Fevarin: instructions for use, analogues and reviews, prices in Russian pharmacies. Fevarin analogues and prices Different composition, may have the same indication and method of application

One Fevarin tablet contains: fluvoxamine maleate - 100 or 50 mg.

Excipients: corn starch - 80 or 40 mg; - 303 or 152 mg; pregelatinized starch - 12 or 6 mg; Sodium stearyl fumarate - 3.5 or 1.8 mg; colloidal silica - 1.5 or 0.8 mg.

Shell composition: macrogol 6000 - 2 or 1.5 mg; hypromellose - 5.6 or 4.1 mg; talc - 0.4 or 0.3 mg; titanium dioxide - 2.1 or 1.5 mg.

The drug does not contain lactose And sugar .

Release form

Tablets, regardless of dosage, are produced in blisters of 15 and 20 pieces, in a cardboard pack there are 4, 3, 2 or 1 such blister.

pharmachologic effect

The drug has antidepressant effect .

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

The drug selectively inhibits reuptake by brain cells and has minimal effect on noradrenergic transfer. Has a weak ability to interact with histaminergic, cholinergic, alpha And beta-adrenergic, m-dopaminergic And serotonergic receptors .

Pharmacokinetics

When taken orally, it is completely adsorbed from the intestines. The maximum concentration is observed 4–8 hours after administration, equilibrium concentration is achieved after two weeks. Bioavailability – 53% after initial metabolism in the liver. Food does not affect the pharmacodynamics of Fevarin.

Approximately 80% of the molecules of the active substance bind to blood proteins.

The half-life from the blood for a single dose is 13–15 hours, for multiple doses it is 17–22 hours.

The metabolism of Fevarin is localized in the liver. The drug undergoes biotransformation by oxidative demethylation . Metabolites are excreted by the kidneys. Only 2 out of 9 metabolites have pharmacological activity.

Pharmacokinetics are the same regardless of age and the presence of renal failure. Metabolism may be inhibited in persons with liver disease.

Indications for use of Fevarin

Indications for the use of Fevarin boil down to the need for prevention and therapy, treatment obsessive-compulsive symptoms.

Contraindications

It is forbidden to prescribe Fevarin simultaneously with MAO inhibitors, or ramelteon . Treatment with the drug can be started only 14 days after discontinuation of irreversible MAO inhibitors , and the next day after stopping the intake of inverse inhibitors MAO .

Therapy MAO inhibitors start 1 week after discontinuation of Fevarin.

The drug is contraindicated in persons with fluvoxamine maleate or to any other components of the medicinal product, with severe liver disease and children under eight years of age.

Side effects

• From the hematopoietic system: (gastrointestinal, gynecological, ecchymoses ).
• From the endocrine system: imbalance in production.
• From the side of nutrition and metabolism: hyponatremia , change in body weight.
• From the mental side: hallucinations, mania, suicidal thoughts and behavior.
• From the nervous system: excitement, anxiety, nervousness, drowsiness, headache, ataxia , convulsions , serotonin syndrome , .
• From the point of view: mydriasis , .
• From the cardiovascular system: hypotension .
• From the digestive system: abdominal pain, nausea, liver dysfunction.
• Skin: sweating, rash, itching, photosensitivity.
• From the musculoskeletal system: pain in muscles and joints, fractures.
• From the genitourinary system: various urinary disorders (urinary retention, incontinence, enuresis and others), late ejaculation , Galactorrhea, anorgasmia, menstrual disorders.
• General violations: asthenia, general weakness, withdrawal syndrome.

Stopping treatment often causes the development of withdrawal syndrome. It is recommended to discontinue the drug gradually.

Instructions for use of Fevarin

According to the instructions for use of Fevarin, the dosage regimen is set individually in each individual case. Initially, the daily dose of the drug is 50-100 mg (1 or 2 tablets depending on the dosage). It is recommended to take the drug at night. If necessary, the daily dose is 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 taken in two or three doses.

Overdose

Overdose symptoms.

• From the digestive system: nausea , impaired liver function.
• From the nervous system: convulsions , drowsiness , dizziness .
• Heart problems have also been reported: bradycardia, tachycardia, hypotension .

Fatalities due to overdose fluvoxamine occur extremely rarely. The highest recorded dose for an overdose is 12 grams. The person who took this dose made a complete recovery.

Treatment. There is no specific antidote. In case of overdose, it is necessary to rinse the stomach and prescribe symptomatic treatment. Recommended use. or forced diuresis ineffective.

Interaction

• When taken together with MAO inhibitors there is a possibility of serotonin syndrome .
• When used together with , The concentration of these drugs in the blood increases, and their negative effects intensify.
• When taken simultaneously with , carbamazepine, trimipramine, theophylline their content in the blood plasma increases.
• When used together, its effectiveness decreases; With valproic acid – its effects are activated; c – its concentration and the risk of bleeding increase; c – its negative effects intensify; c — the lithium content in the blood increases.
• Using the drug together with increases the risk of extrapyramidal disorders.
• When used together with quinidine its metabolism is inhibited and clearance decreases.

Terms of sale

The drug is available only with a prescription.

Storage conditions

Keep away from children. Store in a dry, dark place at a temperature less than 20 degrees.

