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Pharmacological properties

Vita-melatonin is a synthetic analogue of melatonin, a neuropeptide produced by the pineal gland (pineal gland). the main effect of vita-melatonin is inhibition of the secretion of gonadotropins. to a lesser extent, the drug inhibits the secretion of other hormones of the adenohypophysis - corticotropin, thyrotropin, growth hormone. in addition, the content of gamma and serotonin in the midbrain and hypothalamus increases.

The above processes contribute to the normalization of circadian rhythms, the change of sleep and wakefulness, the rhythm of gonadotropic effects and sexual function, increase mental and physical performance, reduce the severity of stress reactions.

The drug has antioxidant properties, which determines its membrane-stabilizing effect. It normalizes the permeability of the vascular wall and increases its resistance to damaging factors, improves microcirculation.

The drug improves only the impaired functional state of the endothelium, without affecting its normal function. Melatonin reduces systolic blood pressure and heart rate in elderly patients at rest, reduces high blood pressure during psycho-emotional stress. The drug normalizes the autonomic nervous regulation of the cardiovascular system mainly in the night period, which helps to improve the disturbed circadian blood pressure profile.

Vita-melatonin, stimulating the reaction of cellular immunity, has an immunomodulatory effect on the body.

Pharmacokinetics After ingestion, melatonin undergoes a significant transformation during the initial passage through the liver. The bioavailability of the drug is 30-50%. When taken orally at a dose of 3 mg Cmax in blood plasma and saliva is achieved after 20 and 60 minutes, respectively.

Melatonin penetrates the BBB, is determined in the placenta. Medium T½ melatonin is 45 min. Excreted by the kidneys.

Indications

Vita-melatonin is used for the prophylaxis and treatment of circadian rhythm sleep-wake disorders with changing time zones, which are manifested by increased fatigue; sleep disorders, including chronic insomnia of functional origin, insomnia in the elderly (including with concomitant ag and hypercholesterolemia); to increase mental and physical performance, as well as the elimination of stressful reactions and depressive states of a seasonal nature. increased hell and hypertension (stage I – II) in elderly patients (as part of complex therapy).

Application

For treatment, Vita-melatonin is prescribed to adults at a dose of 3-6 mg (1-2 tablets) per day for 30 minutes at bedtime every day, preferably at the same time.

The course of treatment is continued until the physiological rhythm of "sleep – wakefulness" is restored, but not more than 1 month.

For prophylactic purposes, the dose of the drug and the duration of its use are determined by the doctor depending on the individual characteristics of the patient and the course of the disease. Usually, 1-2 tablets are prescribed per day for 30 minutes before bedtime, preferably at the same time every day for 2 months with a week break between courses (course of use - 1 month).

For the treatment of chronic sleep disorders (including concomitant hypertension and / or hypercholesterolemia) in elderly patients, the drug is prescribed in a minimum effective dose of 1.5 mg (½ tablet) once a day 30 minutes before bedtime. With insufficient effectiveness, the dose is increased to 3 mg. Drug withdrawal should be carried out gradually, reducing the dose within 1-2 weeks.

In the same way, the drug is taken with high blood pressure and hypertension, elderly patients. The drug can be used for 3–6 months at intervals of 1 week between monthly courses of treatment.

Renal failure.There are no studies regarding the effect of varying degrees of renal failure on the pharmacokinetics of melatonin, so melatonin should be used with caution in such patients.

Impaired liver function. There is no experience with the use of melatonin in patients with impaired liver function. Published data indicate markedly increased levels of endogenous melatonin in the daytime as a result of reduced clearance in such patients. Therefore, melatonin is not recommended for patients with impaired liver function.

Contraindications

Hypersensitivity to the components of the drug, autoimmune diseases, lymphogranulomatosis, leukemia, lymphoma, myeloma, epilepsy, diabetes mellitus, the simultaneous use of inhibitors of MAO, corticosteroids, cyclosporine.

Side effects

In some cases, when using the drug, adverse reactions can be noted.

Infections and infestations: herpes zoster.

On the part of the blood and lymphatic system: leukopenia, thrombocytopenia.

From the cardiovascular system: angina pectoris, palpitations.

From the psyche: irritability, irritability, anxiety, insomnia, unusual dreams, mood changes, aggressiveness, agitation, tearfulness, early morning awakening, increased libido, depression.

From the side of the central nervous system: migraine, increased psychomotor activity, dizziness, drowsiness, memory impairment, impaired attention, impaired sleep quality, paresthesia.

From the side of the organ of vision: decreased visual acuity, blurred vision, increased lacrimation.

On the part of the organ of hearing and the vestibular apparatus: dizziness with a change in body position.

Vascular disorders: flushing.

