Instruction for use: Ludiomil

Dosage form: coated tablets

Active substance: Maprotiline*

ATX

N06AA21 Maprotiline

Pharmacological group:

Antidepressants

Composition and release form

Tablets covered with a film membrane 1 tab.

Maprotiline hydrochloride 10 mg; 25 mg

auxiliary substances: lactose monohydrate; corn starch; calcium phosphate; silicon dioxide colloidal anhydrous; talc; magnesium stearate; stearic acid; hydroxypropylmethylcellulose (hypromellose); titanium dioxide; polysorbate 80; iron oxide is yellow; iron oxide red (tablets of 25 mg)

in a blister of 10 pcs .; in a pack of cardboard 3, 5 or 10 blisters.

Concentrate for the preparation of a solution for infusions 5 ml (1 amp.)

Maprotiline methanesulfonate 25 mg

auxiliary substances: mannitol (mannitol), free from pyrogenic substances; methanesulfonic acid; water for injections

in the ampoule 5 ml; in a pack of cardboard 10 ampoules.

Pharmachologic effect

Pharmacological action - antidepressant.

Dosing and Administration

Inside, swallowing whole and with enough liquid.

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 and a decrease in the daily, or the appointment of the entire daily dose in the afternoon at 1 reception.

After a significant decrease in the severity of symptoms, a reduction in the dose of the drug is possible. However, with worsening of the patient's condition against the background of a dose reduction, the dose of the drug should immediately be increased to the initial level. The goal of the treatment is to achieve a therapeutic effect by applying the minimum effective dose of the drug. This is especially important in adolescents and elderly patients with unstable autonomic nervous system, in the treatment of which undesirable side reactions are more often noted.

The maximum daily dose of the drug is 150 mg.

The drug Ludomil® is prescribed 25 mg 1-3 times daily or in a dose of 25-75 mg once a day, depending on the severity of the symptoms and the effect of treatment. If necessary, the daily dose can be gradually increased to a maximum of 150 mg, in one or more doses, depending on the tolerability and the clinical effect. The efficacy and safety of treatment with Ludomil® for children and adolescents (under the age of 18) has not been established. The use of Ludomil® in this age group is not recommended.

For older patients, the drug should be given in smaller doses. 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 slowly and gradually increased to 25 mg 3 times daily or up to 75 mg once a day, depending on the tolerability and clinical effect.

IÌ, in the form of infusions (in case of insufficient effect when taking the drug inside or in case of refractory to oral therapy of depression).

The dosage regimen should be selected individually, changing it taking into account the patient's condition and its reaction to the drug.

The recommended daily dose is 25 to 100 mg.

To prepare an infusion solution from 25 to 50 mg (1-2 amp content - 5-10 ml concentrate), dilute 250 ml isotonic sodium chloride solution or glucose. The duration of infusions is from 1.5 to 2 hours.

In cases where a higher dose of 75 to 150 mg is required (content 3-6 amp), the volume of the dilution solution should be 500 ml, and the duration of the infusion is 2 to 3 hours.

As soon as there is a clear positive dynamics of symptoms (usually within 1-2 weeks), it is necessary to switch to the appointment of the drug inside.

Patients older than 60 years, as a rule, the recommended dose for starting therapy is 1 amp. (25 mg) diluted with 250 ml of physiological saline or glucose solution administered as infusions for 1.5 to 2 hours. If necessary, depending on the tolerability of the Ludomil® preparation and the patient's response to treatment, the daily dose can be gradually increased to contents 2 or 3 amp. (ie, 50 or 75 mg) diluted from 250 to 500 ml of saline or glucose solution administered as infusions for 2 to 3 hours.

Do not abruptly cancel the drug or drastically reduce the dose due to possible adverse reactions.

Storage conditions for Ludiomil

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life of Ludiomil

5 years.

Do not use after the expiry date printed on the package.