Fevarin 100 mg 30 pcs. film-coated tablets

Antidepressants help restore normal levels of chemicals in the brain that are involved in regulating sadness and anxiety. In people with depression who take antidepressants, the levels of neurotransmitters (hormones) in the brain normalize. When antidepressants, which affect the brain by affecting serotonin, are suddenly stopped, the body may respond by developing physical and emotional symptoms caused by the sudden absence of the increased serotonin levels that occur when taking the antidepressant.

These symptoms are not the same as physical withdrawal from the drug. Physiological withdrawal occurs when a patient takes a drug that can be addictive. However, the question “How to get off antidepressants” is asked by patients to a psychiatrist very often. In some cases, you can take antidepressants for the rest of your life, but their withdrawal is also possible, but this issue should be dealt with by a specialist. The patient must understand that it is possible to decide how much antidepressant to take only together with the attending physician. Psychiatrists at the Yusupov Hospital individually develop optimal timing and dosages for taking medications for each patient, allowing them to achieve the desired treatment effect while avoiding side effects.

Antidepressants are not addictive. The effect of antidepressant withdrawal is not related to addiction, but may reflect the physiological effects of stopping the drug in the same way as when a person with diabetes stops taking insulin. Almost one in five people who take antidepressants for six weeks or more may experience withdrawal symptoms if they suddenly stop taking the medication.

It is impossible to predict whether you will experience withdrawal symptoms after stopping an antidepressant. Scientists believe that suddenly stopping an antidepressant does not give the brain time to adjust to rapid changes in neurotransmitter levels. Therefore, you should not stop taking antidepressants.

All depression medications have the potential to cause unwanted symptoms, but some are much more likely to cause symptoms than others. Withdrawal symptoms are more likely to occur with antidepressants that remain in the body for a shorter period of time, especially those that affect both serotonin and norepinephrine.

You should not suddenly stop taking antidepressants, even if you feel better. Stopping antidepressants too early may cause depressive symptoms to return. If you need advice on taking or properly stopping antidepressants, or you have undesirable symptoms that have developed as a result of self-cessation of an antidepressant, and you urgently need advice from a psychiatrist, contact the Yusupov Hospital. You can make an appointment with a private psychiatrist at our clinic on the website.

The Yusupov Hospital employs doctors who have higher medical degrees.

education and specialization in psychiatry. Doctors at Yusupov Hospital

They regularly take advanced training courses and do internships in leading foreign psychiatric clinics.

When treating patients, doctors at the Yusupov Hospital use only new medications that have passed all studies and have proven effective in treating mental illnesses in the Russian Federation and have a minimal range of side effects.

Duration of taking antidepressants

According to numerous studies, the duration of taking antidepressants is at least 6 months after the patient begins to notice improvement.

Patients who stop taking medications for up to 8 months may experience a return of symptoms. For patients who have had one or more relapses of depression, the duration of taking antidepressants is about 24 months. And those patients who experience frequent relapses of depression require long-term treatment, which can last several years.

To correctly select the dose of the drug and determine the duration of treatment, the Yusupov Hospital employs psychiatrists of the highest category with a scientific degree. Each patient is given close attention. Patients who seek medical help at the clinic are constantly under the supervision of a specialist throughout the entire treatment. Psychiatrists can be consulted about rehabilitation after treatment, which makes it possible to reduce the incidence of recurrent symptoms of depression.

Independent and uncontrolled use of antidepressants entails the development of unwanted side effects, which in turn leads to early drug withdrawal and ineffective treatment.

Expert opinion

Author:

Elena Mikhailovna Bunina

Psychiatrist, doctor of the highest category

Statistics show that 5% of the population suffers from symptoms of depression. In most cases, psychiatrists decide to prescribe antidepressants. The drugs are included in the list of complex therapy used for depressive disorder.

Antidepressants work by restoring normal levels of chemicals responsible for regulating sadness and anxiety. Numerous clinical studies have proven that drugs of this pharmacological group are not addictive. However, one in five experience withdrawal symptoms. They are associated with abrupt cessation of taking prescribed medications. It is impossible to predict the development of withdrawal symptoms in advance.

Psychiatrists at the Yusupov Hospital select an individual treatment plan for each patient. It includes complex therapy using antidepressants that have undergone quality and safety control. The medications have proven effectiveness and are included in the list of world standards for the treatment of depression. Doctors do not recommend stopping the prescribed course on your own or abruptly. This can worsen the situation and lead to the development of unwanted symptoms.

