Moditen Depot is a neuroleptic used for maintenance treatment and prevention of exacerbation of schizophrenia.
Release form and composition
Moditen depot is produced in the form of an oily solution for intramuscular injection (1 ml in dark glass ampoules, 5 ampoules in packaged cell boxes, 1 pack in a carton box).
The composition of 1 ml of the solution contains the active substance: fluphenazine decanoate - 25 mg.
Indications for use
- Prevention of exacerbation of schizophrenia;
- Long-term maintenance treatment of chronic forms of schizophrenia.
- Severe cardiovascular diseases (arterial hypotension, decompensated chronic circulatory failure);
- Severe depression of central nervous system function and comatose states of any etiology;
- Traumatic brain injuries, progressive systemic diseases of the brain and spinal cord;
- Impaired function of the blood and liver;
- Age up to 12 years;
- Pregnancy and lactation;
- Hypersensitivity to the drug.
Conditions / diseases for which Moditen Depot is prescribed with caution:
- Mammary cancer;
- Parkinson's disease;
- Alcoholism (increased susceptibility to hepatotoxic reactions);
- Epilepsy, a history of convulsive seizures;
- Peptic ulcer and duodenal ulcer (during exacerbation);
- Allergic reactions to phenothiazine derivatives in history;
- Pathological changes in blood (impaired blood formation);
- Chronic diseases associated with respiratory failure (especially in children);
- Angle-closure glaucoma;
- Diseases accompanied by an increased risk of thromboembolic complications;
- Prostate hyperplasia with clinical manifestations;
- Renal and / or liver failure;
- Reye syndrome (increased risk of developing hepatotoxicity in children and adolescents);
- Elderly age.
Dosing and Administration
Moditen Depot solution is administered intramuscularly. The drug is not intended for treatment courses lasting less than 3 months.
The recommended initial dose for most patients varies from 12.5 to 25 mg (0.5-1 ml). The doses of the solution applied later and the intervals between its injections are determined individually, depending on the response to therapy.
For patients who have not previously received phenothiazine derivatives, the initial dose is selected through the administration of flufenazine hydrochloride (fast-acting flufenazine).
With maintenance therapy, a single injection of Moditen Depot is enough to control the symptoms of schizophrenia for 28 days. In some patients during the maintenance treatment, the effect of a single dose lasts up to 42 days.
The dose of the drug should not exceed 100 mg. If necessary, the introduction of 50 mg of solution, each subsequent dose should be increased with caution, not more than 12.5 mg.
Therapy in patients with severe arousal should begin with flufenazine hydrochloride for injection (flufenazine fast acting). The use of Moditen Depot solution (at a dosage of 25 mg) is allowed after the subsidence of acute manifestations. Further doses of the drug (if necessary) should be adjusted.
In the case of disorders predisposing to the development of adverse reactions or known hypersensitivity to phenothiazine derivatives, treatment should be started with caution from taking flufenazine hydrochloride orally or parenterally.
After determining the optimal dose and evaluating the pharmacological effect, it is possible to administer equivalent doses of the solution of fluanazine decanoate solution.
Further dose adjustment is carried out depending on the response to therapy.
There is no unified scheme for transferring a patient from flufenazine with a fast action to the Moditen Depot solution. However, it has been established that a dose of 20 mg fluphenazine hydrochloride per day is equivalent to a single injection of 25 mg (1 ml) of flufenazine decanoate solution every 3 weeks.
In most cases, elderly patients require smaller doses of the drug - from 1/4 to 1/3 of the dose prescribed to young patients, and monitoring the response to therapy. The dose of the solution, if necessary, can be gradually increased.