Best before date

Three years.

special instructions

Patients with other conditions must be under constant supervision of the attending physician until the condition improves.

In persons with hypofunction of the liver or kidneys, treatment should begin with small doses under the supervision of the attending physician.

Should be used with caution fluvoxamine persons with convulsive syndrome in the anamnesis. If the patient develops convulsions or becomes more frequent, therapy should be discontinued.

Rarely when used fluvoxamine (and other selective serotonin reuptake blockers) may occur hyponatremia which disappears after discontinuation of the drug. The vast majority of episodes hyponatremia recorded in elderly patients.

The most common negative effect of treatment fluvoxamine nausea and vomiting occur, but they disappear after the first two weeks of therapy.

Withdrawal syndrome may occur when treatment is stopped fluvoxamine . The most common symptoms observed after withdrawal fluvoxamine : sensory disturbances, dizziness, sleep disturbances, irritability, agitation, confusion, headache, emotional instability, nausea, vomiting, sweating, anxiety. As a rule, these phenomena are mild and disappear on their own. They are observed in the first days after cessation of therapy. In this regard, it is advised to slowly reduce the dose consumed fluvoxamine .

Fevarin in a daily dose of 150 mg does not affect the ability to drive a car. However, drowsiness may develop during treatment, so caution must be exercised until your individual response to the medication has been studied.

Fevarin's analogs

The most common analogues of Fevarin are those containing fluvoxamine , How Deprivox And Fluvoxamine Sandoz .

For children

The antidepressant Fevarin is contraindicated in children under 8 years of age.

During pregnancy and lactation

Use of drugs based on fluvoxamine , especially in later stages, can increase the possibility of development persistent pulmonary hypertension of newborns . Therefore, Fevarin should not be used during pregnancy, unless the patient's condition requires therapy with this drug.

The drug can pass into breast milk in small quantities, so the use of the drug in women during lactation is contraindicated.

Fevarin is an antidepressant drug (3rd generation), produced in France, which belongs to the group of serotonin reuptake inhibitors. In clinical practice, the drug has been prescribed since the early 80s of the last century. Along with other antidepressants, it is used in the diagnosis of psychiatric or neurological disorders, as well as somatic or neuroendocrine pathology. There are no exact structural analogues of Fevarin in pharmacies; if you need to select a replacement, you should consult your doctor. An experienced specialist will prescribe a suitable drug from the group of antidepressants with a similar mechanism of action and therapeutic effect.

The drug in the form of tablets of 50 and 100 mg is sold in pharmacies after presenting a prescription from a doctor.

The active substance of the drug is fluvoxamine; the manufacturer uses silicon, corn starch, and mannitol as auxiliary components.

Pharmacological effect

The active component of the tablets is fluvoxamine, which is capable of selectively blocking the reuptake of serotonin. As a result, antidepressant and anti-stress effects are observed. The drug does not affect metabolic processes in the area of ​​other neurotransmitters (dopamine, norepinephrine). Complete absorption of the active ingredient is observed after oral administration, reaching maximum concentration after 4-7 hours.

The half-life, depending on the frequency of use of the drug, is from 14 to 21 hours. Achievement of equilibrium concentration is observed after 12-15 days of regular tablet use.

Indications

Fevarin is indicated for use in:

Important! You should refrain from using Fevarin when treating depressive disorders accompanied by lethargy, apathy, and lethargy.

Contraindications

Among the direct contraindications to taking pills are:

• hypersensitivity to the active ingredients of the tablets;
• breastfeeding period;
• treatment of children under 8 years of age;
• combined use with medications based on tizanidine or a group of MAO inhibitors.

Caution is required when using tablets for the following categories of people:

• elderly;
• patients with renal or liver failure;
• pregnant women;
• patients with organic convulsive syndrome, epilepsy;
• people with a history of bleeding or thrombocytopenia.

The drug is not intended for self-medication; before using it, you should consult a doctor.

Mode of application

Treatment begins with the minimum dosage selected by the doctor. As the patient adapts to the recommended medication, the dosage may be increased. The highest doses are recommended for patients with depressive disorders accompanied by suicidal tendencies, as well as obsessive-compulsive disorders. The tablet should be taken whole, not chewed, and washed down with water.

Important! Fevarin should not be stopped abruptly: the dosage is reduced over 1-1.5 months. Abrupt withdrawal may provoke a worsening of the clinical picture of the disease.

In order to achieve a pronounced therapeutic effect, the antidepressant must be taken for a long time, under the supervision of specialists. If there is no effectiveness several months after the start of treatment, it is necessary to reconsider the recommended treatment regimen and select another medicine with an antidepressant effect.

Side effects

The most common adverse reactions that occur during the use of Fevarin may be:

• increased sweating, allergies;
• decreased blood pressure, complaints of tachycardia;
• feeling of nausea, which goes away after 1-2 weeks, loss of appetite, development of dyspepsia, dry mouth, pain in the abdominal area, stool disorders;
• the occurrence of increased drowsiness, headache, anxiety, dizziness, agitation;
• development of disorders of the reproductive system.

Interaction with other drugs

Special caution and careful dosage adjustment is required when prescribed with other antidepressants. In this case, there is a possibility of serotonin syndrome.

Simultaneous use with drugs from the group of anticoagulants increases the likelihood of bleeding.