From the digestive system: abdominal pain, constipation, dry mouth, ulceration of the oral cavity, vomiting, abnormal intestinal noise, flatulence, increased secretion of saliva, halitosis, gastroesophageal reflux.

From the side of metabolism: hypertriglyceridemia, hypocalcemia, hyponatremia.

On the part of the hepatobiliary system: hyperbilirubinemia, increased activity of hepatic enzymes, impaired liver function, abnormal data from laboratory tests.

On the part of the skin and subcutaneous tissue: night sweating, dermatitis, eczema, erythema, rash, itching, dry skin, psoriasis, damage to the nails.

On the part of skeletal muscles and connective tissue: pain in the limbs, muscle cramps, neck pain, arthritis.

From the genitourinary system: glucosuria, proteinuria, menopausal symptoms, polyuria, hematuria, nocturia, priapism, prostatitis.

Common disorders: asthenia, chest pain, fatigue, thirst.

Other disorders: weight gain, changes in electrolyte balance.

special instructions

Do not use in women planning a pregnancy, in connection with some contraceptive effect of melatonin.

When using Vita-melatonin, bright lighting should be avoided.

In patients with cirrhosis, the level of metabolism of melatonin is reduced, therefore, it is necessary to use the drug in these patients with caution.

The drug can be used in patients with high blood pressure (especially systolic) and hypercholesterolemia. With prolonged use, Vita-melatonin reduces the level of cholesterol in patients with hypercholesterolemia, but does not affect the level of cholesterol with its normal content in the blood plasma. The drug reduces the level of insulin and glucose in blood plasma, so it can be used in patients with hypertension and hypercholesterolemia, accompanied by insulin resistance (HOMA index 3).

With caution is prescribed for hormonal disorders and / or hormonal therapy, as well as for patients with allergic diseases.

Melatonin causes drowsiness.With caution, the drug should be used if probable drowsiness may be associated with a risk or danger to the patients health.

It is not recommended for use in autoimmune diseases.

Patients with hereditary diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galatose malabsorption should not use this drug.

The simultaneous use of alcohol reduces the effectiveness of melatonin.

Use during pregnancy and lactation. The drug is not used during pregnancy and lactation due to the lack of clinical data.

Children. There is no experience with the use of the drug in childhood.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Given that the drug causes drowsiness, while taking the drug should refrain from driving vehicles and performing other work requiring attention.

Interactions

Drugs that block β-adrenergic receptors, clonidine, dexamethasone, fluvoxamine and some other drugs can alter the secretion of endogenous melatonin.

Vita-melatonin can affect the effectiveness of hormonal drugs (estrogens, androgens, etc.), increase the binding of benzodiazepines to specific receptors, so their simultaneous use requires medical monitoring.

Melatonin can enhance the sedative properties of benzodiazepines and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. Clear evidence has been obtained of the pharmacodynamic interaction of melatonin and zolpidem 1 h after combined use. The simultaneous use leads to a more pronounced violation of attention, memory and coordination compared with the use of zolpidem alone.

Vita-melatonin may potentiate the antitumor effect of tamoxifen.

The dopaminergic and serotonergic effects of methamphetamine can be enhanced while it is used with Vita-melatonin.

Vita-melatonin can potentiate the antibacterial effect of isoniazid.

Melatonin can be used with lisinopril in concomitant antihypertensive therapy in patients with functional pineal gland insufficiency, enhancing its effect.

In accordance with existing observations, melatonin induces CYP 3A in vitro at concentrations exceeding therapeutic. The clinical significance of this result is unknown. The occurrence of induction can cause a decrease in plasma concentrations of drugs that are administered in parallel.

Fluvoxamine increases the level of melatonin by inhibiting its metabolism by the hepatic isoenzymes CYP 1A2 and CYP 2C19 of cytochrome P450 (CYP). This combination should be avoided.

Patients receiving 5- or 8-methoxypsoralen, which increases plasma levels of melatonin by inhibiting its metabolism, should be closely monitored.

Patients receiving cimetidine, a CYP 2D inhibitor that increases plasma levels of melatonin by inhibiting its metabolism, should be closely monitored.

Smoking can reduce melatonin levels by inducing CYP 1A2.

Patients receiving estrogens (such as contraceptives or hormone replacement therapy) should be carefully monitored because melatonin levels increase due to inhibition of its metabolism of CYP 1A1 and CYP 1A2.

CYP 1A2 inhibitors, such as quinolones, can help enhance the effects of melatonin.

CYP 1A2 inducers, such as carbamazepine and rifampicin, can help lower plasma melatonin concentrations.

Overdose

Cases of overdose of melatonin are described (simultaneous administration of 24-30 mg of melatonin). with an overdose, disorientation, prolonged sleep, anterograde memory loss may develop. symptomatic therapy.

Storage conditions

In the original packaging at a temperature not exceeding 25 ° C.

Tags: Melatonin