induce liver enzymes - accelerate the elimination of diazepam;
Clozapine - promotes the development of severe arterial hypotension, loss of consciousness, respiratory depression;
Metoprolol - risk of worsening psychomotor reactions, decreased visual acuity;
Levodopa - may lose its antiparkinsonian effect;
Lithium carbonate - the development of a coma is possible;
Risperidone - the risk of developing neuroleptic malignant syndrome;
Paracetamol - reduces the excretion of diazepam and its metabolite;
Rifampicin - enhances the metabolism of diazepam and accelerates its excretion;
Theophylline - violates the sedative effect of the drug;
Cimetidine, disulfiram, omeprazole - can increase the intensity and duration of action of diazepam;
Fluvoxamine - promotes an increase in the concentration of diazepam in blood plasma and the development of undesirable phenomena;
Phenytoin, phenobarbital - can accelerate the metabolism of diazepam;
Bupivacaine - increases its content in blood plasma;
Diclofenac - causes increased dizziness;
Isoniazid - slows down the elimination of diazepam from the body;
Ethanol, ethanol-containing drugs - increase the depressing effect on the respiratory center and the central nervous system as a whole, increase the risk of pathological intoxication syndrome.

The drug inhibits the metabolism of phenytoin and enhances its effect.

The mechanism and degree of drug interactions when taking Relium against the background of long-term preliminary therapy with beta-blockers, centrally acting antihypertensive drugs, anticoagulants, cardiac glycosides are unpredictable.

Analogs

Relium analogs are: Apaurin, Diazepam, Diazepam-Ratiopharm, Seduxen, Relanium.

Terms and conditions of storage

Keep out of the reach of children, protected from light at temperatures up to 25 ° C, keep the tablets from moisture.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!