Antipsychotic drugs, antidepressants, fevarin, avoxin, fluvoxamine. Fevarin - instructions for use Fevarin on what form is dispensed

Fevarin (fluvoxamine) pharmacologically belongs to the group of antidepressants. Manufactured by Abbot.

The composition includes the active substance fluvoxamine maleate - 50 mg or 100 mg, as well as auxiliary components mannitol, corn starch, as well as pregelatinized stearyl fumarate in the form of sodium salt, silicon dioxide in the form of a colloid.

The shell is made of hypromellose, macrogol, talc, titanium dioxide.

Externally, the 50 mg tablets are coated, round and biconvex in shape, white in color, have a line on one side, engraved with 291 on the sides, and on the back of the tablet there is the letter S above the triangle icon.

Tablets of 100 mg are also film-coated, oval in shape, biconvex, white, scored, engraved on both sides with 313, on the reverse side there is also the letter S above the triangle icon

Pharmacodynamically, the mechanism of action of Fevarin is based on the ability of the active substance fluvoxamine to selectively inhibit the reuptake of serotonin produced by brain neurons.

At the same time, Fevarin has a weak degree of binding to alpha, beta-adrenergic, m-cholinergic receptors, histaminergic, dopaminergic or serotonergic receptors.

Pharmacokinetically, after administration, fluvoxamine is completely absorbed from the gastrointestinal tract. Its maximum concentration in plasma occurs approximately 5-7 hours after administration.

After passing through the stage of primary metabolism in the liver, absolute bioavailability reaches 53%. Eating simultaneously with the drug does not affect the pharmacokinetics.

The binding of fluvoxamine to plasma proteins reaches 80%. Metabolism of fluvoxamine occurs predominantly in the liver, the resulting metabolites are excreted by the kidneys.

The average half-life of Fevarin from the body is 13-15 hours for a single dose and increases slightly with a course of administration (up to twenty-two hours), the equilibrium concentration in plasma is usually achieved within two weeks.

Two of the nine main metabolites formed as a result of hepatic metabolism have negligible pharmacological activity. Other metabolites do not appear to have pharmacological activity.

Fevarin significantly inhibits cytochrome P450 subtype 1A2, moderately inhibits cytochrome P450 subtype 2C and P450 subtype ZA4, and to a small extent inhibits cytochrome P450 subtype 2D6. The pharmacokinetics of a single dose of Fevarin is linear.

The steady-state concentration of fluvoxamine is higher than that of a single dose and is not linearly higher at higher daily doses.

The pharmacokinetics of fluvoxamine does not change in the elderly, or in patients with renal failure.

The metabolism of Fevarin tends to decrease in liver diseases. The equilibrium concentration of Fevarin in plasma is twice as high in children (6-11 years) than in adolescents (12-17 years), having similar concentrations as in adults.

Content:

Indications

The drug Fevarin is intended for the treatment of various origins, obsessive-compulsive disorders (OCD). Can be used in complex therapy of chronic pain syndrome.

Contraindications

Contraindications include hypersensitivity to fluvoxamine or any of the auxiliary components.

Concomitant use of tizanidine and MAO inhibitors is contraindicated.

Fluvoxamine therapy should begin the day after using a reversible MAO inhibitor, and in the case of using an irreversible MAO inhibitor, only 2 weeks after stopping use.

At the same time, the use of any MAO inhibitors after stopping the use of fluvoxamine should begin no earlier than a seven-day period.

Fevarin should be used with caution in case of existing renal or liver failure, in the presence of a history of epilepsy and seizures.

In old age, as well as in patients with a tendency to bleeding (thrombocytopenia).

Use during pregnancy and breastfeeding

Due to insufficient observations, no adverse effects of Fevarin on pregnancy were identified; the potential risk is unknown. In the same time,

Caution is necessary, as there are isolated cases of withdrawal syndrome in newborns after using fluvoxamine during pregnancy.

Fluvoxamine has the ability to pass into breast milk in small quantities. In this regard, Fevarin therapy is not recommended during breastfeeding.

Mode of application

Fevarin is taken orally, but the tablet should not be chewed; it must be taken with a sufficient amount of water.

Depression:

• In adults, the starting dose should be 50 or 100 mg (single dose, in the evening); if there is a risk of side effects, you can start with a dose of 25 mg. Gradually the dose is increased to the effective level. The effective daily dose is usually 100 mg and should be adjusted individually, taking into account the patient's response to therapy. The daily dose can be 300 mg, while daily doses above 150 mg should be distributed over several doses.
• According to official WHO recommendations, the duration of antidepressant therapy should be six months of remission after a depressive episode.
• To prevent a relapse of a depressive episode, the recommended dose of Fevarin is 100 mg once a day.

Obsessive-compulsive disorders (OCD):

• In adults, the starting dose is 50 mg Fevarin per day for 3-4 days. The effective daily dose is usually 100-300 mg and should not exceed 300 mg for adults. To the level of the optimal dosage regimen, doses should be increased gradually. At the same time, for doses up to 150 mg, a single daily dose is acceptable, preferably in the evening, and daily doses above 150 mg should be divided into 2 or 3 doses.
• Children over 8 years old and teenagers. The initial dose is 25 mg per day in one dose. The maintenance dose is 50-200 mg per day. For the treatment of OCD in children aged 8 to 18 years, the daily dose used should not exceed 200 mg. In this case, a daily dose of more than 100 mg should be distributed into 2-3 doses.

If a good therapeutic effect has been obtained from treatment with Fevarin, therapy can be continued, with the daily dose selected for each case. The use of Fevarin should be reconsidered if there is no improvement after 10 weeks of treatment.

No systematic studies have been conducted, as a result of which the issue of the permissible duration of treatment with Fevarin was resolved.

At the same time, since obsessive-compulsive disorders are chronic, it is permissible to extend therapy beyond 10 weeks for those patients in whom the use of Fevarin has given a positive therapeutic response.

The minimum effective maintenance dose should be selected individually and with great care. The need for continued therapy should be periodically assessed. Some experts recommend sessions of concomitant psychotherapy in patients who have had a good response to pharmacotherapy.

Treatment of patients with liver or kidney failure is recommended to begin with the use of low doses and always under strict medical supervision.

Side effects

During clinical trials, some side effects were noted that depended on the symptoms of existing depression and were not related to the drug therapy.

All side effects are divided into common (> 1%), uncommon (> 0.1%), rare (> 0.01%).

Frequent: malaise, asthenia, palpitations with tachycardia, sweating may increase, manifestations of anorexia.

Gastrointestinal disorders: dyspepsia, dry mouth, abdominal pain, nausea and vomiting, diarrhea or constipation.

Nervous system disorders: increased excitability, tremor, agitation, anxiety, headache, dizziness, drowsiness or insomnia.