During the period of application of the Moditen Depot solution, side effects may occur on the part of some body systems:
- Central nervous system: extrapyramidal disorder, such as hyperreflexia, opisthotonos, oculogyric crises, akathisia, dyskinesia, dystopia, extrapyramidal syndrome, tardive dyskinesia (a syndrome manifested by involuntary choreoathetoid movements of muscles of the trunk and limbs, tongue, mouth, muscles of the face, lips, or jaw, for example, chewing movements, stretching the lips, puffing out the cheeks, protruding the tongue);
- Other neurological disorders: malignant neuroleptic syndrome with possible fatal outcome (changes in mental state, muscle stiffness, hyperpyrexia, autonomic disorders - cardiac rhythm disturbances, increased sweating, tachycardia, fluctuation in blood pressure or pulse rate), the syndrome can also be accompanied by an increase in the activity of creatine phosphinosis, lymphomas, lymphomas, or fluctuations in blood pressure or pulse rate), the syndrome can also be accompanied by an increase in the activity of creatine phosphinosis, lymphomas, blood pressure or pulse rate). heart failure, impaired liver function, the development of fever and leukemia; swelling of the brain, changes in the encephalogram and protein content in the cerebrospinal fluid, confusion, drowsiness;
- Vegetative nervous system: dry mouth, sweating, polyuria, nausea, constipation, headache, loss of appetite, fluctuations in blood pressure, drooling, orthostatic hypotension (usually disappear after reducing the dose or discontinuation of the drug), hypotension. Intestinal obstruction, nasal congestion, tachycardia, atony of the bladder, glaucoma, visual disturbances may also occur;
- Cardiovascular system: cardiac arrest, sudden death, ventricular tachycardia, ventricular arrhythmias, including ventricular fibrillation, prolongation of the QT interval;
- Endocrine and metabolic disorders: changes in women’s libido, impotence in men, a false-positive pregnancy test, menstrual disorder, gynecomastia, pathological lactation, antidiuretic hormone secretion disorder syndrome, hyponatremia, peripheral edema, weight change;
- Allergic reactions: laryngeal edema, angioedema, bronchospasm, anaphylactic reactions, eczema and exfoliative dermatitis, photosensitization, seborrhea, urticaria, erythema, pruritus;
- Blood system: pancytopenia, eosinophilia, thrombocytopenic and non-thrombocytopenic purpura, agranulocytosis, leukopenia;
- Liver function: clinical signs of hepatitis, changes in laboratory parameters of liver function, cholestatic jaundice, especially in the first months of treatment;
- Other: convulsive seizures; long-term use - venous thromboembolism, including deep vein thrombosis and pulmonary artery embolism, asymptomatic disease, irreversible dyskinesia, angle-closure glaucoma, pigmentary retinopathy, renal dysfunction, clouding of the crystalline lens and cornea, skin pigmentation, changes, electrocardiography, changes in electrocardiography, changes in electrocardiography, cardiography .
Moditen Depot should be administered with caution to patients with a history of allergic reactions to phenothiazine derivatives.
If a side effect in the form of cholestatic jaundice occurs, therapy should be interrupted.
When conducting surgical operations to patients receiving high doses of Moditen Depot, a sharp decrease in blood pressure may be observed. In some patients, it may be necessary to reduce the doses of neuroleptics or anesthetics; potentiation of the effect of m-holinoblokatorov is possible.
When poisoning with phosphorus insecticides or in very hot weather, patients with convulsive seizures in history, pheochromocytoma, mitral valve insufficiency or other disorders of the cardiovascular system should be administered with caution.
You should also be careful when applying Moditen Depot on the background of breast cancer, because in this case the risk of disease progression and the development of resistance to treatment with cytostatic and hormonal drugs increases.
If there are risk factors for venous thromboembolism, before and during treatment, it is necessary to evaluate these factors and, if necessary, to take appropriate preventive measures.
With the appointment of Moditen Depot in Parkinson's disease may increase extrapyramidal effects.
Extrapyramidal symptoms that occur in the form of adverse reactions are usually reversible, but in some cases may be persistent. The likelihood of development and the severity of these undesirable adverse reactions is determined to a greater extent by individual sensitivity than by other factors, but also the age of the patient and the magnitude of the dose matter. Usually, to fix these disorders, it is enough to prescribe antiparkinsonian drugs or m-anticholinergic blockers and / or reduce the dose of the drug.
During treatment, with a decrease in dose or after cessation of therapy, tardive dyskinesia may occur. Early detection of the disease is very important. To do this, it is recommended to periodically reduce the dose of an antipsychotic at the initial stage (if the patient's condition allows it) and observe the patient's condition during this period. It must be borne in mind that the use of Moditen Depot can hide the manifestations of tardive dyskinesia.
