Fevarin how many tablets are in a package. Fevarin instructions for use, contraindications, side effects, reviews. Registration Certificate Holder

Antidepressant Fevarin based on substance fluvoxamine is one of the most powerful serotonin reuptake inhibitors.

The French drug is successfully used in psychiatry, allowing patients to be treated even with severe mental disorders.

It requires careful use, as it can cause addiction and is dangerous due to severe adverse reactions.

Can be used in complex treatment, on the background .

Prescription restrictions

It is prohibited to prescribe an antidepressant for:

• individual immunity of the body to the components of the composition;
• taking monoamine oxidase inhibitors;
• pregnancy.

Taking an antidepressant is allowed no earlier than 2 weeks after stopping MAO inhibitors.

Prescribed with caution when breastfeeding.

Through clinical studies, it was possible to find out that the substance fluvoxamine can be transmitted to the baby through mother's breast milk, causing negative reactions in the child.

For this reason, it is not recommended to prescribe an antidepressant during lactation. In case of emergency, when the mental state of a young mother is at risk and therapy with Fevarin is required, for the period of treatment for breastfeeding must abstain.

It is not advisable to take an antidepressant if:

• convulsive states;
• elderly and childhood;
• kidney pathologies;
• liver diseases;
• thrombocytopenia.

If the prescription of safer analogues is inappropriate, therapy should be accompanied by constant monitoring doctor

Possible negative reactions

When taking an antidepressant, adverse reactions may occur:

• decreased appetite;
• body weight deficiency, until the onset of the condition;
• hallucinations;
• persecution mania;
• confusion;
• suicidal tendencies;
• anxiety;
• nervousness;
• increased excitability;
• at night;
• daytime sleepiness;
• seizures;
• dizziness;
• headache;
• tachycardia;
• nausea;
• vomiting;
• diarrhea;
• disturbances in liver function;
• hypotension (decreased blood pressure);
• increased sweating;
• urinary disorders;
• photosensitivity.

In women during therapy with Fevarin, there may be a violation menstrual cycle.

Like most antidepressants, Fevarin causes " withdrawal syndrome ", especially if you abruptly stop taking the drug.

The patient begins to feel body aches, nervousness, heavy depressive state, insomnia, convulsions, rapid heartbeat, headache.

These symptoms go away quite quickly when taken next dose antidepressant. This worsens the patient’s dependence on the drug.

Antidepressants are compared with narcotic substances– a powerful dependence occurs on the drug, and when you stop taking it, the patient experiences sensations similar to drug withdrawal.

To alleviate the patient’s condition and avoid “withdrawal syndrome,” it is necessary to gradually reduce the dose of the drug, until it is completely discontinued.

Overdose

Exceeding the permissible dose of antidepressants is very dangerous, as it can put the patient into a coma or lead to fatal outcome .

According to statistics, such situations arise mainly when intentionally taking large doses of Fevarin (for example, with suicidal tendencies).

Also, an overdose of Fevarin may be accompanied by:

• nausea;
• vomiting;
• diarrhea;
• drowsiness during the day;
• dizziness;
• loss of consciousness;
• sharp decline blood pressure;
• cardiac dysfunction;
• convulsions;
• liver pathologies.

At overdose an antidepressant, it is necessary to perform gastric lavage; if necessary, it is prescribed symptomatic therapy.

The patient needs to drink activated carbon (at a dosage of 1 tablet for every 10 kilograms of weight). In some cases, the patient is prescribed diuretic drugs.

Instructions for use

For depressive syndrome, the patient is prescribed 50 or 100 mg drug for a single dose in the evening.

If necessary, the dose can be gradually increased up to 300 mg(150 mg morning and evening). Therapy should last at least six months.

At obsessive-compulsive disorder in the first 3-4 days the patient is prescribed a minimum dose of 50 mg per day. The dosage is gradually increased, but it is unacceptable to take more than 300 mg of Fevarin per day.

If after 3 months of taking the drug there is no positive results, the patient is selected for a different therapy.

Price

The drug is made in France and is one of the most expensive antidepressants.

You can buy 15 tablets containing 50 mg of the active ingredient for approximately 870 rubles .

The cost of 15 tablets of 100 mg is within 1060 rubles .

It is released for sale strictly according to a psychiatrist’s prescription, while the prescription remains in the pharmacy to record potent drugs.

A drug Fevarin- an antidepressant, is a potent serotonin reuptake inhibitor both in vitro and in vivo and has minimal affinity for serotonin receptor subtypes. The drug has little ability to bind to α-adrenergic receptors, ß-adrenergic receptors, histaminergic, muscarinic, cholinergic or dopaminergic receptors.
Fluvoxamine has a high affinity for sigma-1 receptors, for which it acts as an agonist in therapeutic doses.
Pharmacokinetics.
Fluvoxamine is completely absorbed after oral administration. The maximum concentration in blood plasma is achieved 3 - 8:00 after administration. Through the first pass mechanism, the average bioavailability is 53%.
The pharmacokinetics of the drug Fevarin is not affected by simultaneous food intake.
In vitro, 80% of fluvoxamine is bound to plasma proteins. The volume of distribution in humans is 25 l/kg.
Fluvoxamine is extensively metabolized in the liver. Although in vitro the main isoenzyme involved in the metabolism of fluvoxamine is CYP2D6, plasma concentrations in individuals with reduced CYP2D6 activity are not significantly higher than in individuals with good metabolism.
The half-life is 13-15 hours after a single dose and increases slightly (17-22 hours) with repeated doses. Equilibrium concentration in blood plasma is achieved within 10 to 14 days.
Fluvoxamine is extensively transformed in the liver, primarily by oxidative demethylation, resulting in at least nine metabolites that are excreted by the kidneys. The two main metabolites show little pharmacological activity. Other metabolites are pharmacologically inactive. Fluvoxamine is a potent inhibitor of CYP1A2 and 2C19 and moderately inhibits CYP2C9, CYP2D6 and CYP3A4.
Fluvoxamine exhibits linear pharmacokinetics when administered as a single dose. Steady-state plasma concentrations are greater than those calculated from single-dose data, and this disproportionate increase is most pronounced at higher daily doses.

Indications for use:
A drug Fevarin used to treat depression and obsessive-compulsive disorder (OCD).

