Relanium

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

Solution for intravenous and intramuscular administration of Relanium

Relanium is a tranquilizer (anxiolytic).

Release form and composition

Dosage form - solution for intravenous and intramuscular administration: yellow-green or colorless, transparent (2 ml in ampoules, 5 ampoules in a plastic holder, in a cardboard box 1, 2 or 10 holders).

Active ingredient: diazepam - 5 mg in 1 ml.

Additional components: benzyl alcohol, glacial acetic acid, ethanol 96%, acetic acid 10% (up to pH 6.3-6.4), sodium benzoate, propylene glycol, water for injection.

Indications for use

Treatment of neurosis-like and neurotic disorders, accompanied by manifestations of anxiety;
Therapy of conditions accompanied by an increase in muscle tone (including acute disorders of cerebral circulation and tetanus);
Relief of convulsive conditions and epileptic seizures of various etiologies;
Relief of psychomotor agitation associated with anxiety;
Relief of withdrawal symptoms and delirium in alcoholism;
Complex treatment of arterial hypertension, accompanied by increased excitability and anxiety, as well as vascular spasms, hypertensive crisis, menstrual and climacteric disorders.

Also Relanium is used for ataralgesia and premedication in obstetric and surgical practice during diagnostic procedures (in combination with analgesic and other neurotropic agents).

Contraindications

Absolute:

Sleep apnea syndrome;
Closed-angle glaucoma;
Severe myasthenia gravis;
Shock;
Coma;
Acute respiratory failure;
Severe chronic obstructive pulmonary disease;
State of alcoholic intoxication;
History of alcohol or drug addiction (with the exception of alcoholic delirium and withdrawal symptoms);
The period of pregnancy (especially I and III trimesters) and lactation;
Children's age up to 30 days inclusive;
Acute intoxication with drugs that have a depressing effect on the central nervous system (psychotropic, hypnotic and narcotic drugs);
Hypersensitivity to the components of the drug or other benzodiazepines.

Relative:

Absances (petit mal);
Lennox-Gastaut syndrome;
History of epilepsy and epileptic seizures;
Hepatic and / or renal failure;
Spinal and cerebral ataxia;
Hyperkinesis;
Organic brain diseases;
Depression;
Propensity to abuse psychotropic drugs;
Hypoproteinemia;
Elderly age.

Method of administration and dosage

Relanium is administered intravenously (i / v) or intramuscularly (i / m).

Recommended dosages:

Relief of anxiety-related psychomotor agitation: IV, 5-10 mg once, if necessary, after 3-4 hours, the drug is re-administered at the same dose;
Status epilepticus: intravenous or intramuscularly 10-20 mg once, if necessary, the administration is repeated in a similar dose after 3-4 hours;
Tetanus: intravenously slowly or intramuscularly in a dose of 10 mg, then intravenously drip at a rate of 5-15 mg / h 100 mg in 500 ml of 0.9% sodium chloride solution or 5% glucose solution;
Removal of skeletal muscle spasm: i / m 10 mg 1-2 hours before surgery;
In obstetrics: i / m 10-20 mg with the opening of the cervix by 2-3 fingers.

For newborns older than 30 days, Relanium is injected slowly intravenously at 0.1-0.3 mg / kg to a maximum dose of 5 mg. If necessary, the drug is administered again after 2-4 hours.

For children from 5 years old, the drug is administered slowly intravenously, 1 mg every 2-5 minutes, up to a maximum dose of 10 mg. If necessary, after 2-4 hours, it is re-administered.

Side effects

Allergic reactions: skin rashes, itching;
From the side of the central and peripheral nervous system: at the beginning of treatment (especially in the elderly) - increased fatigue, dizziness, impaired concentration, drowsiness, ataxia, slowing down of mental and motor reactions, dulling of emotions, disorientation, anterograde amnesia; rarely - catalepsy, tremor, confusion, depression, dystonic extrapyramidal reactions (uncontrolled movements), hyporeflexia, muscle weakness, euphoria, dysarthria, asthenia, headache; in some cases - paradoxical reactions (sleep disturbances, psychomotor agitation, muscle spasm, anxiety, fear, confusion, outbursts of aggression, hallucinations, suicidal tendencies);
From the digestive system: hypersalivation or dry mouth, liver dysfunction, hiccups, nausea, vomiting, constipation, gastralgia, heartburn, decreased appetite, jaundice, increased activity of hepatic transaminases and alkaline phosphatase;
From the hematopoietic system: agranulocytosis (severe fatigue or weakness, sore throat, hyperthermia, chills), neutropenia, leukopenia, anemia, thrombocytopenia;
From the reproductive system: dysmenorrhea, increased or decreased libido;
On the part of the respiratory system: with too rapid administration of the drug - respiratory depression;
From the urinary system: impaired renal function, incontinence or urinary retention;
From the side of the cardiovascular system: tachycardia, arterial hypotension;
Local reactions: phlebitis or venous thrombosis (pain, swelling, redness) at the injection site;
Others: drug dependence, addiction; rarely - weight loss, bulimia, diplopia, depression of the respiratory center.

