Fevarin - instructions for use, analogs, reviews and release forms (antidepressant tablets 50 mg and 100 mg) of the drug for the treatment of depression in adults, children and pregnancy. Interaction with alcohol

In this article, you can read the instructions for using the drug Fevarin. Comments of visitors of the site - consumers of this medication, as well as opinions of doctors of experts on the use of antidepressant Fevarin in their practice are presented. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Fevarin in the presence of existing structural analogues. Use to treat depression and obsessive-compulsive disorder inadults, children, as well as during pregnancy and lactation. Interaction of the drug with alcohol.

Fevarin antidepressant. Studies on binding to receptors have shown that fluvoxamine (the active ingredient of the drug Fevarin) is a potent inhibitor of serotonin reuptake with minimal affinity for the serotonin receptor subtypes. Its ability to bind to alpha and beta adrenoreceptors, histamine, m-cholinergic receptors or dopamine receptors is negligible.

Fevarin has a high affinity for sigma-1 receptors, acting as an agonist in therapeutic doses.

Composition

Fluvoxamine maleate + excipients.

Pharmacokinetics

After ingestion, Fevarin is completely absorbed from the digestive tract. Absolute bioavailability is 53% after the primary metabolism in the liver. Simultaneous administration of the drug with food does not affect the pharmacokinetics of fluvoxamine. Fluvoxamine is biotransformed in the liver (mainly by oxidative demethylation) to at least 9 metabolites. The two main metabolites have little pharmacological activity, the rest are pharmacologically inactive.Fluvoxamine is excreted in the urine in the form of metabolites. The metabolism of fluvoxamine is lower in patients with liver disease.

Indications

• depression of different genesis;
• obsessive-compulsive disorder.

Forms of release

Tablets coated with 50 mg and 100 mg.

Instructions for use and dosing regimen

In the treatment of depression for adults, the recommended initial dose is 50 mg or 100 mg once a day, in the evening. Increasing the dose is recommended to be carried out gradually. The effective dose, which is usually 100 mg per day, is selected individually depending on the patient's response to treatment. The daily dose can reach 300 mg.

Doses of more than 150 mg per day should be divided into several doses.

In accordance with official WHO recommendations, treatment with antidepressants should be continued for at least 6 months after remission after a depressive episode.

To prevent the recurrence of depression, fevarin is recommended to be administered at a dose of 100 mg once a day daily.

Due to lack of clinical experience, Fevarin is not recommended for the treatment of depression in children and adolescents under the age of 18 years.

In the treatment of obsessive-compulsive disorders, the recommended initial dose for adults is 50 mg per day for 3-4 days. Increasing the dose should be carried out gradually until an effective daily dose, which is, as a rule, 100-300 mg. The maximum effective dose is 300 mg per day. Doses up to 150 mg can be taken 1 time per day, preferably in the evening. Doses of more than 150 mg per day are recommended for 2 or 3 divided doses.

In the treatment of obsessive-compulsive disorders, the initial dose for children older than 8 years and adolescents is 25 mg per day for 1 dose. The maintenance dose is 50-200 mg per day. The maximum daily dose is 200 mg. Doses of more than 100 mg per day are recommended to be divided into 2 or 3 doses.

With the development of an adequate therapeutic effect, treatment can be continued with an individually selected daily dose. If improvement is not achieved after 10 weeks of taking the drug, fluvoxamine treatment should be reviewed. So far, no systematic studies have been organized that could answer the question of how long fluvoxamine treatment can be administered,however, obsessive-compulsive disorders are chronic, it may be considered advisable to prolong the course of treatment with the drug Fevarin for more than 10 weeks in patients with an adequate therapeutic effect. Selection of the minimum effective maintenance dose should be done individually and with caution. Periodically, it is necessary to re-evaluate the need for treatment. Some clinicians recommend concomitant psychotherapy in patients with a good pharmacotherapy effect.

For hepatic or renal failure, treatment should begin with the lowest dose under strict doctor supervision.

Tablets Fevarin should be taken orally, without chewing and washing with water.

