Moditenum of Depot

Moditenum of Depot – a polyvalent neuroleptic with the long expressed antipsychotic and moderate sedative action, has antiemetic effect.

Form of release and structure

Dosage form – solution for intramuscular introduction (in oil) oil: transparent liquid of oily structure, light yellow color, existence of a slight smell of benzyl alcohol is possible (on 1 ml in glass ampoules of dark color, in a blister strip packaging of 5 ampoules, in a cardboard pack 1 packaging).

Active agent of Moditenum of Depot – Fluphenazin деканоат, in 1 ml – 25 mg.

Auxiliary components: sesame oil, benzyl alcohol.

Indications to use

• The supporting long therapy of various forms of schizophrenia;
• Prevention of exacerbations of schizophrenia.

Contraindications

• Arterial hypotension, dekompensirovanny chronic circulatory unefficiency and other severe forms of cardiovascular pathologies;
• Disturbances of system of blood;
• Functional disorder of a liver;
• The expressed oppression of function of the central nervous system;
• Coma of any etiology;
• The progressing general diseases and injuries of a head and spinal cord;
• Period of pregnancy and lactation;
• Age up to 12 years;
• Individual intolerance of components of drug.

With care patients need to appoint Moditenum of Depot with pathological (caused by hemopoiesis disturbance) blood changes, closed-angle glaucoma, breast cancer, clinical displays of a hyperplasia of a prostate, a liver and/or renal failure, convulsive attacks in the anamnesis, at diseases with the increased risk of tromboembolic episodes, Parkinson's diseases (because of strengthening of extrapyramidal effects), an aggravation of a peptic ulcer of a stomach and duodenum, epilepsy, a myxedema, chronic pathologies with breath disturbance (especially at children), at a syndrome to Reja (the risk of development of a hepatotoxic in teenagers increases), vomiting, a cachexia, alcoholism, at advanced age.

Route of administration and dosage

Moditenum of Depot is intended for course treatment lasting course of 3 months and more.

The patients who for the first time were given assignment of drug from group of fenotiazin should make selection of an initial dose administration of Fluphenazin of a hydrochloride (a neuroleptic of bystry action).

For most of patients the initial dose of Fluphenazin of a dekanoat makes 12,5-25 mg, or 0,5-1 ml of solution. Depending on therapeutic effect and portability of drug the following dose and the period between injections is defined.

One maintenance dose of drug usually controls schizophrenia symptoms for 4 weeks, at some patients its effect remains up to 6 weeks.

The maintenance dose should not exceed 100 mg.

At purpose of a dose more than 50 mg of drug, it is necessary to increase increase carefully, gradually increasing each following introduction by 12,5 mg.

Treatment of patients with the expressed excitement needs to be begun with administration of Fluphenazin of bystry action (Fluphenazin a hydrochloride). After removal of acute displays of a disease enter 25 mg (1 ml) of Moditenum of Depot, the subsequent doses should be adjusted individually.

At the increased risk of complications at patients with hypersensitivity to fenotiazina or the frustration contributing to adverse reactions it is necessary to begin treatment with hydrochloride Fluphenazin, accepting it orally or by introduction in oil. Only after establishment of an optimum dose on the basis of objective assessment of efficiency of the previous therapy the patient can enter Fluphenazin деканоат. Further dose adjustment should be carried out taking into account the response to treatment.

At treatment of children 12 years are more senior introduction of 6,25-18,75 mg in oil of drug to week is recommended. On the basis of clinical indications at satisfactory portability the single dose can be raised to 12,5-25 mg and to enter every 1-3 week. The uniform scheme of transition to administration of solution of Fluphenazin of a dekanoat from Fluphenazin of bystry action does not exist. Upon the specified transition it is necessary to be guided by the fact that the dose of Fluphenazin of a hydrochloride of 20 mg a day is equivalent to introduction of 25 mg of Fluphenazin of a dekanoat of 1 times to 3 weeks.

Treatment of elderly patients is recommended to begin 1/4-1/3 usual doses of Moditenum of Depot with appointment, further the dose can be raised gradually at careful observation of reaction of the patient to treatment.

