Relanium side effects. "endangered" tranquilizers. Can I buy without a prescription


Effective and widely used in the field of psychiatry and neurology is the drug "Relanium" - a tranquilizer that has a strong inhibitory effect on the central nervous system. Before using Relanium, the annotation approved by the manufacturer should be studied and a consultation with a specialized doctor should be completed. The doctor, based on the analysis of the diagnostic examination, will confirm the diagnosis and prescribe a treatment regimen. This drug is a prescription drug, therefore, without medical prescriptions, it will not be possible to purchase it at a pharmacy.

Composition and form of release

The drug "Relanium" is sold in the form of tablets and solution for injection in ampoules. The pills are placed in aluminum blisters of 10 pieces and sealed in boxes of 3 blisters each. The solution is poured into glass ampoules, which are placed in special fixatives of 5 pcs. There are 1 or 10 containers in a carton package. As part of the tranquilizer, the active substance is diazepam, additional components are:

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  • phenylcarbinol;
  • food additive E211;
  • ethanoic acid;
  • food additive E1520;
  • acetic acid;
  • methylcarbinol;
  • injection water.

Working mechanism


The drug is not dispensed without a doctor's prescription.

The pharmacological group of the drug "Relanium" is a tranquilizer. The drug belongs to the list No. 1 of potent substances of the PKKN of the Ministry of Health of the Russian Federation. The medicine is dispensed by prescription, as it has pronounced actions, namely:

  • exhibits a hypnotic effect;
  • has a sedative effect on the central nervous system;
  • relieves convulsive conditions;
  • relaxes skeletal muscles.

"Relanium" reduces the state of overexcitation of the brain, slows down the functioning of spinal protective reflexes. The pharmaceutical drug reduces emotional stress, acts against the feeling of anxiety, worry, stops the feeling of fear. "Relanium" has a sedative effect on the brain stem, reduces neurotic symptoms. The hypnotic effect of the drug is due to the inhibition of the functions of the cells of the brain stem and the central parts of the spinal cord. Against the background of taking Relanium, a decrease in blood pressure and an expansion of the coronary vascular walls can be observed.

The maximum concentration in the blood is observed an hour after the administration of the drug. When used intravenously, the medicinal substance spreads to various parts of the body in a short period of time, but is more localized in the liver and brain. The percentage of interaction of a medical product with blood proteins is 99. With prolonged use, it is addictive, which makes the medication ineffective.

Indications


The drug is prescribed for sleep disorders.

The appointment of "Relanium" is relevant for sleep disorders, convulsions, anxiety disorders, irritability and spastic conditions. The medicine is prescribed in complex therapy for epilepsy, arterial hypertension, eczema, problems with the menstrual cycle, ulcerative lesions of the gastrointestinal tract, intoxication with chemicals of medicines. Effective "Relanium" and in such pathological conditions:

  • inflammation of the joints;
  • bursitis;
  • inflammatory process in skeletal muscles;
  • pain in the spine;
  • severe headaches;
  • pain in the center of the chest;
  • tremor of the limbs;
  • tension;
  • vasospasm;
  • chronic joint disease with limited mobility;
  • alcohol withdrawal syndrome.

Instructions for use indicate that "Relanium" can be used as a preparatory agent before endoscopic surgery. In addition, a medication is used for preliminary drug preparation before general anesthesia or in case of myocardial infarction. Relanium works effectively if necessary to facilitate childbirth, as well as in psychiatry and neurology.

Instructions for use "Relanium"


Doses of the drug and the method of administration are determined solely by the doctor.

"Relanium" is considered a serious drug that is categorically contraindicated for use as an independent treatment. It is important that the medication is prescribed only by specialized doctors, based on the results of the tests and the general condition of the patient. The dosage of "Relanium" depends on the diagnosis and the patient's well-being. Tablets in the dosage prescribed by the doctor are taken orally with purified water. If the patient needs a dropper, then the dose of the drug solution is 4 ml. Only a qualified physician should administer intravenously or inject injections into the muscle (intramuscularly), since it is important to follow the manipulation algorithm during the injection.

Contraindications and side effects

A potent drug is not allowed to be taken by everyone. The main limitations and possible side effects are presented in the table:

When is it not assigned?Negative reactions
Individual intoleranceDizziness
Autoimmune neuromuscular diseaseDisorientation
ComaFatigue
Alcohol intoxicationEuphoria
Acute respiratory failureAtaxia
Age up to 1 month of lifeSleep disorders
Breast-feedingConfusion
I and III trimesters of pregnancymuscle weakness
Liver and kidney dysfunctionpsychomotor agitation
Spinal ataxiasDry mouth
Elderly ageA sore throat
depressive statesA sharp drop in blood pressure
Low blood proteinRashes and itching on the skin
Weight loss
Increased sweating

Active substance

ATH:

Pharmacological group

Nosological classification (ICD-10)

Composition and form of release


in ampoules of 2 ml; in a box of 5, 10 or 50 ampoules.

Description of the dosage form

Clear colorless or yellow-green liquid.

pharmachologic effect

pharmachologic effect- sedative, muscle relaxant, anticonvulsant, hypnotic, tranquilizer.

Pharmacodynamics

It has a depressant effect on the central nervous system, which is realized mainly in the thalamus, hypothalamus and limbic system. Enhances the inhibitory effect of GABA, which is one of the main mediators of pre- and postsynaptic inhibition of the transmission of nerve impulses in the central nervous system.

Stimulates the benzodiazepine receptors of the supramolecular GABA-benzodiazepine-chlorionophoric receptor complex, causes a decrease in the excitability of the subcortical structures of the brain, and inhibition of polysynaptic spinal reflexes.

Pharmacokinetics

After i / m administration, diazepam is absorbed incompletely and unevenly (depending on the injection site); when injected into the deltoid muscle, absorption is rapid and complete. Bioavailability - 90%. C max in blood plasma after i / m administration is achieved after 0.5-1.5 h from the moment of administration and within 0.25 h with i / v administration. Equilibrium concentrations are achieved with constant intake after 1-2 weeks.

Diazepam and its metabolites pass through the BBB and placental barriers, are found in breast milk at concentrations corresponding to 1/10 of the plasma concentration. Protein binding - 98%.

Metabolized in the liver with the participation of the enzyme system CYP2C19, CYP3A4 , CYP3A5, CYP3A7 to pharmacologically very active desmethyldiazepam and less active temazepam and oxazepam.

