Relanium

Relanium – a tranquilizer (anxiolytic).

Form of release and structure

Dosage form – solution for intravenous and intramuscular administration: flavovirent or colourless, transparent (on 2 ml in ampoules, on 5 ampoules in the plastic holder, in a pack of cardboard 1, 2 or 10 holders).

Active ingredient: diazepam – 5 mg in 1 ml.

Additional components: benzyl alcohol, acetic acid ice, ethanol of 96%, acetic acid of 10% (to рН 6,3-6,4), Natrium benzoicum, propylene glycol, water for injections.

Indications to use

• Treatment of the neurosis-like and neurotic frustration which are followed by manifestations of alarm;
• Therapy of the states which are followed by increase in a muscle tone (including acute disorders of cerebral circulation and tetanus);
• Stopping of convulsive states and epileptic seizures of various etiology;
• Stopping of the psychomotor excitement connected with alarm;
• Stopping of an abstinence syndrome and delirium at alcoholism;
• Complex treatment of the arterial hypertension which is followed by a hyperexcitability and alarm and also vasospasms, hypertensive crisis, menstrual and climacteric frustration.

Also Relanium is applied to an ataralgeziya and premedication in obstetric and surgical practice when holding diagnostic procedures (in a combination with analgetic and other neurotropic means).

Contraindications

Absolute:

• Syndrome of a night apnoea;
• Closed-angle glaucoma;
• Severe form of a myasthenia;
• Shock;
• Coma;
• Acute respiratory insufficiency;
• Serious chronic obstructive illness of lungs;
• Alcohol intoxication;
• Alcohol or drug addiction in the anamnesis (except for a tremens and an abstinence syndrome);
• Pregnancy period (especially I and III trimesters) and lactations;
• Children's age up to 30 days inclusive;
• Acute intoxication medicines which have the oppressing effect on the central nervous system (psychotropic, hypnotic drugs and drugs);
• Hypersensitivity to components of drug or other benzodiazepines.

Relative:

• Absentias epileptica (petit mal);
• Lennox-Gasto's syndrome;
• Epilepsy and epileptic seizures in the anamnesis;
• Liver and/or renal failure;
• Spinal and cerebral ataxy;
• Hyperkinesia;
• Organic diseases of a brain;
• Depression;
• Tendency to abuse of psychotropic drugs;
• Hypoproteinemia;
• Advanced age.

Route of administration and dosage

Relanium enter intravenously (in/in) or intramusculary (in oil).

The recommended dosages:

• Stopping of the psychomotor excitement connected with alarm: in/in on 5-10 mg once, if necessary in 3-4 hours the drug is administered repeatedly in the same dose;
• Epileptic status: in/in or 10-20 mg in oil once, if necessary repeat introduction in a similar dose in 3-4 hours;
• Tetanus: in/in slowly or in oil it is deep in a dose of 10 mg, then in/in kapelno with a speed of 5-15 mg/h of 100 mg of 500 ml of solution of sodium of chloride of 0,9% or solution of glucose of 5%;
• Spasmolysis of skeletal muscles: 10 mg in oil in 1-2 hours prior to operation;
• In obstetrics: 10-20 mg in oil at disclosure of a neck of uterus on 2-3 fingers.

The newborn 30 days Relanium are more senior enter slowly in/in 0,1-0,3 mg/kg to the maximum dose of 5 mg. If necessary the drug is administered repeatedly in 2-4 hours.

To children of 5 years means is entered slowly in/in on 1 mg by each 2-5 minutes to the maximum dose of 10 mg. If necessary in 2-4 hours it is entered repeatedly.

Side effects

• Allergic reactions: skin rashes, itch;
• From the central and peripheral nervous system: in an initiation of treatment (especially at elderly people) – increased fatigue, dizziness, disturbance of concentration of attention, drowsiness, an ataxy, delay of mental and motor reactions, obtusion of emotions, a disorientation, an ecmnesia; seldom – a katalepsy, a tremor, confusion of consciousness, a depression, dystonic extrapyramidal reactions (the uncontrollable movements), a hyporeflexia, muscular weakness, euphoria, a dysarthtia, an adynamy, a headache; in some cases – paradoxical reactions (sleep disorders, psychomotor arousing, a muscular spasm, alarm, fear, confusion of consciousness, flash of aggression, a hallucination, suicide bents);
• From the alimentary system: hypersalivation or dryness in a mouth, abnormal liver functions, a hiccups, nausea, vomiting, a lock, a gastralgia, heartburn, a loss of appetite, jaundice, increase in activity of hepatic transaminases and an alkaline phosphatase;
• From system of a hemopoiesis: an agranulocytosis (the expressed fatigue or weakness, a pharyngalgia, a hyperthermia, a fever), a neutropenia, a leukopenia, anemia, thrombocytopenia;
• From a reproductive system: dysmenorrhea, increase or decrease in a libido;
• From respiratory system: at too bystry administration of drug – respiratory depression;
• From an urinary system: renal failure, incontience or ischuria;
• From cardiovascular system: tachycardia, arterial hypotension;
• Local reactions: phlebitis or venous thrombosis (pain, a swelling, redness) in an injection site;
• Others: medicinal dependence, accustoming; seldom – decrease in body weight, bulimia, a diplopia, oppression of a respiratory center.