Uncommon: orthostatic hypotension, myalgia and arthralgia, ataxia and extrapyramidal disorders, impaired (delayed) ejaculation may occur.

A state of confusion, hallucinations, and hypersensitivity skin reactions may occur (rash, itching, possible angioedema).

Rare: liver dysfunction, in the form of increased activity of liver enzymes.

The appearance of seizures, galactorrhea, photosensitivity reactions. Mania may develop.

Side effects have also been reported during post-marketing use of fluvoxamine. The exact frequency is not provided.

Hemorrhages were observed (gastrointestinal, ecchymosis, purpura), suppression of antidiuretic hormone secretion and hyponatremia were noted, and changes in body weight could occur, both in the direction of decrease and increase.

Effects from the nervous system could occur: serotonin syndrome, neuroleptic malignant syndrome, akathisia, skin sensitivity disorders, taste disorders.

Cases of suicidal behavior have been reported during fluvoxamine therapy and shortly after its completion.

Also noted were urinary disorders (expressed as urinary retention, urinary incontinence, or increased frequency of urination, nocturia), and the phenomenon of anorgasmia.

Cases of Fevarin withdrawal syndrome, including withdrawal syndrome in newborns. Symptoms noted during withdrawal: headache, dizziness, nausea, anxiety, paresthesia. In most cases, these symptoms are mild and self-limiting. Upon completion of therapy, the dose should be reduced gradually.

Overdose

The most characteristic symptoms include gastrointestinal disorders (nausea up to vomiting and diarrhea), drowsiness and non-vestibular dizziness. There is also evidence of cardiac dysfunction (various rhythm changes, arterial hypotension), liver dysfunction, convulsions and depression of consciousness.

However, overdose is possible only with sufficiently large doses of Fluvoxamine. Since its introduction, there have been extremely rare reports of deaths believed to be due to overdose of fluvoxamine alone.

The highest dose recorded was 12 grams of fluvoxamine taken by a patient. At the same time, the patient was completely cured. More serious complications have been reported in cases where fluvoxamine overdose was intentional and combined with other drugs.

There is no specific antidote for Fevarin. In case of overdose, gastric lavage is necessary as early as possible.

Symptomatic therapy, repeated intake of activated carbon, and, if necessary, the prescription of osmotic laxatives are also recommended. At the same time, dialysis or forced diuresis are not effective.

special instructions

Interaction with other drugs

Fluvoxamine is significantly capable of inhibiting the cytochrome P450 1A2 isoenzyme, and to a lesser extent the P450 2C and P 450 3A4 isoenzymes. Drugs metabolized by these isoenzymes are eliminated more slowly and may reach higher plasma concentrations when used concomitantly with Fevarin.

This is significant for drugs with a narrow therapeutic dose range. In these cases, patients should be closely monitored, and if necessary, the dose of these drugs should be adjusted.

Let's take a closer look at each.

• Isoenzyme cytochrome P450 1A2

With simultaneous use of fluvoxamine, it was noted that the concentrations of antipsychotics (olanzapine, clozapine), as well as tricyclic antidepressants (primarily amitriptyline, as well as less commonly used imipramine and clomipramine) increased.

It is known that these drugs are largely metabolized by the cytochrome P450 1A2 isoenzyme. Based on this, if fluvoxamine therapy is started, it is necessary to review the doses of these drugs downward.

Patients who simultaneously take fluvoxamine and drugs that have a narrow therapeutic range of action and are metabolized by the cytochrome P450 1A2 isoenzyme (for example, tacrine, mexiletine, theophylline, methadone) must be under the supervision of a specialist.

It is recommended to adjust the dose of these drugs. There are isolated cases of cardiotoxicity with the simultaneous use of thioridazine and fluvoxamine. When fluvoxamine and propranolol interact, an increase in the concentrations of propranolol in the blood plasma has been recorded.

With simultaneous therapy of fluvoxamine and ropinirole, an increase in the concentration of ropinirole in plasma is possible, and therefore, the development of an overdose of ropinirole becomes possible. Monitoring, dose reduction or discontinuation of ropinirole during fluvoxamine therapy is necessary.

• Isoenzyme cytochrome P450 2 C

Constant monitoring is required, and, if necessary, dose reduction in patients who take fluvoxamine together with drugs with a narrow range of therapeutic effects, and if these drugs are metabolized by the cytochrome P450 2C isoenzyme (for example, phenytoin).

When using Fevarin together with warfarin, a significant increase in the concentration of warfarin in plasma and an increase in prothrombin time were noted.

• Isoenzyme cytochrome P450 ZA4

Terfenadine, cisapride, astemizole: when used in combination with fluvoxamine, plasma concentrations of terfenadine, cisapride or astemizole may increase, thereby increasing the risk of an increase in the QT interval - ventricular paroxysmal tachycardia of the "pirouette" type. The use of fluvoxamine in combination with these medications is not recommended.

Patients simultaneously taking fluvoxamine and drugs that have a narrow therapeutic range of action require monitoring and dose adjustment of these drugs if these drugs are metabolized by the cytochrome P450 3A4 isoenzyme (for example, cyclosporine, carbamazepine).

With the simultaneous use of fluvoxamine and benzodiazepines that undergo oxidative metabolism, for example, triazolam, diazepam, midazolam, alprazolam, there is a possibility of increasing their concentration in the blood plasma. Therefore, the dose of these benzodiazepines should be reduced while fluvoxamine is being used.

Pharmacodynamic interactions of the drug are also important during Fevarin therapy. When combined with fluvoxamine and serotonergic drugs (tramadol, triptans, SSRI antidepressants, and St. John's wort), the serotonergic effects of fluvoxamine may be enhanced.

Fevarin in some cases was used in combination with lithium drugs to treat severely drug-resistant patients. It should be noted that lithium (and probably the amino acid tryptophan) enhances the serotonergic effects of fluvoxamine, so such combination pharmacotherapy should be used with caution.

With the simultaneous use of Fevarin and oral anticoagulant drugs, the risk of hemorrhage may increase. Such patients require medical supervision and supervision.

• General special instructions

During treatment with Fevarin, you should stop drinking alcoholic beverages.

Depression is associated with an increased risk of suicidal thoughts or acts. The risk remains until the patient's condition has significantly improved.

In this regard, careful monitoring and monitoring of the patient's condition is necessary until sustainable improvement occurs, since improvement may not occur during the first few weeks of therapy or longer.

However, in clinical practice, an increase in the risk of suicide in the early stages of recovery is common.

The risk of suicidal events is also increased in cases of OCD. Also, OCD can be accompanied by major depression. In this regard, when treating patients with such disorders, the same precautions should be taken as when treating patients with major depression.

Constant monitoring of patients, especially those at high risk, is necessary throughout the entire duration of therapy, as well as in the early stages of therapy and after dose changes.