Excreted by the kidneys - 70% (in the form of glucuronides), unchanged - 1-2% and less than 10% - with feces. T 1/2 of desmethyldiazepam - 30-100 hours, temazepam - 9.5-12.4 hours and oxazepam - 5-15 hours. T 1/2 can be extended in newborns (up to 30 hours), elderly and senile patients (up to 100 hours) and in patients with hepatic and renal insufficiency (up to 4 days).

With repeated use, the accumulation of diazepam and its active metabolites is significant. Refers to benzodiazepines with a long T 1/2, excretion after cessation of treatment is slow, tk. metabolites persist in the blood for several days or even weeks.

Indications for Relanium®

Neurotic and neurosis-like disorders with manifestation of anxiety (treatment).

Relief of psychomotor agitation associated with anxiety.

Relief of epileptic seizures and convulsive conditions of various etiologies.

Conditions accompanied by an increase in muscle tone (tetanus, acute disorders of cerebral circulation, etc.).

Relief of withdrawal symptoms and delirium in alcoholism.

For premedication and ataralgesia in combination with analgesics and other neurotropic drugs in various diagnostic procedures, in surgical and obstetric practice.

In the complex therapy of hypertension, accompanied by anxiety, increased excitability, hypertensive crisis, vasospasm, menopausal and menstrual disorders.

Contraindications

Hypersensitivity to benzodiazepine derivatives, severe myasthenia gravis, coma, shock, angle-closure glaucoma, history of dependence (drugs, alcohol, except for the treatment of alcohol withdrawal syndrome and delirium), sleep apnea syndrome, alcohol intoxication of varying severity, acute drug intoxication, having a depressing effect on the central nervous system (narcotic, hypnotics and psychotropic drugs), severe COPD (danger of progression of respiratory failure), acute respiratory failure, infancy (up to 30 days inclusive), pregnancy (especially I and III trimesters), breastfeeding period.

Caution - Absence (petit mal) or Lennox-Gastaut syndrome (when administered intravenously, it can provoke the development of tonic status epilepticus); history of epilepsy or epileptic seizures (initiation of treatment with diazepam or its abrupt withdrawal may accelerate the development of seizures or epileptic status), hepatic and / or renal failure, cerebral or spinal ataxia, hyperkinesia, a tendency to abuse psychotropic drugs, organic diseases of the brain (possible paradoxical reactions), hypoproteinemia, old age, depression (see "Special Instructions").

Use during pregnancy and lactation

Contraindicated in pregnancy (I and III trimesters). At the time of treatment should stop breastfeeding.

Side effects

From the nervous system: especially in elderly patients - drowsiness, dizziness, fatigue; impaired concentration; ataxia, disorientation, dullness of emotions, slowing of mental and motor reactions, anterograde amnesia (develops more often than when taking other benzodiazepines); rarely - headache, euphoria, depression, tremor, catalepsy, confusion, dystonic extrapyramidal reactions (uncontrolled body movements), asthenia, muscle weakness, hyporeflexia, dysarthria; extremely rarely - paradoxical reactions (aggressive outbursts, psychomotor agitation, fear, suicidal tendencies, muscle spasm, hallucinations, anxiety, sleep disturbances).

From the side of the hematopoietic organs: leukopenia, neutropenia, agranulocytosis (chills, pyrexia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia.

From the digestive tract: dry mouth or hypersalivation, heartburn, hiccups, gastralgia, nausea, vomiting, loss of appetite, constipation; abnormal liver function, increased activity of hepatic transaminases and alkaline phosphatase, jaundice.

From the side of the cardiovascular system: palpitations, tachycardia, decreased blood pressure.

From the genitourinary system: incontinence or urinary retention, impaired renal function, increased or decreased libido, dysmenorrhea.

Allergic reactions: skin rash, itching.

Effect on the fetus: teratogenicity (especially in the first trimester), CNS depression, respiratory failure and suppression of the sucking reflex in newborns whose mothers used the drug.

Local reactions: at the injection site - phlebitis or venous thrombosis (redness, swelling and pain at the injection site).

Others: addiction, drug dependence, rarely - depression of the respiratory center, visual impairment (diplopia), bulimia, weight loss.

With a sharp decrease in the dose and discontinuation of the intake, the “withdrawal” syndrome (increased irritability, headache, anxiety, fear, psychomotor agitation, sleep disturbances, dysphoria, spasm of the smooth muscles of the internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting , tremor, perception disorders, including hyperacusis, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely psychotic disorders). When used in obstetrics - in newborns - muscle hypotension, hypothermia, dyspnea.

Interaction

MAO inhibitors , respiratory analeptics and psychostimulants reduce the activity of Relanium ® .

With hypnotics, sedatives, narcotic analgesics, other tranquilizers, benzodiazepine derivatives, muscle relaxants, general anesthesia, antidepressants, antipsychotics, alcohol - a sharp increase in the inhibitory effect on the central nervous system.

With cimetidine, disulfiram, erythromycin, fluoxetine, as well as with oral contraceptives and estrogen-containing drugs that competitively inhibit liver metabolism (oxidation processes), it is possible to slow down the metabolism of Relanium ® and increase its plasma concentration.

Isoniazid, ketoconazole and metoprolol - slowing down the metabolism of Relanium ® and increasing its plasma concentration.

Propranolol and valproic acid increase the level of Relanium ® in the blood plasma.

Rifampicin may increase the metabolism of Relanium ® and, as a result, reduce its plasma concentration.

Inducers of microsomal liver enzymes reduce the effectiveness.

Antihypertensive drugs may increase the severity of blood pressure reduction.

Clozapine - may increase respiratory depression.

With simultaneous use with cardiac glycosides, an increase in the concentration of the latter in the blood serum and the development of digitalis intoxication (as a result of competitive binding to plasma proteins) are possible.

Reduces the effectiveness of levodopa in patients with parkinsonism.

Omeprazole prolongs the elimination time of diazepam.

Potentially increased toxicity of zidovudine.

Theophylline (at low doses) may reduce the sedative effect of Relanium ® .

Pharmaceutically incompatible in the same syringe with other drugs.

Premedication with diazepam reduces the dose of fentanyl required for induction of general anesthesia and reduces the time to onset of general anesthesia.

Dosage and administration

I/V, slowly, into a large vein, at a rate of 5 mg (1 ml) / min; i/m.

Relief of psychomotor agitation associated with anxiety - 10-20 mg, if necessary, repeat the dose after 3-4 hours.

With tetanus: intramuscularly or intravenously (stream or drip) - 10-20 mg every 2-8 hours.

With epileptic status - 10-20 mg, if necessary, repeat the dose after 3-4 hours.