Mode of application:
Fevarin tablets should be swallowed without chewing, with plenty of water.
Depression(adults).
The recommended starting dose is 50 or 100 mg once in the evening. It is recommended to increase the dose gradually until an effective dose is reached. The effective dose is usually 100 mg per day. It should be selected individually, in accordance with the patient's response to treatment. The daily dose should not exceed 300 mg. When prescribing doses exceeding 150 mg, they should be administered in several doses. According to settings World Organization healthcare, after the patient has recovered from depression, treatment must be continued for at least another 6 months. The recommended dose to prevent relapse of depression is 100 mg of fluvoxamine once a day.
Obsessive-compulsive disorder.
Adults.
The recommended starting dose is 50 mg per day for the first 3 to 4 days of treatment. The effective dose is usually 100 - 300 mg per day. The dose should be gradually increased until an effective dose is reached. The maximum daily dose of Fevarin for adults is 300 mg.
Doses up to 150 mg can be taken once daily, preferably in the evening. When prescribing doses of more than 150 mg, they should be divided into 2 to 3 doses during the day. If the therapeutic effect has been achieved, treatment can be continued further at a dose selected in accordance with the clinical effect. If there is no improvement within ten weeks of treatment, it is advisable to continue using the drug Fevarin for review. Although systematic studies have not been conducted on how long treatment with fluvoxamine can last, given the chronic nature of obsessive-compulsive disorder, it is reasonable to continue treatment for patients who have achieved clinical response beyond 10 weeks. The dose must be selected very carefully and individually so that the patient receives maintenance therapy with the drug in the minimum effective dose. The advisability of continuing treatment should be reviewed periodically. Patients who have positive effect from pharmacotherapy, some clinicians recommend concomitant behavioral psychotherapy.
Children aged 8 years and older.
The starting dose for children over 8 years of age is 25 mg per day, preferably at bedtime. It is allowed to increase the dose by 25 mg every 4-7 days until an effective dose is achieved. The effective daily dose is usually 50 - 200 mg. The maximum daily dose for children should not exceed 200 mg. If a daily dose exceeds 50 mg, it should be divided into 2 doses. If, in the case of dividing the dose into two parts, one of the parts turns out to be larger, this larger part should be taken before bed.
Abrupt withdrawal of treatment with fluvoxamine should be avoided. When stopping treatment with fluvoxamine, the dose should be gradually reduced over 1 to 2 weeks in order to reduce the risk of withdrawal syndrome (see Sections " Adverse reactions" and "Application Features"). If intolerable symptoms develop after dose reduction or discontinuation, the previous dose should be resumed. The doctor may then continue to reduce the dose, but more gradually.
Treatment of patients with hepatic or renal failure should be started with a low dose under the supervision of a physician based on the patient's health condition.
Children.
Fevarin should not be used to treat children and adolescents (under 18 years of age), with the exception of patients with obsessive-compulsive disorder (OCD). Fluvoxamine cannot be recommended for the treatment of depression in children due to lack of clinical experience applications. Suicidal behavior (suicidal attempts and suicidal ideation) and hostility (mainly aggression, oppositional behavior and anger) were observed more frequently in clinical trials in children and adolescents receiving antidepressants compared with placebo. If a treatment decision is made based on clinical need, the patient should be closely monitored for the emergence of suicidal symptoms.
In addition, long-term data on the safety of the drug in children and adolescents regarding physical, sexual, cognitive and behavioral development are insufficient.

Side effects:
Adverse events observed during clinical trials at the frequencies listed below were often disease-related and not necessarily related to treatment.
Endocrine disorders. Frequency unknown: hyperprolactinemia, inadequate ADH secretion.
Metabolic and nutritional disorders. Often anorexia (loss of appetite). Frequency unknown: hyponatremia, weight gain or loss.
Mental disorders. Uncommon: hallucinations, confusion, aggression. Rarely mania. Frequency unknown: suicidal ideation, suicidal behavior.
From the outside nervous system. Often agitation, nervousness, anxiety, insomnia, drowsiness, tremor, headache, dizziness. Uncommon: extrapyramidal disorders, ataxia. Rarely seizures. Frequency unknown: serotonin syndrome, phenomena similar to neuroleptic malignant syndrome; akathisia/psychomotor agitation; paresthesia; dysgeusia.
From the organs of vision. Frequency unknown: glaucoma, mydriasis.
From the side of the heart. Frequent palpitations/tachycardia.
From the side of blood vessels. Uncommon: hypotension (orthostatic). Not known: bleeding (including gastrointestinal bleeding, gynecological bleeding, ecchymosis, purpura).
Gastrointestinal disorders. Often abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, nausea, vomiting.
Hepatobiliary system. Rarely, liver dysfunction.
From the skin and subcutaneous tissues. Often hyperhidrosis. Uncommon: skin hypersensitivity reactions (including rash, itching, angioedema). Rarely, photosensitivity reaction.
From the musculoskeletal system and connective and bone tissue. Uncommon: arthralgia, myalgia. Frequency unknown: bone fractures*. * Epidemiological studies, primarily conducted in patients over the age of 50 years, have shown an increased risk of bone fractures in patients receiving SSRIs (selective serotonin reuptake inhibitors) and TCAs (tricyclic antidepressants).

The mechanism leading to this risk is unknown.
From the kidneys and urinary system. Not known: urinary disorders (including urinary retention, urinary incontinence, pollakiuria, nocturia and enuresis).
From the reproductive system and mammary glands. Infrequently (late) ejaculation is impaired. Rarely galactorrhea. Not known: anorgasmia, menstrual disorders (such as amenorrhea, hypomenorrhea, metrorrhagia and menorrhagia).
General disorders. Often asthenia, general malaise. Frequency unknown: drug withdrawal syndrome, incl. in newborns.
Withdrawal symptoms that occur when you stop taking fluvoxamine
Stopping treatment with fluvoxamine (especially abruptly) usually results in withdrawal symptoms. To avoid withdrawal symptoms, it is recommended to gradually stop using fluvoxamine with a gradual dose reduction (see Sections “Method of administration and dosage” and “Peculiarities of use”).

Contraindications:
A drug Fevarin contraindicated in patients with hypersensitivity to fluvoxamine maleate or to any of the other components of the drug.
Do not prescribe simultaneously with tizanidine, MAO inhibitors (MAOIs) (see Sections “Interaction with other medicines and other types of interactions" and "Features of application").
Treatment with Fevarin can be started no earlier than two weeks after stopping taking non-negotiable MAOIs or the day after stopping taking negotiable MAOIs (eg moclobemide, linezolid).
Treatment with any of the MAOI drugs can be started no earlier than a week after stopping Fevarin.
Fevarin cannot be prescribed simultaneously with ramelteon (see Sections “Interaction with other drugs and other types of interactions”).

Pregnancy:
Epidemiological evidence suggests that use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, especially during later, may increase the risk of persistent pulmonary hypertension in newborns (PPHN). The risk was approximately 5 per 1000 pregnancies. In the general population, there are 1-2 cases of PPHN per 1000 pregnancies.
Fluvoxamine should not be used during pregnancy unless clinical condition women require treatment with fluvoxamine.
Isolated cases of withdrawal syndrome in a newborn have been described after the use of fluvoxamine at the end of pregnancy. After the use of selective serotonin reuptake inhibitors during the third trimester of pregnancy, some newborns experienced difficulty feeding and/or breathing, convulsions, temperature instability, hypoglycemia, tremor, impaired muscle tone, nervousness, cyanosis, irritability, lethargy, drowsiness, vomiting, sleep disturbance and persistent crying, which may require prolonged hospitalization.
Fluvoxamine is excreted in small amounts in breast milk and should not be given to women who are breastfeeding.
Reproductive toxicity studies in animals have shown that fluvoxamine reduces reproductive function in male and female animals. The relevance of these data to humans is unknown. Fluvoxamine should not be used in patients who are trying to conceive, unless the patient's clinical condition requires treatment with fluvoxamine.