In the event of the development of a malignant neuroleptic syndrome, it is necessary to immediately stop taking neuroleptics and other medications taken that do not affect the maintenance of vital functions, and conduct intensive symptomatic therapy under constant monitoring of vital functions, as well as therapy for concomitant diseases.
When applying Moditen Depot, care must be taken by patients at risk of developing cerebral circulation disorders.
Hypotension during treatment with fluphenazine is rare. More often it develops in patients with pheochromocytoma, renal, cerebrovascular and severe heart failure. The condition of these patients should be carefully monitored. In the event of severe hypotension, vasoconstrictor drugs should be rapidly injected (norepinephrine is best, epinephrine should not be used due to the possible increase in blood pressure reduction).
In cases of development of diseases of the mucous membranes of the mouth, throat or gums, or the occurrence of upper respiratory tract infections in combination with a change in the number of leukocytes (which confirms the suppression of blood formation), the use of Moditen Depot should be discontinued and necessary therapeutic measures should be prescribed.
Patients with a history of convulsive seizures Moditen Depot should be prescribed with caution.
It should be borne in mind that the antiemetic effect of the drug may mask vomiting, which is associated with an overdose of other drugs.
With the abrupt cancellation of the drug, cases of gastritis, vomiting, nausea, and dizziness were sometimes noted (with the use of high doses). These abnormalities were diminished by the subsequent intake of anti-parkinsonian drugs for several weeks after withdrawal.
The preparation contains sesame oil, which in some cases can lead to the development of severe allergic reactions.
The benzyl alcohol contained in the solution can cause severe anaphylactoid and toxic reactions in children from 12 years of age.
Moditen Depot has a strong effect on the psychomotor reactions of the patient, therefore, during the period of therapy it is prohibited to drive vehicles or work with mechanisms.
With the simultaneous use of Moditen Depot with some drugs, undesirable effects may occur:
- Alcohol, hypnotics, sedatives, strong analgesics: increasing their effects;
- Narcotic analgesics: the development of hypotension, depression of central nervous system function and respiration;
- Tricyclic antidepressants: a violation of their metabolism; strengthening and prolongation of the sedative and m-anticholinergic effects and arrhythmogenic action; increased serum concentrations of Moditen Depot and tricyclic antidepressants;
- Lithium preparations: an increase in neurotoxicity;
- Thiazide diuretics, angiotensin-converting enzyme inhibitors: increased hypotensive action;
- Guanethidine, clonidine, and possibly other anti-adrenergic agents: a decrease in the antihypertensive effect;
- Clonidine: reduced antipsychotic effect of Moditen Depot;
- Beta-blockers: increasing their concentration, as well as the concentration of Moditen depot in the blood plasma (a decrease in the dose of drugs is recommended);
- Metrizamide: development of convulsive seizures (Moditen Depot should be canceled 48 hours before myelography and after it should not be prescribed for at least 24 hours);
- Epinephrine and other adrenomimetics: the development of severe hypotension;
- Levodopa: reduction of its antiparkinsonian effect;
- M-holinoblockers: increased blocking of cholinergic receptors, especially in elderly patients, potentiation or prolongation of m-anticholinergic blocking effects (careful selection of doses of drugs and monitoring of the condition are necessary);
- Cimetidine: a decrease in the concentration of Moditen depot in the blood plasma;
- Anorectics / amphetamine: development of pharmacological antagonism;
- Antidiarrheal agents / antacids: Moditen Depot absorption disorder;
- Anticonvulsants: reducing their anticonvulsant effect;
- Hypoglycemic agents: development of diabetes mellitus decompensation;
- Inhibitors or substrates of the CYP2D6 isoenzyme: an increase in the concentration of Moditen depot in plasma, manifestation of cardiotoxicity, the development of orthostatic hypotension or adverse reactions associated with m-anticholinergic blocking effect.
Terms and conditions of storage
Store in a dark, out of reach of children at a temperature of 15-25 ° C.
Shelf life - 2 years.
Storing the drug in the refrigerator can lead to precipitation of triglycerides, which are part of sesame oil. When a precipitate appears, the solution must be heated to 37 ° C, and the precipitate will dissolve without losing the activity of the fluanozine decanoate.