The simultaneous use of Fevarin with MAO inhibitors and tizanidine-based drugs (central-acting muscle relaxants) is contraindicated.

Concomitant use with drugs that belong to the group of neuroleptics poses a risk of developing neuroleptic malignant syndromes. If such a combination of medications is necessary, their dosages must be adjusted.

If combination with benzodiazepines is necessary, their dose must be reduced.

While using the antidepressant Fevarin, you must adhere to the following recommendations from qualified specialists:

1. The drug is not intended for self-medication; it can be purchased with a prescription from your doctor.
2. It is contraindicated to start treatment immediately with high dosages.
3. If any unwanted side reactions develop, you must inform your doctor about them.
4. For mild depression, the drug will not provide the desired therapeutic result.

Storage of tablets must be carried out in accordance with the manufacturer's recommendations: in a dark, dry place at a temperature of no more than 25 degrees.

Analogues, cost

The cost of the drug Fevarin in October 2017 is:

In Russia, the drug has no exact structural analogues. If a replacement is necessary, you should discuss with your doctor the possibility of selecting the following cheaper analogues:

• Fluoxetine – from 130-150 rubles.
• Citalopram (Siozam) – from 340-450 rubles.

These drugs are also not intended for self-medication! A preliminary consultation with a doctor is required.

Uses of Fluoxetine

Fluoxetine is a drug that partially inhibits serotonin reuptake. The active substance of the drug helps eliminate feelings of anxiety, reduces fear, and eliminates increased tension. The drug does not cause toxic effects on the patient's body and does not provoke orthostatic hypotension.

The drug is used for:

It is recommended to refrain from taking tablets in case of individual intolerance, during pregnancy and breastfeeding, in case of bladder atony, chronic renal failure, prostate adenoma.

The tablets can be taken regardless of food, the dosage depends on the indications for use and associated disorders.

Uses of Citalopram

Citalopram-based drugs selectively block the uptake of the hormone serotonin. The tablets help eliminate fears and increased anxiety, improve mood, reduce psycho-emotional stress, eliminate dysphoria, panic, and obsessive thoughts. The highest concentration of the substance is observed 3-5 hours after the patient takes the tablet.

Indications for the use of drugs based on Citalopram are:

The drug is used for postpartum depression, to eliminate the manifestations of menopause.

If the patient does not comply with the dosage recommended by the doctor, drowsiness, vomiting, convulsions, arrhythmia, and bluish skin may develop. Carrying out symptomatic and detoxification therapy helps to alleviate the well-being of patients.

Tablets - 1 tablet:

• active substance: fluvoxamine maleate 100 mg;
• excipients: mannitol 303.0 mg, corn starch 80.0 mg, pregelatinized starch 12.0 mg, sodium stearyl fumarate 3.5 mg, colloidal silicon dioxide 1.5 mg;
• shell: hypromellose 5.6 mg, macrogol 6000 2.0 mg, talc 0.4 mg, titanium dioxide (E171) 2.1 mg.

15 or 20 tablets in PVC/PVDC/Al blister.

1, 2, 3 or 4 blisters per cardboard box along with instructions for use.

Description of the dosage form

Tablets, film-coated, oval, biconvex, white, scored on one side, engraved with 313 on both sides of the score.

pharmachologic effect

Antidepressant.

Pharmacokinetics

Suction

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

Distribution

The binding of fluvoxamine to plasma proteins is 80% (in vitro). Volume of distribution - 25 l/kg.

Metabolism

Metabolism of fluvoxamine occurs primarily in the liver. 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.

The average plasma half-life of 13-15 hours for a single dose increases slightly with multiple doses (17-22 hours), and equilibrium plasma concentrations are usually achieved within 10-14 days.

Fluvoxamine undergoes biotransformation in the liver (mainly by oxidative demethylation) to at least nine metabolites, which are excreted through the kidneys. The two main metabolites have little pharmacological activity. Other metabolites are probably pharmacologically inactive.

Fluvoxamine significantly inhibits cytochrome P450 1A2 and P450 2C19, moderately inhibits cytochromes P450 2C9, P450 2D6 and P450 3A4.

The pharmacokinetics of a single dose of fluvoxamine is linear. The steady-state concentration of fluvoxamine is higher than that of a single dose, and this disproportionality is more pronounced at higher daily doses.

Special patient groups

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.

The steady-state plasma concentration of fluvoxamine is twice as high in children (aged 6–11 years) than in adolescents (aged 12–17 years). Plasma concentrations of the drug in adolescents are similar to those in adults.

Pharmacodynamics

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-cholino or dopamine receptors is negligible.

Fluvoxamine has a high affinity for ϭ1 receptors, acting as their agonist.

Indications for use Fevarin

Depression of various origins; obsessive-compulsive disorders.

Contraindications to the use of Fevarin

Concomitant use with tizanidine and monoamine oxidase inhibitors (MAO inhibitors).

Treatment with fluvoxamine can be started:

• 2 weeks after stopping the irreversible MAO inhibitor;
• the day after stopping a reversible MAO inhibitor (eg, moclobemide, linezolid).

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

Simultaneous use with the drug ramelteon.

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

Carefully:

Hepatic and renal failure, history of seizures, epilepsy, old age, patients with a tendency to bleed (thrombocytopenia), pregnancy, lactation.