Adults (from 18 to 24 years old). A meta-analysis of placebo-controlled clinical observations of the use 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 fluvoxamine, it is necessary to weigh the benefits of its use against the possible risk of suicide.

Patients of the older age group. Although data obtained from monitoring the treatment of elderly patients and younger patients showed the absence of any clinically significant differences between their usual daily doses, increasing doses of Fevarin in elderly patients should be done more slowly and with more caution.

Akathisia (psychomotor agitation). The development of akathisia while taking Fevarin is characterized by subjectively unpleasant and painful anxiety. In this case, the need for movement is often accompanied by the inability to stand or sit in a calm state.

This occurrence is more likely to occur during the first few weeks of therapy. If the dose of Fevarin is increased in patients with such symptoms, there is a possibility of a deterioration in their well-being.

It is important to start therapy for patients with a history of liver or kidney failure with low doses of Fevarin, and in these cases strict monitoring should be carried out by the attending physician.

In rare cases, the use of Fevarin can lead to an increase in the activity of liver enzymes, most often accompanied by corresponding clinical symptoms, and discontinuation of Fevarin is necessary.

Nervous system disorders that require attention during Fevarin therapy. Caution is required when prescribing Fevarin to patients with a history of seizures. Fevarin should not be used in patients with unstable epilepsy, and patients with stable epilepsy require strict monitoring.

Fevarin therapy should be discontinued if epileptic seizures occur or their frequency increases.

During therapy with Fevarin, blood glucose levels may change (hypo- or hyperglycemia may occur, as well as impaired glucose tolerance), especially at an early stage of use. Based on these facts, when prescribing Fevarin to patients suffering from diabetes mellitus, the dose of antidiabetic drugs should be adjusted.

• Hematological disorders

There is information about intradermal hemorrhages (ecchymosis and purpura), hemorrhagic manifestations (gastrointestinal bleeding) observed with the use of SSRI antidepressants.

Caution is required when prescribing these drugs in the elderly, in patients simultaneously receiving drugs that affect platelet function (atypical antipsychotics and phenothiazines, tricyclic antidepressants, acetylsalicylic acid, NSAIDs), drugs that increase the risk of bleeding, as well as in patients with a history of bleeding or prone to bleeding (in particular, thrombocytopenia).

• Cardiac disorders requiring attention during Fevarin therapy

When combined with Fevarin with terfenadine or astemizole or cisapride, due to an increase in the concentration of the latter in plasma, the risk of increasing the QT interval increases, as well as the development of ventricular paroxysmal tachycardia of the “pirouette” type in the patient. In this regard, Fevarin is not recommended to be prescribed together with these drugs.

Fevarin, administered to healthy volunteers in doses up to 150 mg, had no or only a slight effect on the ability to drive a car and control machinery. At the same time, there were reports of a feeling of drowsiness noted during the use of Fevarin.

Based on this, caution is necessary until the individual response to the drug is definitively determined.

Storage conditions

Fevarin should be stored in its original packaging, in a dry, dark place at a temperature not exceeding 25°C. Protect access for children. Shelf life: 3 years.

Analogs

Fevarin is an original drug that has no analogues at the time of publication. It is inappropriate to call other antidepressants and serotonin reuptake inhibitors analogues of Fevarin, although from time to time the author of the site comes across this point of view.

Price

Fevarin is a prescription drug available with a doctor's prescription (the prescription or a copy thereof must be kept at the pharmacy). Average prices may vary among pharmacies and are approximately:

• Tablets 50 mg, pack of 15 tablets 650-850 rubles.
• Tablets of 50 mg, pack of 30 tablets 1100-1300 rubles.
• Tablets 100 mg, pack of 15 tablets 830-1150 rubles.
• Tablets 100 mg, pack of 30 tablets 1340-1780 rubles.

You should not self-medicate. Before using Fevarin, consult your doctor!

Compound

Active ingredient: fluvoxamine;

1 tablet 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).

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

film-coated tablets, 50 mg: round, convex on both sides, white or almost white, film-coated, scored on one side and marked “291” on both sides of it; diameter - approximately 9 mm; The tablet can be divided into two equal parts.

Film-coated tablets 100 mg: oval, convex on both sides, white or almost white, film-coated, scored on one side and marked “313” on both sides of it; length - approximately 15 mm, width - approximately 8 mm; The tablet can be divided into two equal parts.

Pharmacological group

Antidepressants. Selective serotonin reuptake inhibitors.

Pharmacological properties

Pharmacological.

Receptor binding studies have shown that fluvoxamine 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.

Suction.

Fluvoxamine is completely absorbed after oral administration. The maximum concentration in blood plasma is achieved 3-8 hours after administration. Through the first pass mechanism, the average bioavailability is 53%.

The pharmacokinetics of Fevarin ® are not affected by simultaneous food intake.

Distribution.

In vitro, 80% of fluvoxamine is bound to plasma proteins. The volume of distribution in humans is 25 l/kg.

Metabolism.

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 approximately 13-15 hours after a single dose and increases slightly (17-22 hours) with repeated doses. Equilibrium concentration in blood plasma is achieved within 10-14 days.

Fluvoxamine is extensively transformed in the liver, mainly by oxidative demethylation, resulting in the formation of at least nine metabolites that are excreted by the kidneys. The two main metabolites show little pharmacological activity. Other metabolites are 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.

Special groups of patients.

The pharmacokinetics of fluvoxamine are similar in healthy adults, the elderly, and patients with renal impairment. The metabolism of fluvoxamine is impaired in patients with liver disease.

Steady-state plasma concentrations of fluvoxamine are twice as high in children aged 6 to 11 years as in children aged 12 to 17 years. Plasma concentrations in children aged 12 to 17 years are the same as in adults.

Indications

• Depression.
• Obsessive-compulsive disorder (OCD).

Contraindications

Do not co-administer with tizanidine, MAO inhibitors (MAOIs) or ramelteon. Treatment with Fevarin ® can be started no earlier than two weeks after discontinuation of irreversible MAOIs, and the day after discontinuation of reversible MAOIs (for example, moclobemide, linezolid).

Treatment with any of the drugs in the MAOI group can be started no earlier than a week after discontinuation of Fevarin ® .

The drug is contraindicated in patients with hypersensitivity to fluvoxamine maleate or to any of the other components of the drug.

Interaction with other drugs and other types of interactions

MAO inhibitors.

The drug 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 isoenzymes (CYPs). In vitro and in vivo studies show a strong inhibitory effect of fluvoxamine on CYP1A2 and 2C19, but CYP2C9, CYP2D6 and CYP3A4 are inhibited to a lesser extent. Drugs predominantly metabolized by these isoenzymes are eliminated more slowly and may have higher plasma concentrations when used concomitantly with fluvoxamine. Fluvoxamine therapy should be initiated concomitantly with such drugs or adjusted to the lowest effective dose. Plasma concentrations, effects or side effects of concomitant therapy drugs are subject to careful monitoring and, if necessary, their dosage should be reduced. This is especially true for drugs with a narrow therapeutic index.