Interaction with other drugs:
Monoamine oxidase inhibitors.
A drug Fevarin should not be prescribed in combination with MAO inhibitors, including linezolid, due to the risk of serotonin syndrome (see section "Contraindications").
The effect of fluvoxamine on the oxidative metabolism of other drugs.
Fluvoxamine may inhibit the metabolism of drugs metabolized by certain cytochrome P450 (CYP) isoenzymes. In vitro and in vivo studies show a powerful inhibitory effect of fluvoxamine on CYP1A2 and 2C19, but CYP2C9, CYP2D6 and CYP3A4 are inhibited to a lesser extent. Drugs that are metabolized predominantly by these isoenzymes may have higher, and in some cases lower (for example, clopidogrel, which is a prodrug) concentrations active substance/ metabolites in blood plasma when used simultaneously with fluvoxamine. Treatment with fluvoxamine concomitantly with such drugs should be initiated or adjusted at a dose lower than, rather than higher than, their therapeutic range. In this case, their plasma concentrations, the effectiveness or side effects of concomitant therapy drugs should be carefully monitored and, if necessary, their dose should be reduced or increased. This is especially important to consider when using drugs with a narrow therapeutic index.
Ramelteon. When administering fluvoxamine maleate immediate-release tablets 100 mg twice daily for 3 days, followed by a single dose of 16 mg ramelteon concomitantly with fluvoxamine maleate immediate-release tablets, the AUC of ramelteon increased approximately 190-fold and the Cmax increased approximately 70-fold compared with when ramelteon was prescribed as monotherapy.
Compounds with a narrow therapeutic index.
Patients receiving concomitant use of fluvoxamine and drugs with a narrow therapeutic index (eg, tacrine, theophylline, methadone, mexiletine, phenytoin, carbamazepine, and cyclosporine) that are metabolized exclusively by CYP or through CYPs that are inhibited by fluvoxamine should be carefully monitored.

If necessary, it is recommended to adjust the doses of these medications.
Tricyclic antidepressants and antipsychotics.
Increased plasma concentrations of tricyclic antidepressants (e.g. clomipramine, imipramine, amitriptyline) and antipsychotics (e.g. clozapine, olanzapine, quetiapine), which are primarily metabolized by cytochrome P450 1A2, have been reported when administered concomitantly with fluvoxamine. The need to reduce the dose of these drugs should be considered when added to fluvoxamine treatment.
Benzodiazepines. When taken concomitantly with fluvoxamine, plasma concentrations of benzodiazepines that are metabolized by oxidation (such as triazolam, midazolam, alprazolam and diazepam) may increase. The dose of these benzodiazepines should be reduced when used concomitantly with fluvoxamine.
Increased concentration in blood plasma.
When taking ropinirole in combination with fluvoxamine, its plasma concentration may increase, which increases the risk of overdose. Given this, monitoring of patients is required, and if necessary, a reduction in the dose of ropinirole (both during treatment with fluvoxamine and after its discontinuation).
Since the plasma concentration of propranolol increases when administered concomitantly with fluvoxamine, it may be necessary to reduce the dose.
When used with fluvoxamine, the plasma concentration of warfarin increases significantly and the prothrombin time increases.
Increased likelihood of an adverse reaction.
Isolated cases of cardiac disorders (cardiotoxic effect) have been recorded with the simultaneous use of fluvoxamine with thioridazine.
Plasma levels of caffeine may increase when administered concomitantly with fluvoxamine. May be observed side effects caffeine (tremor, palpitations, nausea, anxiety, insomnia). Therefore, patients who take significant amounts of caffeine-containing beverages should reduce their intake if they are to take fluvoxamine.
For terfenadine, astemizole, cisapride, sildenafil, see “Peculiarities of use.”
Glucuronidation. The drug does not affect the plasma concentration of digoxin.
Renal excretion. The drug does not affect the plasma concentration of atenolol.
Pharmacodynamic interaction.
Serotonergic effects may be enhanced when fluvoxamine is administered concomitantly with other serotonergic drugs (including triptans, tramadol, selective serotonin reuptake inhibitors and St. John's wort) (see.

See also section “Application Features”).
Fluvoxamine has been used in combination with lithium in the treatment of severely ill patients resistant to therapy. However, lithium (and possibly also tryptophan) enhances the serotonergic effects of fluvoxamine. This combination should be used with caution in patients with severe, treatment-resistant depression. Patients taking oral anticoagulants and fluvoxamine should be closely monitored because their risk of bleeding may be increased.
As with other psychotropic drugs Patients should avoid drinking alcohol while using fluvoxamine.

Overdose:
Symptoms of drug overdose Fevarin include complaints from gastrointestinal tract(nausea, vomiting, diarrhea), drowsiness and dizziness. Disorders have also been reported of cardio-vascular system(tachycardia, bradycardia, hypotension), liver dysfunction, convulsions and coma.
Fluvoxamine has a wide range of safety in overdose. Since its introduction to the market, reports of deaths due to fluvoxamine overdose have been extremely rare. The highest documented dose of fluvoxamine taken by the patient was 12 g. The patient recovered completely. Serious complications have sometimes been observed in cases of intentional overdose in combination with other drugs.
Treatment. There is no specific antidote for fluvoxamine. In case of overdose, it is necessary to rinse the stomach as quickly as possible and begin symptomatic treatment. Repeated appointments are also recommended. activated carbon and, if necessary, an osmotic laxative. Forced diuresis or hemodialysis are ineffective.

Storage conditions:
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children!

Release form:
Fevarin - tablets, coated film-coated 50 mg and 100 mg.
Packaging: tablets are packaged in PVC / PVDC-aluminum blisters, 15 tablets per blister, 1 or 2 blisters per cardboard box or 20 tablets in a blister, 3 blisters in a cardboard box.

Compound:
1 tablet Fevarin contains fluvoxamine maleate 50 mg or 100 mg.
Excipients: mannitol (E 421), corn starch, corn starch, sodium stearyl fumarate, colloidal silicon dioxide, hypromellose, macrogol 6000, talc, titanium dioxide (E 171).

Additionally:
Suicide/suicidal ideation or clinical worsening
Depression is associated with an increased risk of suicidal ideation, self-harm and suicide (suicide-related events).

This risk persists until remission is achieved. Since improvement may not occur during the first few weeks of treatment or even over a longer period, patients should be closely monitored by a physician until improvement is observed. General clinical experience suggests that the risk of suicide may increase during the early stages of recovery.
Other mental states patients treated with fluvoxamine may also be associated with an increased risk of suicide-related events. In addition, such conditions may be comorbid with major depressive disorder. Therefore, when treating patients with other mental disorders, they should be closely monitored.
It is known that patients who have a history of suicide-related events and patients who demonstrate high level suicidal ideation before the start of therapy, have greater risk suicidal thoughts or suicide attempts, so they need careful monitoring during treatment.
Close supervision of patients, including those in the group high risk, necessary for drug therapy, especially at the beginning of treatment and after changes in dosage.
Patients (and those caring for them) should be warned to monitor for any clinical worsening, suicidal behavior or thoughts, and unusual changes in behavior and to seek immediate medical attention if these symptoms occur.
Akathisia/psychomotor agitation
Fluvoxamine may be associated with the development of akathisia, which is characterized by a subjectively unpleasant or debilitating restlessness and need to move, often accompanied by an inability to sit or stand still. The occurrence of such phenomena is most likely during the first few weeks of treatment. For patients who develop these symptoms, increasing the dose may be harmful.
In patients with liver or kidney failure, treatment should begin with low doses under close medical supervision.
Rarely, fluvoxamine treatment has been associated with increases in liver enzyme activity, usually accompanied by associated clinical symptoms. In such cases, treatment with the drug should be discontinued.
Nervous system disorders
Despite the fact that animal studies have not revealed the convulsive properties of fluvoxamine, caution should be exercised when prescribing fluvoxamine to patients with a history of seizure disorders.

