Ludomil® (Ludiomil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMaprotilineMaprotiline
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  • Ludomil®
    pills inwards 
    Novartis Pharma AG     Switzerland
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance - Maprotiline hydrochloride 10 mg, 25 mg;

    Excipientslactose monohydrate 45 mg / 30 mg, corn pregelatinized corn starch 27 mg / 27 mg, calcium phosphate 10 mg / 10 mg, silicon dioxide colloidal anhydrous 5 mg / 5 mg, talc 2 mg / 2 mg, magnesium stearate 0.5 mg / 0.5 mg, stearic acid 0.5 mg / 0.5 mg; Hypromellose capsule 2,12 mg / 2,11 mg, talc 1,870 mg / 1,860 mg, titanium dioxide 0.39 mg / 0.33 mg, polysorbate 80 0.1 mg / 0.1 mg, iron dye oxide yellow 0, 02 mg / 0.07 mg; tablets, film-coated 25 mg, also contain a ferric oxide red oxide of 0.03 mg.

    Description:

    Tablets, film-coated, 10 mg: round, slightly biconcave with chamfered edges, covered with a film coating of light yellow color. On one side engraving "CG", on the other - "SO". On the cross-section - the core of white color.

    Tablets, film-coated, 25 mg: round, slightly biconcave with chamfered edges, covered with a film coat of gray-orange color. On one side engraving "CG", another - "DP". On the cross-section - the core of white color.

    Pharmacotherapeutic group:Antidepressant
    ATX: & nbsp

    N.06.A.A.21   Maprotiline

    Pharmacodynamics:

    Maprotiline is a tetracyclic antidepressant, a non-selective monoamine reuptake inhibitor, which also exhibits the therapeutic properties inherent in tricyclic antidepressants. The drug has a balanced spectrum of action: improves mood, eliminates anxiety and agitation, as well as psychomotor retardation. With masked depression, the drug can have a beneficial effect on somatic manifestations.

    The mechanism of action of maprotiline is associated with a pronounced inhibitory effect on norepinephrine reuptake by presynaptic neurons of the cerebral cortex with very little inhibition of serotonin reuptake. Maprotiline has a weak or moderate affinity to the central alpha1-adrenoceptors; has a significant inhibitory effect on histamine Hi-receptors and moderate m-holinoblocking action.

    With prolonged use of the drug in its mechanism of action, it may also be important to change the functional state of the neuroendocrine system (growth hormone, melatonin, endorphinergic system) and / or a system of neurotransmitters (norepinephrine, serotonin, gamma-aminobutyric acid).

    Pharmacokinetics:

    Suction

    After a single ingestion of tablets coated with a film membrane, maprotiline slowly but completely absorbed. The average absolute bioavailability is 66-70%. After a single oral dose of 50 mg, the maximum concentration of maprotiline in the blood plasma is 48-150 nmol / L (13-47 ng / ml) and is reached within 8 hours.

    With repeated use of the drug inside or intravenously at a dose of 150 mg per day, the equilibrium concentration of maprotiline in the blood is reached in the second week of treatment and is 320-1270 nmol / L (100-400 ng / ml), regardless of whether the whole daily dose is applied one reception or separately in 3 admission. The values ​​of the equilibrium concentration are in linear dependence on the dose of the drug, although in some patients they vary considerably.

    Distribution

    The distribution coefficient of maprotiline between blood and plasma is 1.7. The average value of the apparent volume of distribution is 23-27 l / kg.The binding of maprotiline to plasma proteins is 88-90%, regardless of the age of the patient and the nature of the disease. The concentration of maprotiline in the cerebrospinal fluid is 2-13% of the serum concentration.

    Metabolism

    Maprotiline is largely metabolized, only 2-4% of the dose is excreted in the urine unchanged. The main metabolite is the pharmacologically active desmethyl derivative. Several secondary metabolites are formed by hydroxylation and / or methoxylation; are excreted in the urine in the form of conjugates.