Side effect

• increased excitability;
• anxiety;
• dizziness;
• insomnia or drowsiness;
• tremor;
• headache;
• convulsions;
• a confused state of mind;
• hallucinations;
• mania;
• abdominal pain;
• constipation;
• diarrhea;
• dry mouth;
• dyspepsia;
• anorexia;
• nausea, vomiting;
• palpitation;
• tachycardia;
• orthostatic hypotension;
• increased sweating;
• photosensitivity reaction;
• skin reactions of hypersensitivity (including rash, itching, angioedema);
• arthralgia;
• myalgia;
• ejaculation impairment (delay);
• galactorrhea;
• asthenia;
• malaise;
• hemorrhages (eg, gastrointestinal bleeding, ecchymosis, purpura);
• increase in body weight;
• decreased body weight;
• paresthesia;
• urination disorders (including urinary retention, urinary incontinence, frequent urination, nocturia and enuresis);
• anorgasmia;
• disorders of the menstrual cycle (such as amenorrhea, hypomenorrhea, metrorrhagia, menorrhagia);
• withdrawal syndrome, including withdrawal syndrome in newborns.

Contraindications

• simultaneous administration with tizanidine and MAO inhibitors;
• simultaneous reception with ramelteon;
• hypersensitivity to the active substance or to any of the components of the drug.

Treatment with fevarin can be started:

• 2 weeks after discontinuation of the intake of the irreversible MAO inhibitor;
• the day after discontinuation of the administration of the reversible MAO inhibitor.

The interval between stopping fluvoxamine intake and initiating therapy with any MAO inhibitor should be at least 1 week.

Application in pregnancy and lactation

Epidemiological data suggest that,that the use of selective serotonin reuptake inhibitors in pregnancy, especially during the last months of pregnancy, may increase the risk of persistent pulmonary hypertension (PLH) in newborns.

The drug should be given to pregnant women with caution. The potential risk to humans is unknown.

Individual cases of abstinence syndrome in newborns after Fevarin use at the end of pregnancy have been described.

In some newborns, after the action of selective serotonin reuptake inhibitors in the 3rd trimester of pregnancy, feeding and / or breathing difficulties, convulsive disorders, unstable body temperature, hypoglycemia, tremor, muscle tone disorders, increased nervous reflex excitability syndrome and continuous crying longer hospitalization.

Fluvoxamine penetrates into breast milk. In this regard, the drug should not be used during lactation.

Application in elderly patients

Caution should be given to elderly patients.

Use in children

Fevarin should not be used to treat children and adolescents under the age of 18, except for patients with obsessive-compulsive disorder. Due to lack of clinical experience, Fevarin is not recommended for the treatment of depression in children. In clinical trials conducted in children and adolescents, suicidal behavior (suicidal attempts and thoughts) and hostility (mainly aggression, opposition behavior and anger) were more common in patients receiving an antidepressant compared with those receiving a placebo. If, on the basis of clinical necessity, a decision is made on the treatment, the patient should be carefully monitored for suicidal symptoms.

In addition, there is no long-term safety data for children and adolescents regarding the growth, development and development of cognitive behavior.

In the treatment of obsessive-compulsive disorders, the initial dose for children older than 8 years and adolescents is 25 mg per day for 1 dose. The maintenance dose is 50-200 mg per day. The maximum daily dose is 200 mg. Doses of more than 100 mg per day are recommended to be divided into 2 or 3 doses.

special instructions

Depression is associated with an increased risk of suicidal thoughts or suicidal behavior (self-harm or suicide). This risk persists until the state of significant improvement. Because improvement may not occur within the first few weeks of treatment or longer, patients should be carefully monitored until such an improvement occurs.

In clinical practice, an increased risk of suicide in the early stages of recovery is widespread.

Obsessive-compulsive disorders can also be associated with an increased risk of suicidal events. In addition, these conditions can accompany deep depression. Therefore, when treating patients with obsessive-compulsive disorders, the same precautions should be followed as in the treatment of patients with deep depression.

It is known that patients with a history of suicide-related events or who have a significant degree of suicidal thinking prior to starting treatment have a greater risk of suicidal thoughts or suicidal actions and should be carefully observed during treatment.

Careful monitoring of patients, especially those at high risk, should accompany drug therapy, especially in its early stages and after dose changes.

It is necessary to warn patients (and caregivers) about the need to monitor any clinical deterioration, suicidal behavior or suicidal thoughts, unusual behavioral changes, and immediately seek the advice of a specialist if such symptoms occur.

The development of akathisia associated with the administration of fluvoxamine is characterized by subjectively unpleasant and painful anxiety. The need to move was often accompanied by an inability to sit or stand still. The development of this condition is most likely during the first few weeks of treatment. An increase in the dose of the drug in patients with such symptoms may worsen their condition

Care should be taken when prescribing patients with a history of seizures. Avoid the administration of fluvoxamine in patients with unstable epilepsy, and patients with stable epilepsy should be closely monitored. Treatment with the drug Fevarin should be discontinued if there are epileptic seizures or their frequency increases.