Ramelteon.

When fluvoxamine was given at a dose of 100 mg twice daily for 3 days, and then when a single dose of 16 mg ramelteon was given concurrently with a dose of fluvoxamine, 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. It is recommended to adjust the dosage of this medication if necessary.

Tricyclic antidepressants and antipsychotics.

Increased plasma concentrations of tricyclic antidepressants (e.g. clomipramine, imipramine, amitriptyline) and antipsychotics (e.g. clozepine, olanzapine, quetiapine), which are primarily metabolized by cytochrome P450 1A2, have been reported when administered concomitantly with fluvoxamine. Consideration should be given to reducing the dose of these drugs when added to fluvoxamine treatment.

Benzodiazepines.

When taken simultaneously with fluvoxamine, the plasma concentration of benzodiazepines that are metabolized by oxidation (for example, triazolam, midazolam, alprazolam and diazepam) may increase. The dose of these benzodiazepines should be reduced when used concomitantly with fluvoxamine.

Cases of increased plasma concentrations.

When taking ropinirole in combination with fluvoxamine, its plasma concentration may increase, which increases the risk of overdose. Taking this into account, monitoring of patients is required, and if necessary, reducing 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.

Cases increase the 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. Side effects of caffeine may occur (tremors, palpitations, nausea, anxiety, insomnia). Therefore, patients who take significant amounts of caffeine-containing beverages should reduce their intake if they are prescribed fluvoxamine.

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 also Precautions).

The use of fluvoxamine concomitantly with lithium (in patients with severe forms of the disease) requires caution, since lithium (and possibly tryptophan) may enhance the serotonergic effect of fluvoxamine. Therefore, concomitant use of these drugs should be limited to 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.

Features of application

Suicide/suicidal ideation or clinical worsening

Depression is associated with an increased risk of suicidal ideation, self-harm and suicide (suicidal events). This risk persists until remission is achieved. Since improvement may not occur during the first few weeks of treatment, 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 psychiatric conditions treated with fluvoxamine may also be associated with an increased risk of suicidal events. In addition, such conditions can be combined with major depressive disorder. Therefore, when treating patients with other psychiatric conditions, such patients require careful monitoring.

Patients with a history of suicidal behavior and patients who demonstrate a high level of suicidal ideation before treatment may be at greater risk for suicidal ideation or suicide attempts. Therefore, they need careful monitoring during treatment.

Careful monitoring of patients, including those at high risk, is necessary during 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 has been 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.

Liver and kidney dysfunction

In patients with impaired renal or liver function, treatment should begin with low doses under close medical supervision.

Rarely, treatment with fluvoxamine has been associated with an increase in liver enzyme activity, usually accompanied by corresponding clinical symptoms. In such cases, treatment with the drug should be discontinued.

Nervous system disorders

Despite the fact that the drug did not cause a trial when studied in animals, one must be careful when prescribing fluvoxamine to patients with a history of seizures (in particular epilepsy). 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 phenomena have been reported in connection with treatment with Fevarin, especially when used concomitantly with other serotonergic and/or neuroleptic drugs. These syndromes are characterized by a cluster of several symptoms such as hyperthermia, rigidity, myoclonus, instability of the autonomic nervous system with possible rapid changes in vital signs, mental status changes such as confusion, irritability, excessive agitation with progression to delirium and coma. Since these syndromes can cause life-threatening conditions, if they occur, treatment with Fevarin ® should be stopped and supportive symptomatic therapy should be started.

Metabolism and eating disorders

Rarely, when taking fluvoxamine, as well as other selective serotonin reuptake inhibitors, hyponatremia occurs, which disappears after discontinuation of the drug. Some cases may have been associated with ADH deficiency syndrome. Most cases of hyponatremia have been reported in elderly people.

Glycemic control may be impaired (in particular hyperglycemia, hypoglycemia, decreased glucose tolerance), especially in the early stages of treatment. In patients with a history of diabetes mellitus, the dose of antidiabetic medications must be adjusted while taking fluvoxamine.

Nausea, sometimes accompanied by vomiting, is a common side effect accompanying fluvoxamine treatment. However, this side effect usually disappears within the first two weeks of treatment.

Visual disorders

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.

hematological disorders

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 while taking selective serotonin reuptake inhibitors. It is recommended to prescribe such drugs with caution 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 and non-steroidal anti-inflammatory drugs) or drugs that increase the risk of bleeding, and also in patients with a history of hemorrhagic conditions or conditions that cause a tendency to bleeding (for example, thrombocytopenia or blood clotting disorders).

heart disorders

When coadministered with fluvoxamine, plasma concentrations of terfenadine, astemizole, or cisapride may be increased, resulting in an increased risk of QT prolongation/TdP. Therefore, it should not be prescribed together with these medications. Fluvoxamine may cause a slight decrease in heart rate (2-6 beats per minute).

Electroconvulsive therapy (ECT)

Reaction to drug withdrawal

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, partial confusion, emotional instability, headache, 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").

Elderly people

Data for elderly individuals indicate that there are no clinically significant differences in the usual daily dose compared to younger individuals. However, for elderly patients, dose titration should be titrated more slowly than for other patients and dosing should always be done with caution.

Young adults (18 to 24 years old)

A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders showed an increased risk of suicidal behavior with antidepressants compared with those treated with placebo for adult patients under 25 years of age.

Use during pregnancy or breastfeeding.

Epidemiological evidence suggests that use of selective serotonin reuptake inhibitors (such as fluvoxamine) during pregnancy, particularly late in pregnancy, may increase the risk of persistent pulmonary hypertension of the newborn (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; this is only justified if the woman’s condition requires treatment with fluvoxamine.

Isolated cases of withdrawal syndrome in a newborn child have been recorded after the use of fluvoxamine at the end of pregnancy. After the use of selective serotonin reuptake inhibitors (such as fluvoxamine) during the third trimester of pregnancy, some newborns experienced difficulty swallowing and/or breathing, convulsions, temperature instability, hypoglycemia, tremor, impaired muscle tone, tremors, cyanosis, irritability, lethargy, somnolence , vomiting, sleep disturbances and constant crying, which may require prolonged hospitalization.

The drug passes into breast milk in small quantities, so it should not be prescribed to women who are breastfeeding.

A study of the effect of taking fluvoxamine on the reproductive state of animals revealed a decrease in fertility in male and female animals. The relevance of these data to humans is unknown. Fluvoxamine should not be used to treat patients who are trying to conceive, unless the patient requires treatment with fluvoxamine.