    Excretion

    The half-life of maprotiline averages 43-45 hours. The average value of the total clearance varies from 510 to 570 ml / min. After applying a single dose, withdrawal of the active substance occurs within 21 days: 2/3 of the dose is excreted in the urine (unchanged or in the form of conjugates) and about 1/3 - with feces.

    For maprotiline characterized by a dose-dependent change pharmacokinetic parameters in the range of 25-150 mg.

    Pharmacokinetics in selected patient groups

    For elderly patients, the plasma concentration of maprotiline is characterized by a decrease in the activity of maprotiline metabolism and a decrease in renal function. Patients this category (over 60 years), compared with young patients, with the same dose of the drug, the equilibrium concentrations of the active substance in the blood are higher, the apparent half-life is longer; therefore the daily dose should be reduced 2 times. Have patients with impaired renal function of mild and moderate severity with preserved liver function do not require dose adjustment maprotiline. Excretion of metabolites by the kidneys decreases, but this is compensated by an increase in excretion with bile. Sexual and ethnic differences do not affect the exchange of maprotiline, but individual differences associated with genetic characteristics are possible metabolism.

    Indications:

    Depression

    - Endogenous and involuntary depression.

    - Psychogenic, reactive and neurotic depression, asthenic depression.

    - Somatogenic depression.

    - Masked depression.

    - Menopausal (menopausal) depression.

    Other depressive mood disorders, characterized by anxiety, dysphoria or irritability; a state of apathy (especially in the elderly); psychosomatic or somatic manifestations in patients with depression and / or in the presence of anxiety.

    Contraindications:

    - Hypersensitivity to maprotiline or any other components of the drug; cross-sensitivity to tricyclic antidepressants;

    - diseases accompanied by convulsive syndrome or reduced threshold of convulsive readiness (for example, brain damage of various etiologies, alcoholism);

    - acute stage of myocardial infarction and intracardiac conduction disturbances (including congenital syndrome of elongated QT interval);

    - marked violations of the liver or kidney;

    - an angle-closure glaucoma, a delay in the outflow of urine (eg, due to prostatic diseases);

    - simultaneous treatment with monoamine oxidase inhibitors (MAO), and also within 14 days after their cancellation;

    - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

    - Acute poisoning with alcohol, sleeping pills or psychotropic drugs;

    - age <18 years.

    Carefully:

    If you have any of the listed diseases before taking the drug, be sure to consult a doctor.

    When Lydiomil® was used in therapeutic doses in patients without evidence of convulsive activity in a history, seizures developed in rare cases.In some cases, these patients have factors that contribute to the development of seizures (for example, simultaneous use of drugs that reduce the threshold of convulsive alertness). The risk of seizures may increase with simultaneous use of the drug Ludomil® with antipsychotic drugs (for example, phenothiazine derivatives, risperidone), with the abrupt withdrawal of simultaneous with the drug Ludomil® reception of benzodiazepines or in the case of a rapid increase in the recommended dose of Ludomil®. Although a clear causal relationship between the use of the drug Ludomil® and the development of seizures is not established, to reduce the risk of seizures should start treatment with a drug Ludomil® with a small dose; keep the initial dose unchanged for 2 weeks; carry out a slow and gradual increase in the dose; use the minimum effective dose of the drug for long-term maintenance therapy; carefully select a dose of drugs that reduce the threshold of convulsive readiness (for example, phenothiazine derivatives) or avoid their simultaneous use with the drug Ludomil®, avoid a sharp withdrawal of benzodiazepines while using with the drug Ludomil®.

    With the use of tricyclic and tetracyclic antidepressants, it is possible to develop arrhythmia, sinus tachycardia and slowing of intracardiac conduction. Caution should be exercised when prescribing tricyclic and tetracyclic antidepressants to elderly patients and patients with cardiovascular disease, including a history of myocardial infarction, arrhythmias and / or ischemic heart disease. In this category of patients, especially with prolonged treatment with antidepressants, regular monitoring of heart function, including ECG, should be performed. Patients with orthostatic hypotension should regularly monitor blood pressure.

