Expiration dtae: 10/2025

Composition

1 ml of the solution contains:

active substance: alimemazine tartrate in terms of dry matter - 5.0 mg,

excipients: ascorbic acid - 1.0 mg, sodium sulfite - 0.5 mg, water for injection - up to 1 ml.

Dosage form

solution for infusions and intramuscular administration

Description

A colorless or slightly colored, transparent or slightly opalescent liquid.

Pharmacodynamics

It is a derivative of phenothiazine. Due to its antihistamine activity, alimemazine is used for allergic diseases, especially respiratory tract, and skin itching. Alimemazine is more active in antihistamine and sedation than diprazine. It has antiemetic and antitussive activity. Alimemazine also acts as a mild sedative and anti-anxiety agent, has a positive effect on senestopathy, obsession and phobia.

It is used for psychosomatic manifestations developing as a result of neurovegetative disorders, vascular, traumatic and infectious disorders of the central nervous system.

The sedative effect helps to normalize sleep in patients of this category.

The antipruritic effect is due to the effect on histamine receptors of the first type.

The sedative and anxiolytic effect is due to the blockade of adrenoreceptors of the reticular formation of the brain stem.

The antiemetic and vegetative stabilizing effect is due to the blockade of dopamine D2 receptors in the trigger zone of the vomiting center.

Pharmacokinetics

It is rapidly and completely absorbed by any route of administration. The effect of alimemazine begins 15-20 minutes after administration and lasts 6-8 hours. The bond with plasma proteins is 20-30%. It is metabolized in the liver. It is excreted by the kidneys - 70-80% in the form of a metabolite (sulfoxide).

Indications for use

Symptomatic treatment of allergic conditions of various origins (rhinitis, conjunctivitis, itching, urticaria, angioedema).

As a sedative and anxiolytic agent for relieving symptoms in neurotic and psychovegetative disorders.

As a sedative for premedication and in the postoperative period.

In the complex therapy of alcohol withdrawal syndrome.

Contraindications

Hypersensitivity to phenothiazines or to any component of the drug.

Deep depression of the central nervous system and comatose state.

Simultaneous treatment with monoamine oxidase (MAO) inhibitors, the drug can be used no earlier than 14 days after discontinuation of treatment with MAO inhibitors.

Alcohol intoxication, acute intoxication with sleeping pills and narcotic analgesics.

Glaucoma.

Sleep apnea syndrome.

Episodic manifestations of vomiting in children of unknown origin.

Pregnancy.

Breastfeeding period.

Use during pregnancy and lactation

It is contraindicated for use during pregnancy and lactation (breastfeeding). If pregnancy occurs during the treatment period, the drug should be discontinued. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Side effects

Side effects are extremely rare and mild.

From the nervous system: drowsiness, lethargy, fatigue (occur mainly in the first days of administration and rarely require withdrawal of the drug), paradoxical reaction (anxiety, agitation, nightmares, irritability), confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor).

From the sensory organs: blurred visual perception (paresis of accommodation), noise or ringing in the ears.

From the cardiovascular system: dizziness, decreased blood pressure (BP), tachycardia.

From the digestive system: dryness of the oral mucosa, atony of the gastrointestinal tract, constipation, decreased appetite.

From the respiratory system: dryness in the nose, pharynx, increased viscosity of bronchial secretions.

From the urinary system: atony of the bladder, urinary retention.

Other: allergic reactions, inhibition of bone marrow hematopoiesis, increased sweating, muscle relaxation, photosensitization.

Interaction

Alimemazine enhances the effects of narcotic analgesics, hypnotics, anxiolytic (tranquilizers) and antipsychotic (neuroleptics) drugs (drugs), as well as drugs for general anesthesia, m-cholinoblockers and hypotensive drugs (dose adjustment is required).

Tricyclic antidepressants and anticholinergic drugs enhance the m-cholinergic activity of alimemazine.

With the simultaneous use of alimemazine with ethanol, it is possible to increase the depression of the central nervous system.

Alimemazine weakens the effect of phenamine derivatives, m-cholinomimetics, ephedrine, guanethidine, levodopa, dopamine.

With the combined use of alimemazine with antiepileptic drugs and barbiturates, the threshold of convulsive activity decreases (dose adjustment is required).

With the combined use of alimemazine with beta-blockers, a marked decrease in blood pressure and arrhythmias are possible.

Alimemazine weakens the effect of bromocriptine. With simultaneous use in nursing mothers, an increase in the concentration of prolactin in the blood serum is possible.

With the simultaneous use of alimemazine and MAO inhibitors (simultaneous use is not recommended) and alimemazine and phenothiazine derivatives, the risk of arterial hypotension and extrapyramidal disorders increases.

With the simultaneous use of alimemazine with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.

The combined use of phenothiazine derivatives (which include alimemazine) with hepatotoxic drugs may enhance the manifestations of hepatotoxicity of the latter.

Method of administration and dosage

It is used intramuscularly, with caution, to avoid accidental subcutaneous injection, which can lead to local necrosis at the injection site.

The dosage is determined by the doctor individually, depending on the nature of the disease.

The maximum daily dose is 200 mg.

Symptomatic treatment of allergic conditions is 25 mg 1-2 times a day.

In acute cases and in psychiatric practice, adults are prescribed up to 100-200 mg / day.

As a sedative during premedication - 25-50 mg 1-2 hours before surgery.

In the complex therapy of alcohol withdrawal syndrome - 50 mg 1-2 times a day.

Overdose

Symptoms: increased manifestations of the described side effects, with the exception of allergic reactions.

Treatment: withdrawal of the drug, symptomatic therapy.

Special instructions

Alimemazine can mask the ototoxic effect (tinnitus, dizziness) of drugs used together.

Alimemazine increases the body's need for riboflavin.

To prevent distortion of the results of skin scarification tests for allergens, the drug should be discontinued 72 hours before allergological testing.

It should be borne in mind that the injection solution contains sulfites, which can enhance anaphylactic reactions.

During the treatment period, false positive results for pregnancy are possible.

Alcohol should not be consumed during the treatment period.

Influence on the ability to drive vehicles and manage mechanisms

Against the background of drug treatment, you should not engage in activities that require increased concentration of attention and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, the work of a dispatcher and operator).

Release form

Solution for infusions and intramuscular administration, 5 mg/ml.

Packaging

In production at JSC Novosibkhimpharm

5 ml each in ampoules of light-proof glass.

10 ampoules together with instructions for use and an ampoule opener or ampoule scarifier in a cardboard box, pasted with a label-parcel made of offset printing paper.

5 or 10 ampoules each in a contour cell package made of polyvinyl chloride film or polyethylene terephthalate tape and aluminum foil or polyethylene-coated paper or without foil, or without paper.

1 or 2 contour cell packages together with instructions for use and a knife for opening ampoules or an ampoule scarifier in a pack of cardboard.

When packing ampoules with a fracture ring or a fracture point, an ampoule opener or ampoule scarifier is not inserted.

During production at the Federal State Budgetary Institution RKNPC of the Ministry of Health of the Russian Federation

5 ml each in ampoules of light-proof glass.

5 ampoules each in a contour cell package made of polyvinyl chloride film.

1 or 2 contour cell packages together with instructions for use in a pack of cardboard.

Conditions of release from pharmacies

By prescription

Storage conditions

In a place protected from light, at a temperature not exceeding 25 C.

Keep out of reach of children.

Expiration date

3 years.Do not use after the expiration date indicated on the package.