Ludiomil 25 mg 30 pcs film-coated tablets


Pharmacodynamics and pharmacokinetics

The drug Ludiomil belongs to tetracyclic antidepressants and non-selective monoamine reuptake inhibitors, which additionally have therapeutic properties similar to tricyclic antidepressants. When taking it, it was noted: a significant improvement in mood, elimination of anxiety, agitation and psychomotor retardation . Treatment of masked depression has a beneficial effect on somatic symptoms.

Long-term use of the drug may affect the functional state of the neuroendocrine system, for example, hormones , melatonin or the endorphinergic system, as well as the neurotransmitter : serotonin, norepinephrine, gamma-aminobutyric acid.

After injection, the drug is quickly distributed in the body, tightly binding to plasma proteins. Metabolism results in the formation of several metabolites . Excretion occurs mainly through the kidneys, in the form of metabolites.

Indications

Ludiomil is used for various conditions accompanied by pathological depression of mood. Its appointment is justified in the following cases:

  • Depressive episode;
  • Recurrent depressive disorder;
  • Bipolar disorder, current episode of depression;
  • Pathological depression of mood due to somatic pathology;
  • Neurasthenia;
  • Masked depression;
  • Anxiety-phobic disorder, accompanied by a pathological decrease in mood.

Ludiomil may help combat moderate to severe depressive episodes. It is recommended both for mental disorders and for diseases of internal organs accompanied by decreased mood.

Contraindications for use

This drug is not prescribed to patients with:

  • hypersensitivity to it and other tricyclic antidepressants;
  • diseases accompanied by convulsive syndrome or a reduced threshold of convulsive readiness, such as brain lesions of various etiologies and alcoholism;
  • acute stage of myocardial infarction and intracardiac conduction disorders;
  • severe dysfunction of the liver or kidneys;
  • angle-closure glaucoma or urinary retention;
  • acute poisoning with alcohol, psychotropic and sleeping pills.

Also, Ludiomil is not prescribed to patients under 18 years of age.

There is a large list of features when treatment must be carried out with increased caution. Therefore, it is contraindicated to use this drug on your own.

Ludiomil®

In patients with schizophrenia, during therapy with tricyclic antidepressants, exacerbation of psychotic symptoms is possible. Like tricyclic antidepressants, the risk of developing such a complication should be taken into account when prescribing Ludiomil®. In patients with cyclic bipolar disorders during treatment with tricyclic antidepressants during the depressive phase of the disease, hypomanic or manic episodes occurred. Like tricyclic antidepressants, in such cases it may be necessary to reduce the dose of Ludiomil®, up to its discontinuation, and to prescribe an antipsychotic drug.

In severe depression, the increased risk of suicidal behavior may persist until significant remission occurs. Patients with depression, both adults and children, may experience increased depression and/or suicidal behavior or other psychopathological symptoms, regardless of whether they are receiving antidepressant therapy or not. In short-term studies in children, adolescents, and adults less than 25 years of age with depression and other psychiatric disorders, antidepressants increased the risk of suicidal ideation and behavior. In rare cases, antidepressants may cause an exacerbation of suicidal intentions (tendencies).

In one study, an increase in suicidal behavior was detected in a group of patients receiving preventive treatment with Ludiomil® for unipolar depression. The incidence of death due to overdose during treatment with Ludiomil® is comparable to other antidepressants. Therefore, careful monitoring of patients is necessary at all stages of treatment. All patients taking Ludiomil® for any indication should be monitored for worsening clinical symptoms, suicidal behavior and other psychopathological symptoms, especially during the initial phase of therapy or when the dose of the drug is changed. In such patients, the possibility of changing the treatment regimen should be considered, including possible discontinuation of the drug Ludiomil®, especially if such changes are pronounced, appeared suddenly or were not observed in the patient before prescribing the drug.

Families and caregivers of patients receiving antidepressants for various indications should be advised to monitor patients for the risk of other psychopathological symptoms, including suicidal behavior, and to promptly report such symptoms to their prescribers.

The goal of treatment is to achieve a therapeutic effect using the minimum effective dose, especially in patients (over 18 years of age) with incomplete growth processes or in the elderly, who tend to have instability of the autonomic nervous system and who are generally more likely to develop adverse events.

In order to reduce the risk of overdose, the prescription should indicate the minimum amount of the drug required to maintain an adequate treatment regimen. Maprotiline, like tricyclic antidepressants, can provoke the development of drug-induced (delirious) psychoses in predisposed patients and in elderly patients, especially at night. Psychosis usually resolves on its own within a few days after discontinuation of the drug.