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 operate machinery. In healthy volunteers, no effect on psychomotor skills associated with driving and operating machinery was detected. However, drowsiness may occur during treatment, so caution should be exercised until your individual response to the drug is established.

Directions for use and doses

Fevarin ® tablets should be swallowed without chewing, with a sufficient amount of water.

Depression (adults).

The recommended starting dose is 50 mg or 100 mg per day. It should be taken once a day, preferably before bed. According to the doctor's decision, increase the dose gradually until a clinical effect is achieved. The effective dose is usually 100 mg per day. It should be selected individually, depending on the patient’s reaction. The daily dose should not exceed 300 mg. When prescribing doses exceeding 150 mg, they should not be taken at a time, but distributed into 2-3 doses during the day. According to the guidelines of the World Health Organization, after the patient’s symptoms of depression disappear, 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 3-4 days of treatment, after which it should be gradually increased until the maximum effective dose is reached, which is usually 100-300 mg per day. The maximum daily dose of Fevarin ® for adults is 300 mg.

Doses up to 150 mg should be taken once daily, preferably at bedtime. When prescribing doses of more than 150 mg, they should be divided into 2-3 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 no improvement occurs within ten weeks of treatment, the advisability of further administration of Fevarin ® should be reconsidered. 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 takes maintenance therapy with the drug at the minimum effective dose. The advisability of continuing treatment should be reviewed periodically. Patients who experience a positive effect from pharmacotherapy may additionally be prescribed behavioral psychotherapy.

Children aged 8 years and older.

The starting dose for children aged 8 years and older is 25 mg per day, preferably at bedtime. It is allowed to increase the dose by 25 mg every 4-7 days to achieve an effective dose. The effective daily dose is usually in the range of 50 mg - 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 tablet into two parts for dosing 2 times a day, 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 the decision to discontinue treatment with fluvoxamine is made, the dose should be gradually reduced over 1-2 weeks in order to reduce the risk of withdrawal syndrome (see Sections "Adverse reactions" and "Peculiarities of use"). If withdrawal symptoms develop after dose reduction or discontinuation, dosage should be resumed at the previous level. The doctor may then continue to reduce the dose, but more gradually.

Treatment of patients with liver or kidney failure should begin with a low dose under the supervision of a physician based on the patient's health condition.

Fevarin ® should not be used to treat children and adolescents under the age of 18, except for patients with OCD (obsessive-compulsive disorder). OCD (obsessive-compulsive disorder) is the only indication for the use of Fevarin ® in children over 8 years of age.

Due to insufficient clinical experience, Fevarin ® cannot be recommended for the treatment of depression in children. In clinical studies, children treated with antidepressants were more likely to experience suicidal behavior (suicidal thoughts or suicide attempts), as well as hostility, anger, and aggression compared to placebo. If a decision is made to initiate therapy based on clinical need, the patient should be carefully monitored for any suicidal symptoms.

In addition, there are no data on the long-term effects of fluvoxamine treatment in children and adolescents, as well as its effects on growth, maturation, cognitive and behavioral development.

Overdose

Symptoms. From the gastrointestinal tract (nausea, vomiting, diarrhea), drowsiness and dizziness. Cardiovascular disorders (tachycardia, bradycardia, hypotension), liver dysfunction, convulsions and coma have also been reported.

Fluvoxamine has a wide range of safety in overdose. Reports of deaths due to overdose of fluvoxamine alone are extremely rare. The highest dose recorded for an overdose was 12 g. The patient took this dose and completely recovered. 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 perform gastric lavage as quickly as possible and begin supportive symptomatic treatment. Activated charcoal and, if necessary, an osmotic laxative are also recommended. Forced diuresis or hemodialysis are ineffective.

Adverse reactions

Adverse events observed during clinical trials at the frequencies listed below were often disease-related and not necessarily related to treatment.

Side effects are classified by frequency as follows:

Very often ≥ 1/10.

Often ≥1/100 to<1/10.

Uncommon ≥1/1000 to<1/100.

Rarely ≥1/10000 to<1/1000.

Very rarely<1/10000.

Frequency unknown: cannot be estimated from existing data.

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 nervous system

Often agitation, nervousness, anxiety, insomnia, drowsiness, tremor, headache, dizziness.

Uncommon: extrapyramidal disorders, ataxia.

Rarely convulsions.

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

Frequently rapid heartbeat/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 (excessive sweating).

Uncommon: allergic skin 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, predominantly conducted in patients aged 50 years and older, 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

Uncommon late ejaculation.

Rarely galactorrhea.

Not known: anorgasmia, menstrual disorders (such as amenorrhea, hypomenorrhea, metrorrhagia and menorrhagia).

General disorders and reactions at the injection site

Often asthenia, general malaise.

Not known: drug withdrawal syndrome, including drug withdrawal syndrome in neonates.

Release form:

white, round, biconvex, with a score on one side, with “291” engraved on both sides of the score.

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: hypromellose - 4.1 mg, macrogol 6000 - 1.5 mg, talc - 0.3 mg, titanium dioxide (E171) - 1.5 mg.

Film-coated tablets white, oval, biconvex, with a score on one side, with “313” engraved on both sides of the score.

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: hypromellose - 5.6 mg, macrogol 6000 - 2 mg, talc - 0.4 mg, titanium dioxide (E171) - 2.1 mg.

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

Pharmacotherapeutic group:

• Neurotropic agents

Pharmacological properties:

Pharmacodynamics

Antidepressant. Receptor binding studies have shown that fluvoxamine is a potent serotonin reuptake inhibitor both in vitro and in vivo with minimal affinity for serotonin receptors. Its ability to bind to α- and β-adrenergic receptors, histamine, m-cholinergic receptors or dopamine receptors is negligible.

Fluvoxamine has a high affinity for σ 1 receptors, acting as their agonist.

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. Concomitant use of fluvoxamine with food does not affect pharmacokinetics.

Distribution

The degree of binding to plasma proteins is about 80% (in vitro). Vd - 25 l/kg. C ss in blood plasma is usually achieved after 10-14 days.

The pharmacokinetics of fluvoxamine after a single dose is linear. C ss concentration of fluvoxamine is higher than the concentration after a single dose, and this disproportionality is more pronounced at higher daily doses.

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.

Fluvoxamine significantly inhibits the isoenzymes of cytochrome P450 (CYP) 1A2 and 2C19, and moderately inhibits the isoenzymes CYP2C9, 3A4 and 2D6.

Although the 2D6 isoenzyme of cytochrome P450 is the main one in the metabolism of fluvoxamine, the concentration of the drug in the blood plasma in individuals with reduced function of this isoenzyme is not much higher than in individuals with normal metabolism.

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 are similar in healthy people, the 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.