    Patients with impaired renal and hepatic and mild liver function should be given caution.

    Pregnancy and lactation:

    The safety of the drug in humans during pregnancy has not been established to date. Limited data did not reveal the relationship between the use of Ludomil® and the development of reproductive toxicity in animals.

    Do not use Ludomil® during pregnancy, except when the expected benefit to the mother exceeds the potential risk to the fetus.

    In order to prevent the development of symptoms such as shortness of breath, lethargy, irritability, tachycardia, marked decrease in blood pressure, convulsions, nervous excitement and hypothermia in the newborn, the drug Ludomil® should be discontinued at least 7 weeks before the expected day of childbirth (provided that, that the patient's condition allows it).

    Maprotiline penetrates into breast milk. After taking Ludomil® in a daily dose of 150 mg for 5 days, the concentration of maprotiline in breast milk exceeds the concentration in the plasma by 1.3-1.5 times. Although data on the development of adverse events in newborns when used in nursing mothers, maprotiline is not available, patients receiving treatment with Ludomil® should either stop using the drug or stop breastfeeding.

    Dosing and Administration:

    During treatment with the drug, the patient must be under medical supervision. The dosage regimen should be selected individually, changing it taking into account the patient's condition and its reaction to the drug. For example, it is possible to redistribute the dose of the drug: an increase in the evening dose and a decrease in the daily dose or the administration of the entire daily dose in a single dose.

    The goal of the treatment is to achieve a therapeutic effect by applying the minimum effective dose of the drug.

    Tablets should be swallowed whole and washed down with a sufficient amount of liquid.

    The maximum daily dose of the drug is 150 mg.

    The drug Ludomil® is prescribed 25 to 75 mg once a day or divided into several doses depending on the severity symptoms.

    The maximum daily dose of 150 mg should be achieved gradually, depending on the tolerability of the drug. The maintenance dose is 75-150 mg per day.

    After prolonged regular use of the drug, it is recommended to gradually reduce the dose under the supervision of a doctor. Do not abruptly cancel the drug or drastically reduce the dose due to the possibility of developing the "withdrawal" syndrome. Tactics gradual reduction of the dose of the drug is selected individually taking into account the patient's condition and is conducted for at least 4 weeks.

    To patients of advanced age the drug is recommended to be administered in smaller doses, since the development of adverse events in this category of patients is more likely. At the beginning of treatment, the drug Ludomil® is used at a dose of 10 mg 3 times a day or 25 mg once a day. If necessary, the daily dose of Ludomil® can be slow and gradually increase - up to 25 mg 3 times a day or up to 75 mg once a day, depending on the tolerance and clinical effect.

    Side effects:

    The observed adverse events are usually mild and transient, disappear when the Ludomil® drug is continued or if its dose is reduced. They do not always clearly correlate with the concentration of the active substance in the blood plasma or with the dose of the drug. Often there are difficulties in the differential diagnosis of certain undesirable phenomena and symptoms of depression: feelings of fatigue, sleep disturbances, agitation, anxiety, constipation, dry mouth.

    When developing serious adverse events, for example, from the central nervous system, the drug Ludomil® should be discontinued.

    The elderly are particularly sensitive to the m-cholinoblocking effects of Ludomil®, as well as its effect on the central nervous and cardiovascular systems. In elderly patients with a reduced ability to metabolize and withdraw drugs, the risk of a significant increase in the concentration of active substance in the blood plasma when the drug is administered in therapeutic doses increases.

    Below are the undesirable phenomena observed with the use of both the drug Ludomil® and tricyclic antidepressants listed in frequency, starting with the most frequent. The frequency of unwanted reactions is estimated as follows: very often (1/10); often (1/100, <1/10); infrequently (1 / 1,000, <1/100); rarely (1 / 10,000, <1 / 1,000); very rarely (<1 / 10,000), including individual messages.