The drug should be avoided in patients with unstable epilepsy, and the condition of patients with controlled epilepsy should be carefully monitored. If the patient develops seizures or their frequency increases, treatment should be discontinued.
Isolated cases of serotonin syndrome or neuroleptic malignant syndrome-like effects have been reported in association with treatment with fluvoxamine, especially when used concomitantly with other serotonergic and/or neuroleptic drugs. Because these syndromes can lead to potentially life-threatening conditions, treatment with fluvoxamine should be discontinued if such actions (characterized by the occurrence of a group of symptoms such as hyperthermia, rigidity, myoclonus, instability of the autonomic nervous system with possible rapid changes in vital parameters, changes mental status including confusion, irritability, excessive agitation progressing to delirium and coma) occur, and begin supportive symptomatic treatment.
Metabolism and eating disorders
As with other selective serotonin reuptake inhibitors, hyponatremia has rarely been reported with fluvoxamine, which disappears when the drug is discontinued. Some cases may have been associated with ADH deficiency syndrome. Most reports involved older people.
Glycemic control may be impaired (particularly hyperglycemia, hypoglycemia, decreased glucose tolerance), especially on early stages treatment. Patients with diabetes mellitus history, while taking fluvoxamine, the dose of antidiabetic drugs must be adjusted.
Nausea, sometimes accompanied by vomiting, is a common side effect observed with fluvoxamine treatment. This side effect usually decreases during the first two weeks of treatment.
Mydriasis has been reported with the use of selective serotonin reuptake inhibitors (such as fluvoxamine). Therefore, it is recommended to prescribe fluvoxamine with caution to patients with elevated intraocular pressure or an increased risk of acute angle-closure glaucoma.
Cases of cutaneous hemorrhage such as ecchymosis and purpura, as well as other hemorrhagic manifestations such as gastrointestinal bleeding or gynecological bleeding, have been reported during use of selective serotonin reuptake inhibitors.

It is recommended to prescribe such drugs with caution to patients taking selective serotonin reuptake inhibitors, especially in elderly patients and patients who are concomitantly using drugs that affect platelet function (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs), or drugs that increase the risk of bleeding, as well as patients with a history of hemorrhagic conditions and patients with conditions that cause a tendency to bleeding (in particular thrombocytopenia or bleeding disorders).
When used concomitantly with fluvoxamine, plasma concentrations of terfenadine, astemizole or cisapride may increase, leading to an increased risk of QT prolongation/torsade de pointes. Therefore, it should not be prescribed together with these drugs. Fluvoxamine may cause a slight decrease in heart rate (2 to 6 beats per minute).
It is recommended to prescribe fluvoxamine with caution in combination with ECT due to insufficient clinical trial data.
Drug withdrawal reactions
There is a possibility of drug withdrawal reactions when treatment with fluvoxamine is stopped, but available preclinical and clinical data do not suggest that this drug is addictive. The most common symptoms reported in association with fluvoxamine withdrawal are: dizziness, sensory disturbances (including paresthesias, visual disturbances, and electrical sensations), sleep disturbances (including insomnia and vivid dreams), agitation, irritability, confusion, emotional instability, headache pain, nausea and/or vomiting, diarrhea, sweating, palpitations, tremor and anxiety (see section "Adverse reactions"). In general, these phenomena are mild or moderate and resolve on their own, but in some patients they can be severe and/or prolonged. They are usually observed within the first few days after stopping treatment. Therefore, it is recommended to gradually reduce the dose of fluvoxamine to discontinue treatment according to the patient's needs (see Section "Dosage and Administration").
Mania/hypomania
It is recommended to prescribe fluvoxamine with caution to patients with a history of mania/hypomania. Fluvoxamine should be discontinued in any patient who develops a manic phase.
Elderly people
Data for elderly patients do not support clinically significant differences in normal daily doses compared with those for younger patients. However, for elderly patients, dose titration should be increased more slowly and dosing should always be done with caution.
Young adults (18 to 24 years old)
A meta-analysis of placebo-controlled clinical trials using antidepressants in adult patients under 25 years of age with mental disorders showed an increased risk of suicidal behavior when treated with antidepressants (compared with placebo).
The ability to influence the reaction rate when driving vehicles or other mechanisms.
Fevarin at a dose of 150 mg has no or almost no effect on the ability to drive vehicles and work with machinery. In healthy volunteers, no effect on psychomotor reactions associated with driving and operating machinery was detected. However, cases of drowsiness have been reported during treatment with fluvoxamine, so individual response to the drug should be assessed with caution.

Instructions for use:

Fevarin is a drug from the group of antidepressants that selectively inhibits the reuptake of serotonin. Active substance– fluvoxamine – selectively blocks the uptake of serotonin by neurons in the brain. Fevarin has virtually no effect on the processes of norepinephrine metabolism and has a weak affinity for adrenergic receptors, serotonin, dopamine, histamine and cholinergic receptors. Reviews of Fevarin from neuropsychiatrists indicate the high effectiveness of this drug.

When taken orally, Fevarin is well absorbed from the gastrointestinal tract. Has a first pass effect through the liver. Bioavailability – 53%. The food intake does not affect the rate of absorption of Fevarin, as well as its bioavailability. Maximum plasma concentration is achieved 3-8 hours after administration. Fevarin binds to plasma proteins in an amount of more than 80%. Metabolized in the liver.

The half-life is 13-18 hours. It is excreted by the kidneys in the form of metabolites.

With liver pathology, the metabolism of the drug slows down.

Indications for use of Fevarin

The instructions for Fevarin indicate that this drug used for depression of various etiologies, obsessive-compulsive disorders.

Directions for use, dosage

Fevarin is intended for oral administration. The tablet should be swallowed whole, without crushing. The maximum daily dosage is 300 mg. The daily dose is usually prescribed at one time. It is recommended to take the drug in the evening, if necessary, split the dose - morning and evening. The dosage and duration of therapy in each individual case is determined by the doctor.

The average daily dosage for the treatment of depression in adult patients is 50-100 mg. If the therapeutic effect is insufficient, the dosage is increased gradually. When a clinical effect is achieved, it is recommended to continue treatment for at least six months to prevent relapses.

The dosage of Fevarin for the prevention of relapse in the treatment of depressive disorders is 100 mg.