There are rare cases of the development of a serotonergic syndrome or a condition similar to the NSA,which may be associated with the administration of fluvoxamine, especially in combination with other serotonergic and / or antipsychotic medications. These syndromes can lead to potentially life-threatening conditions manifested by hyperthermia, rigidity of muscles, myoclonus, lability of the autonomic nervous system with possible rapid changes in vital parameters (including pulse, respiration, BP), changes in mental status, including confusion, irritability, extreme agitation, reaching to delirium or coma. Therefore, in such cases, Fevarin should be withdrawn and appropriate symptomatic treatment started.

As with other selective serotonin reuptake inhibitors, in rare cases, hyponatremia may occur, which is reversed after the withdrawal of fluvoxamine. Some cases were caused by the syndrome of insufficient ADH secretion. In most cases, these cases were observed in elderly patients.

Control over the level of glucose in the blood (eg, hyperglycemia, hypoglycemia, impaired glucose tolerance) may be impaired, especially in the early stages of treatment.In case of prescribing the drug Fevarin to patients with diabetes in history, it may be necessary to correct the dose of hypoglycemic drugs.

The most commonly observed symptom associated with the use of the drug is Fevarin, nausea, sometimes accompanied by vomiting. This side effect usually disappears during the first 2 weeks of treatment.

There are reports of intradermal hemorrhage such as ecchymosis and purpura and hemorrhagic manifestations (e.g. gastrointestinal bleeding) was observed with selective serotonin reuptake inhibitors. Care should be taken when assigning these drugs in elderly patients and in patients simultaneously receiving drugs acting on platelet function (e.g., atypical antipsychotics and phenothiazines, most tricyclic antidepressants, aspirin, NSAIDs) or drugs that increase the risk of bleeding, and also patients with bleeding history or prone to bleeding (eg, with thrombocytopenia).

Increased risk of prolongation of the QT interval / paroxysmal ventricular tachycardia of the pirouette type with combined therapy with fluvoxamine with terfenadine or astemizole or cisapride, due to increased plasma concentrations of the latter. Therefore, fluvoxamine should not be administered together with these drugs.

Fluvoxamine may cause a slight decrease in heart rate (by 2-6 beats / min).

With the discontinuation of fluvoxamine administration, withdrawal symptoms may develop, although available data from preclinical and clinical studies have not revealed the occurrence of dependence on fluvoxamine treatment. Symptoms noted in case of drug withdrawal: dizziness, paresthesia, headache, nausea, anxiety. Most of these symptoms are mild and stop themselves. When discontinuing treatment with a drug, a gradual dose reduction is recommended.

Treatment of patients with hepatic or renal failure should begin with the appointment of the drug in a low dose, such patients require strict medical supervision. In rare cases, fluvoxamine treatment may lead to an increase in hepatic enzyme activity,which is most often accompanied by the corresponding clinical symptoms; in such cases, Fevarin should be canceled.

A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders revealed an increased risk of suicidal behavior when taking antidepressants compared with placebo in patients younger than 25 years of age. When prescribing the drug, Fevarin should correlate the risk of suicide and the benefits of its use.

Data obtained in the treatment of elderly patients and younger patients indicate that there are no clinically significant differences between the usual daily doses used. However, increasing doses in elderly patients should always be slower and with greater caution.

As with the use of other psychotropic drugs, during the treatment with fevarin, alcohol is not recommended.

Impact on the ability to drive vehicles and manage mechanisms

When used in healthy volunteers, Fevarin in doses up to 150 mg did not influence or had any insignificant effect on the ability to drive and drive cars.At the same time, there are reports of drowsiness noted during treatment with fluvoxamine. In this regard, before final determination of the individual response to the drug, patients are advised to exercise caution when engaging in potentially hazardous activities.

Drug Interactions

Fevarin can not be used in combination with MAO inhibitors. Treatment with the drug Fevarin can be started 2 weeks after stopping the intake of an irreversible MAO inhibitor; the day after discontinuation of the use of the reversible MAO inhibitor; The time interval between stopping the intake of Fevarin and beginning therapy with any MAO inhibitor should be at least 1 week.

Fluvoxamine significantly inhibits the isoenzyme CYP1A2, and to a lesser extent - the isozymes CYP2C and CYP3A4. Drugs that are heavily metabolized by these isoenzymes are more slowly excreted and may have higher concentrations in the blood plasma, in the case of simultaneous application with the drug Fevarin. This is especially important for drugs that have a narrow therapeutic range.Patients need careful monitoring, if necessary, it is recommended to correct the dose of these drugs. Fluvoxamine has a minimal inhibitory effect on CYP2D6 and probably does not affect non-oxidative metabolism and renal excretion.