To relieve spasm of skeletal muscles: intramuscularly - 10 mg 1-2 hours before the start of the operation.

In obstetrics: in / m - 10-20 mg with the opening of the cervix by 2-3 fingers.

Newborns (after the 5th week of life): i/v slowly - 0.1-0.3 mg / kg to a maximum dose of 5 mg, if necessary, the injection is repeated after 2-4 hours (depending on clinical symptoms).

Children aged 5 years and older: IV slowly - 1 mg every 2-5 minutes up to a maximum dose of 10 mg; if necessary, the introduction is repeated after 2-4 hours.

Overdose

Symptoms: drowsiness, depression of consciousness of varying severity, paradoxical excitation, decreased reflexes to areflexia, decreased response to painful stimuli, dysarthria, ataxia, visual impairment (nystagmus), tremor, bradycardia, decreased blood pressure, collapse, cardiac and respiratory depression (up to apnea) activities, coma.

Treatment: gastric lavage, forced diuresis, the appointment of activated charcoal, symptomatic therapy (maintenance of breathing and blood pressure), mechanical ventilation. Flumazenil is used as a specific antagonist in a hospital setting. Hemodialysis is ineffective.

Flumazenil is not indicated in patients with epilepsy treated with benzodiazepines. In such patients, flumazenil may cause the development of epileptic seizures.

Precautionary measures

When prescribing diazepam for severe depression, special care is required - it is possible to use the drug to realize suicidal intentions.

In renal / hepatic insufficiency and long-term treatment, it is necessary to monitor the picture of peripheral blood and liver enzymes.

The risk of developing drug dependence increases with the use of large doses, a significant duration of treatment, in patients who have previously abused alcohol or drugs. Without special instructions should not be used for a long time.

Abrupt discontinuation of use is unacceptable due to the risk of a "withdrawal" syndrome, but due to the slow elimination of diazepam from the body, its manifestations are less pronounced than in other benzodiazepines.

If patients experience such unusual reactions as increased aggressiveness, psychomotor agitation, anxiety, fear, suicidal thoughts, hallucinations, increased muscle cramps, difficult falling asleep, superficial sleep, treatment should be discontinued.

Initiation of diazepam treatment or its abrupt withdrawal in patients with epilepsy or with a history of epileptic seizures may accelerate the development of seizures or status epilepticus.

It has a toxic effect on the fetus and increases the risk of congenital malformations when used in the first trimester of pregnancy. Taking therapeutic doses later in pregnancy may cause fetal CNS depression. Chronic use during pregnancy may lead to physical dependence - possible "withdrawal" symptoms in the newborn.

Children, especially at a younger age, are very sensitive to the CNS depressant effects of benzodiazepines.

Newborns are not recommended to prescribe drugs containing benzyl alcohol - a toxic syndrome may develop, manifested by metabolic acidosis, CNS depression, difficulty breathing, renal failure, hypotension and, possibly, epileptic seizures, as well as intracranial hemorrhage.

Use in doses above 30 mg within 15 hours before delivery or during childbirth can cause respiratory depression in the newborn (up to apnea), decreased muscle tone and blood pressure, hypothermia, a weak act of sucking (the so-called "sluggish baby syndrome").

Elderly patients Relanium ® should be administered with extreme caution and recommended doses should not be exceeded.

The introduction of Relanium ® into the arterial bed is contraindicated due to the possible development of gangrene.

The risk-benefit ratio should be carefully assessed when prescribing to pregnant women, as well as to patients with liver and kidney diseases.

special instructions

When using the drug, you should refrain from work that requires a quick psycho-emotional reaction (driving vehicles, working with mechanisms).

During treatment with Relanium ®, alcohol intake is prohibited.

Storage conditions of Relanium®

In a place protected from light, at a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life of Relanium®

3 years.

Do not use after the expiry date stated on the packaging.

Instructions for the drug Relanium

Instructions for use of the tranquilizer Relanium contains complete information about the drug: its composition and packaging, pharmacological action and indications for use. Also, the accompanying sheet will acquaint the consumer with contraindications for admission and with the manifestation of side effects. The dosage regimen, as well as the use by patients of different age categories, overdose symptoms and methods of its treatment, and other necessary information should be carefully studied before starting the drug for treatment.

Release form and packaging

The drug Relanium is produced in the form of tablets and a solution for intravenous and intramuscular administration.

Relanium in ampoules

Relanium drug for intravenous and intramuscular administration is a clear, colorless or sometimes yellow-green liquid.

It enters medical institutions in cardboard packs, in which holders for ampoules made of plastic are enclosed, containing five pieces each with a volume of two milliliters. Packs can contain one, two or ten holders with ampoules.

Relanium tablets

The drug Relanium in the form of tablets is represented by three of their types with different concentrations of the active substance.

  1. Relanium tablets 2 milligrams have a round biconvex shape and a light orange color.
  2. Relanium tablets 5 mg are round, biconvex and light green in color.
  3. Relanium tablets 10 milligrams have a round biconvex shape and white color.

In pharmacies, the drug comes in cardboard packs, which contain three blisters of ten tablets each.

Relanium composition

The composition of the tablets includes the active ingredient diazepam in the required proportions and the auxiliary components are microcrystalline cellulose, lactose, monohydrate, corn starch, talc, silicon dioxide and magnesium stearate.

The active substance of the injection solution is also diazepam in the required amount, and it is supplemented with propylene glycol substances, ethanol 96%, benzyl alcohol, sodium benzoate, glacial acetic acid, acetic acid 10% and water for injection.

Terms and conditions of storage

Relanium is a potent drug, so one of the main conditions for its storage will be the choice of a place that will prevent accidental use, especially by children.

Relanium should be stored both in the form of tablets and in the form of a solution in rooms protected from light and moisture, where the temperature ranges from 15 to 25 degrees. Storage of the drug is allowed for five years.

Pharmacology

Being an anxiolytic agent (tranquilizer) of the benzodiazepine series, Relanium is capable of providing sedative, hypnotic, anticonvulsant and central muscle relaxant effects. Relanium enhances the inhibitory effect of Gamma-aminobutyric acid in the central nervous system due to an increase in the sensitivity of the mediator receptors, resulting in a decrease in the excitability of the subcortical structure of the brain of the head, and also inhibition of the spinal polysynaptic receptors.

The action of a tranquilizer can be manifested by a decrease in emotional tension, a decrease in anxiety, as well as anxiety and fear. There will also be a sedative effect on anxiety and fear. However, the drug has practically no effect on acute disorders in the form of affect, delusions or hallucinations.

