Melatonin-ZZ pills 3mg, 60pcs

Composition

Pharmacological action

Synthetic analog of pineal gland hormone (epiphysis); has adaptogenic, sedative, hypnotic effects.

Normalizes circadian rhythms. Increases the concentration of GABA and serotonin in the midbrain and hypothalamus, changes the activity of pyridoxal kinase, which is involved in the synthesis of GABA, dopamine and serotonin.

Regulates the sleep-wake cycle, daily changes in locomotor activity and body temperature, has a positive effect on the intellectual and mnestic functions of the brain, the emotional and personal sphere.

Promotes the organization of biological rhythm and normalization of night sleep. Improves sleep quality, accelerates falling asleep, and regulates neuroendocrine functions. Adapts the body of weather-sensitive people to changes in weather conditions.

Indications

Sleep disorders, including those caused by a violation of the sleep-wake rhythm, such as desynchronosis (sudden jet lag).

Recommendations for use

Inside, for 30-40 minutes. In case of sleep disorders – 3 mg 1 time a day.

In case of desynchronization as an adaptogen when changing time zones-1 day before the flight and in the next 2-5 days-3 mg. The maximum daily dose is 6 mg.

Elderly patients. With age, melatonin metabolism decreases, which should be taken into account when choosing a dosage regimen for elderly patients. Taking this into account, in elderly patients, it is possible to take the drug 60-90 minutes before bedtime.

Kidney failure. The effects of varying degrees of renal failure on the pharmacokinetics of melatonin have not been studied, so melatonin should be taken with caution in such patients. In patients with severe renal insufficiency, the use of the drug is not recommended.

Contraindications

hypersensitivity to the components of the drug;

autoimmune diseases;

liver failure;

severe renal failure;

pregnancy;

breast-feeding period;

children under 18 years of age.

With caution:  patients with varying degrees of renal insufficiency.

Side effects

Classification of the frequency of side effects according to WHO recommendations: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (

Infectious and parasitic diseases:  rarely — herpes zoster.

Blood and lymphatic system disorders:  rarely-leukopenia, thrombocytopenia.

From the immune system:  frequency unknown-hypersensitivity reactions.

From the side of metabolism and nutrition:  rarely — hypertriglyceridemia, hypokalemia, hyponatremia.

Mental disorders:  infrequently-irritability, nervousness, restlessness, insomnia, unusual dreams, nightmares, anxiety; rarely-mood swings, aggression, agitation, tearfulness, stress symptoms, disorientation, early morning awakening, increased libido, low mood, depression.

Nervous system disorders:  infrequently-migraine, headache, lethargy, psychomotor hyperactivity, dizziness, drowsiness; rarely-fainting, memory impairment, impaired concentration, delirium, restless legs syndrome, poor sleep quality, paresthesia.

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

Hearing disorders and labyrinth disorders:  rarely-vertigo, positional vertigo.

From the CCC side:  infrequently-arterial hypertension; rarely-angina pectoris of tension, palpitation, hot flashes.

From the gastrointestinal tract:  infrequently-abdominal pain, abdominal pain in the upper abdomen, dyspepsia, ulcerative stomatitis, dry mouth, nausea; rarely-GERD, gastrointestinal disorder or disorder, bullous stomatitis, ulcerative glossitis, vomiting, increased peristalsis, bloating, hypersecretion of saliva, bad breath, abdominal discomfort, gastric dyskinesia, gastritis.

Liver and biliary tract disorders:  infrequently — hyperbilirubinemia.

Skin and subcutaneous tissue disorders:  infrequently-dermatitis, night sweating, pruritus and generalized pruritus, rash, dry skin; rarely-eczema, erythema, dermatitis of the hands, psoriasis, generalized rash, itchy rash, nail damage; frequency unknown-angioedema, oral mucosal edema, tongue edema.

Musculoskeletal and connective tissue disorders:  infrequently-pain in the extremities; rarely-arthritis, muscle spasms, neck pain, night cramps.

From the side of the kidneys and urinary tract:  infrequently-glucosuria, proteinuria; rarely-polyuria, hematuria, nocturia.

From the genitals and breast:  infrequently-menopausal symptoms; rarely-priapism, prostatitis; frequency unknown-galactorrhea.

General disorders and disorders at the injection site:  infrequently-asthenia, chest pain; rarely-fatigue, pain, thirst.

Laboratory and instrumental data:  infrequently-deviation from the norm of laboratory parameters of liver function, increase in body weight; rarely-increased activity of hepatic transaminases, deviation from the norm of blood electrolyte content, deviation from the norm of laboratory test results.

Interaction

Pharmacokinetic interaction

-melatonin is known to induce the CYP3A isoenzyme in vitro at concentrations significantly higher than therapeutic levels. The clinical significance of this phenomenon is not fully understood. If signs of induction develop, consideration should be given to reducing the dose of concomitantly administered drugs;

– at concentrations significantly higher than therapeutic, melatonin does not induce CYP1A isoenzymes in vitro. Therefore, the interaction of melatonin with other drugs due to the effect of melatonin on CYP1A isoenzymes is apparently insignificant;

– melatonin metabolism is mainly mediated by CYP1A isoenzymes. Therefore, melatonin may interact with other drugs due to the effect of melatonin on isoenzymes of the CYP1A group;

– caution should be exercised in patients taking fluvoxamine, which increases the concentration of melatonin (an increase in AUC by 17 times and_CMAX by 12 times) due to inhibition of its metabolism by cytochrome P 450 isoenzymes: CYP1A2 and CYP2C19. You should avoid this combination;

– use caution in patients receiving 5 – and 8-methoxypsoralen, which increases the concentration of melatonin as a result of inhibition of its metabolism;

– use caution in patients taking cimetidine (an inhibitor of CYP2D isozymes), as it increases the content of melatonin in the plasma due to the inhibition of the latter;

– Smoking can reduce the concentration of melatonin due to induction of isoenzyme CYP1 AND 2;

– use caution in patients taking estrogens (e. g., contraceptives or hormone replacement therapy), which increase the concentration of melatonin by inhibiting their metabolism isoenzymes CYP1A1 and CYP1A2;

inhibitors of isoenzymes CYPA2, for example chinolone, is able to increase the exposure of melatonin;

the isoenzyme CYP1A2 inducers, such as carbamazepine and rifampicin, can reduce the plasma concentration of melatonin;

in modern literature there are many data concerning the influence of agonists/antagonists of the adrenergic and opioid receptors, antidepressants, inhibitors of PG, benzodiazepines, tryptophan and alcohol on the secretion of endogenous melatonin. Studies of the mutual effect of these drugs on the dynamics or kinetics of melatonin have not been conducted.

Pharmacodynamic interaction

-alcohol should not be consumed while taking melatonin, as it reduces the effectiveness of the drug;

– melatonin potentiates the sedative effect of benzodiazepine and non-benzodiazepine hypnotics, such as zaleplon, zolpidem and zopiclone. In a clinical study, clear signs of a transient pharmacodynamic interaction between melatonin and zolpidem were observed one hour after administration. Combined use may lead to a progressive disorder of attention, memory and coordination in comparison with zolpidem monotherapy;

– in the course of research, melatonin was prescribed together with thioridazine and imipramine, drugs that affect the central nervous system. No clinically significant pharmacokinetic interaction was observed in any of the cases. However, concomitant use