The dosage for the treatment of obsessive-compulsive disorders is 50 mg. If the effect is insufficient, the dosage is increased after 2-3 days. The maximum dosage for this pathology is also 300 mg.

The daily dosage of Fevarin for children 8-18 years old is 25 mg. In case of insufficient clinical effect it is possible to increase the indicated dosage after 2-3 days. The maximum daily dosage is 200 mg. If there is no effect after 10 weeks, the drug must be discontinued.

According to the instructions, Fevarin for liver pathology must be prescribed in the minimum clinically effective dosage. When increasing the dosage over several days, the patient should be under medical supervision.

Contraindications to the use of Fevarin

The instructions for Fevarin indicate the following contraindications:

• increased individual sensitivity to fluvoxamine;
• simultaneous treatment with monoamine oxidase inhibitors, tizanidine;
• alcoholism;
• age under 8 years due to lack of sufficient experience in using Fevarin in this age category;
• severe pathology of the kidneys and liver, epilepsy, tendency to bleeding.

Side effects of Fevarin

When taking this drug, you may develop large quantity side effects, which often causes negative reviews of Fevarin from patients who have used this drug. The following side effects of Fevarin are registered:

• from the gastrointestinal tract: vomiting, nausea, epigastric pain, loss of appetite, dry oral mucosa, stool disorders, increased levels of liver enzymes;
• from the central nervous system and peripheral nervous system: headache, weakness, dizziness, agitation, anxiety, tremor, ataxia, disturbance of sleep and wakefulness, extrapyramidal disorders;
• from the cardiovascular system: decreased heart rate, cardiac arrhythmia, postural hypotension, palpitations;
• allergic reactions: urticaria, itching, angioedema, photosensitivity;
• others: muscle and joint pain, sexual dysfunction, increased sweating, galactorrhea, urinary disorders, changes in body weight.

When taking Fevarin and analogues, hyponatremia may occur, which disappears after discontinuation of the drug.

The development of serotonin syndrome (muscle rigidity, increased body temperature, mental changes, coma, lability of the autonomic nervous system) has been observed extremely rarely.

For prevention side effects Fevarin should be taken under medical supervision and only as prescribed by your doctor.

Use of Fevarin during pregnancy

There is not enough data on the effect of the drug on the fetus. In cases where the expected benefit to the mother significantly outweighs the possible risks to the fetus, Fevarin can be prescribed during pregnancy. When treating with Fevarin in the third trimester of pregnancy, careful monitoring of the condition of the newborn is necessary, due to the risk of developing withdrawal syndrome.

Interaction of Fevarin with other drugs

The simultaneous use of Fevarin and hypoglycemic drugs requires dosage adjustment of the latter.

Taking Fevarin and analogs simultaneously with MAO inhibitors is contraindicated.

The drug changes the pharmacokinetics of terfenadine, cisapride, astemizole, theophylline, mexiletine, methadone, carbamazepine, phenytoin.

Fevarin increases the blood concentration of caffeine, warfarin, propranolol, midazolam, ropinirole, diazepam.

The combination of Fevarin with ethanol is contraindicated.

Overdose

In case of an overdose of Fevarin, signs of pathology of the gastrointestinal tract, cardiovascular system, and nervous system occur: vomiting, nausea, weakness, sleep disturbance, decreased blood pressure, heart rhythm disturbances, convulsions, liver failure. There is no specific antidote. It is recommended to rinse the stomach, take enterosorbents and carry out symptomatic treatment. Hemodialysis and forced diuresis are not effective in case of an overdose of Fevarin.

• Instructions for use Fevarin ®
• Composition of the drug Fevarin ®
• Indications of the drug Fevarin ®
• Storage conditions for the drug Fevarin ®
• Shelf life of the drug Fevarin ®

ATX code: Nervous system (N) > Psychoanaleptics (N06) > Antidepressants (N06A) > Selective serotonin reuptake inhibitors (N06AB) > Fluvoxamine (N06AB08)

Release form, composition and packaging

white or almost white, round, biconvex, with a score and engraving “291” on both sides of the score on one side, without engraving on the other; tablet diameter is about 9 mm; The tablet can be divided into two parts.

Excipients: mannitol - 152 mg, corn starch - 40 mg, pregelatinized starch - 6 mg, sodium stearyl fumarate - 1.8 mg, colloidal silicon dioxide - 0.8 mg.

Shell composition: opadry white 03F28509 (hypromellose - 4.1 mg, macrogol 6000 - 1.5 mg, talc - 0.3 mg, titanium dioxide (E171) - 1.5 mg).

Film-coated tablets white or almost white, oval, biconvex, with a score and engraving “313” on both sides of the score on one side, without engraving on the other side; tablet length - about 15 mm, width - about 8 mm; The tablet can be divided into two equal parts.

Excipients: mannitol - 303 mg, corn starch - 80 mg, pregelatinized starch - 12 mg, sodium stearyl fumarate - 3.5 mg, colloidal silicon dioxide - 1.5 mg.

Shell composition: opadry white 03F28509 (hypromellose - 5.6 mg, macrogol 6000 - 2 mg, talc - 0.4 mg, titanium dioxide (E171) - 2.1 mg).

15 pcs. - blisters (1) - cardboard packs.

Description medicinal product FEVARIN ® based on officially approved instructions for use of the drug and made in 2013. Update date: 03/19/2013

pharmachologic effect

Antidepressant. The mechanism of action of the drug Fevarin ® is associated with selective inhibition of serotonin reuptake by brain neurons and is characterized by minimal effects on the noradrenergic system. Fevarin ® has a weak ability to bind to α- and β-adrenergic receptors, histamine receptors, m-cholinergic receptors, dopamine and serotonin receptors.

Pharmacokinetics

Suction

After oral administration, fluvoxamine is completely absorbed from the gastrointestinal tract. Cmax in blood plasma is achieved after 3-8 hours. Absolute bioavailability is 53% after primary metabolism in the liver. Simultaneous administration of the drug with food does not affect the pharmacokinetics of fluvoxamine.

Distribution

C ss in blood plasma is usually achieved after 10-14 days.

Plasma protein binding is about 80% (in vitro). Vd - 25 l/kg.

Metabolism

Fluvoxamine is biotransformed in the liver (mainly by oxidative demethylation) to at least 9 metabolites. Two main metabolites have little pharmacological activity, the rest are pharmacologically inactive.

Although the CYP2D6 isoenzyme is the main one in the metabolism of fluvoxamine, the concentration of the drug in the blood plasma in individuals with low activity of this isoenzyme is slightly higher than in individuals with normal metabolism.

Fluvoxamine significantly inhibits the CYP1A2 isoenzyme, moderately inhibits the CYP2C and CYP3A4 isoenzymes, and slightly inhibits CYP2D6.

Removal

After taking a single dose, the average T1/2 from blood plasma is 13-15 hours; with multiple doses, T1/2 increases slightly and is 17-22 hours.

Fluvoxamine is excreted in the urine in the form of metabolites.

Pharmacokinetics in special clinical situations

The pharmacokinetics of fluvoxamine is the same in healthy people, elderly and patients with renal failure.

The metabolism of fluvoxamine is reduced in patients with liver disease.