Pharmacokinetics

When taken orally, it is completely absorbed from the gastrointestinal tract. Cmax is reached in 3–8 hours, equilibrium concentration is achieved in 10–14 days. Absolute bioavailability is 53% after primary metabolism in the liver. Simultaneous administration of Fevarin® with food does not affect the pharmacokinetics.

Plasma protein binding is approximately 80%. Volume of distribution - 25 l/kg.

Metabolism of Fevarin® occurs mainly 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 T1/2 from the blood plasma, which is 13–15 hours for a single dose, increases slightly with repeated doses (17–22 hours), and the equilibrium concentration in the blood plasma is usually achieved after 10–14 days.

Fevarin® undergoes biotransformation in the liver (mainly by oxidative demethylation) to at least 9 metabolites, which are excreted through the kidneys. The 2 main metabolites have little pharmacological activity. Other metabolites are probably pharmacologically inactive. Fluvoxamine significantly inhibits cytochrome P450 1A2, moderately inhibits cytochromes P450 2C and P450 3A4, and slightly inhibits cytochrome P450 2D6.

The pharmacokinetics of fluvoxamine are similar in healthy people, the elderly and patients with renal failure. Metabolism is reduced in patients with liver disease.

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

Antidepressant withdrawal symptoms

Withdrawal symptoms most often occur within three days of stopping antidepressants. Usually the symptoms are not severe and disappear within two weeks.

Symptoms of antidepressant withdrawal include:

• anxiety,
• depression and mood swings,
• dizziness,
• problems with balance,
• electric shock sensation
• headache,
• fatigue,
• flu symptoms (chills, muscle pain),
• loss of coordination
• muscle twitching and spasms,
• nausea,
• sleep disorders (nightmares, vivid dreams, insomnia),
• vomit.

Having antidepressant withdrawal symptoms does not mean that you are dependent on the drug.

Addiction represents harmful long-term chemical changes in the brain. It is characterized by intense cravings, an inability to control the use of a substance, and negative consequences of using that substance.

In rare cases, stopping an antidepressant can cause mania. Antidepressants, namely monoamine oxidase inhibitors, can lead to confusion and psychotic symptoms. If you are thinking about stopping an antidepressant, you should see a mental health professional to help prevent or minimize unwanted symptoms and discuss the risks and benefits of stopping treatment.

In many cases, stopping most antidepressants involves gradually reducing the dose of the antidepressant over several weeks or more under your doctor's supervision. This technique allows the brain to adjust to chemical changes and may prevent drug withdrawal symptoms. Do not try to reduce the dose of the drug or stop it on your own.

In some cases, your doctor may prescribe additional medications to ease withdrawal symptoms such as nausea and insomnia. Your doctor may also recommend switching from short-acting to long-acting antidepressants to ease withdrawal symptoms.

It can be difficult to distinguish withdrawal symptoms from depression symptoms after stopping an antidepressant. If you have any questions, you can make an appointment for a consultation by calling the Yusupov Hospital phone number. A psychiatrist provides assistance to patients around the clock.

Composition and release form

in a blister 15 or 20 pcs.; in a cardboard pack there are 1, 2, 3 or 4 blisters.

Directions for use and doses

Orally, without chewing and with a small amount of water.

Depression. The recommended starting dose is 50 or 100 mg (once, in the evening). It is recommended to gradually increase the starting 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. According to official WHO recommendations, treatment with antidepressants should be continued for at least 6 months of remission after a depressive episode. To prevent relapses of depression, it is recommended to take 100 mg of Fevarin® once a day.

Obsessive-compulsive disorders. It is recommended to start with a dose of 50 mg 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 as single doses, preferably in the evening. Daily doses above 150 mg are recommended to be divided into 2 or 3 doses.

Doses for children over 8 years of age and adolescents: initial - 25 mg/day for 1 dose, maintenance - 50-200 mg/day. 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 response to the drug, treatment can be continued at an individually selected daily dose. If improvement is not achieved after 10 weeks of treatment, fluvoxamine should be discontinued. Until now, 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, and therefore it can be considered advisable to extend treatment with Fevarin® beyond 10 weeks in patients with good responders to this drug. The selection of the minimum effective maintenance dose should be done with caution on an individual basis. Some clinicians recommend concomitant psychotherapy in patients who have responded well to pharmacotherapy.

Treatment of patients suffering from liver or kidney failure should begin with the lowest doses under strict medical supervision.