Indications for use:

Depression of various origins;

Obsessive-compulsive disorders.

Refers to diseases:

• Depression

Contraindications:

Concomitant use with tizanidine and MAO inhibitors (treatment with fluvoxamine can be started 2 weeks after stopping taking an irreversible MAO inhibitor, the day after stopping taking a reversible MAO inhibitor (for example, moclobemide, linezolid). The time interval between stopping taking fluvoxamine and starting therapy with any MAO inhibitor should be at least 1 week;

Simultaneous use with ramelteon;

Hypersensitivity to the active substance or to any of the components of the drug.

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

Directions for use and dosage:

Fluvoxamine tablets should be taken orally, without chewing, with water. The tablet can be divided into 2 equal parts.

Depression

adults is 50 mg or 100 mg 1 time/day, in the evening. It is recommended to gradually increase the dose to the effective level. The effective daily dose, usually 100 mg, is selected individually depending on the patient's response to treatment. The daily dose can reach 300 mg. Daily doses above 150 mg should be divided into several doses.

To prevent relapses 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 under 18 years of age.

Obsessive-compulsive disorders (OCD)

Recommended starting dose for adults is 50 mg/day for 3-4 days. The effective daily dose is usually from 100 to 300 mg. Doses should be increased gradually until an effective daily dose is reached, which should not exceed 300 mg in adults. Doses up to 150 mg can be taken once daily, preferably in the evening. Daily doses above 150 mg are recommended to be divided into 2 or 3 doses.

Initial dose for children over 8 years old and teenagers 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.

With a good therapeutic response, treatment can be continued with an 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 in nature, 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.

Withdrawal syndrome after discontinuation of fluvoxamine

Abrupt withdrawal of the drug should be avoided. When discontinuing treatment with fluvoxamine, the dose should be gradually reduced over at least 1-2 weeks to reduce the risk of withdrawal symptoms. If intolerable symptoms occur after a dose reduction or after treatment is discontinued, consideration may be given to resuming treatment at the previously recommended dose. Later, the doctor may begin reducing the dose again, but more gradually.

At liver or kidney failure

Side effect:

Some side effects observed in clinical trials were often related to the disease and not to treatment with Fevarin. All reactions are distributed according to organ systems and frequency of development: often (>1% and<10%); нечасто (>0.1% and<1%); редко (>0.01% and<0.1%); частота неизвестна.

From the blood coagulation system: frequency unknown - bleeding (for example, gastrointestinal bleeding, gynecological bleeding, ecchymosis, purpura).

From the endocrine system: frequency unknown - hyperprolactinemia, syndrome of inadequate ADH production.

Metabolism and nutrition: often - anorexia; frequency unknown - hyponatremia, weight loss, weight gain.

From the mental side: infrequently - hallucinations, a state of confused consciousness; rarely - mania; frequency unknown - suicidal thinking, suicidal behavior.

From the nervous system: often - anxiety, increased excitability, restlessness, insomnia, drowsiness, tremor, headache, dizziness; uncommon - extrapyramidal disorders, ataxia; rarely - convulsions; frequency unknown - serotonin syndrome, NMS, akathisia/psychomotor agitation, paresthesia, dysgeusia.

From the side of the organ of vision: frequency unknown - glaucoma, mydriasis.

From the cardiovascular system: often - palpitations, tachycardia; infrequently - orthostatic hypotension.

From the digestive system: often - abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, nausea, vomiting; rarely - liver dysfunction (increased activity of liver enzymes).

For the skin and subcutaneous tissues: often - increased sweating; uncommon - skin hypersensitivity reactions (including rash, itching, angioedema); rarely - photosensitivity reactions.

From the musculoskeletal system: infrequently - arthralgia, myalgia; frequency unknown - bone fractures.*

From the urinary system: frequency unknown - urinary disorders (including urinary retention, urinary incontinence, pollakiuria, nocturia and enuresis).

From the reproductive system: infrequently - disturbance (delay) of ejaculation; rarely - galactorrhea; frequency unknown - anorgasmia, menstrual irregularities (such as amenorrhea, hypomenorrhea, metrorrhagia, menorrhagia).

Common disorders: often - asthenia, malaise; frequency unknown - drug withdrawal syndrome, including withdrawal syndrome in newborns whose mothers took fluvoxamine in late pregnancy.

* - epidemiological studies performed primarily on patients aged 50 years and older have shown an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism by which this risk increases is unknown.

Withdrawal syndrome after discontinuation of fluvoxamine

Stopping the use of fluvoxamine (especially abruptly) often leads to the development of withdrawal syndrome. For this reason, if treatment with fluvoxamine is no longer required, it is recommended to gradually reduce the dose until the drug is completely discontinued.

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 intentional overdose of fluvoxamine during concomitant pharmacotherapy.

Treatment: gastric lavage, which should be performed as soon as possible after taking the drug; carry out symptomatic therapy. In addition, repeated intake of activated carbon is recommended, and, if necessary, the appointment of osmotic laxatives. There is no specific antidote. Forced diuresis or dialysis are ineffective.

Use during pregnancy and breastfeeding:

Epidemiological data suggest that the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, especially in the last months of pregnancy, may increase the risk of persistent pulmonary hypertension (PPH) in the newborn. Available data indicate that PLH occurs in approximately 5 cases per 1000 births (as opposed to 1-2 cases per 1000 births if the mother did not use SSRIs in late pregnancy).

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

Some newborns after exposure to SSRIs in the third trimester of pregnancy experienced feeding and/or breathing difficulties, convulsive disorders, unstable body temperature, hypoglycemia, tremors, muscle tone disorders, increased neuro-reflex excitability syndrome, cyanosis, irritability, lethargy, drowsiness, nausea, difficulty falling asleep and continuous crying, which may require longer hospitalization.

Fluvoxamine passes into breast milk in small quantities. In this regard, the drug should not be used during lactation.

Fluvoxamine should not be prescribed patients who are planning pregnancy, unless the patient's clinical condition requires the use of fluvoxamine.

Experimental studies reproductive toxicity in animals showed that fluvoxamine affects the reproductive function of males and females, increases the risk of intrauterine fetal death and reduces fetal body weight in doses exceeding the maximum recommended dose for humans by approximately 4 times. In addition, an increased incidence of perinatal mortality in puppies was observed in pre- and postnatal studies. The significance of these data for humans is unknown.

Interaction with other drugs:

Fluvoxamine should not be used in combination with MAO inhibitors, including linezolid, due to the risk of developing serotonin syndrome.

Fluvoxamine may inhibit the metabolism of drugs that are metabolized by certain cytochrome P450 isoenzymes. In in vitro and in vivo studies shows a powerful inhibitory effect of fluvoxamine on cytochrome P450 isoenzymes 1A2 and 2C19 and, to a lesser extent, on cytochrome P450 isoenzymes 2C9, 2D6 and 3A4.

