Moditen depot, 25 mg/ml 1 ml 5 pcs

A long-acting antipsychotic (neuroleptic); has a mild antiemetic effect. It relieves anxiety and irritability, hallucinations and delirium. Antipsychotic action is caused by blockade of dopamine D2-receptors of mesolimbic and mesocortical systems.

The sedative action (moderate in pronounced and observed when using in high doses) is caused by the blockade of adrenoreceptors of reticular formation of brain stem; antiemetic action – by the blockade of dopamine D2-receptors of trigger zone of vomiting center; hypothermic action – by the blockade of dopamine receptors of hypothalamus.

In contrast to other phenothiazine derivatives, it is characterized by greater activity (by neuroleptic activity it is 25 times superior to chlorpromazine) and less pronounced ability to cause extrapyramidal and somatic disorders.

It is especially effective in malignant nuclear (hebephrenic, catatonic, early paranoid form) and long-lasting schizophrenia. In the form of decanoate (solution in oil) it has a long-lasting effect (release of the drug is gradual) – the effect lasts up to 1-2 weeks or more (depending on the dose).

Indications

Schizophrenia, Mental Disorders

Various forms of schizophrenia and paranoia.

Active ingredient

Fluphenazine

Composition

1 ml of the solution contains

the active ingredient:

fluphenazine decanoate – 25 mg,

excipients:

benzyl alcohol and sesame oil.

How to take, the dosage

Internal administration of 1-5 mg of Moditen-depo 2 times a day. If necessary, the daily dose can be increased up to 20 mg.

Intramuscularly (deeply) administered in a dose of 12.5-25 mg every 2-4 weeks. It is possible to increase the single dose to 50 mg, in some cases to 100 mg.

Interaction

It weakens the vasoconstrictor effect of ephedrine. Reduces the effectiveness of antiepileptic drugs. Reduces the antiparkinsonian effect of levodopa (due to induced blockade of dopamine receptors), as well as the effects of amphetamines, clonidine and guanethidine. It enhances anticholinergic effects of other drugs. Drugs, while its own antipsychotic effect may be reduced.

It may mask some ototoxicity manifestations (tinnitus, dizziness) of ototoxic drugs, especially antibiotics. It should not be combined with combined drugs containing reserpine. Prolonged combination with analgesics and antipyretics is undesirable (possible development of hyperthermia).

When used concomitantly with other drugs with CNS depressant effect (drugs for general anesthesia, narcotic analgesics, ethanol and drugs containing it, barbiturates, anxiolytics (tranquilizers), etc.), the depressant effect may be increased, as well as respiratory depression.

The use together with tricyclic antidepressants, maprotiline or MAO inhibitors increases the risk of neuroleptic malignant syndrome; with the drugs for thyrotoxicosis treatment increases the risk of agranulocytosis; with other drugs that cause extrapyramidal reactions, increases the frequency and severity of extrapyramidal disorders; with hypotensive drugs increases the severity of orthostatic BP decrease. Antacids, antiparkinsonics, Li+ drugs may interfere with absorption. Other hepatotoxic drugs – risk of hepatotoxicity.

Injection of epinephrine should be avoided during treatment (because of the possibility of perversion of the effect of epinephrine and further decrease in BP).

Special Instructions

Moditen-depo is administered with caution in liver diseases, heart rhythm disorders, increased thyroid function, epilepsy, Parkinson’s disease, closed-angle glaucoma, as well as in patients who work in conditions of high temperature and elderly patients.

At the time of treatment it is necessary to refrain from potentially dangerous activities requiring increased attention, rapid mental and motor reactions. The drug Moditen-depo increases the inhibitory effect of various drugs and alcohol.

Contraindications

• severe hepatic and renal dysfunction,
• severe heart failure,
• blood disorder,
• adenoma of the prostate,
• serious depression,

high sensitivity to Moditen-depressants.

• adenoma of the prostate,
• severe depression,
• high sensitivity to the drug Moditen-depo.

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Side effects

• fatigue, dizziness,
• intellectual dysfunction, seizure reactions,
• menstrual cycle disorders,
• blood pattern disorders,
• liver function disorders.

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Overdose

Expronounced extrapyramidal disorders, hypotension, excessive sedation, depression of consciousness up to coma with areflexia. In such cases, the drug should be withdrawn and supportive symptomatic treatment should be initiated.

In case of development of severe hypotension, immediate intravenous administration of vasopressors is necessary. Epinephrine (adrenaline) should not be used, since a perverse reaction (even a greater decrease in blood pressure) is noted against phenothiazines.

If pronounced extrapyramidal disorders develop, antiparkinsonian drugs are prescribed for several weeks. Antiparkinsonian drugs should be withdrawn gradually to avoid a relapse of extrapyramidal disorders. Hemodialysis, peritoneal dialysis, exchange transfusions and forced diuresis in Moditen^® Depot poisoning are ineffective.