Relanium indications for use

Relanium tablets: application

The drug Relanium in the form of tablets is indicated for those patients who suffer from the following ailments:

  • With alcohol withdrawal syndrome: with anxiety, nervous tension, restlessness;
  • With neuroses, transient reactive states;
  • With psychosis and organic diseases of the central nervous system;
  • With insomnia;
  • With spasm of skeletal muscles (presence of local injury);
  • In spastic conditions that are associated with brain damage, both brain and spinal (with cerebral palsy, athetosis, tetanus);
  • With myositis, bursitis, arthritis, rheumatic pelvispondylitis, progressive chronic polyarthritis;
  • With arthrosis, accompanied by tension in the muscles of the skeleton;
  • With vertebral syndrome, angina pectoris, arterial hypertension;
  • With psychosomatic disorders in the field of obstetrics and gynecology (with menopausal and menstrual disorders, toxicosis in pregnant women;
  • With eczema and other diseases that are accompanied by severe itching and irritability.

Relanium injections application

In the form of an injectable solution, Relanium is usually prescribed

  • For the treatment of neurotic and neurosis-like disorders with manifestations of anxiety;
  • For the relief of psychomotor agitations that are associated with anxiety;
  • For the relief of an epileptic seizure and a convulsive state;
  • In conditions that are accompanied by increased muscle tone (with tetanus, acute disorders of cerebral circulation);
  • For the relief of withdrawal symptoms in alcoholics;
  • With premedication and ataralgesia, using a combination with analgesics and other neurotropic drugs for various diagnostic procedures, in surgery and obstetrics;
  • With arterial hypertension, which is accompanied by anxiety and increased excitability, with a hypertensive crisis, vasospasm, menopausal and menstrual disorders.

Contraindications

The drug Relanium in any form of its release is contraindicated for treatment for those patients who suffer from the following diseases, or are in the following conditions:

  • With a severe form of myasthenia gravis;
  • When in a coma;
  • in a state of shock;
  • With angle-closure glaucoma;
  • With indications in the anamnesis of drug and alcohol addiction (treatment of alcohol withdrawal syndrome is excluded);
  • With sleep apnea syndrome;
  • In a state of alcoholic intoxication of any severity;
  • In acute intoxication with drugs that have a depressant effect on the central nervous system (narcotic, hypnotic and psychotropic drugs);
  • In severe chronic obstructive pulmonary disease (with the danger that respiratory failure will progress);
  • With acute respiratory failure;
  • In childhood up to one month;
  • During pregnancy (especially in the I and III trimester);
  • For lactating women;
  • With hypersensitivity to benzodiazepines.

Careful prescription of the drug requires in the following cases:

  • When Lennox-Gastaut syndrome occurs, intravenous administration can create a situation where the development will receive tonic status epilepticus,
  • When epilepsy or epileptic seizures are indicated in the anamnesis, both the initiation of diazepam treatment and its abrupt withdrawal can accelerate the development of a seizure or status epilepticus,
  • When a patient has liver and/or kidney failure,
  • When cerebral and spinal ataxia occurs,
  • hyperkinesis,
  • When a patient has a tendency to abuse psychotropic drugs,
  • When depressed,
  • When organic diseases of the brain are detected, the likelihood of paradoxical reactions is high.
  • for elderly patients.

Relanium instructions for use

Relanium in ampoules

Psychomotor agitation is prescribed at 5 or 10 milligrams intravenously by slow administration. If necessary, after a few hours, you can re-administer at the same dose.

Tetanus is prescribed at 10 milligrams slowly intravenously or intramuscularly deeply, after which 100 milligrams of diazepam dissolved in sodium chloride solution 9% (500 milliliters) or in 5% glucose solution are injected intravenously. The rate of administration is from 5 to 15 milligrams per hour.

Status epilepticus is prescribed at 10 or 20 milligrams by any route of administration. If necessary, after a few hours, repeat the administration of the drug at the same dose.

Skeletal muscle spasm is prescribed 10 milligrams intramuscularly 2 hours before surgery.

Obstetrics is prescribed intramuscularly at 10 or 20 milligrams when the cervix is ​​open by 2 or 3 fingers.

Relanium tablets

The dosing regimen is set using an individual approach.

In psychiatry, 5 or 10 milligrams are prescribed three times a day. If absolutely necessary, it is allowed to increase the dose to 60 milligrams per day. This dose is indicative. For each disease, the doctor calculates the dosage.

In the field of obstetrics and gynecology, 2 or 5 milligrams are prescribed three times a day.

Relanium during pregnancy

Pregnant women should not take Relanium.

The use of Relanium by children

For newborns, the drug can be prescribed only in the second month of life. Intravenously slowly at 100 or 300 micrograms per kilogram of body weight. If necessary, the introduction can be repeated after a few hours. The maximum dose is 5 milligrams.

For children over 5 years of age, 1 milligram slowly intravenously every 5 minutes up to a maximum dose of 10 milligrams. If necessary, the infusion is repeated after a few hours.

In the form of tablets, the drug is prescribed with a gradually increasing dose. The daily dose can be divided into several doses, where the main dose is for evening use. Daily dosage: children from 1 to 6 years old, 1-6 milligrams, children from 6 to 14 years old, 6-10 milligrams.

The use of Relanium by the elderly

Elderly patients the drug is prescribed with great caution.

Side effects of Relanium

The drug Relanium, when used, can have a number of side effects, which should be taken into account when prescribing.

  • In the form of lethargy, drowsiness, muscle weakness;
  • In the form of a dulling of emotions, a decrease in concentration, ataxia;
  • In the form of confusion, depression, impaired visual function, diplopia, dysarthria, headaches, tremors, dizziness;
  • In the form of acute psychomotor agitation, anxiety, sleep disturbances, hallucinations (paradoxical reactions),
  • In the form of constipation, bouts of nausea, dry mouth, hypersalivation;
  • In the form of increased activity of hepatic transaminase and alkaline phosphatase, jaundice, drug dependence;
  • In the form of an increase or decrease in libido, urinary incontinence, skin rash.

Overdose

Overdose symptoms may be the occurrence of paradoxical excitation of the central nervous system, the onset of a coma, areflexia, respiratory and cardiac depression, respiratory arrest.

As a first aid, the victim should wash the stomach and prescribe activated charcoal. As necessary, he should be placed in a hospital of a medical institution for symptomatic treatment. The specific antidote is flumazenil. Extrarenal blood purification is ineffective.

Drug Interactions

The effect of Relanium comes into sharp conflict with antidepressants, as well as with strychnine and corazol.

