Meladapt, 3 mg 10 pcs

Interaction

Pharmacokinetic interaction

Melatonin is known to induce the CYP3A isoenzyme under in vitro conditions at concentrations significantly greater than therapeutic. The clinical significance of this fact is not fully known. If signs of induction develop, consideration should be given to reducing the dose of concomitantly administered drugs.

Melatonin does not induce CYP1A isoenzymes at concentrations significantly higher than the therapeutic ones under in vitro conditions. Therefore, the interaction of melatonin with drugs, due to the effect of melatonin on CYP1A isoenzymes, appears to be insignificant.

The metabolism of melatonin is mainly mediated by CYP1A isoenzymes. Therefore, melatonin may interact with other medications due to the effect of melatonin on CYP1A isoenzymes.

Patients should be cautious about those taking fluvoxamine which when used concomitantly with melatonin increases its plasma concentrations (17 fold AUC and 12 fold Cmax) due to inhibition of its metabolism by the CYP1A2 and CYP2C19 cytochrome P450 isoenzymes. Concomitant use should be avoided.

Patients taking 5- and 8-methoxypsoralen, which increase plasma concentrations of melatonin due to inhibition of its metabolism, should be treated with caution.

Patients taking cimetidine (CYP2D isoenzyme inhibitor) should be treated with caution because it increases melatonin plasma concentrations due to inhibition of the latter.

Tobacco smoking reduces the plasma concentration of melatonin by inhibiting the CYP1A2 isoenzyme.

Cautions are required in patients taking estrogens (e.g., contraceptives or hormone replacement therapy), which increase plasma concentrations of melatonin due to inhibition of their metabolism by CYP1A1 and CYP1A2 isoenzymes.

Inhibitors of CYPA2 isoenzyme, such as quinolones, can increase melatonin exposure when used simultaneously.

Inducers of the CYP1A2 isoenzyme, such as carbamazepine and rifampicin, can decrease the plasma concentration of melatonin when used simultaneously.

Many studies have been published in the literature regarding the effects of adrenergic and opioid receptor agonists/antagonists, antidepressants, prostaglandin inhibitors, benzodiazepines, tryptophan and ethanol on endogenous melatonin secretion. No studies have been conducted on the possible interaction of these drugs on the pharmacodynamics and pharmacokinetics of melatonin.

Pharmacodynamic interaction

Ethanol when used concomitantly with melatonin reduces its effectiveness.

Meladapt potentiates the sedative effects of benzodiazepine and non-benzodiazepine sleeping pills such as zaleplon, zolpidem and zopiclone.

In a clinical study, there was clear evidence of transient pharmacodynamic interaction between melatonin and zolpidem 1 hour after their administration. Simultaneous use may lead to progressive impairment of attention, memory and coordination compared to zolpidem monotherapy.

In clinical studies, melatonin has been used concomitantly with thioridazine and imipramine, medications that affect the central nervous system. No clinically significant pharmacokinetic interactions have been identified in any case. However, concomitant use with melatonin resulted in an increased sense of calmness and difficulty performing certain activities compared with imipramine monotherapy, as well as an increased sense of “blurring in the head” compared with thioridazine monotherapy.

Special Instructions

During the use of the drug Meladapt it is recommended to avoid being in bright light.

Women planning pregnancy should be informed about the weak contraceptive effect of the drug.

There is no clinical data on the use of melatonin in patients with autoimmune diseases; therefore, the drug is not recommended for this patient group (see Contraindications section).

When using Meladapt, do not drink alcohol, which decreases its effectiveness.

Melatonin metabolism decreases with age; this must be considered when choosing a dosing regimen in elderly patients (see section “Dosage and administration”).

Influence on driving and operating ability

. When using the drug Meladapt it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities requiring increased concentration and rapid psychomotor reactions (risk of drowsiness).

Synopsis

Round biconvex convex film-coated tablets white or almost white with a ridge on one side. A cross section of the tablets shows two layers: the core is white or white with a yellowish tint, and the film coating.

Contraindications

Hypersensitivity to melatonin and other drug components, severe renal impairment (creatinine clearance less than 30 ml/min) autoimmune diseases (no clinical data available), hepatic failure, pregnancy and breastfeeding, age under 18 years (effectiveness and safety not established).

With caution

Kidney failure (CK greater than 30 mL/min), advanced age.