    From the central and peripheral nervous system: very often - drowsiness, dizziness, headache, tremor, myoclonus; often - sedation, memory loss, attention disturbance, paresthesia, dysarthria; rarely - cramps, akathisia, ataxia; very rarely - dyskinesia, fainting, a violation of taste.

    Mental disorders: often - anxiety, anxiety, agitation, manic disorders, violation of libido, aggressiveness, sleep disturbance, insomnia, nightmares, increased symptoms of depression; rarely - oppression of consciousness of various degrees, delirious disorders, hallucinations (mainly in elderly patients), increased excitability; very rarely - the activation of symptoms of psychosis, depersonalization.

    From the cardiovascular system: often - sinus tachycardia, palpitations, orthostatic hypotension, "hot flashes" (sensation of heat); rarely - arrhythmia; very rarely - violations of intracardiac conduction (eg, expansion of the QRS complex, bundle branch blockade, changes in the PQ interval), prolongation of the QT interval, ventricular tachycardia, ventricular fibrillation, torsade des pointes, purpura.

    There are reports of individual cases of ventricular tachycardia, ventricular fibrillation, bi-directional spindle-shaped ventricular torsade des pointes (fatal).

    From the digestive system: very often - dry mouth; often - nausea, vomiting, discomfort in the abdomen, constipation; rarely diarrhea; very rarely - stomatitis, hepatitis, accompanied or not accompanied by jaundice.

    From the skin: often - allergic dermatitis, rash, hives, photosensitization, hyperhidrosis; very rarely - itching, skin vasculitis, alopecia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

    From the endocrine system and metabolism: often - increased appetite, weight gain; very rarely - the syndrome of inadequate secretion of antidiuretic hormone.

    From the respiratory system: very rarely - allergic alveolitis (with or without eosinophilia), interstitial lung diseases (including subacute interstitial pneumonitis), bronchospasm, nasal congestion.

    On the part of the hematopoiesis system: very rarely - leukopenia, agranulocytosis, eosinophilia, thrombocytopenia.

    From the sense organs: often - "blurring" of vision, violation of accommodation; very rarely - noise in the ears.

    From the side of the musculoskeletal system and connective tissue: often - muscle weakness.

    From the excretory and reproductive systems: often - urination disorders, erectile dysfunction; very rarely - urinary retention, mammary gland hypertrophy, galactorrhea.

    Common disorders and reactions at the site of administration: very often fatigue; often - fever; very rarely - swelling (local or general).

    Laboratory and instrumental studies: often - electrocardiographic disorders (for example, changes in the ST segment and T wave); rare - marked increase in blood pressure, deviation of functional hepatic samples; very rarely - violations on the electroencephalogram.

    Other: very rarely - falls, dental caries.

    The manifestation of the syndrome of "withdrawal"

    After a sudden withdrawal or rapid dose reduction, the following symptoms rarely occur: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, increased excitability, anxiety, increased depression or relapse of depressive mood disorders.

    Fractures of bones

    In patients aged ≥50 years, receiving selective serotonin reuptake inhibitors and tricyclic antidepressants, there was an increased risk of fractures, the mechanism of occurrence of which is not known.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms of an overdose of Ludomil® in the form of tablets are similar to the symptoms of an overdose of tricyclic antidepressants, including fatal outcomes. The main complications are violations of the cardiovascular system and neurological disorders. In children, the inadvertent administration of Ludomil® medication to the inside should be considered a serious and fatal outcome regardless of the dose.

    Symptoms of overdose usually appear within 4 hours after taking the drug Ludomil® and reach maximum expression after 24 hours. Due to delayed absorption (m-cholin-blocking effect), a long half-life and hepatoenteric recirculation of maprotiline, the risk to the patient's life persists for 4-6 days.

    Symptoms of overdose:

    From the central nervous system: drowsiness, stupor, coma, ataxia, anxiety, agitation, increased reflexes, rigidity of muscles, choreoathetoid movements, convulsions.

    From the cardiovascular system: a marked decrease in blood pressure, tachycardia, arrhythmias, intracardiac conduction disorders, shock, heart failure, ventricular tachycardia, ventricular fibrillation, torsade des pointes, cardiac arrest, which can lead to death.