Fevarin Use during pregnancy and children

Pregnancy

Epidemiological data suggest that the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, particularly 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 exposed to SSRIs in the third trimester of pregnancy experienced feeding and/or breathing difficulties, seizure disorders, unstable body temperature, hypoglycemia, tremors, muscle tone disorders, hyperexcitability syndrome, cyanosis, irritability, lethargy, drowsiness, nausea, difficulty falling asleep and continuous crying, which may require longer hospitalization.

Lactation period

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

Fertility

Reproductive toxicity studies in animals have shown that fluvoxamine affects male and female reproductive function, increases the risk of intrauterine fetal death, and reduces fetal body weight at doses approximately 4 times the maximum recommended human dose. 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.

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

Fevarin Side effects

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

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

General: often (1–10%) - asthenia, headache, malaise.

From the cardiovascular system: often (1–10%) - palpitations, tachycardia; sometimes (less than 1%) - postural hypotension.

From the gastrointestinal tract: often (1–10%) - abdominal pain, anorexia, constipation, diarrhea, dry mouth, dyspepsia; rarely (less than 0.1%) - impaired liver function (increased levels of liver transaminases).

From the side of the central nervous system: often (1–10%) - nervousness, anxiety, agitation, dizziness, insomnia or drowsiness, tremor; sometimes (less than 1%) - ataxia, confusion, extrapyramidal disorders, hallucinations; rarely (less than 0.1%) - convulsions, manic syndrome.

On the skin: often (1–10%) - sweating; sometimes (less than 1%) - skin hypersensitivity reactions (rash, itching, angioedema); rarely (less than 0.1%) - photosensitivity.

From the musculoskeletal system: sometimes (less than 1%) - arthralgia, myalgia.

From the reproductive system: sometimes (less than 1%) - delayed ejaculation; rarely (less than 0.1%) - galactorrhea.

Other: rarely (less than 0.1%) - change in body weight; serotonergic syndrome, neuroleptic malignant syndrome-like condition, hyponatremia and antidiuretic hormone deficiency syndrome; very rarely - paresthesia, anorgasmia and taste perversion.

When you stop taking fluvoxamine, withdrawal symptoms may develop - dizziness, paresthesia, headache, nausea, anxiety (most symptoms are mild and self-limiting). When discontinuing the drug, a gradual dose reduction is recommended.

Hemorrhagic manifestations - ecchymosis, purpura, gastrointestinal bleeding.

Drug interactions

MAO inhibitors

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

The effect of fluvoxamine on the oxidative process of other drugs

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

Ramelteon

When taking Fevarin® twice daily at 100 mg for 3 days before concomitant use of ramelteon at a dose of 16 mg, the AUC value (area under the concentration-time curve) for ramelteon increased approximately 190-fold, and the Cmax value ( maximum concentration) increased approximately 70-fold compared with these parameters when administering ramelteon alone.

Drugs with a narrow therapeutic index

Patients concomitantly taking fluvoxamine and drugs with a narrow therapeutic index that are metabolized exclusively or by a combination of cytochrome 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.

Tricyclic antidepressants and antipsychotics

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.

Benzodiazepines

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.

Cases of increased plasma concentration

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.

Cases of increased incidence of side effects

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.

Cytochrome P450 isoenzyme 3A4

Gerfenadine, astemizole, cisapride, sildenafil: When combined 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.

Glucuronidation

Fluvoxamine has no effect on plasma digoxin concentrations.

Renal excretion

Fluvoxamine has no effect on plasma concentrations of atenolol.

Pharmacodynamic interactions

In case of simultaneous 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.

Dosage of Fevarin

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

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.

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)

Adults

The recommended starting dose for adults is 50 mg of Fevarin® per 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.

Children over 8 years old and teenagers

The initial dose is 25 mg/day at a time. Maintenance dose 50 - 200 mg/day. When treating OCD in children aged 8 to 18 years, the daily dose should not exceed 200 mg. Daily doses above 100 mg are recommended to be divided into 2 or 3 doses.

If there is a good therapeutic response to the drug, treatment can be continued with an individually selected daily dose. If improvement is not achieved after 10 weeks, treatment with fluvoxamine should be reconsidered. Until now, there have been no systematic studies that could answer the question of how long fluvoxamine treatment can last, however, obsessive-compulsive disorders are chronic in nature, and therefore it may be advisable to extend fluvoxamine treatment beyond 10 weeks in patients who respond well for this drug.

The selection of the minimum effective maintenance dose should be done with caution on an individual basis. The need for treatment should be reassessed periodically. Some clinicians recommend concomitant psychotherapy in patients who have responded well to pharmacotherapy.

Withdrawal syndrome after stopping fluvoxamine use

Abrupt withdrawal of the drug should be avoided. When stopping treatment with fluvoxamine, the dose should be gradually reduced over a period of at least 1-2 weeks to reduce the risk of withdrawal syndrome (see section "Side effects" and "Special instructions"). If intolerable symptoms occur after dose reduction or after discontinuation of treatment, you can consider resuming treatment at the previously recommended dose. Later, the doctor may begin reducing the dose again, but more gradually.

Treatment of patients with liver or kidney failure should begin with low doses under strict medical supervision.