Fluvoxamine plasma Css were twice as high in children (aged 6–11 years) than in adolescents (aged 12–17 years). Concentrations of the drug in the blood plasma of adolescents are similar to those in adults.

Dosage regimen

At treatment of depression For adults The recommended initial dose is 50 mg or 100 mg 1 time / day, in the evening. It is recommended to increase the dose gradually. The effective dose, usually 100 mg/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/day should be divided into several doses.

For prevention of relapse of depression Fevarin ® is recommended to be prescribed at a dose of 100 mg 1 time/day daily.

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

At recommended starting dose for adults is 50 mg/day for 3-4 days. The dose should be increased gradually until an effective daily dose is reached, which is usually 100-300 mg. The maximum effective dose is 300 mg/day. Doses up to 150 mg can be taken 1 time/day, preferably in the evening. Doses of more than 150 mg/day are recommended to be divided into 2 or 3 doses.

At treatment of obsessive-compulsive disorders starting dose for children over 8 years old and teenagers under 18 years old is 25 mg/day for 1 dose. Maintenance dose - 50-200 mg/day. The maximum daily dose is 200 mg. Doses of more than 100 mg/day are recommended to be divided into 2 or 3 doses.

If an adequate therapeutic effect develops, treatment can be continued with individually selected daily dose. If improvement is not achieved after 10 weeks of taking the drug, treatment with fluvoxamine should be reconsidered. So far, no systematic studies have been organized that could answer the question of how long treatment with fluvoxamine can be carried out, however, obsessive-compulsive disorders are chronic, it can be considered advisable to extend the course of treatment with Fevarin ® for more than 10 weeks in patients with adequate therapeutic effect. The selection of the minimum effective maintenance dose should be done individually and with caution. The need for treatment needs to be re-evaluated periodically. Some clinicians recommend concomitant psychotherapy in patients with a good effect of pharmacotherapy.

At liver or kidney failure

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

Side effects

Some side effects observed in clinical trials were often related to symptoms of depression rather than to treatment with Fevarin ® .

From the nervous system: often (>1% and<10%) - повышенная возбудимость, тревога, ажитация, головокружение, бессонница или сонливость, тремор, головная боль;

From the mental side: uncommon (>0.1% and<1%) - состояние спутанного сознания, галлюцинации;

From the digestive system: often (>1% and<10%) - боль в животе, запор, диарея, сухость во рту, диспепсия, анорексия, тошнота, рвота;

From the cardiovascular system: often (>1% and<10%) - сердцебиение, тахикардия;

From the side of metabolism: often (>1% and<10%) - анорексия.

For the skin and subcutaneous tissues: often (>1% and<10%) - повышенное потоотделение;

Allergic reactions: uncommon (>0.1% and<1%) - кожные реакции гиперчувствительности (включая сыпь, зуд, ангионевротический отек).

From the musculoskeletal system: uncommon (>0.1% and<1%) - артралгия, миалгия.

From the reproductive system: uncommon (>0.1% and<1%) - нарушение (задержка) эякуляции;

Others: often (>1% and<10%) - астения, недомогание.

In addition to the side effects described during clinical trials, the following spontaneous side effects have been reported during post-marketing use of fluvoxamine (available data are insufficient to determine their frequency).

From the blood coagulation system: hemorrhages (eg, gastrointestinal bleeding, ecchymosis, purpura).

From the endocrine system: hyperprolactinemia, insufficient ADH secretion.

From the side of metabolism: hyponatremia, weight gain, weight loss.

From the nervous system: serotonin syndrome, NMS-like phenomena, akathisia/psychomotor agitation, paresthesia, dysgeusia.

From the mental side: Cases of suicidal ideation and suicidal behavior have been reported during or shortly after treatment with fluvoxamine.

From the urinary system: urinary disorders (including urinary retention, urinary incontinence, frequent urination, nocturia and enuresis).

From the reproductive system: anorgasmia.

Others: drug withdrawal syndrome, including withdrawal syndrome in newborns.

Contraindications for use

• simultaneous use with tizanidine and MAO inhibitors;
• hypersensitivity to the components of the drug.

Treatment with fluvoxamine can be started:

• 2 weeks after stopping the irreversible MAO inhibitor;
• the day after stopping the reversible MAO inhibitor.

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

WITH caution The drug should be prescribed for liver and kidney failure, a history of seizures, epilepsy, patients with a tendency to bleeding (thrombocytopenia), during pregnancy, and elderly patients.

Use during pregnancy and breastfeeding

During pregnancy, the drug should be prescribed with caution. The potential risk to humans is unknown.

Small observational data do not indicate any adverse effects of fluvoxamine during pregnancy. To date, no other epidemiological data are available.

Isolated cases of withdrawal syndrome in newborns have been described following the use of fluvoxamine late in pregnancy.

Some newborns after exposure to selective serotonin reuptake inhibitors in the third trimester of pregnancy experienced feeding and/or breathing difficulties, seizure disorders, unstable body temperature, hypoglycemia, tremors, muscle tone disorders, hyperexcitability syndrome and continuous crying, which may require longer hospitalization.

Fluvoxamine is excreted in breast milk. Therefore, the drug should not be prescribed during lactation (breastfeeding).

Use for liver dysfunction

At liver failure treatment should begin with the lowest dose under the strict supervision of a physician.

WITH caution the drug should be prescribed for liver failure

Use for renal impairment

At renal failure treatment should begin with the lowest dose under the strict supervision of a physician.

WITH caution the drug should be prescribed for renal failure

Use in children

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

At treatment of obsessive-compulsive disorders The initial dose for children over 8 years of age and adolescents is 25 mg/day for 1 dose. Maintenance dose - 50-200 mg/day. The maximum daily dose is 200 mg. Doses of more than 100 mg/day are recommended to be divided into 2 or 3 doses.

special instructions

Depression is associated with an increased risk of suicidal thoughts or behaviors (self-harm or suicide). This risk persists until the condition significantly improves. Because Improvement may not occur within the first few weeks of treatment or longer; patients should be closely monitored until such improvement occurs.

Increased risk of suicide in the early stages of recovery is widespread in clinical practice.

Obsessive-compulsive disorders may also be associated with an increased risk of suicidal events. In addition, these conditions may accompany major depression. Therefore, when treating patients with obsessive-compulsive disorder, the same precautions should be taken as when treating patients with major depression.

Patients with a history of suicidal events or a significant degree of suicidal ideation are known to be at greater risk of suicidal ideation or behavior before treatment and should be closely monitored during treatment.

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

Patients (and their caregivers) should be warned to monitor for any clinical deterioration, suicidal behavior or thoughts, or unusual changes in behavior, and to immediately seek professional advice if such symptoms occur.

The development of akathisia associated with 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. Increasing the dose of the drug in patients with such symptoms may worsen their condition.

Caution should be exercised when prescribing the drug to patients with a history of seizures. Fluvoxamine should be avoided in patients with unstable epilepsy, and patients with stable epilepsy should be closely monitored. Treatment with Fevarin ® should be discontinued if epileptic seizures occur or their frequency increases.