Sudden withdrawal or sharp reduction in the dose of Ludiomil® should be avoided, as this may lead to the development of withdrawal syndrome. The drug should be discontinued gradually, as quickly as the clinical situation allows. It should be borne in mind that abrupt withdrawal of the drug may be accompanied by the development of certain symptoms.

Electroconvulsive therapy during the period of use of the drug Ludiomil® should be carried out only with careful monitoring of the patient. Although there are only isolated reports of changes in the number of leukocytes in peripheral blood during treatment with the drug, periodic monitoring of this indicator and vigilance for symptoms such as fever and sore throat are nevertheless necessary. Following these recommendations is especially important in the first months of treatment and during long-term therapy with Ludiomil®.

During long-term therapy with Ludiomil®, it is recommended to regularly monitor liver and kidney function indicators.

Ludiomil® should be used with caution in patients with a history of increased intraocular pressure, severe chronic constipation or urinary retention, especially with prostatic hyperplasia. Since maprotiline exhibits some of the properties of tricyclic antidepressants, it should be taken into account that tricyclic antidepressants may contribute to the development of paralytic ileus, especially in elderly patients or in hospitalized patients. Therefore, if the patient experiences constipation, appropriate measures must be taken. During therapy with Ludiomil®, the m-anticholinergic action characteristic of tricyclic antidepressants cannot be excluded: a decrease in tear production and a relative increase in the amount of mucus in the tear fluid, which can lead to damage to the corneal epithelium in patients using contact lenses. The drug Ludiomil® should be used with caution in patients with hyperthyroidism, as well as in those taking thyroid hormone medications (an increase in the frequency of adverse reactions from the heart is possible).

Increased incidence of dental caries has been reported with long-term treatment with antidepressants. In this regard, during long-term therapy, systematic dental examinations are recommended.

Before performing general or local anesthesia, the anesthesiologist should be warned that the patient is receiving the drug Ludiomil®. Continuing treatment with Ludiomil® appears to be safer compared to those disorders that may occur as a result of sudden discontinuation of the drug before surgery.

Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions

Patients who experience blurred vision, dizziness, drowsiness or other disorders of the central nervous system while using the drug Ludiomil® should not drive vehicles or operate machinery or engage in potentially hazardous activities.

Side effects

When treated with Ludiomil, transient or mild negative effects may develop. They usually go away after stopping the drug or adjusting the dosage.

Often, undesirable effects can coincide with the symptoms of the underlying disease, so recognizing them is quite difficult. The most common side effects are: feeling tired, agitation, sleep disturbances, anxiety, constipation, dry mouth, headaches, tremors and others. Therefore, when during treatment there is an increase in symptoms characteristic of a depressive state, it is necessary to exclude the possibility of the development of undesirable actions.

There are also disturbances in the activity of the cardiovascular, digestive, endocrine, respiratory and other systems and organs.

Ludiomil

From the nervous system: loss of the ability to adequately react emotionally, headache, dizziness, small-scale tremor, myoclonus, epileptic seizures, ataxia, dysarthria, weakness, paresthesia, blurred visual perception, accommodation paresis, hearing loss, increased fatigue, lethargy, drowsiness, sleep disturbances, agitation, anxiety, nightmares, confusion, delirious psychosis, hallucinations, hypomanic and manic states, taste disturbances.

From the digestive system: dry mouth, nausea, vomiting, constipation, increased activity of “liver” transaminases, hepatitis (with and without jaundice), diarrhea.

From the cardiovascular system: orthostatic hypotension, tachycardia, arrhythmias, intraventricular conduction disturbances, palpitations, increased blood pressure, fainting.

Allergic reactions to the components of the drug: skin rash, urticaria (in some cases with fever), acute vasculitis, itching, purpura, photosensitivity, edema (local or generalized), allergic alveolitis (with or without concomitant eosinophilia).

From the endocrine system: rarely - gynecomastia, galactorrhea.

Laboratory indicators: leukopenia, agranulocytosis, eosinophilia.

Other: weight gain, sexual deviations, swelling of the testicles, baldness, stomatitis, dental caries.

Anticholinergic effects: dry mouth, blurred vision, accommodation paresis, urinary retention, constipation, feeling of heat.

Overdose. Symptoms: depression or stimulation of the central nervous system (drowsiness, anxiety, ataxia, convulsions, stupor, hyperpyrexia, coma), pronounced anticholinergic effects (tachycardia, arrhythmias, decreased blood pressure, depression of the respiratory center).

Treatment: There is no special antidote. In case of overdose, gastric lavage should be done. The patient must be hospitalized. If respiratory depression occurs, artificial respiration should be performed immediately. If vascular collapse occurs, plasma substitutes should be administered. If heart failure develops, administer a drip infusion of dopamine or dobutamine. For arrhythmia that has developed against the background of metabolic acidosis and low concentration of K+ in the blood serum, intravenous administration of sodium bicarbonate and K+ salts is effective. When seizures occur, diazepam is effective.

