Index of drugs

Major depressive disorders. Obsessive-compulsive disorder.

1 tabl powl. contains 50 mg or 100 mg of fluvoxamine maleate.

Antidepressant - a selective serotonin reuptake inhibitor. The mechanism of action is related to the inhibition of serotonin reuptake in brain neurons. There is minimal interaction with noradrenergic processes. Fluvoxamine has a low binding capacity to the α- and β-adrenergic, histaminergic, muscarinic receptors in the cholinergic, dopaminergic and serotoninergic systems. Fluvoxamine has a high affinity for sigma-1 receptors on which it acts agonistically at therapeutic doses. Fluvoxamine is completely absorbed after oral administration. Maximum plasma concentrations occur within 3-8 h after administration. The mean absolute bioavailability is 53% due to metabolic processes during the first pass through the liver. Binding to plasma proteinsin vitro is 80%. Fluvoxamine is extensively metabolised in the liver. Although in conditionsin vitroCYP2D6 is the major isozyme responsible for the metabolism of fluvoxamine; however, plasma concentrations in individuals with a slow metabolic rate of CYP2D6 are slightly higher than in those with extensive metabolism. Medium T_0,5 in plasma is about 13-15 h after a single dose and is slightly longer (17-22 h) in the case of multiple dosing. In general, plasma concentrations reach steady state within 10-14 days.

Hypersensitivity to the active substance or any of the excipients. Co-administration with tizanidine and MAO inhibitors. Treatment with fluvoxamine can be started 2 weeks after discontinuation of irreversible MAO inhibitors or 1 day after discontinuation of reversible MAO inhibitors (eg moclobemide). Administration of MAO inhibitors may be initiated at least 1 week after discontinuation of fluvoxamine.

Depression is associated with an increased risk of suicidal thoughts, self-mutilation and suicide. This risk persists until full remission is achieved. The patient should be closely monitored until improvement occurs and at an early stage of recovery (increased risk of suicide). In patients treated for other psychiatric disorders, the same precautions should be taken as in patients with severe depressive disorder. Patients with a history of suicide-related events or patients exhibiting a significant degree of suicidal ideation prior to commencement of treatment are considered to be at increased risk of suicidal thoughts or suicide attempts and should be closely monitored during treatment, particularly in patients below 25 years of age. During treatment, especially at the beginning of therapy and after dose adjustment, patients should be closely monitored, particularly those at high risk. Fluvoxamine should not be used to treat children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder. In the course of clinical trials, suicide (suicide attempts and suicidal thoughts) and hostility (especially aggression, rebel behavior and anger) were more frequently observed in children and adolescents treated with antidepressants than in the placebo group. If, based on the existing clinical need, however, a decision to treat is made, the patient should be closely monitored for signs of suicide. In addition, there are no long-term data on the safety of the medicine in children and adolescents regarding growth, maturation and cognitive development and behavioral development. Patients with hepatic or renal failure should start with a low dose and remain under strict control. If there is an increase in liver enzymes with clinical symptoms, treatment should be discontinued. Flotoxamine should be used with caution in patients with mania / hypomania; Fluvoxamine should be discontinued if the patient enters a mania phase. In patients with symptoms of akathisia, increasing the dose may be harmful.Caution is recommended in patients with a history of seizures. Fluvoxamine should be avoided in patients with unstable epilepsy, and patients with controlled seizures should be carefully monitored. Treatment with fluvoxamine should be discontinued if seizures occur or their incidence increases. In case of symptoms of serotonin syndrome or neuroleptic malignant syndrome, treatment with fluvoxamine should be discontinued and supportive symptomatic treatment should be given. There are rare reports of hyponatremia receding after discontinuation of fluvoxamine (most in elderly patients). Some cases may have been associated with abnormal secretion of antidiuretic hormone. Blood Glucose disturbances are possible (i.e., hyperglycemia, hypoglycaemia, reduced glucose tolerance), especially at an early stage of treatment. If fluvoxamine is administered to patients with diabetes, the dosage of antidiabetic agents may need to be adjusted. Due to the risk of abnormal bleeding (gastrointestinal bleeding, gynecological bleeding and other bleeding within the skin and mucous membranes) caution should be exercised in patients taking SSRIs, especially in elderly patients and those taking concomitant medications affecting platelet function (eg, atypical antipsychotics or phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid, NSAIDs) or drugs that increase the risk of bleeding and if there is a history of bleeding and predisposing bleeds (e.g., thrombocytopenia and bleeding disorders). Due to the risk of prolongation of the QT interval and type-related arrhythmiastorsades de pointes fluvoxamine should not be used in combination with terfenadine, astemizole or cisapride. Due to lack of clinical experience, it is recommended to pay special attention to patients after acute myocardial infarction. Due to limited clinical experience, caution should be exercised when co-administering fluvoxamine and electroconvulsive therapy.

