Melitor (agomelatine) coated tablets 25 mg. №28

Description

Melitor composition
active substance: agomelatine;
1 tablet contains: 25 mg of agomelatine;
excipients: lactose monohydrate; corn starch; povidone; sodium starch glycolate (type A); stearic acid; magnesium stearate; colloidal anhydrous silica; hypromellose; iron oxide yellow (E 172); glycerin; macrogol 6000; titanium dioxide (E 171).

Dosage form
Film-coated tablets.

Pharmacological properties
The specified drug Melitor belongs to psychoanaleptics.
The active substance is a melatonergic agonist of MT1 and MT2 receptors and an antagonist of 5-HT2c receptors. The drug does not affect the uptake of monoamines and has no affinity for α- and β-adrenergic receptors, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors.
The drug has resynchronizing properties with respect to circadian rhythms. Under its influence, the release of dopamine and norepinephrine into the frontal parts of the cerebral cortex increases. No effect on extracellular serotonin levels was recorded.
The highest content of the drug is achieved in 1-2 hours. Food with a high fat content affects the metabolism of the drug.

Indications
Melitor is indicated for the treatment of serious depressive conditions.

Contraindications
The drug in question is contraindicated for use in cases where the patient has severe hypersensitivity (allergy) to the main or to one of the auxiliary components.
The drug has the following contraindications:

• dysfunction of the liver (cirrhosis of the liver or active phase of liver disease) or an increase in the level of transaminases by more than 3 times from the upper limit of the norm;
• use in combination with CYP1A2 inhibitors (fluvoxamine, ciprofloxacin).

Children
The drug is not used in pediatrics.

Application during pregnancy and lactation
This drug is not recommended for pregnant women – only under strict indications, determined by the attending physician.
If it is necessary to take the drug during breastfeeding, lactation is suspended.

Method of administration and dosage
The recommended dose of Melitor is 25 mg once a day, before bedtime.
If, 2 weeks after the start of therapy, the improvement of the clinical condition is not enough, the dose can be increased to 50 mg once a day, that is, 2 tablets of 25 mg, which must be taken simultaneously before bedtime.
When deciding to increase the dose, the increased risk of an increase in transaminase levels should be taken into account. An increase in the dose to 50 mg should be carried out on an individual basis for each patient after assessing the “benefit / risk” indicator with mandatory liver tests.

Overdose
In case of an overdose, the following symptoms may occur:

• pain in the epigastric region;
• drowsiness;
• fatigue; agitation;
• anxiety;
• tension;
• dizziness;
• cyanosis or malaise.

Side effects
The drug is usually well tolerated when used in the recommended doses.
The following reactions can be observed:

• dizziness;
• insomnia;
• migraine;
• paresthesia;
• restless legs syndrome;
• nausea, diarrhea, constipation, vomiting;
• increased ALT and / or AST levels;
• backache;
• delay in urination;
• fatigue;
• increase in body weight.

Storage conditions and periods
Expiration date – up to 3 years from the production date indicated on the package. Storage periods should not be exceeded.
Storage temperature should not exceed 25 ° C. Temperature deviations can change the properties of the preparation, therefore it should always be stored in its original packaging.