Drugs that are significantly metabolized by these isoenzymes are eliminated more slowly and may have higher plasma concentrations when used concomitantly with fluvoxamine. Such drugs should be prescribed at a minimum dose or the dose should be reduced to a minimum when used simultaneously with fluvoxamine. Close monitoring of plasma concentrations, effects or side effects is required, and dosage adjustments of these drugs are required if necessary. This is especially important for drugs that have a narrow therapeutic index.

When taking the drug Fevarin 100 mg 2 times / day for 3 days before simultaneous use of the drug ramelteon at a dose of 16 mg, the AUC value for ramelteon increased approximately 190 times, and the Cmax value increased approximately 70 times compared to these parameters with prescription of one ramelteon.

Patients concomitantly taking fluvoxamine and drugs with a narrow therapeutic index that are metabolized solely or by a combination of cytochrome P450 isoenzymes that inhibit fluvoxamine (such as tacrine, theophylline, methadone, mexiletine, phenytoin, carbamazepine, and cyclosporine) should be closely monitored. If necessary, dose adjustment of these drugs is recommended.

With simultaneous use of fluvoxamine, an increase in the concentration of tricyclic antidepressants (for example, clomipramine, imipramine, amitriptyline) and antipsychotics (for example, clozapine, olanzapine, quetiapine), which are significantly metabolized by the cytochrome P450 1A2 isoenzyme, was observed. Therefore, if treatment with fluvoxamine is initiated, a dose reduction of these drugs should be considered.

When used 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.

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.

When fluvoxamine interacted with propranolol, an increase in plasma concentrations of propranolol was observed. In this regard, it can be recommended to reduce the dose of propranolol in case of simultaneous use with fluvoxamine.

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

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

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.

During combination therapy with fluvoxamine, plasma concentrations of terfenadine, astemizole or cisapride may increase, increasing the risk of QT prolongation/torsade de pointes (TdP). Therefore, fluvoxamine should not be prescribed together with these drugs.

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 this type of combination pharmacotherapy should be carried out with caution.

With the simultaneous use of indirect anticoagulants and fluvoxamine, the risk of hemorrhage may increase. Such patients should be under medical supervision.

Special instructions and precautions:

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

Depression is associated with an increased risk of suicidal ideation, self-harm, and suicide attempts (suicidal behavior). This risk persists until the condition significantly improves. Since 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.

Other psychiatric disorders for which fluvoxamine is prescribed may also be associated with an increased risk of suicidal behavior. In addition, these conditions may accompany major depression. Therefore, patients with other mental disorders should be closely monitored.

Patients with a history of suicidal behavior or a significant degree of suicidal ideation are known to be at greater risk of suicidal ideation or suicide attempts 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.

Cases of mydriasis have been reported with the use of SSRIs such as fluvoxamine. Therefore, patients with elevated intraocular pressure or patients at increased risk of acute angle-closure glaucoma should be prescribed fluvoxamine with caution.

There are reports of intradermal hemorrhages such as ecchymosis and purpura, as well as other hemorrhagic manifestations (for example, gastrointestinal bleeding or gynecological bleeding), observed with the use of selective serotonin reuptake inhibitors. Caution should be exercised when prescribing these drugs in elderly patients and 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, as well as in patients with a history of bleeding or prone to bleeding (for example, thrombocytopenia or coagulation disorders).

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).

There is limited clinical experience with the use of fluvoxamine in conjunction with ECT, so such therapy should be carried out with caution.

When you stop taking fluvoxamine, withdrawal syndrome may develop, although available data from preclinical and clinical studies have not revealed the occurrence of dependence on fluvoxamine treatment. The most common symptoms noted in case of drug withdrawal: dizziness, sensory disturbances (including paresthesia, visual disturbances and electric shock sensations), sleep disturbances (including insomnia and vivid dreams), agitation, irritability, confusion, emotional lability, headache, nausea and /or vomiting, diarrhea, sweating, palpitations, tremors and anxiety. Most of these symptoms are mild or moderate and self-limiting, but in some patients they can be severe and/or prolonged. These symptoms usually occur within the first few days after stopping treatment. For this reason, it is recommended to gradually reduce the dose of fluvoxamine before complete discontinuation according to the patient's condition.

Fluvoxamine should be used with caution in patients with a history of mania/hypomania. If the patient develops a manic phase, fluvoxamine should be discontinued.

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.

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.

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 fluvoxamine, the risk of suicide should be weighed against the benefits of its use.

Use in pediatrics

Fluvoxamine should not be used to treat children and adolescents under 18 years of age, with the exception of patients with obsessive-compulsive disorder. Due to the lack of clinical experience, the use of fluvoxamine in children for the treatment of depression cannot be recommended. In clinical studies conducted among 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 to 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.

For impaired renal function

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

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 in old age

WITH caution the drug should be prescribed to elderly patients.

Use in childhood

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.

Storage conditions:

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

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.

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.

How is it produced?

The antidepressant Fevarin is available in tablet form. There is only one release form for Fevarin. Their shape is round, convex on both sides. The color is white or slightly gray. The tablets are coated and are marked either 291 or 313. The score makes the tablets easily split into two.

Tablets are sold in 15 pieces in a blister, one or two blisters in a box, or twenty tablets in a blister, three blisters in a box.

One Fevarin tablet contains 50 or 100 mg of the active substance - fluvoxamine in the form of maleate. Auxiliary components are corn starch, sodium stearyl fumarate, silicon dioxide, hypromelose, macrogol, talc, titanium dioxide.

pharmachologic effect

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.

The speed of action of the drug is not affected by food intake.

The drug binds to plasma proteins and is actively processed by the liver. On average, the half-life is about fifteen hours after a single use of the drug, but increases if the drug is taken for a long time.

Equilibrium concentrations of the drug are achieved within half a month. The speed of action of the drug is the same for all age groups, as well as for patients with liver diseases.

Equilibrium concentrations of the drug in the plasma of children under 11 years of age are twice as high as those in children from 11 to 17 years of age - this should be taken into account when choosing a dosage. In children aged 11 to 17 years, steady-state concentrations are similar to adults.

Who is the drug indicated for?

Fevarin's indications are quite limited. Indications for the use of Fevarin include depression and obsessive-compulsive disorders. The drug is used for depression of various types: social depression, accompanied or not accompanied by agitation, depression with anxiety.

Contraindications

According to the instructions for use of Fevarin, its use with tizanidine, any drugs that inhibit monoamine oxidase, and also simultaneously with ramelteon is contraindicated. There is a general contraindication for all representatives of this drug group - they are prohibited for use with parallel use of MAO inhibitors, as well as for a half-month after the end of treatment with them.

