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

Various forms of schizophrenia and paranoia.

Pharmacological effect

Long-acting antipsychotic (neuroleptic); has a weak antiemetic effect. Eliminates anxiety and irritability, hallucinations and delusions. The antipsychotic effect is due to the blockade of dopamine D2 receptors in the mesolimbic and mesocortical systems.

The sedative effect (moderately expressed and observed when used in high doses) is due to the blockade of adrenergic receptors in the reticular formation of the brain stem; antiemetic effect – blockade of dopamine D2 receptors in the trigger zone of the vomiting center; hypothermic effect – blockade of dopamine receptors of the hypothalamus.

Unlike other phenothiazine derivatives, it is characterized by greater activity (25 times greater than chlorpromazine in neuroleptic activity) and a less pronounced ability to cause extrapyramidal and somatic disorders.

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

Special instructions

Moditene Depot is prescribed with caution for liver diseases, heart rhythm disorders, increased thyroid function, epilepsy, Parkinson’s disease, angle-closure glaucoma, as well as for patients working in conditions of high temperature and elderly patients.

During the treatment period, it is necessary to refrain from potentially dangerous activities that require increased attention and rapid mental and motor reactions. The drug Moditen-depot enhances the inhibitory effect of various medications and alcohol.

Active ingredient

Fluphenazine

Composition

1 ml of solution contains

active substance:

fluphenazine decanoate – 25 mg,

excipients:

benzyl alcohol and sesame oil.

Contraindications

severe dysfunction of the liver and kidneys,
severe heart failure,
blood diseases,
prostate adenoma,
severe depression,
hypersensitivity to the drug Moditen-depot.

Side Effects

fatigue, dizziness,
impairment of intellectual functions, convulsive reactions,
dry mouth, constipation, nausea, heart rhythm disturbances,
menstrual irregularities,
blood picture abnormalities,
liver dysfunction.

Interaction

Weakens the vasoconstrictor effect of ephedrine. Reduces the effectiveness of antiepileptic drugs. Reduces the antiparkinsonian effect of levodopa (due to the blockade of dopamine receptors), as well as the effects of amphetamines, clonidine and guanethidine. Strengthens the anticholinergic effects of other drugs, while its own antipsychotic effect may decrease.

May mask some manifestations of ototoxicity (tinnitus, dizziness) of ototoxic drugs, especially antibiotics. It should not be combined with combination drugs that contain reserpine. Long-term combination with analgesics and antipyretics is undesirable (possible development of hyperthermia).

When used simultaneously with other drugs that have a depressant effect on the central nervous system (drugs for general anesthesia, narcotic analgesics, ethanol and drugs containing it, barbiturates, anxiolytic drugs (tranquilizers), etc.), an increase in the depressive effect, as well as respiratory depression, is possible.

Prescription together with tricyclic antidepressants, maprotiline or MAO inhibitors increases the risk of developing neuroleptic malignant syndrome; with drugs for the treatment of thyrotoxicosis increases the risk of developing agranulocytosis; with other drugs that cause extrapyramidal reactions, increases the frequency and severity of extrapyramidal disorders; with antihypertensive drugs increases the severity of orthostatic decrease in blood pressure. Antacids, antiparkinsonian drugs, Li+ drugs can interfere with absorption. Dr. hepatotoxic drugs – the risk of developing hepatotoxicity.

During treatment, the administration of epinephrine should be avoided (due to the possibility of distorting the effect of epinephrine and further reducing blood pressure).

Overdose

Severe extrapyramidal disorders, hypotension, excessive sedation, depression of consciousness up to coma with areflexia. In such cases, it is necessary to discontinue the medication and begin supportive symptomatic treatment.

If severe hypotension develops, immediate intravenous administration of vasopressors is necessary. Epinephrine (adrenaline) should not be used, since a perverted reaction is observed against the background of phenothiazines (an even greater decrease in blood pressure).

With the development of severe extrapyramidal disorders, antiparkinsonian drugs are prescribed for several weeks. Antiparkinsonian drugs should be withdrawn gradually to avoid relapse of extrapyramidal disorders. Hemodialysis, peritoneal dialysis, exchange transfusions and forced diuresis in case of poisoning with Moditen® Depot are ineffective.

Storage conditions

Store at a temperature of 15-30 ° C in a place protected from light. Do not store the drug in the refrigerator, as this will lead to precipitation of triglycerides included in sesame oil. If sediment appears, the drug should be heated to 37 °, at

Shelf life

2 years.

Manufacturer

KRKA dd Novo Mesto, Slovenia