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

Fevarin 100 mg 30 pcs. film-coated tablets

pharmachologic effect

Antidepressant.

Composition and release form Fevarin 100 mg 30 pcs. film-coated tablets

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.

Directions for use and doses

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

Depression

Adults

The recommended starting dose for adults is 50 or 100 mg (once, 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.

According to official WHO recommendations, antidepressant treatment should be continued for at least 6 months of remission after a depressive episode.

To prevent relapses of depression, it is recommended to take 100 mg of Fevarin® once a day, daily.

Children

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.

Syndrome "Side effects" and "Special instructions") If intolerable symptoms occur after a 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.

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.

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.

Indications for use Fevarin 100 mg 30 pcs. film-coated tablets

Depression of various origins; obsessive-compulsive disorders.

Contraindications

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.

Application of Fevarin 100 mg 30 pcs. film-coated tablets during pregnancy and breastfeeding

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).

The use of fluvoxamine during pregnancy is not recommended, unless the woman's clinical condition indicates the need for its use.

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.

special instructions

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 stopped 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

If you stop taking fluvoxamine, the syndrome “side effects” may develop.

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.

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.

Treatment

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.

Side effects Fevarin 100 mg 30 pcs. film-coated tablets

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 the drug Fevarin® twice a day, 100 mg for 3 days before the simultaneous use of the drug ramelteon at a dose of 16 mg, the AUC value (area under the curve “conspiracy”). 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.

Scheme for correct withdrawal of fevarin

In order to prevent the development of fevarin withdrawal syndrome, it is necessary to strictly adhere to a specific discontinuation regimen. Its main principle is a gradual reduction in dosage until complete withdrawal of the drug. This allows the cells of the central nervous system to relearn how to function without an additional stimulant, which is fevarin.

First of all, it is worth remembering that after achieving remission in the treatment of any mental illness, it is necessary to continue taking the drug for preventive purposes. To do this, the dose of fevarin is reduced by 50 mg per week until a dosage of 100 mg per day is reached and thus taken for about six months. After this, you can think about stopping the drug.

Stopping taking fevarin does not last long - one to two weeks. The dose is again reduced by 50 mg, taken for a week or two weeks, after which the drug is completely abandoned. If the above-mentioned complaints occur when discontinuing this regimen, you should consult a doctor.

Reviews

Daniil P .: “I took fevarin for a little less than a year at a time when I was depressed. At first I took large doses, then gradually switched to maintenance treatment. Then I decided to just stop drinking it. About two days after taking the last pill, trembling occurred throughout my body, I could not do my usual work, it was even difficult to hold a pen in my hands. I had to resume taking the drug and the trembling stopped.”

Psychiatrist : “Fevarin, like any other antidepressant, changes the activity of brain cells. Neurons get used to functioning while taking the drug, so its abrupt withdrawal leads to a number of side symptoms. To prevent them, simply gradually reduce the dosage of fevarin.”

Content

Manifestations of fevarin withdrawal syndrome

The official instructions for the drug indicate that immediate discontinuation of the drug can lead to withdrawal syndrome. During clinical post-marketing trials of fevarin, no dangerous consequences were identified when stopping this drug. However, some subjects experienced a number of unpleasant side effects.

Fevarin withdrawal syndrome can be suspected when the following symptoms appear:

• Headache;
• Dizziness;
• Trembling and weakness in the arms and legs;
• Paresthesia (feeling of “crawling goosebumps”, electric shock, numbness);
• Insomnia;
• Nightmarish dreams;
• Irritability, aggressiveness, short temper;
• Sudden mood swings;
• Increased appetite.

As a rule, the listed symptoms appear in varying degrees within a day or two after discontinuation of fevarin. Their duration ranges from several days to several weeks. In the most severe cases, some symptoms may persist for a month or more.

Overdose

Symptoms: the most typical are gastrointestinal disorders (nausea, vomiting and diarrhea), drowsiness and dizziness. In addition, there are reports of cardiovascular disorders (tachycardia, bradycardia, hypotension), liver dysfunction, seizures and even coma. To date, there have been over 300 reports of cases of intentional overdose of Fevarin®. The highest recorded dose of Fevarin® received by one patient was 12 g; this 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 carried out as soon as possible after taking the drug, as well as symptomatic therapy. In addition, repeated intake of activated carbon is recommended. Increased diuresis or dialysis seems unjustified. There is no specific antidote.