Rare cases of serotonergic syndrome or NMS-like conditions have been described and may be associated with fluvoxamine, especially in combination with other serotonergic and/or antipsychotic drugs. These syndromes can lead to potentially life-threatening conditions manifested by hyperthermia, muscle rigidity, myoclonus, autonomic nervous system lability with possible rapid changes in vital parameters (including pulse, respiration, blood pressure), mental status changes including confusion, irritability, extreme agitation, reaching delirium or coma. Therefore, in such cases, Fevarin ® should be discontinued and appropriate symptomatic treatment should be started.

As with the use of other selective serotonin reuptake inhibitors, in rare cases hyponatremia may occur, which reverses after discontinuation of fluvoxamine. Some cases have been caused by ADH deficiency syndrome. These cases were mainly observed in elderly patients.

Blood glucose control may be impaired (ie, hyperglycemia, hypoglycemia, impaired glucose tolerance), especially early in treatment. If Fevarin ® is prescribed to patients with a history of diabetes mellitus, dose adjustment of hypoglycemic drugs may be required.

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

There are reports of intradermal hemorrhages such as ecchymosis and purpura, as well as hemorrhagic manifestations (for example, gastrointestinal bleeding) observed with the use of selective serotonin reuptake inhibitors. Caution should be exercised when prescribing these drugs to elderly patients, as well as to patients concomitantly receiving drugs that affect platelet function (for example, atypical antipsychotics and phenothiazines, many tricyclic antidepressants, acetylsalicylic acid, NSAIDs) or drugs that increase the risk of bleeding, and also in patients with a history of bleeding or prone to bleeding (for example, with thrombocytopenia).

Increased risk of prolongation of the QT interval/torsade de pointes (TdP) during combination therapy with fluvoxamine with terfenadine or astemizole or cisapride, due to an increase in the concentration of the latter in the blood plasma. Therefore, fluvoxamine should not be coadministered with these drugs.

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

When you stop taking fluvoxamine, withdrawal symptoms may develop, although available data from preclinical and clinical studies have not shown dependence on fluvoxamine treatment. Symptoms noted in case of drug withdrawal:

• dizziness, paresthesia, headache, nausea, anxiety. Most of these symptoms are mild and self-limiting. When stopping treatment with the drug, a gradual dose reduction is recommended.

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

A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders found an increased risk of suicidal behavior with antidepressants compared with placebo in patients younger than 25 years. When prescribing Fevarin ®, the risk of suicide should be weighed against the benefits of its use.

Data obtained from the treatment of elderly patients and younger patients indicate that there are no clinically significant differences between the daily doses usually used in them. However, dose increases in elderly patients should always be done more slowly and with greater caution.

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

Use in pediatrics

Fevarin ® should not be used to treat children and adolescents under the age of 18, with the exception of patients with obsessive-compulsive disorder. Due to the lack of clinical experience, Fevarin ® is not recommended for the treatment of depression in children. In clinical studies conducted in children and adolescents, suicidal behavior (suicidal attempts and thoughts) and hostility (mainly aggression, oppositional behavior and anger) were observed more often in patients receiving an antidepressant compared with those receiving placebo. If a treatment decision is made based on clinical need, the patient should be closely monitored for the emergence of suicidal symptoms.

Additionally, long-term safety data for children and adolescents regarding growth, development, and cognitive development are lacking.

Impact on the ability to drive vehicles and operate machinery

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

Overdose

Symptoms: The most common symptoms are nausea, vomiting, diarrhea, drowsiness, and dizziness. There are reports of cardiac dysfunction (tachycardia, bradycardia, arterial hypotension), liver dysfunction, convulsions, coma.

Fluvoxamine has a wide therapeutic dose range. To date, deaths associated with fluvoxamine overdose have been extremely rare. The highest recorded dose taken by one patient was 12 g (the patient was cured). More serious complications have been observed in cases of deliberate overdose of fluvoxamine in combination with other drugs.

Treatment: gastric lavage, which should be performed as soon as possible after taking the drug;

Drug interactions

Fevarin ® cannot be used in combination with MAO inhibitors. Treatment with Fevarin ® can be started 2 weeks after stopping the irreversible MAO inhibitor; the day after stopping the reversible MAO inhibitor; the time interval between stopping Fevarin and starting therapy with any MAO inhibitor should be at least 1 week.

Fluvoxamine significantly inhibits the CYP1A2 isoenzyme, and to a lesser extent, the CYP2C and CYP3A4 isoenzymes. Drugs that are significantly metabolized by these isoenzymes are eliminated more slowly and may have higher plasma concentrations when used concomitantly with Fevarin ® . This is especially important when using drugs that have a narrow therapeutic range. Patients require careful monitoring, and if necessary, it is recommended to adjust the dose of these drugs. Fluvoxamine has minimal inhibitory effects on CYP2D6 and does not appear to affect non-oxidative metabolism or renal excretion.

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

Patients simultaneously taking Fevarin ® and drugs with a narrow therapeutic index, metabolized by the CYP1A2 isoenzyme (including tacrine, theophylline, methadone, mexiletine) should be under close medical supervision. If necessary, it is recommended to adjust the doses of these drugs.

Isolated cases of cardiotoxicity have been reported with concomitant use of fluvoxamine and thioridazine.

When fluvoxamine interacted with propranolol, an increase in plasma concentrations of propranolol was observed. In this regard, it is possible to recommend reducing the dose of propranolol in case of simultaneous use with fluvoxamine.

Plasma concentrations of caffeine may increase while taking fluvoxamine. Therefore, patients who consume large amounts of caffeine-containing beverages should reduce their consumption while taking fluvoxamine and when adverse effects of caffeine, such as tremor, palpitations, nausea, restlessness, and insomnia, are observed.

Concomitant use of fluvoxamine and ropinirole may increase the plasma concentration of ropinirole, thereby increasing the risk of overdose. In such cases, monitoring or, if necessary, dose reduction or discontinuation of ropinirole during treatment with fluvoxamine is recommended.

Patients concomitantly taking fluvoxamine and drugs with a narrow therapeutic range of action that are metabolized by the CYP2C isoenzyme (such as phenytoin) should be closely monitored; If necessary, dose adjustment of these drugs is recommended.

When fluvoxamine was used in combination with warfarin, a significant increase in the concentration of warfarin in the blood plasma and prolongation of prothrombin time were observed.

When combined with fluvoxamine, plasma concentrations of terfenadine, astemizole or cisapride may increase, increasing the risk of QT prolongation/TdP. Therefore, fluvoxamine should not be coadministered with these drugs.

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

When administered concomitantly with fluvoxamine, benzodiazepines that undergo oxidative metabolism, such as triazolam, midazolam, alprazolam and diazepam, may increase their plasma concentrations. The dose of these benzodiazepines should be reduced while taking fluvoxamine.

Fluvoxamine has no effect on plasma digoxin concentrations.

Fluvoxamine has no effect on plasma concentrations of atenolol.

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

Fluvoxamine has been used in combination with lithium drugs to treat severely ill patients who respond poorly to pharmacotherapy. It should be noted that lithium (and possibly also tryptophan) enhances the serotonergic effects of the drug, and therefore such combination pharmacotherapy should be carried out with caution.