A sharp depression of the central nervous system is observed when Relanium is combined with drugs of a hypnotic and sedative type, opioid analgesics, other tranquilizers, benzodiazepine derivatives, muscle relaxants, general anesthesia, antidepressants, antipsychotics, ethanol can also be added here.

Simultaneous reception of Relanium with drugs such as

  • Cimetidine;
  • disulfide;
  • Erythromycin;
  • fluoxetine;
  • oral contraceptives;
  • estrogen-containing drugs;
  • Isoniazid;
  • Ketocanazole;
  • metoprolol;
  • Propanol;
  • Valproic acid.

More

  1. Increases the concentration of diazepam in plasma by inhibiting the metabolism of diazepam.
  2. Rifampicin reduces its plasma concentration.
  3. An inducer of microsomal liver enzyme is capable of reducing the effectiveness of Relanium.
  4. The hypotensive effect will be increased when the drugs of this group are combined with Relanium.
  5. There is a possibility of respiratory depression when the drug is combined with clopasin.
  6. When Relanium is combined with preparations of cardiac glycosides, their concentration in the blood serum increases, which leads to digitalis intoxication.
  7. Relanium reduces the effectiveness of the main component of antiparkinsonian drugs.
  8. The effectiveness of Relanium may be reduced when taken with respiratory analeptics and psychostimulants.
  9. Increased toxicity of zidovudine.
  10. The sedative effect of Relanium decreases when taking low doses of theophylline.
  11. Due to the action of Relanium in preliminary preparation for anesthesia, it is possible to reduce the dose of fentanyl and reduce the time of onset of anesthesia.
  12. Do not mix Relanium and other drugs in the same syringe.

Additional instructions

Long-term use of the drug may lead to addiction.

During treatment, one should refrain from those activities that require an increased concentration of attention and speed of response.

The drug can be prescribed to a newborn child only in situations associated with a risk to life.

Relanium analogues

Analogues of the drug are available both in the form of tablets and in the form of a solution for injection.

  • Apaurin in the form of a solution;
  • Relium in the form of a solution;
  • Seduxen in the form of a solution;
  • Diazepam in the form of a solution;
  • Sibazon in the form of coated tablets for children;
  • Sibazon in the form of tablets;

Relanium price

To purchase the Relanium drug, the patient must have a prescription from a doctor in a special form, since it is a potent drug equivalent to a narcotic. Its cost, depending on the region of residence, is approximately 5 mg tablets in a package of 20 pieces - 250-350 rubles, a package with a dozen ampoules of 2 ml - 150-275 rubles.

Relanium reviews

There are not so many reviews about the drug, but they clearly state the effectiveness of the drug when taken according to indications. Many are helped by a drug for the relief of epileptic seizures, and many to cope with depression. The drug is also praised by those who have experienced the delights of alcohol withdrawal syndrome.

Misha: After several days of hard drinking, I drank the drug for three days. The effect is very impressive. Doesn't crave alcohol at all. There is some lethargy, but the state of health is good.

Anastasia: Being in a state of neurosis, which was burdened by a phobia, I drank Relanium for a month and a half as prescribed by a doctor. The effect is small, probably because I drank a little more. Feeling normal. I felt that anxiety decreased, I became calmer and I want to sleep all the time.

Nadezhda Sadness: It saves me from depression. It’s a pity that you can’t just buy it - you have to go to the doctor.

Similar instructions:

Compound

active substance:

Diazepam 10 mg

Excipients:

Gasoline alcohol, ethyl alcohol 96°, sodium beneoate, benzoic acid, propylene glycol, water for injection

pharmachologic effect

Pharmacotherapeutic group Anxiolytic agent.

Indications for use

Severe states of anxiety (paroxysmal anxiety);

Conditions of anxiety and tension occurring with motor excitation in patients with psychosis:

epileptic status;

Withdrawal syndrome in alcoholics - to eliminate acute arousal, muscle tremors; threatening or acute delirium and hallucinosis;

Symptomatically in tetanus

Preparing for operations

Premedication for diagnostic procedures;

indomitable vomiting;

In cardioversion - intravenously;

Additionally - to alleviate muscle spasms caused by a spasm reflex in local pathology (secondary myositis or arthritis, after injuries);

Use strictly as prescribed by the doctor to avoid complications.

Contraindications

Hypersensitivity to benzodiazepines;

Respiratory disorders of central origin and severe respiratory failure, regardless of the cause;

Disturbances of consciousness;

Glaucoma;

myasthenia;

Pregnancy (especially the first trimester) and breastfeeding;

Depressive states with a tendency to suicide;

Balance disorders.

Pregnancy and lactation

There is evidence of a teratogenic effect of drugs from the benzodiazepine group on the fetus.

Diazepam easily crosses the placental barrier; passes into mother's milk. The use of diazepam is especially contraindicated in the first trimester of pregnancy. The drug should not be used during lactation. If there are indications for the mother of treatment with diazepam, feeding should be stopped.

Dosage and administration

Adults are usually prescribed:

2-20 mg intramuscularly or intravenously, depending on the indications and severity of the disease.

In some cases, an increase in dose (tetanus) is required.

In severe conditions, injections can be repeated within 1 hour, although the recommended interval between doses is 3-4 hours.

Elderly patients, debilitated, debilitated or treated with other sedative drugs need a dose reduction (usually 2-5 mg).

In acute cases of anxiety and restlessness, 2-5 mg is prescribed intramuscularly or intravenously, if necessary, the dose is repeated after 3-4 hours. In severe phobic disorders, up to 5-10 mg intramuscularly or intravenously are prescribed, if necessary, the dose is repeated after 3-4 hours. With abstinence syndrome in alcoholics (to alleviate the symptoms of acute agitation, muscle trembling, threatening or acute delirium), first 10 mg intramuscularly or intravenously, if necessary after 3-4 hours 5-10 mg,

Before diagnostic procedures e.g. endoscopy, if the patient has a severe anxiety or stress reaction, slow intravenous administration is recommended, immediately before the diagnostic procedure, usually 10 mg, maximum 20 mg, provided that the patient does not receive narcotic painkillers at the same time. If intravenous administration of the drug is not possible, it should be administered intramuscularly 5-10 mg in 30 minutes. before starting the diagnostic procedure. With tetanus, athetosis, muscle spasms against the background of local pathology, baking starts with a dose of 5-10 mg intramuscularly or intravenously.

