Composition, form of production and packaging
The tablets covered with a film cover of dark pink color, with the squeezed out symbol on one party and a strip on another.
1 tab.
alimamazine tartrate 5 mg
[PRING] lactose, silicon dioxide colloid, refined sugar (sucrose), wheat starch, tapioca starch (tapioca), talc, magnesium stearate.
The composition of the shell: hypromellose, macrogol 6000, titanium dioxide, dye, Osprey R110 pink, talc.
10 pieces. - packings of cellular contour (1) - packs cardboard.
10 pieces. - packings cellular planimetric (2) - packs cardboard.
10 pieces. - packings cellular planimetric (5) - packs cardboard.
25 pcs. - packings of cellular contour (1) - packs cardboard.
25 pcs. - packings cellular planimetric (2) - packs cardboard.
25 pcs. - packings cellular planimetric (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Antipsychotic drug (antipsychotic). Has antihistaminic, spasmolytic, serotonin blocking, moderate alpha-adrenoblocking, antiemetic, hypnotic, sedative and antitussive.
The antipsychotic effect is due to the blockade of dopamine D 2 receptors in the mesolimbic and mesocortical systems. Has a low antipsychotic activity, therefore, in acute psychotic conditions is ineffective.
Sedative action is due to blockade of adrenoreceptors of the reticular formation of the brain stem.
Antiemetic effect is due to blockade of dopamine D 2 receptors in the trigger zone of the vomiting center.
Hypothermic action is due to blockade of dopamine receptors of the hypothalamus.
Due to its good tolerability it is used in children's, adolescent and gerontological practice.
PHARMACOKINETICS
Suction
When ingested quickly and completely absorbed from the digestive tract. C max in plasma is observed after 1-2 h.
Distribution
Binding to plasma proteins is 20-30%.
Metabolism
A metabolite - sulfoxide is formed.
Excretion
It is excreted as a metabolite with urine (70-80%) for 48 hours. T 1/2 is 3.5-4 hours.
INDICATIONS
- neuroses and neurosis-like conditions of endogenous and organic genesis with predominance of the senestopathic, hypochondriacal, phobic and psycho vegetative disorders;
- psychopathy with asthenic and psychoasthenic disorders;
- anxiety-depressive states in the framework of borderline endogenous and vascular diseases;
- Severostatic depression;
- somatized mental disorders;
- state of anxiety and anxiety in somatic diseases;
- sleep disturbances of different genesis;
- Allergic reactions (symptomatic treatment).
DOSING MODE
The drug should be taken orally, distributing the daily dose for 3-4 doses.
The beginning of the drug - in 15-20 minutes, the duration of the action - 6-8 hours.
Adults to achieve a hypnotic effect of 5-10 mg / day; to achieve an anxiolytic effect of 60-80 mg / day. At psychotic conditions - 200-400 mg / sut.
Children from 7 years (depending on age and body weight) to achieve a hypnotic effect of 2.5-5 mg / day; as a symptomatic treatment of allergic reactions at 5-20 mg / day; to achieve an anxiolytic effect of 20-40 mg / day; in psychotic states, an increase in the daily dose of the drug to 60 mg / day is possible.
SIDE EFFECT
From the side of the central nervous system and the peripheral nervous system: drowsiness, lethargy, fast fatigue (arise mainly during the first days of admission and rarely require drug withdrawal), a paradoxical reaction (anxiety, agitation, nightmares, irritability); rarely - confusion, extrapyramidal disorders (hypokinesia, akathisia, tremor); more frequent sleep apnea, increased convulsive activity (in children).
From the sense organs: blurred vision (paresis of accommodation), noise or ringing in the ears.
From the cardiovascular system: dizziness, lowering blood pressure, tachycardia.
From the digestive system: dry mouth, atony GASTROINTESTINAL TRACT, constipation, loss of appetite.
On the part of the respiratory system: dryness in the nose, pharynx, increase in the viscosity of bronchial secretions.
From the urinary system: atony of the bladder, urine retention.
Other: allergic reactions, oppression of bone marrow hematopoiesis, increased sweating, muscle relaxation, photosensitivity.
Usually the drug is tolerated well by patients. Side effects are rare and are negligible.
CONTRAINDICATIONS
- an angle-closure glaucoma;
- hyperplasia of the prostate;
- severe liver disease;
- severe kidney disease;
- Parkinsonism;
- Myasthenia gravis;
- Reye's syndrome;
- simultaneous use of MAO inhibitors;
- Pregnancy;
- the period of breastfeeding;
- children's age till 7 years;
- Hypersensitivity to the components of the drug.
Caution should be applied to the drug in chronic alcoholism, if there is a history of complications with phenothiazine drugs, with obstruction of the bladder neck, predisposition to urinary retention, epilepsy, open-angle glaucoma, jaundice, bone marrow depression, arterial hypotension.
PREGNANCY AND LACTATION
Contraindicated use of the drug during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug in severe kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated use of the drug in severe liver disease. With prolonged treatment should be systematically evaluated liver function.
APPLICATION FOR CHILDREN
Contraindicated in children under 7 years.
SPECIAL INSTRUCTIONS
With long-term treatment should be systematically to conduct a general blood test, evaluate liver function.
Alimamazine can mask the ototoxic effect (tinnitus, dizziness) of medications used together.
To prevent distortion of the results of skin scarification tests for allergens, the drug should be discontinued 72 hours before allergy testing.
During the treatment period, false positive results of a pregnancy test are possible.
During the treatment should not drink alcohol.
Impact on the ability to drive vehicles and manage mechanisms
Against the background of drug treatment should not engage in activities that require increased concentration.
OVERDOSE
Symptoms: depression of consciousness, increased side reactions.
Treatment: symptomatic.
DRUG INTERACTION
Alimamazin increases the effect of opioid analgesics, hypnotics, anxiolytic (tranquilizers) and antipsychotic (antipsychotics) drugs, as well as medicines for general anesthesia, m-holinoblokatorov and hypotensive drugs. Alimazine dose should be adjusted with simultaneous use with the above medicines.
With the simultaneous use of alimamazine with derivatives of amphetamine, m-cholinomimetics, ephedrine, guanethidine, levodopa, dopamine, the effect of the latter is weakened.
With simultaneous use of alimamazine with ethanol and CNS suppressing drugs, CNS depression is observed.
With the simultaneous use of alimamazine with antiepileptic drugs and barbiturates, the threshold of convulsive readiness decreases (a dose adjustment is required).
With the simultaneous use of alimamazine with beta-adrenoblockers, the concentration of the latter in the plasma increases (possibly a marked decrease in blood pressure, arrhythmias).
With the simultaneous use of alimamazine with bromocriptine, the effect of the latter decreases and the concentration of prolactin in the blood serum increases.
With the simultaneous use of alimamazine with tricyclic antidepressants and anticholinergic drugs, the m-cholinoblocking activity of alimamazine increases.
With simultaneous use of alimamazine with MAO inhibitors and phenothiazine derivatives, the risk of arterial hypertension and extrapyramidal disorders increases (simultaneous use is not recommended).
With the simultaneous use of alimamazine with drugs that inhibit bone marrow hematopoiesis, the risk of myelosuppression increases.
With the simultaneous use of alimamazine with hepatotoxic drugs, manifestations of hepatotoxicity of the drug are intensified.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 3 years.