    In addition, respiratory depression, cyanosis, vomiting, fever, mydriasis, excessive sweating, oliguria or anuria are possible.

    Treatment.

    There is no specific antidote, treatment is mostly symptomatic and supportive.Patients with suspected overdose of the drug, especially children, should be hospitalized and under strict medical supervision for at least 72 hours.

    It should be as soon as possible to wash the stomach or, if the patient is conscious, cause vomiting. To slow the absorption of maprotiline, you can use Activated carbon. The use of physostigmine can cause pronounced bradycardia, asystole and seizures. Therefore, the use of physostigmine in an overdose of Ludomil® is not recommended. Hemodialysis and peritoneal dialysis are not effective, as the concentration of maprotiline in the blood plasma is low.

    Interaction:

    Contraindicated interactions

    The drug is contraindicated within 14 days after withdrawal monoamine oxidase inhibitors (MAO), in connection with the possible risk of pronounced drug interactions leading to the development of hyperpyrexia, tremor, generalized clonic convulsions, delirium, a possible death. The same rule is followed if MAO inhibitors are prescribed after previous therapy with Ludomil®.

    Non-recommended drug interactions

    Antiarrhythmics, which are potent inhibitors of the isoenzyme CYP2D6, for example, quinidine and propafenone, should not be taken in combination with the drug Ludomil®. M-holinoblokiruyuschee action of quinidine can be synergistic with the drug Ludomil®, and its severity depends on the doses of these drugs.

    The drug can potentiate the action medicines, possessing m-holinoblocking properties (for example, derivatives of phenothiazine, antiparkinsonian drugs, atropine, biperiden, blockers H2 histamine receptors), the pupil of the eye, the central nervous system, the intestine, and the bladder.

    The combined use of Ludomil® with derivatives of sulfonylureas for oral administration or with insulin can potentiate their hypoglycemic effect. In patients with diabetes mellitus, regular monitoring of blood glucose levels should be performed both at the beginning of therapy with Ludomil® and at the end of therapy.

    Patients taking Ludomil® should be warned that their reaction to alcohol, barbiturates, and other drugs with oppressive effect on the central nervous system, may be more pronounced. Caution should be exercised in the joint appointment of maprotiline and drugs that extend the interval QT, because of the increased risk of ventricular arrhythmias, including ventricular tachycardia and polymorphic ventricular arrhythmia such as "pirouette" (torse de points), especially in patients with risk factors. Possible drug interactions

    Simultaneous application of the drug Ludomil® with selective inhibitors of reverse neuronal seizure of serotonin, which are inhibitors of the isoenzyme CYP2D6, such as fluoxetine or fluvoxamine, which also inhibits isoenzymes CYP3A4, CYP2C19, CYP2C9 and CYP1A2, paroxetine, sertraline or citalopram, can lead to a significant increase in the concentration of maprotiline in the blood and the development of relevant undesirable phenomena. Due to the long half-life of fluoxetine and fluvoxamine, this effect can persist for a long time. In such cases, a dose adjustment may be required.

    The simultaneous use of the drug Ludomil® and benzodiazepines can lead to increased sedation.

    Interactions leading to increased therapeutic effect of Ludomil®

    When taking Ludomyl® in combination with isoenzyme inhibitors CYP2D6 in patients with the phenotype of fast acetylator debrisoquine, an increase in the concentration of maprotiline up to 3.5 times (ie, the manifestation of the phenotype of the slow acetylator of debrisoquine) is possible.

    It was shown that the blocker H2 histamine receptors cimetidine (inhibitor of microsomal liver enzymes P450, including isozymes CYP2D6 and CYP3A4) inhibits the metabolism of certain tricyclic antidepressants, which leads to an increase in their concentration in the blood and an increase in the frequency of adverse events (dry mouth, visual impairment). Despite the lack of data on the interaction of cimetidine with the drug Ludomil®, it can not be ruled out that the dose of Ludomil® should be reduced if they are used simultaneously.