In the treatment of tetanus, it may be necessary to increase the dose. In status epilepticus and in severe recurrent convulsive seizures, the drug should be administered intravenously. If intravenous administration of the drug is not possible, diazepam is administered intramuscularly, first 5-10 mg, if necessary, the injection can be repeated after 10-15 minutes, maximum 30 mg. After 2-4 hours, if necessary, the dose can be repeated with special care. Patients with chronic lung diseases and circulatory failure require special attention. Prophylactically administered up to 100 mg per day intravenously. In preoperative premedication, to eliminate anxiety, fear and tension, 10 mg intramuscularly is administered before surgery. In cardioversion, 5-10 mg is administered intravenously 5-10 minutes before the start of the procedure.

Attention!

For the elderly or debilitated, debilitated, a dose not exceeding half the adult dose is recommended.

Patients with renal and hepatic insufficiency require a dose reduction.

children

In tetanus - children in the fifth week of life are prescribed 1-2 mg intramuscularly or intravenously (slowly), if necessary, repeat the dose after 3-4 hours.

Children aged 5 years and older are prescribed 5-10 mg, if necessary, repeat the dose after 3-4 hours. In status epilepticus and severe, recurrent convulsive seizures - children in the fifth week of life and children under 5 years of age are prescribed 0.2 - 0.5 mg every 2-5 minutes, up to a maximum of 5 mg.

Recommended intravenous administration (slowly), under the control of respiratory function. Children aged 5 years and older are prescribed 1 mg over 2-5 minutes, up to a maximum of 10 mg. Intravenous administration (slowly) is recommended. If necessary, repeat the dose after 2-4 hours. Care must be taken, especially in young children, to administer the IV injection very slowly to avoid respiratory failure.

Method of administration

Diazepam injection solution for parenteral administration should be freshly prepared.

Intramuscular injections:

the medicine should be injected deep into the large muscles.

Intravenous injections;

when in / in the introduction should choose a vein of large caliber. Avoid intra-arterial administration. Diazepam injectable solution should always be administered separately, as it is not compatible with aqueous solutions of other medicines. To prepare a solution of diazepam for intravenous administration, the contents of the ampoule are diluted to 10 ml with saline or 5% glucose solution. So the prepared solution is administered at a rate of up to 4 ml (4 mg) per minute.

Intravenous drip infusion

Approximately: the contents of 10 ampoules (100 mg) are diluted in 500 ml of physiological saline or 5% glucose solution and injected intravenously at a rate of 40 ml/hour (corresponding to 8 mg of the active substance). Sometimes, after diluting the drug, there is a cloudiness that disappears after a few minutes. If the turbidity does not disappear, the drug is unsuitable for use.

Side effect

Often seen:

drowsiness, dizziness, fatigue, fatigue, locomotor ataxia, memory impairment, reduced ability to concentrate and slow reaction rate, decreased skeletal muscle tension, weakened libido, slight decrease in blood pressure. Less commonly observed: skin-allergic reactions, speech disorders, visual impairment, states of confusion and disorientation, bradycardia, collapse, loss of consciousness.

Paradoxical reactions (states of psychomotor agitation, convulsions, anxiety, restlessness, insomnia, increased skeletal muscle tension). Paradoxical reactions appear more often in children and in elderly patients.

Sometimes observed:

after intravenous administration - thrombosis, phlebitis, cold extremities. Repeated use of diazepam can lead to psychological and physiological dependence, as well as to the appearance of an abstinence syndrome in the event of a sudden withdrawal of the drug.

Withdrawal syndrome is characterized by:

psychomotor agitation, fear, vegetative disorders, in severe cases, disturbances of consciousness and convulsions may appear.

Cancellation of the drug

Minor symptoms of drug withdrawal, in the form of sleep and mood disturbances, are noticeable after the sudden cessation of diazepam treatment in patients who have taken the drug in therapeutic doses for several weeks.

More pronounced symptoms of drug withdrawal may occur in patients who have received high doses of the drug for a long time. Do not suddenly stop long-term treatment, reduce the dose gradually.

Overdose

An overdose of the drug can cause toxic symptoms - drowsiness, confusion, disorientation, in severe cases, coma. The use of diazepam together with other drugs, drugs that depress the central nervous system or with alcohol can be life threatening.

Treatment for overdose is symptomatic, it consists in monitoring the basic vital functions of the patient (respiration, pulse, blood pressure). The specific antidote is flumazenil.

Interaction with other drugs

The depressive effect of diazepam on the central nervous system is enhanced by all drugs that have a similar effect: for example. antiepileptics, antihistamines, antipsychotics, tricyclic antidepressants, opioids, sympathicolytic and anticholinergic drugs. Ethyl alcohol has a similar effect. The metabolism of diazepam can be inhibited by: cimetidine, disulfiram, isoniazid, and accelerated by rifampicin and phenobarbital.

Catad_pgroup Anxiolytics (tranquilizers)

Relanium - instructions for use

Registration number:

P N015758/01

Trade name of the drug:

Relanium ®

International non-proprietary name:

Diazepam

Chemical name:

7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one

Dosage form:

Solution for intravenous and intramuscular administration.

Compound:

Composition 1 ml:
active substance: Diazepam 5 mg.
Excipients: propylene glycol 450.0 mg, ethanol 96% 100.0 mg, benzyl alcohol 15.0 mg, sodium benzoate 48.8 mg, glacial acetic acid 2.3 mg, acetic acid 10% to pH approx. 6.3 - 6.4, water for injection up to 1 ml.
2 ml ampoule contains 10 mg diazepam

Description:

Clear, colorless or yellow-green liquid.

Pharmacotherapeutic group:

Anxiolytic agent (tranquilizer).

ATX code:

Pharmacological properties

Pharmacodynamics
Diazepam has a depressant effect on the central nervous system (CNS), which is realized mainly in the thalamus, hypothalamus and limbic system. Enhances the inhibitory effect of gamma-aminobutyric acid (GABA), which is one of the main mediators of pre- and postsynaptic inhibition of the transmission of nerve impulses in the central nervous system.
It has an anxiolytic, sedative, hypnotic, muscle relaxant and anticonvulsant effect. The mechanism of action of diazepam is determined by stimulation of the benzodiazepine receptors of the supramolecular GABA-benzodiazepine-chlorionophore receptor complex, leading to the activation of the GABA receptor, which causes a decrease in the excitability of the subcortical structures of the brain, and inhibition of polysynaptic spinal reflexes.