Side effects

• Cardiovascular system: ventricular arrhythmias, ventricular tachycardia, fibrillation of ventricles, lengthening of an interval of QT, cardiac standstill, sudden death;
• Central nervous system: extrapyramidal frustration, including an extrapyramidal syndrome, dyskinesia, an akathisia, an allotopia, okulogirny crises, a hyperreflexia and an opisthotonos, late dyskinesia (the involuntary choreoathetoid movements of muscles of a trunk, extremities, face muscles, language, a mouth, jaw or lips in the form of inflation of cheeks, protrusions of language, a pulling of lips, chewing movements);
• Autonomic nervous system: dryness in a mouth, fluctuations of arterial pressure, orthostatic hypotension, appetite loss, nausea, hypersalivation, perspiration, a polyuria, a headache, a lock (usually, after a dose decline or drug withdrawal pass independently), hypotension; perhaps – a nose congestion, glaucoma, a vision disorder, tachycardia, impassability of intestines, a bladder atony;
• Other neurologic effects: the malignant antipsychotic syndrome (MAS) with risk of a lethal outcome (muscle tension, a hyper pyrexia, disturbances of mentality, vegetative frustration – the increased sweating, tachycardia, fluctuation of the arterial pressure (AP) and pulse, disturbance of a cordial rhythm), against the background of ZNS development of an acute heart failure, leukosis, fever, abnormal liver functions, increase in activity of a kreatinfosfokinaza is possible; perhaps – confusion of consciousness, drowsiness, changes of an encephalogram, brain hypostasis, disturbance of level of protein content in cerebrospinal fluid;
• Function of a liver: cholestatic jaundice (is more often at the beginning of therapy), laboratory changes of functional indicators of a liver, clinical symptoms of hepatitis;
• Endocrine and metabolic disturbances: change of body weight, a hyponatremia, peripheral hypostases, a syndrome of disorder of secretion of antidiuretic hormone, a gynecomastia, a pathological lactation, the false positive test for pregnancy, disturbance of a menstrual cycle, women have a change of a libido, men have an impotence;
• System of blood: agranulocytosis, Werlhof's disease, leukopenia, not Werlhof's disease, pancytopenia, eosinophilia;
• Allergic reactions: erythema, skin itch, small tortoiseshell, photosensitization, seborrhea, exfoliative dermatitis, eczema, bronchospasm, throat hypostasis, anaphylactic reactions, Quincke's disease;
• Others: convulsive attacks; against the background of prolonged use – vomiting, fever, a volchanochnopodobny syndrome, changes of an electrocardiography (ECG), a xanthopathy, a renal failure, development of closed-angle glaucoma, a cataract and corneas, irreversible dyskinesia, a pigmental retinopathy, a venous thromboembolism (including a deep vein thrombosis and an embolism of a pulmonary artery), an asymptomatic form of pneumonia.

Special instructions

Because of possible cross sensitivity it is necessary to appoint Moditenum of Depot with care at cholestatic jaundice, dermatitis and other allergic reactions to derivatives of a fenotiazin.

Use of drug at a breast cancer can cause progressing of a disease and decrease in sensitivity to endocrine and cytostatic drugs as Fluphenazin promotes prolactin secretion induction.

The antiemetic effect can mask a clinical picture of the vomiting connected with overdose of other means.

Predisposition to gepatotoksichny reactions increases against the background of alcoholism, alcohol intake during treatment is contraindicated.

The patients accepting high doses of drug can have a strong hypotensive reaction during surgery. For stabilization of a condition of the patient it is necessary to resort to a dose decline of anesthetics or neuroleptics.

As Fluphenazin has anticholinergic effect, in certain cases it can exponentiate effect of cholinolytics.

With care it is recommended to appoint drug in the period of hot weather, at poisoning with phosphoric insecticides, insufficiency of the mitral valve and other disturbances of cardiovascular system, a pheochromocytoma, the patient with convulsive attacks in the anamnesis.

During use of Moditenum of Depot sick it is forbidden to be engaged in management of vehicles and mechanisms.

Medicinal interaction

At simultaneous use of Moditenum of Depot:

• Hypnotic drugs, sedatives, alcohol, strong analgetics – strengthen the action;
• Narcotic analgetics – promote oppression of function of the central nervous system, breath, can have strong hypotensive effect;
• Lithium drugs – raise a neurotoxicity;
• Thiazide diuretics, inhibitors of an angiotensin-converting enzyme – can strengthen hypotensive effect;
• The clonidine – reduces antipsychotic effect of fenotiazin;
• Beta adrenoblockers – are capable to increase concentration level in a blood plasma, the and derivatives of a fenotiazin therefore at purpose of this combination it is recommended to lower a dose of each of drugs;
• Antiacid and anti-diarrheal drugs – can cause Fluphenazin absorption disturbance;
• Metrizamid – emergence of convulsive attacks is possible (when carrying out a miyelografiya use of Moditenum of Depot is recommended to be cancelled in 48 hours prior to and to renew in 24 hours after the procedure);
• Adrenomimetiki, including Epinephrinum – being a pharmacological antagonist of a fenotiazin, can promote development of heavy hypotension;
• The levodopa, anticonvulsants – reduce the therapeutic effect;
• Hypoglycemic means – reduce the action;
• M-holinoblokatory – can strengthen blocking of cholinergic receptors (especially at patients of advanced age) and to potentiate or prolong m-holinoblokiruyushchiye effects;
• Cimetidinum – promotes decrease in level of content of Fluphenazin of a dekanoat in a blood plasma;
• Anorexigenic means and amphetamines – pharmacological antagonists of drug;
• Guanetidin, the clonidine and other anti-adrenergic means – decreases their anti-hypertensive action;
• Inhibitors or substrates of an isoenzyme CYP2D6 – promoting increase in concentration in a blood plasma and effect of Fluphenazin, can increase risk of cardiotoxicity, orthostatic hypotension, development of the side reactions caused by m-holinoblokiruyushchim effect of drug.

Moditenum of Depot breaks metabolism of tricyclic antidepressants, causes increase in level of concentration in blood serum and fenotiazin, and tricyclic antidepressants. It can lead to prolongation or strengthening sedative, m-holinoblokiruyushchego of effect and aritmogenny effect of tricyclic antidepressants.

Terms and storage conditions

To protect from children.

To store in the dark place at a temperature of 15-25 °C. It is impossible to place drug in the refrigerator.

Period of validity – 2 years.