Otherwise, if a switch to MAO inhibitor drugs is required, treatment with them begins 7-9 days after finishing taking Fevarin.

Contraindicated in patients with hypersensitivity to any component of the drug, including fluvoxamine.

How to use the drug

Fevarin's instructions warn against chewing and sucking the tablets. The antidepressant Fevarin is taken according to the doctor’s recommendations, swallowing and without chewing the tablet, washing it down with plenty of water.

Depression in adults

How to take Fevarin at the beginning of treatment is determined by the attending physician. It is recommended to take it before bedtime. At the discretion of the attending physician, the dosage can be gradually increased until the desired therapeutic effect is achieved.

The dosage is selected carefully, taking into account the individual reaction of the body. The daily dosage should not exceed 0.3 g. If dosages of more than 0.15 g are prescribed, they must be divided into several doses.

When the signs of depression disappear, it is necessary to continue taking the drug for another six months in maintenance dosages to prevent relapse of depression.

OCD in adults

Fevarin and Triftazin for OCD are prescribed by the attending physician. Begin treatment with small dosages and observe the body’s reaction. After four days, the dosage is gradually increased until the maximum effective dosage is found.

Dosages per day up to 0.15 g are taken in one dose in the evening, dosages over 0.15 g are divided into several doses.

If the desired therapeutic result is not achieved within three months, the advisability of treatment with Fevarin should be reconsidered. Given the chronic nature of OCD in adults, treatment can be continued longer. The advisability of continuing treatment should be reviewed from time to time by the attending physician.

Patients who experience a therapeutic effect should additionally undergo behavioral psychotherapy.

Children from eight years old

The initial dosage should be half that for adults. It is advisable to take the drug before bedtime. It is allowed to gradually increase the dosage once a week until the desired result is achieved.

The maximum dosage for children per day should not be more than 0.2 g. If the daily dosage of 50 mg is exceeded, it is divided into two or three doses. If, when dividing the tablet, one part turns out to be larger, you should drink it before bed.

Treatment with Fevarin in childhood is allowed only for OCD; for all other mental diseases, the drug is contraindicated until the age of 18.

When used to treat depression, paradoxical reactions such as anger, aggressiveness, and suicidal thoughts were observed. Therefore, the drug should be prescribed to a child with OCD only after an accurate diagnosis has been established.

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.

Adverse reactions

Side effects of Fevarin are similar to symptoms of depression, so it is quite difficult to differentiate them from each other.

From the hormonal system, abnormal secretion of the hormone vasopressin is possible. From the metabolic side, a reaction such as loss of appetite is often observed, and rarely an increase or decrease in body weight.

Occasionally, reactions to Fevarin such as hallucinations, confusion, aggressiveness, and even more rarely, the occurrence of mania were observed. When used contrary to contraindications, suicidal thoughts and behavior may develop.

The central nervous system may respond to the drug with agitation, nervousness, anxiety, insomnia, or drowsiness. Headaches and dizziness, hand tremors are possible. If recommendations for drug interactions are violated, serotonin syndrome, which is dangerous to health, may develop.

The cardiovascular system may respond to treatment with Fevarin with an accelerated heartbeat, decreased blood pressure, and tachycardia. Gastrointestinal disorders included abdominal pain, constipation, dry mouth, nausea, and vomiting.

The patient may experience increased sweating, and sometimes arthralgia and myalgia develop. The reproductive system may react with late ejaculation in men and galactorrhea.

Drug interactions

Some patients are prescribed a combination of Fevarin and Triftazin to eliminate panic attacks. The correct treatment regimen should involve small concentrations of Triftazine and standard Fevarin.

Doctors speak well of the combination of Seroquel and Fevarin, but only for the treatment of depression in adults. The regimen can be supplemented with Phenazepam and Fevarin, but the dosage of the latter in this case must be individually calculated and selected by the attending physician.

Information on interactions with MAO inhibitors is given in contraindications.

Effect on the metabolism of other drugs

Fevarin can slow down or completely stop the absorption of drugs that are metabolized by the liver to a greater extent, therefore, before prescribing them, a mandatory consultation with your doctor is necessary. Drugs that are metabolized by the liver may be less cleared, which means their concentrations in the blood will be higher.

Carbamazepine, Theophylline, Methadone

Careful monitoring of patients taking these drugs simultaneously with Fevarin, as well as Tacrine, Mexiletine, Phenytoin, Cyclosporine is necessary. Their dosages need to be adjusted.

Neuroleptics, tricyclic antidepressants

Concentrations of tricyclic antidepressants may increase simultaneously with the drug Fevarin, therefore, when combining these drugs, the dosage of tricyclic antidepressants should be reduced.

Ethanol

It is recommended to avoid the combination of Fevarin and alcohol, as well as medications containing alcohol. The effects of Fevarin and alcohol in combination can be unpredictable and lead to immediate adverse reactions.

Features of treatment

The risk of suicidal phenomena persists until stable remission occurs, therefore patients should be closely monitored by the attending physician in the first six months of treatment.

Taking Fevarin may be accompanied by a debilitating need to move and an inability to maintain a stationary position. The manifestation of such a reaction is possible in the first week of therapy. However, it is not recommended to further increase the dosage.

Patients with liver and kidney disease should begin treatment with the lowest possible dosage under close supervision. Treatment is stopped when the activity of liver enzymes increases.

Concomitant treatment with antipsychotics may be dangerous due to the development of serotonin syndrome.

Reaction to cancellation

Before discontinuing Fevarin, its effect should be analyzed. The withdrawal of Fevarin should be gradual. Otherwise, withdrawal syndrome occurs, although clinical studies have not shown that the drug is capable of causing addiction.

Most often, Fevarin withdrawal syndrome manifests itself in the form of dizziness, goosebumps, and sleep disturbances. Fevarin drug withdrawal syndrome can also manifest itself in excessive agitation, irritation, mood swings, and headaches.

Often these phenomena are mild and go away on their own, but in some patients they can worsen. Therefore, it is recommended to gradually discontinue the drug, and if symptoms occur, return to the previous dosage and reduce it even more slowly.

Pregnant and lactating women

The use of the drug during pregnancy and breastfeeding is prohibited, especially in the second and third trimester.

Cost and analogues

The price of Fevarin depends on the dosage, as well as the region of sale. Price 100 mg - from 1587 to 2029 rubles per package. The price of Fevarin 50 mg is from 911 to 1316 rubles per pack.

Analogues of the drug:

The attending physician must decide which is better between Paxil and Fevarin, but more often the choice is made in favor of the latter. When choosing Truxal or Fevarin, it should be noted that Fevarin is replaced with Truxal if it has side effects. Which is better between Fluoxetine and Fevarin should also be decided with your doctor, since these are drugs of the same pharmacological group.