Instructions for Melatonin 3 mg
Release Form:
Film wrapped tablets
Description:
Pills covered with a film shell of white or almost white color, round, double-bulged, with a risk on one side; On the cross-section of the kernel the white or almost white tablets.
1 tab
melatonin 3 mg
Auxiliary substances: cellulose microcrystalline 102 - 48.5 mg, sodium carboxymethyl starchmal - 6.5 mg, calcium hydrophosphate dihydrate - 41 mg, magnesium staarat - 1 mg.
Shell composition: hypomollosis - 1.53 mg, polysorbate 80 (twine 80) - 0.64 mg, talc - 0.51 mg, titanium dioxide (E171) - 0.32 mg.
ATX codes
N05CH01 Melatonin
Pharmacological groups / Group membership
Adaptogenous drug
Active substance
melatonin
Pharmacy Group
Adaptogenous
Retention Terms
The drug should be stored in a place not accessible to children, protected from light, at a temperature not exceeding 25°C.
Shelf life
Shelf life - 3 years.
Pharmaceuticals:
Synthetic analog of the hormone of the pineal body (epifis); has an adaptogenous, sedative, sleeping-pills effect. Normalizes circadian rhythms. Increases the concentration of gamma-amino oil acid (GAMC, GABA) and serotonin in the middle brain and hypothalamus, alters the activity of pyridoxalkinase involved in GAMC synthesis dopamine and serotonin. Regulates the sleep-waking cycle, daily changes of locomotor activity and body temperature, positively influences the intellectual-mnastic functions of the brain, emotional-personal sphere. It helps to organize the biological rhythm and normalize night sleep. Improves sleep quality, accelerates sleep, regulates neuroendocrine functions. Adapts the body of weather-sensitive people to changes in weather conditions.
Testimonials:
Sleep disorders, including sleep-waking disorders, such as desynchronosis (a sudden change in time zones).
Method of application, course and dosage:
Inside.
In case of sleep disturbance - 3 mg 1 time/day 30-40 minutes before sleep.
For desynchronosis as an adaptogen when changing time zones - 1 day before flight and in the following 2-5 days - 3 mg for 30-40 minutes before sleep.
Maximum daily dose - 6 mg.
Older patients: With age, melatonin metabolism decreases, which should be taken into account when choosing the dosage regime for older patients. Taking this into account in patients of old age, it is possible to take the drug 60-90 minutes before sleep.
Kidney failure: The influence of various levels of kidney failure on the pharmacokinetics of melatonin has not been studied, so melatonin should be applied with caution in such patients. Patients with severe kidney failure use of the drug is contraindicated.
Overdose:
Symptoms: According to available literary data, the use of melatonin in a daily dose of up to 300 mg did not cause clinically significant unwanted reactions. Hyperemia, abdominal spasms, diarrhea, headache and scotom were observed when using melatonin at doses of 3000-6600 mg for several weeks. When using very high doses of melatonin (up to 1 g), there was an involuntary loss of consciousness.
Overdosage may result in sleep.
Treatment: gastric washing and activated carbon, symptomatic therapy.
Intake of the active substance is assumed within 12 hours after taking in.
Drug Interaction:
Pharmaceutical Interaction
It is known that in concentrations significantly higher than therapeutic, melatonin induce the isoferment CYP3A in vitro. The clinical significance of this phenomenon has not been fully clarified. In the case of the development of induction symptoms, consideration should be given to reducing the dose of concurrent drugs.
In concentrations far exceeding therapeutic concentrations, melatonin does not induce the isoferments of the CYP1A in vitro group. Therefore, the interaction of melatonin with other drugs due to the influence of melatonin on the isoferments of the CYP1A group seems to be insignificant.
The metabolism of melatonin is mainly mediated by the isoferments of CYP1A. Therefore, it is possible to interact melatonin with other drugs due to the influence of melatonin on the isoferments of the group SYP1A.
