Melitor

Melitor – drug with antidepressive action.

Form of release and structure

Melitor release in the form of tablets, film coated: oblong, orange-yellow, from blue color a print of a logo of firm on one party (on 14 pieces in blisters, on 1, 2 or 4 blisters in a cardboard pack).

Is a part of 1 tablet:

• Active agent: агомелатин – 25 mg;
• Auxiliary components: monohydrate of lactose, corn starch, povidone, sodium starch glycollate (type A), stearic acid, magnesium stearate, anhydrous colloid silicon dioxide;
• Film cover: глицерол, gipromelloza, iron oxide yellow (E172), macrogoal, magnesium stearate, titanium dioxide (E171);
• Ink: propylene glycol, shellac, indigotinovy (E132) aluminum varnish.

Indications to use

Melitor appoint for treatment of big depressive episodes at adults.

Contraindications

Absolute:

• Functional disturbances of a liver (active diseases of a liver or cirrhosis);
• Rare hereditary diseases: intolerance of a galactose, deficit of lapp lactase or disturbance of absorption of glucose galactose;
• Concomitant use with powerful CYP1A2 inhibitors (fluvoksaminy, ciprofloxacin);
• Hypersensitivity to drug components.

Relative (in connection with limited clinical data it is necessary to be careful during Melitor's reception):

• Moderate or heavy functional disturbances of kidneys;
• Advanced age;
• Pregnancy.

At Melitor's use during a lactation breastfeeding is recommended to be interrupted.

Children are not recommended to carry out therapy (it is connected with lack of data on efficiency and safety of use of drug for this category of patients).

Route of administration and dosage

Melitor accept inside, irrespective of meal, before going to bed.

The recommended single dose makes 25 mg (1 tablet), frequency rate of reception – once a day.

If in 14 days of use of drug the insufficient effect is observed, the single dose can be increased twice.

During therapy it is necessary to control function of a liver: at the beginning of use, then periodically – at the end of an acute phase (approximately in 6 weeks), at the end of a phase of a maintenance therapy (in 12 and 24 weeks), further – according to clinical indications.

Treatment needs to be continued throughout sufficient time, but it is not less than 6 months to be convinced that disease symptoms completely disappeared.

The gradual dose decline at the end of therapy is not required.

Side effects

The side reactions arising during therapy usually have easy or moderate temper and develop for the first 2 weeks of administration of drug. Development of nausea and dizziness is most often noted (as a rule, these disturbances take place independently and cancellations of therapy do not demand).

In certain cases it is difficult to distinguish symptoms of a disease from the side effects connected with administration of drug.

During Melitor's reception the following side effects can develop (≥1/10 – very often; ≥1/100, <1/10 – часто; ≥1/1000, <1/100 – нечасто; ≥1/10 000, <1/1000 – редко; <1/10 000 – очень редко; при невозможности провести оценку на основании имеющихся данных – с неизвестной частотой):

• Nervous system: often – migraine, sleeplessness, drowsiness, a headache, dizziness; infrequently – paresthesia;
• Alimentary system: often – nausea, a lock, diarrhea, pains in an upper part of a stomach;
• Musculoskeletal system: often – a dorsodynia;
• Liver and gall bladder: often – increase in activity of aspartate aminotransferase and/or alaninaminotranspherase; seldom – hepatitis, increase in activity gamma глутамилтрансферазы;
• Integuments and hypodermic fabric: often – a hyperhidrosis; infrequently – an itch, eczema; seldom – erythematic rashes;
• Organ of sight: infrequently – disturbances of clearness of sight;
• Mentality: often – alarm; infrequently – dreadful dreams, agitation and symptoms (concern, irritability) relating to it, aggression, unusual dreams; seldom – a mania and/or a hypomania (can be manifestations of a basic disease), hallucinations; with an unknown frequency – suicide thoughts or behavior;
• Others: often – fatigue.

Special instructions

It is not recommended to carry out therapy of big depressive episodes at elderly patients with dementia as safety and Melitor's efficiency at such patients is not established.

In the presence in the anamnesis of a mania or hypomania during treatment it is necessary to be careful. At development of maniacal symptoms therapy should be interrupted.

The depression can be followed by the increased risk of emergence of suicide thoughts, drawings to itself injuries and a suicide (the events connected with a suicide). The risk of emergence of these symptoms remains until approach of significant remission. In certain cases improvement does not occur in the first a little and more weeks of therapy therefore before improvement behind a condition of the patient it is necessary to conduct careful observation. As the general clinical practice shows, at early stages of recovery the risk of development of a suicide can increase.

Patients with existence in the anamnesis of the events connected with a suicide, and also patients with the significant level of suicide thoughts prior to treatment are more subject to risk of suicide thoughts or attempts of a suicide during Melitor's reception. In this regard behind them it is necessary to conduct careful observation, in particular at early stages of treatment and at changes of a dose.

Simultaneous use with powerful CYP1A2 inhibitors contraindicated, at appointment (propranolol, грепафлоксацин, эноксацин) it is necessary to be careful with moderate CYP1A2 inhibitors as it can lead to increase in exposure of an agomelatin.

At conduct of clinical trials increase in content of transaminases in blood serum was noted, especially at Melitor's use in a daily dose of 50 mg (usually after the end of therapy these values are returned to norm). At all patients it is necessary to control function of a liver. At the increased content of transaminases in blood serum analyses of function of a liver should be carried out repeatedly within 48 hours. At increase in content of transaminases in blood serum by 3 times in comparison with the upper bound of norm therapy should be stopped.

If before Melitor's reception at patients the level of transaminases is increased (exceeding of the upper bound of norm less than by 3 times), therapy should be carried out with care.

In the presence of the symptoms indicating abnormal liver functions it is necessary to carry out analyses on the basis of which it is possible to make the decision on expediency of performing treatment. When developing jaundice Melitor it is necessary to cancel.

Therapy needs to be carried out with care with risk factors of injury of a liver, including obesity, not alcoholic fatty alcoholic disease of a liver, considerable consumption of alcohol or a concomitant use with the drugs having a hepatotoxic action.

Simultaneous use with ethanol is not recommended.

During Melitor's reception it is necessary to manage motor transport and other mechanisms with care.

Medicinal interaction

At simultaneous use of Melitor with some medicines there can be following effects:

• The drugs interacting with isoenzymes of CYP1A2 and CYP2C9/19: reduction or increase in bioavailability of an agomelatin;
• Fluvoksamin, ciprofloxacin: the expressed inhibiting effect on metabolism of an agomelatin (the combination is contraindicated);
• Estrogen: increase in exposure of an agomelatin (it is necessary to be careful).

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C.

Period of validity – 3 years.