The preparation should not be used during pregnancy unless the clinical condition of the woman requires treatment with fluvoxamine. The results of epidemiological studies indicate that the use of SSRIs during pregnancy, especially in late pregnancy, may increase the risk of persistent neonatal hypertension (PPHN). Animal reproductive toxicity studies have shown treatment-related increases in fetal toxicity (fetal mortality, ocular abnormalities). The impact on people is unknown. Single cases of withdrawal symptoms in a newborn as a result of mother's use of fluvoxamine at the end of pregnancy have been described. In neonates exposed to SSRIs in the third trimester of pregnancy, there were: difficulties with feeding and / or breathing, seizures, body temperature instability, hypoglycaemia, tremors, abnormal muscle tone, jitter with nervousness, cyanosis, nervousness, lethargy. , drowsiness, vomiting, sleep problems and constant crying. These disorders may require prolongation of hospitalization. Fluvoxamine is excreted in small amounts in breast milk, so the medicine should not be used by women who are breastfeeding. Reproduction toxicity studies in animals have shown deleterious effects on male and female reproduction. The safety margin regarding this impact has not been determined. The impact on people is unknown. Do not use the preparation in patients planning pregnancy, unless the clinical condition of the patient requires fluvoxamine treatment.

Common: anorexia, psychomotor agitation, nervousness, anxiety, insomnia, drowsiness, tremor, headache and dizziness, palpitations, tachycardia, abdominal pain, constipation, diarrhea, dry mouth, indigestion, nausea and vomiting (usually lessen in the first 2 weeks of treatment), excessive sweating, asthenia, feeling unwell. Uncommon: hallucinations, disorientation, extrapyramidal disorders, ataxia, orthostatic hypotension, skin hypersensitivity reactions (including angioedema rash, pruritus), joint pain, muscle pain, abnormal (delayed) ejaculation. Rare: mania, convulsions, liver dysfunction, hypersensitivity to light, mycotoxicity. Not known: haemorrhagic symptoms (i.e.gastrointestinal bleeding, ecchymosis, purpura), hyperprolactinemia, abnormal secretion of antidiuretic hormone, hyponatremia, weight gain, weight loss, suicidal thoughts, serotonin syndrome, neuroleptic-like events, paresthesia, taste disorders and SIADH, anxiety psychoruchism / akathisia , glaucoma, urinary disorders (including urinary retention, urinary incontinence, pollakiuria, nocturia and involuntary urination), bone fractures (there is an increased risk of bone fractures mainly in patients aged 50 years and older), anorgasmia, menstruation (such as amenorrhea, scanty menstruation, uterine haemorrhage, menorrhagia), withdrawal syndrome (including withdrawal syndrome in the newborn). Discontinuation of fluvoxamine treatment (especially sudden) usually leads to withdrawal symptoms: dizziness, sensory disturbances (including paraesthesia, visual disturbances, sensation of electric shock), sleep disorders (including insomnia and intense dreams), agitation and anxiety, irritability, confusion, emotional instability, nausea and / or vomiting, diarrhea, excessive sweating, palpitations, headaches and tremors. In children and adolescents with obsessive-compulsive disorders, frequently reported adverse reactions occurring more frequently than after placebo were: insomnia, asthenia, agitation, excessive agitation, drowsiness and indigestion; serious side effects also included agitation and hypomania. In children and adolescents, seizures have been reported during clinical use.

Orally.DepressionAdults: the recommended dose is 100 mg daily. Treatment should be started with 50 mg or 100 mg administered in one dose in the evening. Dosage should be evaluated and, if necessary, corrected within 3-4 weeks of starting treatment, and then when clinically necessary. If, after a few weeks of using the medicine at the recommended dose, the response to treatment is insufficient, in some patients it may be beneficial to gradually increase the dose to a maximum of 300 mg a day. Doses up to 150 mg can be administered in a single dose, preferably in the evening. It is recommended that the total daily dose greater than 150 mg should be administered in 2 or 3 divided doses. Dosage should be adjusted carefully, individually for each patient to achieve the lowest effective dose. Patients with depression should be treated for a sufficiently long time, at least 6 months, until they are sure that their symptoms have subsided. Children and adolescents: the preparation should not be used to treat major depressive disorder in children and adolescents under 18 years of age.Obsessive-compulsive disorder. Adults: the recommended dose is between 100 mg and 300 mg a day. It should start with a dose of 50 mg a day. If, after several weeks of taking the drug at the recommended dose, the response to treatment is insufficient, some patients may find it beneficial to gradually increase the dose to a maximum of 300 mg a day. Doses up to 150 mg can be administered in a single dose, preferably in the evening. It is recommended that the total daily dose greater than 150 mg should be administered in 2 or 3 divided doses. If a good therapeutic response is obtained, the treatment can be continued at an individually adjusted dose. Despite the lack of systematic studies on the duration of treatment with fluvoxamine, it should be taken into account that obsessive-compulsive disorders are chronic and therefore patients with a positive therapeutic response should consider continuing treatment for more than 10 weeks. Dosage should be adjusted carefully, individually in each patient to achieve the smallest effective dose. The validity of further treatment should be assessed periodically. In patients who respond positively to pharmacotherapy, some clinicians also recommend using behavioral psychotherapy. The effectiveness of long-term (over 24 weeks) treatment of obsessive-compulsive disorders has not been demonstrated. Children and adolescents: limited data are available on the use of doses up to 100 mg twice daily for 10 weeks in children over 8 years of age and adolescents. The starting dose is 25 mg a day. The dose can be increased by 25 mg every 4-7 days with good tolerability, until an effective dose is obtained. The maximum dose in children should not exceed 200 mg a day. It is recommended that the total daily dose greater than 50 mg should be administered in 2 divided doses.If 2 divided doses are not equal, the higher dose should be given at bedtime. Patients with hepatic or renal impairment should be started at low doses; patients should remain under constant control. In elderly patients, the dose should be increased slowly and always with caution. The tablets should be swallowed without chewing, with water.