Care should be taken with regard to patients taking fluwoksamine, which increases the concentration of melatonin (increase AUC by 17 times and Smax by 12 times) by inhibiting its metabolism by the isoferments of cytochromium P450: CYP1A2 and CYP2C19. Such a combination should be avoided.
Care should be taken with respect to patients taking 5- and 8-methoxypsoralen, which increases the concentration of melatonin due to the inhibiting of its metabolism.
Care should be taken with regard to patients taking cymetidin (CYP2D isoferment inhibitor), since it increases the content of melatonin in plasma by inhibiting the latter
Smoking can reduce the concentration of melatonin due to the induction of the isoferment CYP1A2.
Care should be taken with regard to patients taking estrogen (e.g. contraceptives or hormone replacement therapy), which increase the concentration of melatonin by inhibiting their metabolism by the CYP1A1 and CYP1A2 isoenates.
CYPA2 isoferment inhibitors, such as chinolones, are able to increase the exposure of melatonin.
Inductors of the CYP1A2 isoferment, such as carb
Pharmaceutical Interaction:
When taking melatonin, you should not use alcohol, because it reduces the effectiveness of the drug.
Melatonin potentiates sedative action of benzodiazepine and non-benzodiazepine sleeping aids, such as zolpid, zolpidem and zopiclon. The clinical study showed clear signs of transistor pharmacodynamic interaction between melatonin and zolpidem an hour after their acceptance. Combination application can result in progressive attention, memory and coordination disorders compared to the monotherapy of zolpidem.
In the course of research, melatonin was appointed jointly with thioridazin and imipramin, preparations that affect the CNS. No clinically significant pharmacokinetic interaction was detected in any of the cases. However, simultaneous use with melatonin increased the feeling of calm and caused difficulties in performing certain tasks compared to monotherapy by impramin, and also increased the feeling of "mind-blur" compared to monotherapy by thioridazin.
Use in pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and during breastfeeding.
Side Action
Classification of the frequency of side effects development according to WHO recommendations: very often (≥1/10), often (≥1/100 to <1/10), infrequently (≥1/1000 to <1/100), rarely (≥1/1000 to <1/1000), very rarely (<1/10 000), including individual communications; The frequency is unknown (it is not possible to determine the frequency of occurrence according to available data).
Infectious and parasitic diseases: seldom - the herpes.
On the side of the blood-circulation system and the lymph system: Rarely - leukopia, thrombocytopenia.
From the immune system: Frequency unknown - hypersensitivity reactions.
From metabolism and nutrition: seldom - hypertriglycerydia, hypocalyemia, hypoonatriemia.
Mental health disorders: Infrequently - irritability, nervousness, anxiety, insomnia, unusual dreams, nightmares, anxiety; Rarely - mood changes, aggression, excitement, plaxing, symptoms of stress, disorientation, early morning awakening, increased libido, reduced mood, depression.
On the side of the nervous system: Often - migraine, headache, sluggishness, psychomotor hyperactivity, dizziness, sleepiness; Rarely - fainting, memory disturbance, concentration disorder, delirium, "restless legs" syndrome, poor sleep quality, pastessia.
From the viewpoint: Rarely - reduced vision, blurred vision, increased tear.
On the part of the hearing organ and maze disorders: Rarely - vertical, positional vertical.
On the side of the cardiovascular system: not often - arterial hypertension; Rarely - Stenocardia of tension, feeling of heartbeat, tides.
On the LCT side: Infrequently - abdominal pain, abdominal pain in the upper abdomen, dysfunction, ulcerous dental, dry mouth, nausea; Rarely - gastroesophageal disease, gastrointestinal disorder or disorder, bull dental, ulcer gloss, vomiting, peristaltic strengthening, abdominal swelling, saliva hypersecretion , bad breath, abdominal di
Nozology (ICD codes)
F51.2
Sleep disorders and waking of inorganic etiology
G47.2
Sleep and waking disorders