When taking oral anticoagulants and fluvoxamine simultaneously, the risk of hemorrhage may increase. Such patients should be under medical supervision.

Storage conditions of the drug

List B. The drug should be stored out of the reach of children, in a dry place, protected from light, in its original packaging, at a temperature not exceeding 25°C.

Contacts for inquiries

ABBOTT LABORATORIES S.A., representative office, (Swiss Confederation)

Representative office of JSC "Abbott Laboratories S.A." in the Republic of Belarus

Fevarin is a drug from the group of antidepressants and selective serotonin reuptake inhibitors. It is used for various types of depression; the drug should be prescribed exclusively by a specialist.

Fluvoxamine, the active substance of the drug, like other active components of this group, prevents the neural uptake of serotonin, thereby increasing the concentration of serotonin in the human body. The drug has a low ability to bind to adrenergic receptors and does not bind to histaminergic, cholinergic and dopaminergic receptors, therefore it can be used to treat elderly patients.

After oral administration of the drug, it is completely absorbed. The first improvement from Fevarin can be noted a day after the start of treatment. Maximum blood concentrations are observed after eight hours.

Clinical and pharmacological group

Antidepressant.

Terms of sale from pharmacies

Can buy according to a doctor's prescription.

Price

How much does Fevarin cost in pharmacies? The average price is 360 rubles.

Composition and release form

The active ingredient is fluvoxamine maleate. The type of Fevarin tablets differs depending on the dosage of the active substance per 1 tablet:

• 50 mg fluvoxamine maleate: biconvex, round tablets in a white coating, engraved on one side with “291” on both sides of the score line and engraved “S” with a 7 sign on the other side of the tablet;
• 150 mg fluvoxamine maleate: biconvex, oval tablets in a white coating, engraved on one side with “313” on both sides of the score line and engraved “S” above the 7 on the other side of the tablet.

Pharmacological effect

The main active component of the tablets, Fevarin, has an antidepressant therapeutic effect and also helps reduce the severity of anxiety in the patient. It is realized due to the powerful reuptake of serotonin at the synapses of the nervous system. After taking the Fevarin tablet orally, the active substance is quickly and almost completely absorbed into the systemic circulation.

It is evenly distributed in tissues, enters the structures of the central nervous system through the blood-brain barrier, where it has a therapeutic effect. Biotransformation of the active component occurs in the liver, resulting in the formation of inactive breakdown products, which are excreted primarily in the urine.

Indications for use

Prescribing Fevarin is advisable for the following diseases:

• depressive disorder of various origins;
• obsessive-compulsive disorder.

Contraindications

The instructions for Fevarin indicate the following contraindications:

• increased individual sensitivity to fluvoxamine;
• simultaneous treatment with monoamine oxidase inhibitors, tizanidine;
• alcoholism;
• age under 8 years due to lack of sufficient experience in using Fevarin in this age category;
• severe pathology of the kidneys and liver, epilepsy, tendency to bleeding.

Prescription during pregnancy and lactation

There is not enough data on the effect of the drug on the fetus. In cases where the expected benefit to the mother significantly outweighs the possible risks to the fetus, Fevarin can be prescribed during pregnancy. When treating with Fevarin in the third trimester of pregnancy, careful monitoring of the condition of the newborn is necessary, due to the risk of developing withdrawal syndrome.

Dosage and method of administration

As indicated in the instructions for use, the dosage of Fevarin is determined individually. At the beginning of treatment, the daily dose is 50-100 mg (recommended to be taken at night). If there is insufficient effectiveness, the daily dose can be increased to 150-200 mg. The maximum daily dose is 300 mg. If the daily dose is more than 100 mg, then it should be divided into 2-3 doses.

Adverse reactions

Taking Fevarin may cause the following side effects:

1. Allergic reactions: itching, urticaria and photosensitivity.
2. From the central nervous system: weakness, headache, dizziness, anxiety, agitation, tremor, disturbance of sleep and wakefulness, ataxia and extrapyramidal disorders.
3. From the gastrointestinal tract: nausea, vomiting, epigastric pain, dryness of the oral mucosa, loss of appetite, stool disorders, and increased levels of liver enzymes.
4. From the cardiovascular system: postural hypotension, cardiac arrhythmia and palpitations.

Taking the drug may cause the patient to develop hyponatremia, which goes away on its own after discontinuation of the drug.

In rare cases, the drug causes the development of serotonin syndrome, which involves increased body temperature, muscle rigidity, mental changes, lability of the autonomic nervous system and coma.

Overdose

An overdose of Fevarin manifests itself in symptoms such as nausea, vomiting, stool disturbances, fainting, lethargy and drowsiness. Cardiovascular symptoms reported: tachycardia, hypotension, bradycardia. Possible disturbances in liver function and convulsions. In severe cases, coma may develop.

Reports of deaths are extremely rare. There have been cases recorded with a maximum dosage of 12 g per day, in which patients fully recovered with timely assistance.

If the dosage of the drug is deliberately exceeded, more serious consequences are possible.

The drug does not have a specific antidote. In case of overdose, gastric lavage is done as quickly as possible and treated symptomatically. It is recommended to take activated carbon.

special instructions

Before you start using the drug, read the special instructions:

1. During the treatment period, alcohol consumption is not allowed.
2. Due to the lack of clinical experience, fluvoxamine is not recommended for the treatment of depression in children.
3. With depression, there is usually a high likelihood of attempting suicide, which may persist until sufficient remission is achieved.
4. In patients with hepatic or renal insufficiency, fluvoxamine should be prescribed in low doses at the beginning of treatment under close medical supervision.
5. If symptoms due to increased liver enzyme activity occur, fluvoxamine should be discontinued.
6. In elderly patients, the dose of fluvoxamine should always be increased more slowly and with greater caution.
7. Use with caution in patients with a history of seizures. If an epileptic seizure develops, treatment with fluvoxamine should be discontinued.
8. There are reports of the development of ecchymosis and purpura with the use of selective serotonin reuptake inhibitors. Given this, such drugs should be prescribed with caution, especially concomitantly with drugs that affect platelet function (for example, with atypical antipsychotics and phenothiazines, many tricyclic antidepressants, NSAIDs, including acetylsalicylic acid), as well as in patients with a history of bleeding.

Compatibility with other drugs

When using the drug, it is necessary to take into account interactions with other medications:

1. When used together with Buspirone, its effectiveness decreases; with valproic acid – its effects are activated; with warfarin – its concentration and the risk of bleeding increase; with Galantamine – its negative effects are enhanced; with haloperidol - the lithium content in the blood increases.
2. When taken together with MAO inhibitors, there is a possibility of serotonin syndrome.
3. When used together with Alprazolam, bromazepam, diazepam, the concentration of these drugs in the blood increases and their negative effects intensify.
4. When taken simultaneously with amitriptyline, clomipramine, imipramine, maprotiline, carbamazepine, trimipramine, Clozapine, Olanzapine, propranolol, theophylline, their content in the blood plasma increases.
5. Using the drug together with metoclopramide increases the risk of extrapyramidal disorders.
6. When used together with quinidine, its metabolism is inhibited and clearance is reduced.