With the simultaneous use of Fevarin, an increase in the concentration of tricyclic antidepressants (clomipramine, imipramine, amitriptyline) and neuroleptics (clozapine, olanzapine), which are largely metabolized by the isoenzyme CYP1A2, was observed. In this regard, if treatment with Fevarin is started, the possibility of reducing the dose of these drugs should be considered.

Patients concurrently taking fevarin and drugs with a narrow therapeutic range metabolized by the isoenzyme CYP1A2 (including tacrine, theophylline, methadone, mexiletine) should be carefully monitored. If necessary, it is recommended to correct the doses of these drugs.

Single cases of cardiotoxicity with simultaneous administration of fluvoxamine and thioridazine have been reported.

In the interaction of fluvoxamine with propranolol, there was an increase in plasma Propranolol concentrations.In this regard, it is possible to recommend a reduction in the dose of propranolol in the case of simultaneous administration with fluvoxamine.

During the administration of fluvoxamine, the concentration of Caffeine in the plasma may increase. Thus, patients who consume large amounts of caffeine-containing beverages should reduce their intake for the period of taking fluvoxamine, and when adverse effects of caffeine are observed, such as tremors, palpitations, nausea, anxiety, insomnia.

With simultaneous administration of fluvoxamine and ropinirole, the concentration of ropinirole in plasma may increase, thus increasing the risk of overdose. In such cases, monitoring, or, if necessary, reducing the dose or eliminating ropinirole during the treatment with fluvoxamine is recommended.

Patients taking both fluvoxamine and drugs with a narrow range of therapeutic effects, metabolized by the cytochrome P450 2C isoenzyme (such as phenytoin) should be closely monitored and, if necessary, a dose adjustment of these drugs is recommended.

When fluvoxamine was used in combination with warfarin, a significant increase in plasma concentrations of Warfarin and an increase in prothrombin time were observed.

With combined therapy with fluvoxamine, concentrations of terfenadine, astemizole or cisapride in blood plasma may increase, increasing the risk of prolonging the QT interval / paroxysmal ventricular pirouette tachycardia. Therefore, fluvoxamine should not be given along with these drugs.

Patients taking both fluvoxamine and drugs with a narrow therapeutic range, metabolized by the CYP3A4 isoenzyme (such as carbamazepine, cyclosporine) should be closely monitored, a dose adjustment of these drugs is recommended.

With the simultaneous administration of benzodiazepines with Fevarin, exposed to oxidative metabolism, such as triazolam, midazolam, Alprazolam and diazepam, an increase in their plasma concentration is possible. The dose of these benzodiazepines should be reduced by the time of taking fluvoxamine.

Fluvoxamine does not affect the concentration of Digoxin in plasma.

Fevarin does not affect the concentration of Atenolol in plasma.

In the case of combined administration of fluvoxamine with serotonergic drugs (such as triptans,tramadol, selective serotonin reuptake inhibitors and perforated St. John's wort preparations), serotonergic effects of fluvoxamine may be intensified.

Fluvoxamine was used in combination with lithium drugs to treat severe patients who do not respond well to pharmacotherapy. It should be noted that lithium (and possibly also tryptophan) enhances the serotonergic effects of the drug, and therefore this kind of combined pharmacotherapy should be conducted with caution.

With the simultaneous administration of oral anticoagulants and fluvoxamine may increase the risk of hemorrhage. These patients should be under the supervision of a doctor.

Analogues of the drug Fevarin

Fevarin does not have structural analogs for the active substance.

Analogues for the pharmacological group (antidepressants):

• Azafen;
• Azona;
• Alventa;
• Aleval;
• Amizole;
• Amitriptyline;
• Anaphranil;
• Velaxin;
• Venlaksor;
• Heptor;
• Heptral;
• Deprim;
• Doxepine;
• Duloxetine;
• Zoloft;
• Ixelles;
• Clomipramine;
• Coaxyl;
• Lenuksin;
• Lerivon;
• Maprotiline;
• Miansan;
• Mirzaten;
• Mirtazapine (hemihydrate);
• Nerustin;
• Neuroplant;
• Noxibel;
• Oprah;
• Paxil;
• Paroxetine;
• Pipofezin;
• Pirazidol;
• Plizil;
• Portal;
• Prozac;
• Sedopram;
• Selektra;
• Seralin;
• Sertraline;
• Tianeptine sodium;
• Thorin;
• Fluoxetine;
• Framex;
• Citalon;
• Citalopram;
• Citol;
• Elivel;
• Ephevelone.

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