Expiration date: 06/2025

Structure and Composition:

Tablets, film-coated. One tablet contains active substance:

alimemazine tartrate 5 mg

auxiliary substances: milk sugar (lactose), colloidal silicon dioxide, refined sugar (sucrose), wheat starch, tapioca (tapioca starch), talc, magnesium stearate

film coating: hypromellose Macrogol 6000 titanium dioxide dye Osprey R110 Pink talc

in blisters of 10 or 25 pieces. In the paper cartons 1, 2 or 5 packages.

Description pharmaceutical form:

Tablets, coated dark pink, embossed with a symbol on one side and a strip on the other sides and edges without any damage.

Pharmacokinetics:

Quickly and completely absorbed, Cmax in plasma observed after 1-2 hours after ingestion. Binding to plasma proteins - 20-30%, T1 / 2 -. 3.5-4 hours excreted by the kidneys - 70-80% as metabolites (sulfoxide) for 48 hours, the effect of Home -. 15-20 minutes, duration - 6-8 hours.

Description of the pharmacological actions:

Antipsychotics (antipsychotic) has antihistamine, antispasmodic, serotonin-blocker and mild alpha-adrenoceptor blocking action, as well as antiemetic, hypnotic, sedative and antitussive effect. Antipsychotic effect due to blockade of dopamine D2-receptor and Mesocortical mesolimbic system. Sedative effect due to blockade of adrenergic receptors of the brain stem reticular formation antiemetic action - blockade of D2-receptor trigger zone of the vomiting center hypothermic action - blockade of dopamine receptors of the hypothalamus. Start effect - in 15-20 min, duration - 6-8 hours.

It has a low antipsychotic activity, so in acute psychotic states is ineffective.

Due to the good tolerability is used in child, adolescent and geriatric practice.

Indications:

• neuroses and neurosis-like states and endogenous organic origin with a predominance senestopaticheskih, hypochondriac, phobic and psycho-vegetative disorders
  
• psychopathy with asthenic disorders and psihoastenicheskimi
  
• anxiety-depressive states in the framework of border and vascular diseases
  
• senestopaticheskie depression
  
• somatized mental disorders
  
• state of excitement and anxiety in somatic diseases
  
• sleep disorders of various origins
  
• allergic reactions (symptomatic treatment).
  

Contraindications:

• hypersensitivity
  
• angle-closure glaucoma
  
• prostatic hyperplasia
  
• severe liver and kidney disease
  
• parkinsonism
  
• myasthenia
  
• Reye's syndrome
  
• the simultaneous use of MAO inhibitors
  
• pregnancy
  
• breastfeeding
  
• Children under 7 years old.
  

Carefully:

• chronic alcoholism, if there are indications of a history of complications when using drugs phenothiazine series
  
• bladder neck obstruction
  
• predisposition to urinary retention
  
• epilepsy
  
• open-angle glaucoma
  
• jaundice
  
• suppression of bone marrow function
  
• hypotension.
  

Application of pregnancy and breastfeeding:

Contraindicated during pregnancy. At the time of treatment should stop breastfeeding.

Side effect:

The drug is generally well tolerated. Side effects are extremely rare and are expressed slightly.

From the nervous system: drowsiness, lethargy, fatigue, occurring mainly in the first days of admission and rarely require discontinuation of the drug paradoxical reactions (restlessness, agitation, "nightmarish" dream, irritability) rare - confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor) acceleration of sleep apnea, increased seizure activity (in children).

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

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

From the digestive system: dry mouth, atony of the gastrointestinal tract, constipation, decreased appetite.

The respiratory system: dry nose, throat, increase in the viscosity of bronchial secretions.

From the urinary system: atony bladder, urinary retention.

Other: allergic reactions, suppression of bone marrow hematopoiesis, increased sweating, muscle relaxation, photosensitivity.

Drug Interactions:

It enhances the effects of narcotic analgesics, hypnotics, anxiolytics (tranquilizers) and other antipsychotic (neuroleptics) medicines and drugs for general anesthesia, m-holinoblokatorov and antihypertensive drugs (dose adjustments).

It weakens the effect of amphetamine derivatives, m-holinostimulyatorov, ephedrine, guanethidine, levodopa, dopamine. When combined with ethanol and drugs that suppress the central nervous system - increased CNS depression, with antiepileptic drugs and barbiturates - decrease seizure threshold (dose adjustments).

Beta-blockers increase (each) alimemazin concentration in plasma (possibly marked reduction of blood pressure, arrhythmias).

It weakens the effect of bromocriptine and increases the concentration of prolactin in the blood serum.

Tricyclic antidepressants and anticholinergic drugs increase m-anticholinergic activity alimemazin.

MAO inhibitors (co-administration is not recommended), and other phenothiazine derivatives increase the risk of hypotension, and extrapyramidal disorders.

When concomitant administration with drugs alimemazin depressing bone marrow blood, increases the risk of myelosuppression.

Hepatotoxic drugs increase the expression of the drug hepatotoxicity.

Dosage and administration:

Inside. The daily dose is divided into 3-4 receptions.

Adults - 5-10 mg / day (sleeping pills) 60-80 mg / day (anxiolytic effect). When psychotic states - 0.2-0.4 g / day.

Babies with 7 years prescribed as follows (depending on age and body weight): 2.5-5 mg / day (sedative effect) 5-20 mg / day (as the symptomatic treatment of allergic reactions) 20-40 mg / day (anxiolysis). When psychotic states may increase the daily dose to 60 mg / day.

Overdose:

Symptoms: increased side effects, depression of consciousness.

Treatment: symptomatic.

Special instructions:

Prolonged treatment is necessary to systematically complete blood count, liver function evaluated.

May mask ototoxic effects (ringing in the ears and dizziness) jointly used drugs.

Increases need for riboflavin.

To prevent distortion of the results of skin prick tests on allergens is necessary to stop the drug for 72 hours prior to allergy testing.

During treatment possible false positive pregnancy test.

The treatment should not engage in activities that require high concentration. During treatment should not drink alcohol.