Pharmacokinetics
When administered intramuscularly, the absorption of diazepam can be slow and unstable (depending on the injection site); when injected into the deltoid muscle, absorption is rapid and complete. Bioavailability -90%. Maximum plasma concentrations are reached after 0.5 -1.5 hours with intramuscular injection (hereinafter IM) and within 0.25 hours with intravenous (hereinafter iv); Steady-state concentrations are reached with continuous administration in 1-2 weeks.
Diazepam and its metabolites cross the blood-brain and placental barriers and are found in breast milk at concentrations corresponding to 1/10 of plasma concentrations. Communication with plasma proteins - 98%. Metabolized in the liver with the participation of the enzyme system CYP2C19, CYP3A4, CYP3A5 and CYP3A7 98-99% to pharmacologically very active derivatives (desmethyldiazepam) and less active (temazepam and oxazepam).
It is excreted by the kidneys - 70% (in the form of glucuronides), unchanged - 1-2% and less than 10% - with feces. The half-life (T½) of desmethyldiazepam is 30-100 hours, temazepam is 9.5-12.4 hours and oxazepam is 5-15 hours.
T½ can be prolonged in newborns (up to 30 hours), elderly and senile patients (up to 100 hours) and in patients with hepatic and renal insufficiency (up to 4 days).
With repeated use, the accumulation of diazepam and its active metabolites is significant.
Refers to benzodiazepines with a long half-life, elimination after stopping treatment is slow, because metabolites persist in the blood for several days or even weeks.

Indications for use

  • treatment of neurotic and neurosis-like disorders with manifestation of anxiety.
  • relief of psychomotor agitation associated with anxiety;
  • relief of epileptic seizures and convulsive conditions of various etiologies. Applied in conditions accompanied by an increase in muscle tone (tetanus, with acute disorders of cerebral circulation, etc.);
  • relief of withdrawal symptoms and delirium in alcoholism;
  • it is also used for premedication and ataralgesia in combination with analgesics and other neurotropic drugs in various diagnostic procedures, in surgical and obstetric practice;
  • in the clinic of internal diseases: in the complex therapy of hypertension (accompanied by anxiety, increased excitability), hypertensive crisis, vasospasm, menopausal and menstrual disorders.

Contraindications

Hypersensitivity to benzodiazepine derivatives, severe myasthenia gravis, coma, shock, angle-closure glaucoma, history of dependence (drugs, alcohol, except for the treatment of alcohol withdrawal syndrome and delirium), sleep apnea syndrome, alcohol intoxication of varying severity, acute drug intoxication drugs that have a depressant effect on the central nervous system (narcotic, hypnotics and psychotropic drugs), severe chronic obstructive pulmonary disease (risk of progression of respiratory failure), acute respiratory failure, children under 30 days of age, pregnancy (especially 1st and 3rd trimester), breastfeeding feeding.
Carefully- Absence (petit mal) or Lennox-Gastaut syndrome (when administered intravenously, it can provoke the development of tonic status epilepticus); history of epilepsy or epileptic seizures (initiation of treatment with diazepam or its abrupt withdrawal may accelerate the development of seizures or epileptic status), hepatic and / or renal failure, cerebral and spinal ataxia, hyperkinesia, a tendency to abuse psychotropic drugs, organic diseases of the brain (possible paradoxical reactions), hypoproteinemia, old age, depression (see "Special Instructions").

Dosage and administration

Relief of psychomotor agitation associated with anxiety, fear: the initial dose of 5-10 mg is administered slowly intravenously (in / in); the dose can be repeated after 3-4 hours.
A state of increased muscle tension and tetanus: dose for adults: first, 10 mg is administered as a slow intramuscular injection or deep intramuscular injection (IM), and then 100 mg of diazepam in 500 ml of 0.9% sodium chloride solution or 5% glucose solution is injected intravenously. at a rate of 5-15 mg per hour.
For status epilepticus: appoint / m or / in 10-20 mg, if necessary, repeat the dose after 3-4 hours.
For premedication (removal of spasm of skeletal muscles): 10 mg intramuscularly 1-2 hours before the start of the operation.
In obstetrics: appoint / m 10-20 mg with the opening of the cervix by 2-3 fingers.
Newborns are prescribed after the 5th week of life (over 30 days) in / in slowly at 0.1-0.3 mg / kg of body weight up to a maximum dose of 5 mg, if necessary, injections are repeated after 2-4 hours (depending on the clinical symptoms).
Children aged 5 and over: in / in slowly 1 mg every 2-5 minutes to a maximum dose of 10 mg; if necessary, the treatment can be repeated after 2-4 hours.

Side effect

From the side of the nervous system: at the beginning of treatment (especially in elderly patients) - drowsiness, dizziness, fatigue, impaired concentration, ataxia, disorientation, dulling of emotions, slowing of mental and motor reactions, anterograde amnesia (develops more often than when taking other benzodiazepines); rarely - headache, euphoria, depression, tremor, catalepsy, confusion, dystonic extrapyramidal reactions (uncontrolled body movements), asthenia, muscle weakness, hyporeflexia, dysarthria; extremely rarely - paradoxical reactions (aggressive outbursts, psychomotor agitation, fear, suicidal tendencies, muscle spasm, confusion, hallucinations, anxiety, sleep disturbances).
From the side of the hematopoietic organs: leukopenia, neutropenia, agranulocytosis (chills, pyrexia, sore throat, unusual fatigue or weakness), anemia, thrombocytopenia.
From the digestive system: dry mouth or hypersalivation, heartburn, hiccups, gastralgia, nausea, vomiting, loss of appetite, constipation; abnormal liver function, increased activity of "liver" transaminases and alkaline phosphatase, jaundice.
From the side of the cardiovascular system: palpitations, tachycardia, lowering blood pressure (hereinafter referred to as blood pressure).
From the genitourinary system: incontinence or urinary retention, impaired renal function, increased or decreased libido, dysmenorrhea.
allergic reactions: skin rash, itching.
Effect on the fetus: teratogenicity (especially the first trimester), CNS depression, respiratory failure and suppression of the sucking reflex in newborns whose mothers used the drug.
Local reactions: at the injection site - phlebitis or venous thrombosis (redness, swelling, or pain at the injection site).
Others: addiction, drug dependence; rarely - depression of the respiratory center, visual impairment (diplopia), bulimia, weight loss.
With a sharp dose reduction or discontinuation- "withdrawal" syndrome (increased irritability, headache, anxiety, fear, psychomotor agitation, sleep disturbances, dysphoria, spasm of smooth muscles of internal organs and skeletal muscles, depersonalization, increased sweating, depression, nausea, vomiting, tremor, perception disorders, in including hyperacusis, paresthesia, photophobia, tachycardia, convulsions, hallucinations, rarely psychotic disorders). When used in obstetrics - in newborns - muscle hypotension, hypothermia, dyspnea.