    Simultaneous use of Ludomil® with antipsychotic drugs (for example, derivatives of phenothiazine, risperidone) can lead to an increase in the concentration of maprotiline in the plasma, reduce the threshold of convulsive readiness and the development of seizures.The combined use of Ludomil® with an inhibitor of isoenzyme CYP2D6 thioridazine can lead to the development of severe arrhythmias, and you may need to change the dose. With the simultaneous use of Ludomil® with antipsychotics, the dosage of both drugs may need to be adjusted.

    Methylphenidate can lead to an increase in the concentration of tricyclic antidepressants in the blood plasma and enhance their action, so that it may be necessary to adjust the dose of both preparations.

    When using Ludomil® together with oral terbinafine (antifungal agent, potent inhibitor of isoenzyme CYP2D6) there may be an increase in the concentration of maprotiline in the blood plasma, which requires correction of the dose of Ludomil®. Interactions leading to a weakening of the therapeutic effect of Ludomil®

    Maprotiline is metabolized predominantly by isoenzyme CYP2D6 and to some extent isoenzyme CYP1A2. Induction effect on isoenzyme CYP2D6 it is not revealed, however, simultaneous application of Ludomil® with isozyme inducing substances CYP1A2, may lead to an increase in the formation of desmethylmaprolidine and a decrease in the efficacy of Ludomil®. When taking Ludomil® in combination with inducers of microsomal liver enzymes, especially metabolizing tricyclic antidepressants, such as isozymes CYP3A4, CYP2C19, and / or CYP1A2 (e.g., rifampicin, carbamazepine, phenobarbital and phenytoin), you may need to adjust the dose of Ludomil®.

    Interactions that affect other drugs

    There is no evidence of the ability of Ludomil® to inhibit metabolism anticoagulants, such as warfarin, active Swhose enantiomer is metabolized by an isoenzyme CYP2C9, However, it is recommended that the prothrombin content in the plasma be carefully monitored with this combination. Ludomil® can potentiate cardiovascular effects sympathomimetic drugs, such as epinephrine, norepinephrine, isoprenaline, ephedrine and phenylephrine, included in the composition of drops in the nose or local anesthetics (for example, used in dentistry). Such situations require careful monitoring of the patient (control of blood pressure, heart rate) and careful selection of the dose of drugs.

    Simultaneous use of Ludomil® with β-blockers, which are inhibitors of the isoenzyme CYP2D6, such as propranolol, can lead to an increase in the concentration of maprotiline in the plasma. In such cases it is recommended to monitor the concentration of maprotiline in the plasma, and if necessary adjust the dose. The drug Ludomil® can reduce (or even completely block) the antihypertensive effect of drugs means with adrenoblocking and properties, such as guanethidine, betanidine, reserpine, clonidine and methyldopa. In patients taking the drug Ludomil®, drugs of other classes (for example, diuretics, vasodilators or beta-adrenoblockers not subject to pronounced biotransformation) should be used to treat hypertension. Sudden abolition of Ludomil® can lead to a marked decrease in blood pressure (BP).

    Special instructions:

    In patients with schizophrenia on the background of therapy with tricyclic antidepressants, an exacerbation of psychotic symptoms is possible. Like tricyclic antidepressants, the risk of developing such a complication should be considered when administering Ludomil®.In patients with cyclic bipolar disorders on the background of therapy with tricyclic antidepressants during the depressive phase of the disease, there were hypomanic or manic episodes. Like tricyclic antidepressants in such cases, it may be necessary to reduce the dose of Ludomil®, up to and including its cancellation, and in the appointment antipsychotic.

    In severe depression, an increased risk of suicidal actions may persist until a significant remission occurs. In patients with depression, both in adults and in children, there may be an increase in depression and / or suicidal behavior or other psychopathological symptoms, regardless of whether they receive antidepressant therapy or not. In short-term studies in children, adolescents and adults aged less than 25 years with depression and other psychiatric disorders It is shown that antidepressants increased the risk of suicidal thoughts and suicidal behavior. In rare cases, antidepressants may cause an aggravation of suicidal intentions (tendencies).