Side effects

The side effects are systematized for each of the organ systems according to frequency of occurrence using the World Health Organization classification: very frequently (>1/10), often (>1/100), infrequently (>1/1000, <1/100), frequently(>1/10000, <1/1000), very rarely (<1/10000, including isolated cases), frequency unknown (insufficient data to estimate incidence).

Infectious and parasitic diseases: frequent herpes zoster.

Disorders of the blood and lymphatic system: frequent leukopenia, thrombocytopenia.

Disorders of the immune system: frequency unknown – sensitivity reactions.

Disorders of metabolism and nutrition: rarely – hypertriglyceridemia, hypokalemia, hyponatremia.

Mental disorders: infrequent – irritability, nervousness, restlessness, insomnia, unusual dreams, nightmares, anxiety; frequent – mood swings, aggression, agitation, tearfulness, stress symptoms, disorientation, early morning awakening, increased libido, lower mood, depression.

Nervous system disorders: frequent – migraine, headache, lethargy, psychomotor hyperactivity, dizziness, somnolence; frequent -fainting, memory disturbance, impaired concentration, delirium, restless legs syndrome, poor sleep quality, paresthesia.

Visual disorders: rare – decreased visual acuity, blurred vision, increased lacrimation.

Hearing organ and labyrinth disorders:rarely – vertigo, positional vertigo.

vascular disorders: infrequent – increase in blood pressure; seldom – “rushes” of blood to the face.

Cardiac disorders: frequently – angina pectoris, palpitations.

Gastrointestinal tract disorders: infrequent abdominal pain, upper abdominal pain, dyspepsia, ulcerative stomatitis, dry mouth, nausea; frequently– gastroesophageal disease, gastrointestinal disorders or disorders, bullous stomatitis, ulcerative glossitis, vomiting, increased peristalsis, abdominal bloating, hypersecretion of saliva, bad breath, abdominal discomfort, gastric dyskinesia, gastritis.

Liver and biliary tract disorders: not infrequently – hyperbilirubinemia.

Skin and subcutaneous tissue disorders: infrequent – dermatitis, increased sweating at night, skin itching and generalized itching, skin rash, dry skin; frequently – eczema, erythema, hand dermatitis, psoriasis, generalized rash, itching rash, nail lesions; frequency unknown– angioedema (Quincke’s edema), oral mucosal edema, tongue edema.

Muscular and connective tissue disorders: frequently – pain in the extremities; frequently – arthritis, muscle spasm, neck pain, night cramps.

Kidney and urinary tract disorders: frequent -glucosuria, proteinuria; frequently – polyuria, hematuria, nycturia.

Renital and mammary gland disorders: infrequent – menopausal symptoms; frequently – priapism, prostatitis; frequency unknown – galactorrhea.

General disorders and disorders at the site of administration: infrequent – asthenia, chest pain; frequently – increased fatigue, pain, feeling of thirst.

Laboratory and instrumental findings: frequent – deviation from normal laboratory indicators of liver function, increased body weight; frequently – increased activity of “hepatic” transaminases, deviation from normal blood electrolyte content, deviation from normal results of laboratory tests.

If you get any of the side effects mentioned in the leaflet, or if they get worse, or if you notice any other side effects not mentioned in the leaflet, tell your doctor.

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Overdose

Symptoms

The use of melatonin at daily doses up to 300 mg has not caused clinically significant adverse reactions according to published data. Hyperemia, abdominal cramps, diarrhea, headache, and scotoma have been observed when melatonin doses of 3000 to 6600 mg have been used for several weeks. Involuntary loss of consciousness has been observed with very high doses of melatonin (up to 1 g).

In overdose, somnolence may occur.

Treatment:Gastric lavage and administration of activated charcoal, symptomatic therapy. Clearance of the active substance is expected within 12 hours after ingestion.

Pregnancy use

Pregnancy

There are no data on the effect of melatonin on pregnancy.

The use of Meladapt during pregnancy and in women planning to become pregnant is not recommended.

Breastfeeding

Because endogenous melatonin is detected in breast milk, it is likely that exogenous melatonin may also pass into breast milk.

Breastfeeding should be stopped if Meladapt is to be used during lactation.

Similarities

Melaxen, Sonnovan, Melarena, Melatonin, Wellson, Strengthen Your Immunity by Evalar