Overdose

Symptoms

The most typical symptoms include gastrointestinal disturbances (nausea, vomiting and diarrhea), drowsiness and dizziness. In addition, there are reports of cardiac dysfunction (tachycardia, bradycardia, hypotension), liver dysfunction, seizures and coma.

Fluvoxamine has a wide therapeutic dose range with regard to the safety of overdose. Since marketing, reports of deaths attributed to overdose with fluvoxamine alone have been extremely rare. The highest recorded dose of fluvoxamine taken by one patient was 12 g. This patient was completely cured. More serious complications have been observed in cases of deliberate overdose of fluvoxamine in combination with other drugs.

There is no specific antidote for fluvoxamine. In case of overdose, gastric lavage is recommended, which should be carried out as soon as possible after taking the drug, as well as symptomatic treatment. In addition, repeated intake of activated carbon is recommended, and, if necessary, the appointment of osmotic laxatives. Forced diuresis or dialysis are not effective.

Precautionary measures

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

Suicide/suicidal ideation or clinical deterioration

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.

Children's population

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.

Adults (18 to 24 years old)

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.

Elderly patients

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.

Akathisia/psychomotor agitation

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.

Treatment of patients suffering from liver or kidney failure should begin with low doses and such patients should be under strict medical supervision. In rare cases, treatment with fluvoxamine may lead to an increase in the activity of liver enzymes, most often accompanied by corresponding clinical symptoms, and in such cases Fevarin® should be discontinued.

Nervous system disorders

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 the development of serotonin syndrome or a condition similar to neuroleptic malignant syndrome have been described, which may be associated with the use of fluvoxamine, especially in combination with other serotonergic and/or antipsychotic drugs. Since these syndromes can lead to potentially life-threatening conditions manifested by hyperthermia, muscle rigidity, myoclonus, lability of the autonomic nervous system with possible rapid changes in vital parameters (pulse, respiration, blood pressure, etc.), changes in mental status, including confusion, irritability, extreme agitation, reaching the point of delirium or coma - in such cases, treatment with fluvoxamine should be discontinued and appropriate symptomatic treatment should be started.

Metabolic and nutritional disorders

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 antidiuretic hormone 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 fluvoxamine is prescribed to patients with a history of diabetes mellitus, dosage adjustment of antidiabetic 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 two weeks of treatment.

Visual impairment

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.

Hematological disorders

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, non-steroidal anti-inflammatory drugs) or drugs that increase the risk of bleeding. and in patients with a history of bleeding or who are prone to bleeding (eg, thrombocytopenia or coagulation disorders).

Cardiac disorders

Increased risk of prolongation of the QT interval/paroxysmal ventricular tachycardia of the "pirouette" type during combination therapy of 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 (2-6 beats per minute).

Electroconvulsive therapy (ECT)

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

Withdrawal reactions

When you stop taking fluvoxamine, a 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 (see section "Side effects").

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.

Mania/hypomania

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.

Impact on the ability to drive vehicles and operate machinery

Fevarin®, administered to healthy volunteers in doses up to 150 mg, had no or negligible 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. Therefore, caution is recommended until the individual response to the drug is definitively determined.

Stress, difficult life problems, worries, losses of loved ones and loved ones significantly affect the human nervous system. Sometimes external problems can drive you into a severe depressive state, from which it is very difficult to find a way out.

Many people, unable to get out of the shackles of anxiety and sadness, see only one way - suicide. However, doctors have found a method to combat depression. Antidepressant medications can help the patient bring back the joy of life. Fevarin is one of those saviors of the human soul that can be found on pharmacy shelves.

But for many it is unattainable in terms of acquisition - the price for a package of antidepressant is more than high. Fortunately, a wide range of pharmaceutical drugs allows you to find more affordable analogues of Fevarin, which have a similar method of influencing the human nervous system, while having an attractive price.

Fevarin: basic information about the drug

The American-made drug belongs to the group of antidepressants included in list B (potent drugs dispensed from pharmacies strictly according to a doctor’s prescription).

Let's pay attention to brief instructions for using Fevarin and prices in pharmacies.

Compound

The basis of the antidepressant is the substance fluvoxamine. Each tablet also contains excipients - silicon dioxide, mannitol, sodium and starch.

Indications

An antidepressant is prescribed for severe forms of disturbances in a person’s psycho-emotional state:

• depressive syndrome;
• feeling of anxiety, nervousness;
• sleep disturbance (up to insomnia) due to stress;
• compulsive disorder;
• apathy, loss of interest in everything around.

It is used not only directly during the period of a nervous disorder, but also as a preventive measure to prevent relapse after treatment.

Contraindications

An antidepressant has a serious effect on a person’s well-being, therefore in some cases, its use is strictly prohibited. The list of contraindications includes:

• renal failure;
• liver dysfunction;
• epileptic seizures;
• tendency to thrombocytopenia;
• convulsive state;
• intolerance to the substance included in the drug.

During pregnancy and breastfeeding, the drug can be prescribed in extreme cases and treatment should be accompanied by the close attention of a doctor.

Side effects

Antidepressant may cause a deterioration in the psycho-emotional state of a patient with suicidal tendencies. In this case, the attending physician may refrain from prescribing this drug to the patient or prescribe it in a minimal dosage.

