Moditen Depot
Moditen Depot: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Moditen depo
ATX code: N05AB02
Active ingredient: fluphenazine (Fluphenazine)
Manufacturer: KRKA d.d. (KRKA, dd) (Slovenia)
Description and photo update: 01.10.2019
Prices in pharmacies: from 359 rubles.
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Moditen Depo is a polyvalent antipsychotic with a long-term pronounced antipsychotic and moderate sedative effect, has an antiemetic effect.
Release form and composition
Dosage form - oily solution for intramuscular (i / m) administration: transparent liquid of oily structure, light yellow color, there may be a faint smell of benzyl alcohol (1 ml each in dark glass ampoules, 5 ampoules in a blister strip, in a cardboard box 1 package).
The active substance of Moditen Depot is fluphenazine decanoate, in 1 ml - 25 mg.
Auxiliary components: sesame oil, benzyl alcohol.
Pharmacological properties
Pharmacodynamics
Moditen Depot is a long-acting antipsychotic agent (neuroleptic). The active substance of the drug, fluphenazine, belongs to the group of polyvalent antipsychotics.
The main effects of the drug:
- Moderate sedative effect (noted when used in high doses); develops as a result of blockade of adrenergic receptors of the reticular formation of the brain stem;
- Pronounced antipsychotic effect, which is combined with some activating effect; this property of fluphenazine is due to the blockade of dopamine D2 receptors of the mesocortical and mesolimbic systems;
- Antiemetic action; based on blockade of dopamine D2 receptors in the trigger zone of the vomiting center;
- Hypothermal action; due to blockade of dopamine receptors in the hypothalamus.
Pharmacokinetics
Fluphenazine is metabolized in full, mainly in the liver, excreted in the bile and urine.
The activity of metabolites of the substance has not been studied. The level of binding of fluphenazine to blood plasma proteins is more than 90%. The substance in the form of an ester of a high molecular weight fatty acid and an oil solution is absorbed slowly, accumulation occurs in fat depots, and the release also occurs gradually.
The maximum concentration after intramuscular administration is reached in about 24 hours. The action of Moditen Depot usually manifests itself 24–72 hours after injection, the greatest severity of the antipsychotic effect is observed within 48 to 96 hours after injection.
The half-life of a substance from blood plasma ranges from 7 to 10 days. Fluphenazine crosses the blood-brain and placental barriers. Hemodialysis is not removed from the body.
Indications for use
- Long-term maintenance therapy for various forms of schizophrenia;
- Prevention of exacerbations of schizophrenia.
Contraindications
- Arterial hypotension, decompensated chronic circulatory failure and other severe forms of cardiovascular pathologies;
- Disorders of the blood system;
- Functional liver disorder;
- Pronounced suppression of the function of the central nervous system;
- Coma of any etiology;
- Progressive systemic diseases and injuries of the brain and spinal cord;
- Pregnancy and lactation period;
- Age under 12;
- Individual intolerance to the components of the drug.
According to the instructions, Moditen Depot should be prescribed with caution to patients with pathological (caused by impaired hematopoiesis) blood changes, angle-closure glaucoma, breast cancer, clinical manifestations of prostatic hyperplasia, hepatic and / or renal failure, a history of seizures, in diseases with an increased risk thromboembolic complications, Parkinson's disease (due to increased extrapyramidal effects), exacerbation of gastric ulcer and duodenal ulcer, epilepsy, myxedema, chronic pathologies with respiratory failure (especially in children), with Reye's syndrome (the risk of hepatotoxicity in adolescents increases), vomiting, cachexia, alcoholism, in old age.
Instructions for the use of Moditen Depot: method and dosage
Moditen Depot injections are injected deeply intramuscularly.
The drug is intended for a course of treatment with a course duration of 3 months or more.
The selection of the initial dose for patients who first received the appointment of a drug from the group of phenothiazines should be performed by the administration of fluphenazine hydrochloride (a fast-acting neuroleptic).
For most patients, the starting dose of fluphenazine decanoate is 12.5-25 mg, or 0.5-1 ml of solution. Depending on the therapeutic effect and tolerability of the drug, the next dose and the period between injections are determined.
One maintenance dose of Moditen Depot usually controls the symptoms of schizophrenia for 4 weeks, in some patients its effect lasts up to 6 weeks.
The maintenance dose should not exceed 100 mg.
When prescribing a dose of more than 50 mg of the drug, the increase should be increased carefully, gradually increasing by 12.5 mg each subsequent injection.
