Instructions for use of the drug Moditen depot ampoule 1 pc.

Pharmacology

What medicinal properties are inherent in the drug "Moditen Depot"? Instructions for use, reviews claim that this is a long-acting antipsychotic medicine. It belongs to the group of polyvalent neuroleptics and exhibits pronounced antipsychotic properties, which are combined with some activating and antiemetic effects. This drug also has a moderate sedative effect.

What determines the effectiveness of the drug "Moditen Depot"? The instructions for use state that its antipsychotic effect is associated with the blockade of dopamine D2 receptors in the mesocortical and mesolimbic systems.

The sedative properties of this medication are moderate and are observed only when using high dosages of the solution. They are caused by blockade of adrenergic receptors in certain areas of the brain stem.

As for the antiemetic effect of this medicine, it is associated with the blockade of dopamine D2 receptors in the trigger zones of the vomiting center. It should also be noted that this drug exhibits a hypothermic effect due to the blockade of dopamine receptors in the hypothalamus.

How long does it take for Moditen Depot to start working? Instructions for use (a photo of the injection solution is presented in this article) states that the therapeutic effect of this medicine usually appears 25-72 hours after the injection. It should also be noted that the antipsychotic properties of the drug in question are most pronounced in the period from 49 to 97 hours after administration of the solution.

General information about the drug

This is a parenteral phenothiazine drug of prolonged action, which, in fact, differs from the usual Moditen. It is presented on the pharmaceutical market in the form of an injection solution. The liquid in the ampoules is transparent with a slight yellowish tint and a barely noticeable odor of phenylmethanol (benzyl alcohol), and has an oily consistency. The drug is administered with a syringe deep intramuscularly.

Drug group, INN and scope of application

This medication is a representative of the group of classical antipsychotics (drugs that act on the central nervous system). INN – Fluphenazine.

The drug based on fluphenazine decanoate is a powerful antipsychotic agent. Has a sedative and hypotensive effect. It is used as long-term maintenance therapy for chronic forms of schizophrenia, as well as during exacerbation of the disease.

Forms of release of the drug Moditen Depot

Each blister of this medicine contains 5 ampoules of 1 ml of solution. On the domestic market, the product is presented from different manufacturers, which is why the price of Moditen Depot may differ slightly.

Drug kinetics

What pharmacokinetics are characteristic of the drug "Moditen Depot"? The instructions for use state that fluphenazine in the form of a high-molecular ester, oil solution and fatty acid is able to accumulate in fat depots and is also slowly released.

After intramuscular injection, the maximum concentration of this element in plasma is reached after 25 hours. In this case, fluphenazine binds to blood proteins by 90%.

The drug in question easily penetrates the placental barrier and passes through the blood-brain barrier, and is also not excreted from the body through hemodialysis.

Fluphenazine is completely and actively metabolized in the liver with the participation of enzymes of the cytochrome P450 system. It is excreted from the body along with bile and urine. The activity of the metabolites of this element has not been fully studied.

The half-life of fluphenazine is 7-10 days.

Drug interactions

With simultaneous use of Moditen Depot:

• Sleeping pills, sedatives, alcohol, strong analgesics - increase their effect;
• Narcotic analgesics – contribute to inhibition of the function of the central nervous system, respiration, and can have a strong hypotensive effect;
• Lithium preparations – increase neurotoxicity;
• Thiazide diuretics, angiotensin-converting enzyme inhibitors - may enhance the hypotensive effect;
• Clonidine – reduces the antipsychotic effect of phenothiazines;
• Beta-blockers - can increase the level of concentration in the blood plasma of themselves and phenothiazine derivatives, therefore, when prescribing this combination, it is recommended to reduce the dose of each drug;
• Antacid and antidiarrheal drugs - may cause disruption of fluphenazine absorption;
• Metrizamide – possible occurrence of convulsive seizures (when performing myelography, the use of Moditen Depot is recommended to be discontinued 48 hours before and resumed 24 hours after the procedure);
• Adrenomimetics, including epinephrine - being a pharmacological antagonist of phenothiazines, can contribute to the development of severe hypotension;
• Levodopa, anticonvulsants – reduce their therapeutic effect;
• Hypoglycemic agents – reduce their effect;
• M-anticholinergic blockers - can enhance the blocking of cholinergic receptors (especially in elderly patients) and potentiate or prolong the m-anticholinergic effects;
• Cimetidine – helps reduce the level of fluphenazine decanoate in the blood plasma;
• Anorexigenic drugs and amphetamines are pharmacological antagonists of Moditen Depot;
• Guanethidine, clonidine and other antiadrenergic drugs – their antihypertensive effect is reduced;
• Inhibitors or substrates of the CYP2D6 isoenzyme - by increasing the plasma concentration and effect of fluphenazine, may increase the risk of cardiotoxicity, orthostatic hypotension, and the development of adverse reactions caused by the m-anticholinergic effect of Moditen Depot.

Moditen Depot disrupts the metabolism of tricyclic antidepressants and causes an increase in the serum concentrations of both phenothiazines and tricyclic antidepressants. This can lead to prolongation or intensification of the sedative, m-anticholinergic effect and arrhythmogenic effect of tricyclic antidepressants.