    In one of the studies in the group of patients who received prophylactic treatment with the drug Ludomil® for unipolar depression, there was an increase in suicidal behavior.

    Such patients should consider the possibility of changing the regimen of therapy, including the possible withdrawal of the drug Ludomil®, especially if such changes are pronounced, suddenly or not observed in the patient prior to prescribing the drug.

    Families and caregivers of patients receiving antidepressants for various indications should be warned the need to observe patients because of the risk of other psychopathological symptoms, including suicidal behavior, and immediately report such symptoms to the treating physicians.

    In order to reduce the risk of overdose, the prescription should specify the minimum amount of the drug necessary to adhere to an adequate regimen of therapy. Maprotiline, as well as tricyclic antidepressants can provoke the development of medicinal (delirious) psychoses, in predisposed patients and in elderly patients, especially at night. Psychoses usually stop on their own several days after the drug is discontinued.It should avoid sudden withdrawal or a sharp decrease in the dose of Ludomil®, as this can lead to the development of the "withdrawal" syndrome. The drug should be withdrawn gradually, as quickly as the clinical situation permits. It should be taken into account that the abrupt withdrawal of the drug may be accompanied by the development of certain symptoms. Electroconvulsive therapy during the use of Ludomil® should be carried out only under the condition of careful monitoring of the patient.

    Although only a few reports of changes in the number of leukocytes in peripheral blood are known during drug treatment, nevertheless, periodic monitoring of this indicator and alertness for symptoms such as fever and sore throat. Implementation of these recommendations is especially important in the first months of treatment and with prolonged therapy with Ludomil®.

    During prolonged therapy with Ludomil®, it is recommended to regularly monitor the liver and kidney function.

    The drug Ludomil® should be used with caution in patients who have a history of indication of increased intraocular pressure,severe chronic constipation or delay in urinary outflow, especially with prostatic hyperplasia.

    Because the maprotiline shows some properties inherent in tricyclic antidepressants, it should be borne in mind that tricyclic antidepressants can contribute to the development of paralytic intestinal obstruction, especially in elderly patients or in patients in hospital. Therefore, in case of constipation, the patient should take appropriate measures. Against the background of therapy with the drug Ludomil®, it is impossible to exclude the m-holin-blocking effect characteristic of tricyclic antidepressants: a decrease in tear and a relative increase in the amount of mucus in the lacrimal fluid, which can lead to damage to the corneal epithelium in patients using contact lenses.

    The drug Ludomil® should be used with caution in patients with hyperthyroidism, as well as in those who take drugs of thyroid hormones (possibly increasing the incidence of adverse reactions from the heart).

    With prolonged treatment with antidepressants, the incidence of tooth decay was reported.In this regard, long-term therapy is recommended systematic examination of the dentist.

    Before conducting a general or local Anesthesia should alert the anesthetist that the patient is receiving the drug Ludomil®. Continuation of treatment with Ludomil® appears to be safer than those that may occur due to sudden withdrawal of the drug before surgery.

    Effect on the ability to drive transp. cf. and fur:

    Patients who, when using the drug Ludomil®, there is a "blurring" of vision, dizziness, drowsiness, or other disorders from the central nervous system, do not drive vehicles or work with machinery and engage in potentially hazardous activities.

    Form release / dosage:Tablets, film-coated, 10 mg or 25 mg.
    Packaging:

    Tablets, film-coated, 10 mg or 25 mg: 10 tablets in a blister of Al / PVC / PVDC.

    For 5 blisters (10 mg tablets), 3 or 10 blisters (25 mg tablets) together with instructions in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 30 ° C.

    The drug should be stored out of the reach of children.

    Shelf life:

    5 years.

    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N013135 / 01
    Date of registration:07.07.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC
    Information update date: & nbsp21.03.2018
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