Treatment of patients with severe arousal should begin with the introduction of fast-acting fluphenazine (fluphenazine hydrochloride). After removing the acute manifestations of the disease, 25 mg (1 ml) of Moditen Depot are administered, subsequent doses should be adjusted individually.
At an increased risk of complications in patients with hypersensitivity to phenothiazines or disorders that predispose to adverse reactions, treatment should be initiated with fluphenazine hydrochloride, taken orally or by i / m administration. Only after establishing the optimal dose on the basis of an objective assessment of the effectiveness of previous therapy, the patient can be administered fluphenazine decanoate. Further, dose adjustment should be carried out taking into account the response to treatment.
When treating children over 12 years of age, it is recommended to administer 6.25-18.75 mg of Moditen Depot intramuscularly per week. Based on clinical indications, with satisfactory tolerance, a single dose can be increased to 12.5-25 mg and administered every 1-3 weeks. There is no single scheme for switching to the administration of a solution of fluphenazine decanoate from fast-acting fluphenazine. With this transition, one should be guided by the fact that the dose of fluphenazine hydrochloride 20 mg per day is equivalent to the introduction of 25 mg of fluphenazine decanoate 1 time in 3 weeks.
Treatment of elderly patients is recommended to begin with the appointment of 1 / 4-1 / 3 of the usual dose of Moditen Depot, then the dose can be gradually increased with careful monitoring of the patient's response to treatment.
Side effects
- Cardiovascular system: ventricular arrhythmias, ventricular tachycardia, ventricular fibrillation, prolongation of the QT interval, cardiac arrest, sudden death;
- Central nervous system: extrapyramidal disorders, including extrapyramidal syndrome, dyskinesia, akathisia, dystopia, oculogyric crises, hyperreflexia and opisthotonus, tardive dyskinesia (involuntary choreoathetoid movements of the muscles of the trunk, limbs, muscles of the face, tongue or mouth, in the form of the jaw protruding tongue, stretching lips, chewing movements);
- Autonomic nervous system: dry mouth, fluctuations in blood pressure, orthostatic hypotension, loss of appetite, nausea, salivation, sweating, polyuria, headache, constipation (usually, after a dose reduction or withdrawal of Moditen Depot, go away on their own), hypotension; possibly - nasal congestion, glaucoma, blurred vision, tachycardia, intestinal obstruction, atony of the bladder;
- Other neurological effects: neuroleptic malignant syndrome (NMS) with a risk of death (muscle stiffness, hyperpyrexia, mental disorders, autonomic disorders - increased sweating, tachycardia, fluctuations in blood pressure (BP) and pulse, heart rhythm disturbances), against the background of NMS, development of acute heart failure, leukemia, fever, liver dysfunctions, increased creatine phosphokinase activity; possibly - confusion, drowsiness, changes in the encephalogram, cerebral edema, violation of the level of protein in the cerebrospinal fluid;
- Liver function: cholestatic jaundice (more often at the beginning of therapy), laboratory changes in liver function parameters, clinical symptoms of hepatitis;
- Endocrine and metabolic disorders: changes in body weight, hyponatremia, peripheral edema, antidiuretic hormone secretion disorder syndrome, gynecomastia, pathological lactation, false positive pregnancy test, menstrual irregularities, in women - changes in libido, in men - impotence;
- Blood system: agranulocytosis, thrombocytopenic purpura, leukopenia, non-thrombocytopenic purpura, pancytopenia, eosinophilia;
- Allergic reactions: erythema, pruritus, urticaria, photosensitivity, seborrhea, exfoliative dermatitis, eczema, bronchospasm, laryngeal edema, anaphylactic reactions, angioedema;
- Others: convulsive seizures; against the background of prolonged use - vomiting, fever, lupus-like syndrome, changes in electrocardiography (ECG), skin pigmentation, impaired renal function, the development of angle-closure glaucoma, lens and corneal opacities, irreversible dyskinesia, pigmentary retinopathy, venous thromboembolism (including thromboembolism) arteries), an asymptomatic form of pneumonia.
Overdose
The main symptoms: excessive sedation, hypotension, severe extrapyramidal disorders, depression of consciousness up to coma with areflexia.
Therapy: cancellation of Moditen Depot. If necessary, supportive symptomatic treatment is indicated:
- Severe hypotension: immediate intravenous administration of vasopressors. Epinephrine (adrenaline) should not be used, since a perverse reaction may occur against the background of phenothiazines (expressed in an even greater decrease in blood pressure);
- Severe extrapyramidal disorders: antiparkinsonian drugs for several weeks. Their cancellation is carried out gradually, which makes it possible to exclude the recurrence of extrapyramidal disorders.