In addition, taking Fevarin can cause a number of side effects:

As can be seen from the impressive list of side effects, an antidepressant cannot be perceived as an easy and safe panacea for a bad mood. Even with strict adherence to all recommendations for use, the medication can have an extremely negative impact on human health.

Price

Fevarin is available in tablet form. The cost depends on the content of the main active ingredient in the tablet:

1. a package of tablets, each containing 50 milligrams of fluvoxamine, costs around 700 rubles (for 15 tablets);
2. a package of tablets, each containing 100 milligrams of the main active ingredient, can be purchased for an average of 910 rubles (for 15 tablets).

An antidepressant has a powerful effect not only on a person’s nervous system, but also on his financial condition. It is also necessary to take into account that treatment requires completion of a full course, only in this case can you count on a positive result. Since one package contains only 15 tablets, you will have to pay a significant amount for the treatment of depression.

Cheap analogues

In order not to once again disturb your nervous system, shrouded in depression and anxiety, it is recommended to refrain from purchasing such an expensive drug.

And there is a significant reason for this - in the extensive stocks of any pharmacy you can find a number of drugs that are not inferior to Fevarin in effectiveness, but at the same time you will pay a significantly smaller amount of money for them.

Deprivox

A German-made antidepressant, listed on list B and sold in pharmacies strictly according to a doctor’s prescription.

Compound. The main active ingredient of the antidepressant is fluvoxamine.

Indications. Prescribed for depressive syndrome and obsessive-compulsive conditions. Effective in eliminating panic attacks, anxiety and unreasonable fears.

Contraindications. The main contraindication is individual intolerance to the active ingredient included in the drug. Also, Deprivox should not be combined with other psychotropic drugs.

Price. The antidepressant is available in tablet form. For a package of the drug containing 20 tablets (100 milligrams of active substance each), you will have to pay in the range of 500 rubles.

Comparison with the original. The two drugs contain the same active substance – fluvoxamine. The indications for use are also absolutely identical. The analogue has significantly fewer contraindications, as well as a much more attractive price (500 rubles for 20 tablets containing 100 milligrams of fluvoxamine, versus 910 rubles for 15 tablets of Fevarin).

Fluvoxin (Fluvoxamine)

An antidepressant made in India, it belongs to list B (potent drugs that are dispensed from pharmacies with a doctor’s prescription).

Compound. The basis of the drug is the substance fluvoxamine.

Indications. Prescribed for mental disorders:

• depressive syndrome;
• anxiety;
• panic attacks;
• stress;
• phobias.

Contraindications. Taking the drug is contraindicated if:

• diabetes mellitus;
• epileptic seizures;
• renal failure;
• liver diseases;
• hypersensitivity or absolute intolerance to the main active ingredient;
• pregnancy;
• breastfeeding;
• children up to eight years of age.

Price. You can buy an antidepressant for an average of 400 rubles (10 tablets, each containing 100 milligrams of the active substance).

Comparison with the original. The two drugs are based on the substance fluvoxamine. The two antidepressants are also very similar in indications and contraindications. The main difference is that the analogue is much cheaper.

Fluoxetine

One of the most effective Russian antidepressants, which has a very long history of existence. Refers to drugs from list B (potent drugs dispensed from pharmacies only with a prescription).

Compound. The composition is based on the active ingredient of the same name – fluoxetine.

Indications. The antidepressant is aimed at combating such pathologies of the central nervous system as:

• depression (including severe forms);
• neurosis;
• bulimia (excessively active appetite during a nervous state, stress);
• stress;
• insomnia.

Contraindications. An antidepressant should not be taken if:

• liver and kidney diseases;
• disorders of the genitourinary system;
• glaucoma;
• oncological pathologies;
• epilepsy;
• pregnancy;
• breastfeeding;
• convulsions;
• concomitant use with other psychotropic drugs;
• individual intolerance to the components of the drug.

Price. You can buy Fluoxetine for an average of 60 rubles (20 capsules, each containing 20 milligrams of the main active ingredient). Of course, finding a cheaper analogue will not be easy!

Comparison with the original. Despite the different substances in the drugs, both antidepressants have a similar focus. Significant difference in price. Despite the low cost, Fluoxetine is recognized as one of the most powerful antidepressants in the history of pharmacology.

If you are overcome by severe depression, you should not give up and lose the colors of life. It is necessary to contact an experienced neurologist or psychotherapist who will select an effective medication and draw up a course of treatment.

It is important to remember that psychotropic drugs and medications used to normalize the functioning of the nervous system should absolutely not be prescribed to oneself! By unauthorizedly diagnosing yourself with depression and buying an antidepressant illegally, without a doctor’s prescription, you can significantly harm your health!

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Clinical and pharmacological group

Release form, composition and packaging

White film-coated tablets, round, biconvex, scored and engraved with “291” on both sides of the score on one side of the tablet and the letter “S” above the ∇- icon on the other side.

Excipients: mannitol (152 mg), corn starch, pregelatinized starch, sodium stearyl fumarate, colloidal silicon dioxide.

The tablets are white, oval, biconvex, film-coated, scored and engraved with “313” on both sides of the score on one side of the tablet and the letter “S” above the ∇ symbol on the other side.

Excipients: mannitol (303 mg), corn starch, pregelatinized starch, sodium stearyl fumarate, colloidal silicon dioxide.

