Melatonin
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Clinical Pharmacology
Melaxen is an adaptogenic drug, a chemical analogue of the biogenic amine melatonin.
Synthesized from plant-derived amino acids. The chemical formula is N-acetyl-5-methoxytryptamine, molecular weight 232. It is dissolved in water, alcohol, lipids.
It is a synthetic analogue of the hormone pineal gland. Normalizes circadian rhythms. Regulates the sleep-wake cycle, daily changes in motor activity and body temperature. It contributes to the normalization of night sleep: speeds up sleep, improves the quality of sleep, reduces the number of nightly awakenings, improves health after a morning awakening, does not cause a feeling of lethargy, weakness and fatigue upon waking, dreams become more vivid and emotionally saturated.
Adapts the body to the rapid change of time zones, reduces stress reactions. Shows immunostimulating and pronounced antioxidant properties.
It inhibits the secretion of gonadotropins and to a lesser extent - other hormones of the adenohypophysis (corticotropin, thyrotropin and somatotropin). Not addictive and addictive.
Indications
- As a hypnotic.
- As an adaptogen for the normalization of biological rhythms.
Composition
1 coated tablet contains:
active substance: melatonin 3 mg.
Excipients: disubstituted calcium phosphate, microcrystalline cellulose, magnesium stearate, talc, pharmaceutical glaze, isopropyl alcohol.
Melatonin is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Melaxen | Unipharm | USA | pills |
pills | |||
Sonnovan | pills | ||
Melaritm | Obolensky OP | Russia | pills |
Melarena® | Makiz-Pharma | Russia | pills |
Sonnovan | Canonpharma | Russia | pills |
Circadin | SwissCo Services | Switzerland | pills |
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Dosage and Administration
For oral use, 30–40 minutes before bedtime. Adults take 0.5–1 tablet once a day. As an adaptogen when changing time zones - 1 day before the flight and for the next 2–5 days - 1 tablet per day. The maximum daily dose is up to 2 pills per day.
Adverse reactions
When used in physiological doses, adverse reactions are rare. Along with melatonin intake, allergic reactions, edema (in the first week of administration), headache, nausea, vomiting, diarrhea, and morning drowsiness are described.
Contraindications
- Severe renal dysfunction.
- Autoimmune diseases.
- Leukemia.
- Lymphoma.
- Allergic reactions.
- Lymphogranulomatosis.
- Myeloma.
- Epilepsy.
- Diabetes.
- Chronic renal failure.
- Pregnancy.
- Lactation period (breastfeeding).
- Hypersensitivity to the drug.
Drug interactions
With simultaneous use of melatonin enhances the effect of drugs that have a depressant effect on the central nervous system, and beta-blockers.
Not recommended in conjunction with hormonal drugs.
Not compatible with inhibitors of MAO, corticosteroids and cyclosporine.
Pregnancy and Lactation
The drug is contraindicated for use during pregnancy and lactation (breastfeeding).
Special instructions
It is necessary to inform women who want to become pregnant about the presence of a weakly expressed contraceptive action.
During the period of use of the drug should avoid exposure to bright light.
Contraindicated in severe renal impairment and chronic renal failure.
During the period of treatment, it is necessary to refrain from driving vehicles and other occupations of potentially hazardous activities that require high concentration of attention and speed of psychomotor reactions.
Overdosage
Symptoms: increased severity of side effects.
Treatment: gastric lavage, symptomatic therapy.
- Brand name: Melaxen
- Active ingredient: Melatonin
- Dosage form: Pills
- Manufacturer: Unipharm
- Country of Origin: USA
Studies and clinical trials of Melatonin (Click to expand)
- Identification, distribution, and developmental changes of a melatonin binding site in the song control system of the zebra finch
- Central melatonin receptors in the rainbow trout: Comparative distribution of ligand binding and gene expression
- Melatonin receptors in benign prostate epithelial cells: Evidence for the involvement of cholera and pertussis toxins–sensitive G proteins in their signal transduction pathways
- Cross talk between melatonin and TGF?1 in human benign prostate epithelial cells
- Pinealectomy, melatonin, and courtship behavior in male red-sided garter snakes (Tahmnophis sirtalis parietalis)
- Influence of melatonin on gonad maturation inLineus lacteus (Heteronemertini, Lineidae)
- Putative melatonin receptors in the blind mole rat Harderian gland
- Melatonin and 5-methoxytryptamine induced muscular contraction in sea anemones
- Direct influence of melatonin on the thyroid and comparison with prolactin
- Melatonin induction of filamentous structures in non-neuronal cells that is dependent on expression of the human mt1 melatonin receptor
- Immunocytochemical localization of melatonin in the harderian gland of Syrian hamster
- Effect of exogenous melatonin on the onset of puberty in female albino rats
- Low ACTH and high melatonin concentrations in amniotic fluid as hormonal markers of high risk of fetal abnormalities. Preliminary studies
- Metastable ion studies in the characterization of melatonin isomers
- Circadian photic regulation of melatonin receptor density in rat suprachiasmatic nuclei: Comparison with light induction of fos-related protein
- Enhanced glial cell line-derived neurotrophic factor mRNA expression upon (−)-deprenyl and melatonin treatments
- Melatonin protects hippocampal neurons in vivo against kainic acid-induced damage in mice
- Iron decreases the nuclear but not the cytosolic content of the neurohormone melatonin in several tissues in chicks
- Inhibition of cerebellar nitric oxide synthase and cyclic GMP production by melatonin via complex formation with calmodulin
- Studies on the antiinflammatory, immunoregulatory, and analgesic actions of melatonin
- Melatonin attenuates methamphetamine-induced toxic effects on dopamine and serotonin terminals in mouse brain
- Melatonin: Receptor-mediated events that may affect breast and other steroid hormone–dependent cancers
- Prophylactic effect of melatonin on lead-induced inhibition of heme biosynthesis and deterioration of antioxidant systems in male rats