At sharp reduction of a dose or the termination of reception the withdrawal which is shown the following symptoms can develop: sweating strengthening, tremor, depersonalization, psychomotor excitement, headache, acrimony, spasm of unstriated muscles of internals and skeletal muscles, dysphoria, nausea, vomiting, fear, depression, sleep disorders, alarm, disorders of perception, including hyperacusia, photophobia, paresthesias, hallucinations, spasms, tachycardia; seldom – psychotic frustration.

At use in obstetrics for newborns the hypothermia, a hypomyotonia, a lowering of arterial pressure, the weak act of suction are possible диспноэ.

Special instructions

Patients should appoint Relanium with extra care with a heavy depression as they can use drug for implementation of suicide intentions.

Intravenously solution needs to be entered into a large vein, slowly, not quicker than 5 mg (1 ml) a minute. It is not recommended to carry out continuous intravenous infusions since formation of a deposit in solution and drug adsorption by materials from polyvinylchloride of infusional tubes and cylinders is possible.

At the beginning of use of Relanium and at its sharp cancellation at patients with epileptic seizures or epilepsy in the anamnesis acceleration of development of attacks or the epileptic status is possible.

Relanium should not be applied it is long without special need.

It is impossible to stop sharply treatment since the risk of development of a withdrawal increases.

Patients with a renal and liver failure and at prolonged treatment should control activity of liver enzymes and a picture of peripheral blood.

The risk of development of medicinal dependence increases at purpose of drug in high doses, and also at prolonged treatment of persons who abused medicines or alcohol earlier.

Treatment needs to be stopped in case of such unusual reactions as a superficial dream, difficult backfilling, sensation of fear, psychomotor excitement, hallucinations, the increased aggression, alarm, strengthening of muscular spasms, suicide thoughts.

Because of risk of a gangrenosis Relanium cannot be entered vnutriarterialno.

During therapy it is forbidden to take alcoholic beverages, it is necessary to refrain from driving and performance of potentially dangerous types of the works demanding the high speed of reactions and special attention.

Children, especially younger age, are very sensitive to the oppressing influence of benzodiazepines on the central nervous system.

It is not recommended to appoint the newborn the medicines containing benzyl alcohol as development of a toxic syndrome, the shown arterial hypotension, a renal failure, a metabolic acidosis, breath difficulty, oppression of the central nervous system (CNS) and, perhaps, intracraneal hemorrhage and epileptic seizures is possible.

Medicinal interaction

• Monoamine oxidase inhibitors, Corazolum, strychnine: antagonism concerning effects of diazepam is shown;
• Sedative and hypnagogues, opioid analgetics, benzodiazepine derivatives, other tranquilizers, muscle relaxants, neuroleptics, antidepressants, means for the general anesthesia, ethanol: sharply the oppressing action on TsNS amplifies;
• Disulfiramum, fluoxetine, erythromycin, Cimetidinum, the oral contraceptives and estrogensoderzhashchy drugs competitively inhibiting metabolism in a liver (oxidation processes), метопролол, кетоконазол, an isoniazid: metabolism of diazepam is slowed down and its concentration in a blood plasma increases;
• Valproic acid, propranolol: concentration of diazepam in a blood plasma increases;
• Rifampicin: induces diazepam metabolism owing to what its concentration in a blood plasma decreases;
• Anti-hypertensive drugs: strengthening of hypotensive effect is possible;
• Opioid analgetics: the oppressing influence of diazepam on TsNS amplifies;
• Inductors of microsomal enzymes of a liver: efficiency of Relanium decreases;
• Clozapine: strengthening of respiratory depression is possible;
• Omeprazol: diazepam removal time is extended;
• Levodopa: its efficiency decreases;
• Zidovudine: its toxicity increases;
• Psychostimulants, respiratory analeptics: activity of Relanium decreases;
• Theophylline (in low doses): reduces sedative effect of diazepam;
• Cardiac glycosides: increase in their concentration in blood serum and development of digitalis intoxication is possible.

Premedication Relanium allows to lower the fentanyl dose which is required for introduction general anesthesia and reduces anesthesia approach time.

Relanium cannot be mixed in one syringe with any other medicines.

Terms and storage conditions

To store at a temperature of 15-25 °C in protected from light, the place, unavailable to children.

Period of validity – 5 years.