Composition of the tablet shell: hypromellose, macrogol 6000, talc, titanium dioxide (E171).

15 pcs. - blisters (1) - cardboard packs. 15 pcs. - blisters (2) - cardboard packs. 15 pcs. - blisters (3) - cardboard packs. 15 pcs. - blisters (4) - cardboard packs. 20 pcs. - blisters (1) - cardboard packs. 20 pcs. - blisters (2) - cardboard packs. 20 pcs. - blisters (3) - cardboard packs. 20 pcs. - blisters (4) - cardboard packs.

pharmachologic effect

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

Pharmacokinetics

Suction

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

Distribution

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

The degree of binding to plasma proteins is about 80% (in vitro). Vd - 25 l/kg.

Metabolism

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

Although the 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.

Fluvoxamine significantly inhibits cytochrome P450 1A2, moderately inhibits cytochromes P450 2C and P450 3A4, and slightly inhibits cytochrome P450 2D6.

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.

Steady-state fluvoxamine plasma concentrations were twice as high in children (ages 6–11 years) than in adolescents (ages 12–17 years). Concentrations of the drug in the blood plasma of adolescents are similar to those in adults.

Dosage

When treating depression, the recommended initial dose is 50 mg or 100 mg 1 time / day, in the evening. The dose should be increased gradually. The effective dose, usually 100 mg/day, is selected individually depending on the patient's response to treatment. The daily dose can reach 300 mg.

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

To prevent relapses of depression, Fevarin is recommended to be prescribed at a dose of 100 mg 1 time / day.

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

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

If an adequate therapeutic effect develops, treatment can be continued with an individually selected daily dose. If improvement is not achieved after 10 weeks of treatment, Fevarin should be discontinued. Considering that obsessive-compulsive disorders are chronic, it may be considered appropriate to extend the course of treatment with Fevarin for more than 10 weeks in patients with an adequate therapeutic effect. The selection of the minimum effective maintenance dose should be done individually and with caution. Some clinicians recommend concomitant psychotherapy in patients with a good effect of pharmacotherapy.

In case of liver or kidney failure, treatment should begin with the lowest dose under the strict supervision of a physician.

Fevarin tablets should be taken without chewing and with a small amount of water.

Overdose

Symptoms: the most common are nausea, vomiting, diarrhea, drowsiness, 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 as a result of symptomatic therapy). More serious complications were observed in cases of deliberate overdose of Fevarin against the background of 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 and, if necessary, the administration of osmotic laxatives are recommended. There is no specific antidote. Forced diuresis or dialysis is not advisable.

Drug interactions

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

When combined with Fevarin, plasma concentrations of terfenadine, astemizole or cisapride may increase, increasing the risk of QT prolongation. Therefore, Fevarin should not be prescribed simultaneously with these drugs.

Fluvoxamine is a potent inhibitor of CYP1A2 isoenzymes, and to a lesser extent CYP2C and CYP3A4. Drugs that are significantly metabolized by these isoenzymes are eliminated more slowly and may have higher plasma concentrations when used simultaneously with Fevarin. This is especially important for drugs that have a narrow therapeutic effect. Patients require careful monitoring, and it is recommended that the dosage of these drugs be adjusted if necessary. Fluvoxamine has minimal inhibitory effect on cytochrome P4502D6 and probably does not affect non-oxidative metabolism and renal excretion.

With simultaneous use of Fevarin, an increase in previously stable levels of tricyclic antidepressants (clomipramine, imipramine, amitriptyline) and antipsychotics (clozapine, olanzapine), which are largely metabolized by the CYP1A2 isoenzyme, was observed. In this regard, a reduction in the dose of these drugs may be recommended.

Patients simultaneously taking Fevarin and drugs with a narrow therapeutic index that are metabolized by the CYP1A2 isoenzyme (tacrine, theophylline, methadone, mexiletine), metabolized by the CYP2C isoenzyme (phenytoin) and metabolized by the CYP3A4 isoenzyme (carbamazepine, cyclosporine) should be under close medical supervision. If necessary, it is recommended to adjust the doses of these drugs.

When Fevarin 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 Fevarin and thioridazine.

In studies examining the interaction of Fevarin, an increase in propranolol concentrations was noted after the administration of Fevarin. In this regard, it is possible to recommend reducing the dose of propranolol in case of simultaneous use with Fevarin.

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

When taking Fevarin and ropinirole simultaneously, the plasma concentration of ropinirole may increase, thereby increasing the risk of overdose. In such cases, it is recommended to control, or, if necessary, reduce the dosage of ropinirole during treatment with Fevarin.

When administered simultaneously with fluvoxamine, anxiolytics from the group of benzodiazepines that undergo oxidative metabolism, such as triazolam, midazolam, alprazolam and diazepam, may increase their plasma concentrations. The dosage of these drugs should be reduced while taking Fevarin.

Fluvoxamine has no effect on plasma concentrations of digoxin and atenolol.

In the case of combined use of Fevarin with serotonergic drugs (triptans, serotonin reuptake inhibitors), tramadol, the serotonergic effects of fluvoxamine may be enhanced.

Fevarin was used in combination with lithium drugs to treat severe patients who poorly respond to pharmacotherapy. It should be noted that lithium (and possibly also tryptophan) enhances the serotonergic effects of Fevarin, and therefore this type of combination pharmacotherapy should be carried out with caution.