Instructions for use Ludiomil (Method and dosage)

As the instructions for use of Ludiomil indicate, during the treatment period, patients must be under strict supervision of medical staff. Usually the drug is used for intravenous administration, but if the effect is insufficient, it is prescribed orally.

The treatment regimen is selected individually, taking into account the patient’s condition, his characteristics and tolerability of the drug.

The recommended daily dosage can vary between 25-100 mg.

Abrupt discontinuation of the drug is unacceptable, as this may increase the severity of adverse reactions.

Reviews

Olga M., patient : “I suffered from an anxiety disorder and panic attacks, which was accompanied by a constant decrease in mood. The doctor prescribed me ludiomil because amitriptyline and its analogues did not suit me. The medicine helped me get rid of anxiety and panic, my mood improved significantly. I didn’t notice any side effects.”

Pavel K., patient : “I took Ludiomil for a short time. It was prescribed to me for long-term depression. The medicine didn't work for me. The drug helped reduce blood pressure to 80/40 mmHg. I had to stop taking it and replace it with another antidepressant.”

Doctor's review : “Lyudiomil is a good remedy in the fight against depression of any etiology. It can be prescribed both on an outpatient basis and in a hospital setting. The danger lies in the risk of seizures even in those patients who have no history of them. As a result, it is not recommended to take the drug uncontrolled and increase the dosage on your own.”

Content

Interaction

Taking Ludiomil with CYP2D6 inhibitors and antipsychotics significantly increases the concentration of maprotiline . However, simultaneous treatment with MAO inhibitors is contraindicated, as severe adverse reactions may develop.

Combination with sulfonylurea derivatives and insulin can lead to hypoglycemic effects. Therefore, patients with diabetes require regular monitoring of blood . Ludiomil enhances the effect of some anticholinergic drugs, for example, Atropine , phenothiazines, Biperiden , antiparkinsonian and antihistamine drugs.

It has been established that this drug can reduce the antihypertensive effect of Quinidine, Betanidine, Clonidine , Reserpine and Alpha-methyldopa. When simultaneously treating arterial hypertension , it is necessary to take medications of other classes, for example, diuretics, vasodilators or beta-blockers , which do not undergo pronounced biotransformation. Abrupt withdrawal of Ludiomil often significantly lowers blood pressure .

In combination treatment with Adrenaline, Norepinephrine, Isoprenaline, Ephedrine and Phenylephrine , which are included in some nasal drops or anesthetics , an increase in cardiovascular disorders and so on was noted.

Contraindications

The drug is contraindicated in patients who have:

  • Decompensated chronic diseases of internal organs;
  • Kidney or liver failure;
  • Prostate adenoma;
  • Increased intraocular pressure;
  • History of epileptic seizures.

In addition, the drug is not prescribed in the first trimester of pregnancy, during lactation, or in children under 15 years of age. It is not recommended to combine ludiomil with monoamine oxidase inhibitors, hypnotics and sedatives.

Analogues of Ludiomil

Level 4 ATC code matches:
Doxepin

Ladisan

Melipramine

Anafranil

Amitriptyline

The main analogues of Ludiomil are represented by the following drugs: Maprotibene and Maprotiline.

Reviews about Ludiomil

In most cases, reviews of Ludiomil are found on forums where users actively discuss the effectiveness of the drug and cases of side effects. As a rule, during the treatment process, many patients note an improvement in mood, a cheerful state, and a feeling of lightness. At the same time, they say that almost all the symptoms of somatic disorders that cause depression disappear.

As for side effects, in addition to weakness, drowsiness , lethargy and headaches, weight gain often occurs. This problem worries both men and women, although in general the treatment is very effective.

Some patients report that they cannot find the drug in pharmacies in their city, so they believe that Ludiomil has been discontinued or has simply been banned from production. But according to experts, the production of this drug continues.

It should be noted that Ludiomil is a highly effective antidepressant. But the drug has a strong effect on the body, so it is necessary to follow the exact dosage and therapeutic regimen. Only with this approach can significant improvements in health be achieved.

Compound

Ludiomil is the trade name of the drug. Its active ingredient is the heterocyclic antidepressant mapro tilin . Maprotiline and ludiomil are essentially synonymous words. The dosage of maprotiline in the drug composition corresponds to that indicated on the packaging.

In addition to maprotiline, the composition includes excipients. The tablets contain the following components: lactose, starch, talc, stearate, polysorbate and compounds of inorganic substances. The infusion concentrate contains mannitol, methanesulfonate and water for injection. Excipients are contained in the drug in small quantities, therefore they do not affect the human body.

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