Peritoneal dialysis, hemodialysis, forced diuresis, and exchange transfusions are ineffective.
special instructions
Due to the possible cross-sensitivity, Moditen Depot should be prescribed with caution in cholestatic jaundice, dermatitis and other allergic reactions to phenothiazine derivatives.
The use of Moditen Depot in breast cancer can cause the progression of the disease and a decrease in sensitivity to endocrine and cytostatic drugs, since fluphenazine promotes the induction of prolactin secretion.
The antiemetic effect may mask the clinical picture of vomiting associated with overdose of other drugs.
The predisposition to hepatotoxic reactions increases against the background of alcoholism; alcohol consumption during the treatment period is contraindicated.
Patients taking high doses of Moditen Depot may experience a severe hypotensive reaction during surgery. To stabilize the patient's condition, it is necessary to resort to reducing the dose of anesthetics or antipsychotics.
Since fluphenazine has an anticholinergic effect, in some cases it can potentiate the action 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 patients with a history of seizures.
Influence on the ability to drive vehicles and complex mechanisms
During the period of application of Moditen Depot, patients are prohibited from driving vehicles and mechanisms.
Application during pregnancy and lactation
Moditen Depot injections are contraindicated during pregnancy / lactation.
Pediatric use
Therapy with Moditen Depot is contraindicated for patients under 12 years of age.
With impaired renal function
Patients with renal insufficiency should use Moditen Depot under medical supervision.
For violations of liver function
- Liver dysfunction: therapy is contraindicated;
- Liver failure: Moditen Depot should be used under medical supervision.
Use in the elderly
Moditen Depot therapy in elderly patients should be carried out with caution.
Drug interactions
With the simultaneous use of Moditen Depot:
- Sleeping pills, sedatives, alcohol, strong analgesics - enhance their effect;
- Narcotic analgesics - contribute to the suppression of the function of the central nervous system, respiration, can have a strong hypotensive effect;
- Lithium preparations - increase neurotoxicity;
- Thiazide diuretics, angiotensin-converting enzyme inhibitors - can enhance the hypotensive effect;
- Clonidine - reduces the antipsychotic effect of phenothiazines;
- Beta-blockers - can increase the level of concentration in blood plasma, its own and derivatives of phenothiazine, therefore, when prescribing this combination, it is recommended to reduce the dose of each drug;
- Antacids and antidiarrheals - can cause impaired absorption of fluphenazine;
- Metrizamide - convulsive seizures may appear (during myelography, it is recommended to cancel the use of Moditen Depot 48 hours before and resume 24 hours after the procedure);
- Adrenomimetics, including epinephrine - being a pharmacological antagonist of phenothiazine, can contribute to the development of severe hypotension;
- Levodopa, anticonvulsants - reduce their therapeutic effect;
- Hypoglycemic agents - reduce their effect;
- M-anticholinergics - can enhance the blocking of cholinergic receptors (especially in elderly patients) and potentiate or prolong the m-anticholinergic effects;
- Cimetidine - helps to reduce the level of fluphenazine decanoate in blood plasma;
- Anorexigenic drugs and amphetamines - pharmacological antagonists of Moditen Depot;
- Guanethidine, clonidine and other antiadrenergic drugs - their antihypertensive effect decreases;
- Inhibitors or substrates of the CYP2D6 isoenzyme - by promoting an increase in plasma concentration and the effect of fluphenazine, they can increase the risk of cardiotoxicity, orthostatic hypotension, and the development of adverse reactions caused by the m-cholinergic blocking action of Moditen Depot.
Moditen Depot disrupts the metabolism of tricyclic antidepressants, causes an increase in serum concentrations of phenothiazines and tricyclic antidepressants. This can lead to prolongation or enhancement of the sedative, m-anticholinergic effect and arrhythmogenic effect of tricyclic antidepressants.
Analogs
The analogs of Moditen Depot are: Mirenil, Prolinat, Fluphenazine.
Terms and conditions of storage
Keep out of the reach of children.
Store in a dark place at 15-25 ° C. Do not put the drug in the refrigerator.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Moditene Depot
The reviews about Moditen Depot are mostly positive. It is noted that the drug has better tolerance in comparison with analogues. The developing side effects either go away on their own, or are stopped with the help of drugs.
Price for Moditen Depot in pharmacies
The approximate price for Moditen Depot (oil solution for intramuscular injection of 25 mg / ml) for 5 ampoules in a package is 365–400 rubles.
Moditen Depot: prices in online pharmacies
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Drug name Price Pharmacy |
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Moditen depot 25 mg / ml solution for intramuscular administration (oil) 1 ml 5 pcs. 359 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