Prohibitions on use

The medication in question must not be used in the following cases:

• in severe cardiovascular diseases, including decompensated chronic circulatory failure and arterial hypotension;
• if the patient is hypersensitive to fluphenazine, as well as to other elements of the drug;
• with depressed central nervous system function and comatose states;
• during pregnancy;
• with skull trauma, as well as progressive systemic diseases of the spinal cord and brain;
• during feeding period;
• with impaired functioning of the liver and blood system;
• up to 12 years old.

Careful use of medication

With caution, the drug "Moditen Depot" is prescribed for:

• alcoholism, as well as with an increased predisposition to hepatotoxic reactions;
• pathological changes in the blood, as well as hematopoiesis disorders;
• allergies to phenothiazine derivatives, including a history;
• angle-closure glaucoma;
• breast cancer;
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• liver and/or kidney failure;
• ulcers of the digestive tract, including during exacerbation of the disease;
• prostatic hyperplasia with clinical manifestations;
• myxedema;
• ailments accompanied by thromboembolic complications;
• Parkinson's disease;
• chronic diseases with breathing problems (including in children);
• Reye's syndrome;
• epilepsy, vomiting, seizures;
• cachexia;
• in old age.

special instructions

Due to possible cross-sensitivity, Moditen Depot should be prescribed with caution for cholestatic jaundice, dermatitis and other allergic reactions to phenothiazine derivatives.

The use of Moditen Depot for breast cancer can cause disease progression and decreased sensitivity to endocrine and cytostatic drugs, since fluphenazine helps induce prolactin secretion.

The antiemetic effect may mask the clinical picture of vomiting associated with overdose of other drugs.

Predisposition to hepatotoxic reactions increases against the background of alcoholism; alcohol consumption during treatment is contraindicated.

Patients taking high doses of Moditen Depot may experience a strong hypotensive reaction during surgery. To stabilize the patient's condition, it is necessary to reduce the dose of anesthetics or neuroleptics.

Since fluphenazine has an anticholinergic effect, in some cases it may potentiate the effect of anticholinergics.

It is recommended to prescribe Moditen Depot with caution during hot weather, in case of poisoning with phosphorus insecticides, mitral valve insufficiency and other disorders of the cardiovascular system, pheochromocytoma, and in patients with a history of convulsive seizures.

Impact on the ability to drive vehicles and complex mechanisms

During the period of use of Moditen Depot, patients are prohibited from driving vehicles and machinery.

Medicinal solution "Moditen Depot": instructions for use

In ampoules, this drug is intended for long courses of therapy (at least three months). Its initial dosage for most patients is 12.5-25 mg. Subsequent doses, as well as the interval between injections of the solution, are determined depending on the therapeutic effect.

Treatment of patients with hypersensitivity to phenothiazine should be initiated with extreme caution.

Elderly people require lower doses than younger patients (approximately 1/4 to 1/3 of the dosage). At the same time, they require constant monitoring.

Side effects

Moditen Depot medicinal solution may cause the following undesirable reactions:

• extrapyramidal syndrome, akathisia, tardive dyskinesia, dystopia, oculogyric crises, hyperreflexia, opisthotonus;

• neuroleptic malignant syndrome with possible death;
• orthostatic hypotension, sweating, blood pressure fluctuations, nausea, hypotension, loss of appetite, glaucoma, salivation, bladder atony, polyuria, intestinal obstruction, dry mouth, tachycardia, headache, blurred vision, constipation, nasal congestion;
• ventricular arrhythmia, sudden death, ventricular tachycardia, cardiac arrest;
• pathological lactation, peripheral edema, menstrual irregularities, hyponatremia, impotence in men, changes in body weight, changes in libido in women;
• itching, exfoliative dermatitis, erythema, seborrhea, urticaria, anaphylactic reactions, photosensitivity, angioedema, bronchospasm, laryngeal edema;
• agranulocytosis, leukopenia, cholestatic jaundice;
• seizures, fever, ECG changes, irreversible dyskinesia, vomiting, venous thromboembolism, lupus-like syndrome and others.

Patient reviews

Now you know why Moditen Depot injections are given. Instructions for use, side effects and contraindications for the use of this solution were also discussed above.

According to patients who have previously taken various antipsychotics, the drug “Moditen Depot” acts much more effectively and relieves all the negative symptoms of schizophrenia. The administration of this medicine causes a stable and rather long-term remission.

The only disadvantage of this remedy is the huge number of side reactions. In the first days of therapy, some people experienced hyperthermia, hypertension and autonomic disorders. Also, many patients observed hyperkinesis of the muscles of the mouth and face, smacking movements of the tongue and lips. In addition, the use of this drug often caused depression of varying severity.

Overdose

Main symptoms: excessive sedation, hypotension, severe extrapyramidal disorders, depression of consciousness up to coma with areflexia.

Therapy: discontinuation of Moditene Depot. If necessary, supportive symptomatic treatment is indicated:

• Severe hypotension: immediate intravenous vasopressor administration. Epinephrine (adrenaline) should not be used, since a perverted reaction may be observed in the presence of phenothiazines (expressed in an even greater decrease in blood pressure);
• Severe extrapyramidal disorders: antiparkinsonian drugs for several weeks. Their abolition is carried out gradually, which eliminates the recurrence of extrapyramidal disorders.

Peritoneal dialysis, hemodialysis, forced diuresis and exchange transfusions are ineffective.