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

Use during pregnancy and lactation

Data from a small number of observations did not reveal any adverse effects of fluvoxamine on pregnancy. Potential risk unknown. The drug should be prescribed with caution during pregnancy.

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

Fluvoxamine is excreted in small amounts in breast milk. In this regard, the drug should not be used during lactation.

Side effects

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 two weeks of treatment.

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

From the digestive system: often (1-10%) - abdominal pain, anorexia, constipation, diarrhea, dry mouth, dyspepsia; rarely (< 0.1%) - нарушение функции печени (повышение уровня печеночных трансаминаз).

From the central nervous system and peripheral nervous system: often (1-10%) - asthenia, headache, malaise, nervousness, anxiety, agitation, dizziness, insomnia or drowsiness, tremor; Sometimes (<1 %) - атаксия, спутанность сознания, экстрапирамидные нарушения, галлюцинации; редко (< 0.1%) - судороги, маниакальный синдром, серотониновый синдром, состояние, подобное ЗНС; очень редко - парестезии, извращение вкуса.

Metabolism: hyponatremia, syndrome of insufficient ADH secretion.

From the cardiovascular system: often (1-10%) - palpitations, tachycardia; Sometimes (<1 %) - постуральная гипотензия.

Dermatological reactions: often (1-10%) - increased sweating; rarely (< 0.1%) - фотосенсибилизация.

Allergic reactions: sometimes (<1%) - сыпь, зуд, ангионевротический отек.

From the musculoskeletal system: sometimes (<1 %) - артралгия, миалгия.

From the reproductive system: sometimes (<1%) - замедленная эякуляция; редко (< 0.1%) - галакторея; очень редко - аноргазмия.

From the blood coagulation system: ecchymosis, purpura, gastrointestinal bleeding.

Other: rarely (< 0.1%) - изменение массы тела.

When you stop taking Fevarin fluvoxamine, withdrawal symptoms may develop, although preclinical and clinical studies have not shown dependence on fluvoxamine treatment.

Symptoms observed in case of drug withdrawal: dizziness, paresthesia, headache, nausea, anxiety. Most of these symptoms are mild and self-limiting. When discontinuing the drug, a gradual dose reduction is recommended.

Storage conditions and periods

List B. The drug should be stored in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25°C. Shelf life: 3 years (if stored in undamaged original packaging).

Indications

- depression of various origins;

- obsessive-compulsive disorders.

Contraindications

- simultaneous use with tizanidine;

- simultaneous use with MAO inhibitors;

- hypersensitivity to fluvoxamine maleate or other components of the drug.

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

special instructions

With depression, there is usually a high likelihood of attempting suicide, which may persist until sufficient remission is achieved. Such patients should be monitored.

Patients with hepatic or renal insufficiency at the beginning of treatment should be prescribed Fevarin in the minimum effective doses under the strict supervision of a physician. In rare cases, treatment with Fevarin may lead to an increase in the level of liver transaminases, most often accompanied by corresponding clinical symptoms. In such cases, Fevarin should be discontinued.

Control of blood glucose levels may be impaired, especially in the early stages of treatment with Fevarin, and therefore dose adjustment of hypoglycemic drugs may be required.

Prescribe with caution to patients with a history of seizures. Fevarin should be avoided in patients with unstable epilepsy, and patients with stable epilepsy should be under strict medical supervision. Treatment with Fevarin should be discontinued if epileptic seizures occur or their frequency increases.

Rare cases of the development of serotonin syndrome or a condition similar to NMS have been described, which may be associated with taking fluvoxamine in combination with other serotonergic antidepressants and antipsychotics. Because 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 signs, mental changes including increased irritability, agitation, confusion, delirium and coma - treatment with Fevarin should be discontinued. If necessary, appropriate symptomatic treatment should be carried out.

As with the use of other selective serotonin reuptake inhibitors, in rare cases, while taking Fevarin, hyponatremia may occur, which reverses after discontinuation of the drug. Some cases were caused by ADH deficiency syndrome, which was observed mainly in elderly patients.

There are reports of the development of ecchymosis and purpura, as well as hemorrhagic manifestations (for example, gastrointestinal bleeding) 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 and prone to to bleeding (for example, patients with thrombocytopenia).

Data obtained from the treatment of elderly patients and younger patients indicate that there are no clinically significant differences in the effectiveness of the drug used in usual daily doses. However, in elderly patients, the dose of the drug should always be increased more slowly and with greater caution.

Fevarin may lead to a slight decrease in heart rate (by 2-6 beats/min).

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

Use in pediatrics

Due to the lack of clinical experience, Fevarin is not recommended for the treatment of depression in children.

Impact on the ability to drive vehicles and operate machinery

Fevarin in doses up to 150 mg when administered to healthy volunteers did not affect psychomotor functions associated with driving a car or operating machines and mechanisms. At the same time, there are reports of drowsiness observed during the use of the drug. Therefore, caution is recommended until the individual response to treatment is definitively determined.

Use for renal impairment

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

The drug should be prescribed with caution in case of renal failure.

Use for liver dysfunction

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

The drug should be prescribed with caution in case of liver failure.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Registration numbers