Overdose

Symptoms: drowsiness, depression of consciousness of varying severity, paradoxical excitation, decreased reflexes to areflexia, reduced response to pain stimuli, dysarthria, ataxia, visual impairment (nystagmus), tremor, bradycardia, decreased blood pressure, collapse, cardiac and respiratory depression (up to apnea) activities, coma.
Treatment: gastric lavage, forced diuresis, activated charcoal. Symptomatic therapy (maintenance of breathing and blood pressure), artificial ventilation of the lungs. Flumazenil is used as a specific antagonist (in a hospital setting). Hemodialysis is ineffective. The benzodiazepine antagonist flumazenil is not indicated in patients with epilepsy treated with benzodiazepines. In such patients, the antagonistic effect of benzodiazepines can provoke the development of epileptic seizures.

Interaction with other drugs

When Relanium is used in conjunction with other drugs, the following interaction reactions may occur:

  • with monoamine oxidase inhibitors, strychnine and corazole - antagonism in relation to the effects of Relanium;
  • with hypnotics, sedatives, narcotic analgesics, other tranquilizers, benzodiazepine derivatives, muscle relaxants, general anesthesia, antidepressants, antipsychotics, alcohol - a sharp increase in the inhibitory effect on the central nervous system;
  • with cimetidine, disulfiram, erythromycin, fluoxetine, as well as with oral contraceptives and estrogen-containing drugs that competitively inhibit liver metabolism (oxidation processes) - it is possible to slow down the metabolism of Relanium and increase its plasma concentration;
  • isoniazid, ketoconazole and metoprolol also slow down the metabolism of Relanium and increase its concentration in blood plasma;
  • propranolol and valproic acid increase the level of Relanium in the blood plasma;
  • rifampicin may increase the metabolism of Relanium and, as a result, reduce its concentration in blood plasma;
  • inducers of microsomal liver enzymes - reduce efficiency;
  • narcotic analgesics increase the inhibitory effect on the central nervous system;
  • antihypertensive drugs can increase the severity of lowering blood pressure;
  • clozapine - possibly increased respiratory depression;
  • when used simultaneously with cardiac glycosides, an increase in the concentration of the latter in the blood serum and the development of digitalis intoxication (as a result of a competitive connection with plasma proteins) are possible;
  • reduces the effectiveness of levodopa in patients with parkinsonism;
  • omeprazole prolongs the elimination time of diazepam;
  • monoamine oxidase inhibitors (MAO), respiratory analeptics, psychostimulants - reduce the activity of the drug.
  • potentially increased toxicity of zidovudine;
  • theophylline (used in low doses) may reduce sedation.

Pharmaceutically incompatible in the same syringe with other drugs.
Premedication with diazepam reduces the dose of fentanyl required for induction of general anesthesia and reduces the time to onset of general anesthesia.

special instructions

Special care is required when prescribing diazepam for severe depression, tk. the drug can be used to realize suicidal intentions. In / in the solution of diazepam must be administered slowly, into a large vein, at least for 1 minute for every 5 mg (1 ml) of the drug. It is not recommended to carry out continuous intravenous infusions - sedimentation and adsorption of the drug by polyvinyl chloride materials of infusion balloons and tubes is possible.
With renal / liver failure and long-term treatment, it is necessary to monitor the picture of peripheral blood and "liver" enzymes.
The risk of developing drug dependence increases with the use of large doses, a significant duration of treatment, in patients who have previously abused alcohol or drugs. Without special instructions should not be used for a long time. Abrupt discontinuation of treatment is unacceptable due to the risk of a "withdrawal syndrome", however, due to the slow half-life of diazepam, its manifestation is much weaker than that of other benzodiazepines.
If patients experience such unusual reactions as increased aggressiveness, psychomotor agitation, anxiety, fear, suicidal thoughts, hallucinations, increased muscle cramps, difficulty falling asleep, superficial sleep, treatment should be discontinued.
Initiation or abrupt withdrawal of diazepam in patients with epilepsy or a history of epileptic seizures may precipitate the development of seizures or status epilepticus.
It has a toxic effect on the fetus and increases the risk of congenital malformations when used in the first trimester of pregnancy. Taking therapeutic doses later in pregnancy may cause fetal CNS depression. Chronic use during pregnancy may lead to physical dependence - possible withdrawal symptoms in the newborn.
Children, especially at a younger age, are very sensitive to the CNS depressant effects of benzodiazepines. Newborns are not recommended to prescribe drugs containing benzyl alcohol - a toxic syndrome may develop, manifested by metabolic acidosis, CNS depression, difficulty breathing, renal failure, hypotension and, possibly, epileptic seizures, as well as intracranial hemorrhage.
Use in doses above 30 mg within 15 hours before delivery or during childbirth can cause respiratory depression in the newborn (up to apnea), decreased muscle tone, decreased blood pressure, hypothermia, weak sucking (the so-called "sluggish baby syndrome"). Elderly patients Relanium should be administered with extreme caution and should not exceed the recommended dose.
The risk-benefit ratio should be carefully assessed when administered to pregnant women, as well as to patients with kidney and liver diseases.
The introduction of Relanium into the arterial bed is contraindicated due to the possible development of gangrene.

Influence on the ability to drive vehicles and control mechanisms

While taking Relanium, patients are not recommended to perform work that requires a quick response and is associated with risk, such as driving vehicles and performing other potentially hazardous activities.
During treatment with Relanium, alcohol is prohibited.

Release form

Solution for intravenous and intramuscular administration 5 mg/ml.
2 ml in colorless or orange glass ampoules for ampoules of the first hydrolytic class (Eur.F.). Above the break point of the ampoule is a white or red dot, as well as a red ring-shaped strip.
5 ampoules are placed in a PVC holder with a protective colorless PET film. One holder, or two holders, or ten holders in a carton box along with instructions for use.

Storage conditions

List III of the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation.
Store at 15°C-25°C. Protect from light.
Keep out of the reach of children.

Best before date

5 years.
Do not use after the expiry date stated on the package.

Holiday conditions

Prescription release.

Manufacturer

Warsaw Pharmaceutical Plant Polfa JSC
st. Karolkova 22/24, 01-207 Warsaw, Poland.

Organization accepting consumer claims
JSC "Chemical-Pharmaceutical Plant "AKRIKHIN"
142450, Moscow region,
Noginsky district, Staraya Kupavna, st. Kirova, 29