Memazer^® (Tablets) Instructions for Use

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

ATC Code

R06AD01 (Alimemazine)

Active Substance

Alimemazine (Rec.INN registered by WHO)

Dosage Form

Memazer®

Film-coated tablets 5 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

10 pcs. – blisters (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blisters (5 pcs.) – cardboard packs (50 pcs.) – By prescription
25 pcs. – jars – cardboard packs (25 pcs.) – By prescription
25 pcs. – blisters – cardboard packs (25 pcs.) – By prescription
25 pcs. – blisters (2 pcs.) – cardboard packs (50 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
50 pcs. – jars – cardboard packs (50 pcs.) – By prescription

Clinical-Pharmacological Group

Antipsychotic drug (neuroleptic)

Pharmacological Action

Phenothiazine derivative. Acts as a mild sedative and anxiolytic, has a positive effect on senestopathy, obsessions and phobias. It is used for psychosomatic manifestations developing due to neurovegetative disorders, vascular, traumatic and infectious disorders of the central nervous system functions.

The sedative effect helps to normalize sleep in patients of this category. The sedative and anxiolytic effect is due to the blockade of adrenoreceptors of the brainstem reticular formation.

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

Due to its antihistamine activity, Alimemazine is used for allergic diseases, especially of the respiratory tract, and for skin itching. Alimemazine is more active in terms of antihistamine and sedative effects than diprazine. The antipruritic effect is due to the effect on histamine H₁ receptors.

It has weak anticholinergic activity.

Pharmacokinetics

It is absorbed quickly and completely by any route of administration. Plasma protein binding is 20-30%. It is metabolized in the liver. It is excreted by the kidneys 70-80% as a metabolite (sulfoxide).

Indications

As a sedative and anxiolytic agent for the relief of symptoms in neurotic and psychovegetative disorders; symptomatic treatment of allergic conditions of various origins; as a sedative for premedication and in the postoperative period; as part of the complex therapy of alcohol withdrawal syndrome.

ICD codes

Dosage Regimen

It is used orally and intramuscularly in the appropriate dosage forms.

The dose and frequency of administration are set individually, depending on the indications, treatment regimen, clinical situation, and patient’s age.

For oral administration a single dose for adults is 2.5-10 mg. Maximum dose: for adults – 500 mg/day, for elderly patients – 200 mg/day.

For children over 3 years old, a single dose is 2.5-5 mg. The daily dose is 20-80 mg.

For intramuscular administration a single dose is 25-50 mg. The maximum dose is 200 mg/day.

Adverse Reactions

Side effects are extremely rare and mild.

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

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

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

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

From the respiratory system: dryness in the nose, throat, increased viscosity of bronchial secretion.

From the urinary system: bladder atony, urinary retention.

Contraindications

Hypersensitivity to alimemazine, angle-closure glaucoma, prostatic hyperplasia, severe hepatic and/or renal failure, parkinsonism, myasthenia gravis, Reye’s syndrome, simultaneous use of MAO inhibitors, pregnancy, breastfeeding period, children under 3 years of age when used as an antiallergic agent and as a sedative before surgery, under 7 years of age for other indications.

Use in Pregnancy and Lactation

The use is contraindicated during pregnancy and breastfeeding.

During treatment, false-positive pregnancy test results are possible.

Use in Hepatic Impairment

Contraindication: severe liver diseases.

Use in Renal Impairment

Contraindication: severe kidney diseases.

Pediatric Use

Contraindicated in children under 3 years of age as an antiallergic agent and as a sedative before surgery, under 7 years of age for other indications.

Geriatric Use

Maximum dose: for elderly patients – 200 mg/day.

Special Precautions

Alimemazine may mask the ototoxic effect (tinnitus, dizziness) of concomitantly used drugs.

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.

Alcohol should not be consumed during the treatment period.

Effect on the ability to drive vehicles and mechanisms

During the treatment period, one should not engage in activities requiring increased concentration and speed of psychomotor reactions (driving a car and other vehicles, working with moving mechanisms, work of a dispatcher and operator).

Drug Interactions

It enhances the effects of narcotic analgesics, hypnotics, anxiolytics (tranquilizers) and antipsychotics (neuroleptics), as well as drugs for general anesthesia, m-cholinoblockers and antihypertensive agents (dose adjustment is required).

Tricyclic antidepressants and anticholinergic agents enhance the m-cholinoblocking activity of alimemazine.

When alimemazine is used concomitantly with ethanol, an increase in the inhibitory effect on the central nervous system is possible.

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

When alimemazine is used concomitantly with anticonvulsants and barbiturates, the threshold of convulsive activity decreases (dose adjustment is required).

When alimemazine is used concomitantly with beta-blockers, a pronounced decrease in blood pressure and arrhythmias are possible.

It weakens the effect of bromocriptine. When used concomitantly in nursing mothers, an increase in serum prolactin concentration is possible.

When alimemazine and MAO inhibitors are used concomitantly (concomitant use is not recommended) and alimemazine and phenothiazine derivatives, the risk of arterial hypotension and extrapyramidal disorders increases.

When alimemazine is used concomitantly with drugs that suppress bone marrow hematopoiesis, the risk of myelosuppression increases.

When phenothiazine derivatives (including alimemazine) are used concomitantly with hepatotoxic agents, an increase in the hepatotoxicity of the latter is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.