With a sharp decrease in dose or discontinuation of intake, withdrawal syndrome may develop, manifested by the following symptoms: increased sweating, tremor, depersonalization, psychomotor agitation, headache, increased irritability, spasm of smooth muscles of internal organs and skeletal muscles, dysphoria, nausea, vomiting, fear, depression, sleep disorders, anxiety, perception disorders, incl. hyperacusis, photophobia, paresthesia, hallucinations, convulsions, tachycardia; rarely - psychotic disorders.

When used in obstetrics in newborns, dyspnea, hypothermia, muscle hypotension, a decrease in blood pressure, and a weak sucking act are possible.

special instructions

Relanium should be used with extreme caution in patients with severe depression, since they can use the drug to implement suicidal intentions.

Intravenous solution should be injected into a large vein, slowly, not faster than 5 mg (1 ml) per minute. Continuous intravenous infusion is not recommended because the formation of a precipitate in the solution and adsorption of the drug by materials from polyvinyl chloride of infusion tubes and balloons is possible.

At the beginning of the use of Relanium and with its abrupt withdrawal in patients with a history of epileptic seizures or epilepsy, it is possible to accelerate the development of seizures or status epilepticus.

Relanium should not be used for a long time without special need.

You can not abruptly stop treatment, because the risk of developing withdrawal syndrome increases.

Patients with renal and hepatic insufficiency and with long-term treatment should monitor the activity of hepatic enzymes and the picture of peripheral blood.

The risk of developing drug dependence increases with the appointment of the drug in high doses, as well as with long-term treatment of persons who have previously abused drugs or alcohol.

Treatment should be discontinued if unusual reactions such as shallow sleep, difficulty falling asleep, fear, psychomotor agitation, hallucinations, increased aggression, anxiety, increased muscle cramps, suicidal thoughts occur.

Due to the risk of gangrene development, Relanium cannot be administered intra-arterially.

During therapy, it is forbidden to consume alcoholic beverages, you should refrain from driving and performing potentially dangerous types of work that require a high speed of reactions and increased attention.

Children, especially young children, are very sensitive to the depressing effect of benzodiazepines on the central nervous system.

It is not recommended to prescribe drugs containing benzyl alcohol to newborns, since a toxic syndrome may develop, manifested by arterial hypotension, renal failure, metabolic acidosis, difficulty breathing, depression of the central nervous system (CNS) and, possibly, intracranial hemorrhage and epileptic seizures.

Drug interactions

Monoamine oxidase inhibitors, corazole, strychnine: antagonism is manifested in relation to the effects of diazepam;
Sedatives and hypnotics, opioid analgesics, benzodiazepine derivatives, other tranquilizers, muscle relaxants, antipsychotics, antidepressants, general anesthetics, ethanol: the depressing effect on the central nervous system is sharply increased;
Disulfiram, fluoxetine, erythromycin, cimetidine, oral contraceptives and estrogen-containing drugs that competitively inhibit liver metabolism (oxidation processes), metoprolol, ketoconazole, isoniazid: diazepam metabolism slows down and its concentration in blood plasma increases;
Valproic acid, propranolol: increases the concentration of diazepam in blood plasma;
Rifampicin: induces the metabolism of diazepam, as a result of which its concentration in blood plasma decreases;
Antihypertensive drugs: it is possible to increase the hypotensive effect;
Opioid analgesics: the depressing effect of diazepam on the central nervous system is enhanced;
Inducers of liver microsomal enzymes: the effectiveness of Relanium decreases;
Clozapine: possible increased respiratory depression;
Omeprazole: the elimination time of diazepam is prolonged;
Levodopa: its effectiveness decreases;
Zidovudine: its toxicity increases;
Psychostimulants, respiratory analeptics: the activity of Relanium decreases;
Theophylline (in low doses): reduces the sedative effect of diazepam;
Cardiac glycosides: an increase in their concentration in the blood serum and the development of digitalis intoxication are possible.

Premedication with Relanium reduces the dose of fentanyl required for induction of general anesthesia and shortens the onset of anesthesia.

Relanium cannot be mixed in the same syringe with any other drugs.

Analogs

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

Terms and conditions of storage

Store at 15-25 ° C, protected from light, out of reach of children.

The shelf life is 5 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!