Rokona, 100 mg 30 pcs.

Pharmacotherapeutic group: antidepressant

ATX code: N06AB08

Pharmacological action

Pharmacodynamics

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

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

Pharmacokinetics

Intake

Intake

.p>After oral administration, fluvoxamine is completely absorbed from the gastro-
intestinal tract. Maximum concentrations of fluvoxamine in plasma
blood are noted 3-8 hours after ingestion. Absolute bioavailability
is 53% after primary metabolism in the liver. Concomitant intake
fluvoxamine with food does not affect pharmacokinetics.

Distribution

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

Metabolism

The metabolism of fluvoxamine occurs primarily in the liver. Although
cytochrome P 450 isoenzyme 2D6 is the major enzyme in the metabolism of
fluvoxamine, plasma concentrations of the drug in persons with decreased
function of this isoenzyme are not much higher than in persons with normal
metabolism.

The average plasma half-life, which is 13-15 hours for a single
dose, is slightly longer with multiple doses (17-22 hours),
and the equilibrium plasma concentration is usually reached 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
insignificant pharmacological activity. Other metabolites are probably
pharmacologically inactive.

Fluvoxamine significantly inhibits cytochrome P450 1A2 and P450 2C19, moderately
inhibits cytochrome P450 2C9, P450 2D6 and P450 WA4.

Pharmacokinetics of a single dose of fluvoxamine is linear. The equilibrium
concentration of fluvoxamine is higher than that of a single dose, and this
disproportionality is more pronounced at higher daily doses.
Special patient groups

Pharmacokinetics of fluvoxamine are similar in healthy subjects, elderly
patients with renal impairment. The metabolism of fluvoxamine is reduced
patients with liver disease.

The equilibrium plasma concentration of fluvoxamine is twice as high in children (ages
6-11 years) as in adolescents (ages 12-17 years). Plasma concentrations in adolescents are similar to those in adults.

Indications

– depression of various origins;
– obsessive-compulsive disorders.

Pharmacological effect

Pharmacotherapeutic group: antidepressant

ATC code: N06AB08

Pharmacological action

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 a – and α-adrenergic receptors, histamine, m-cholino- or
dopamine receptors is insignificant.

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

Pharmacokinetics

Suction

After oral administration, fluvoxamine is completely absorbed from the gastrointestinal tract. Maximum concentrations of fluvoxamine 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). Distribution volume: 25 l/kg.

Metabolism

Fluvoxamine metabolism occurs primarily in the liver. Although the 2D6 isoenzyme of cytochrome P 450 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 half-life from blood plasma, which is 13-15 hours for a single
dose, increases slightly with multiple doses (17-22 hours),
and equilibrium concentration in blood plasma is 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
insignificant 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 the concentration of a single dose, and this
disproportionality is more pronounced at higher daily doses.
Special patient group

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

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

Special instructions

As with other psychotropic medications, alcohol consumption is not recommended during treatment with fluvoxamine.
Suicide/suicidal ideation or clinical worsening
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.
In clinical practice, there is a widespread increase in the risk of suicide in the early stages of recovery.
Other mental disorders for which fluvoxamine is prescribed may also be associated with an increased risk of suicidal behavior. In addition, these conditions may be accompanied by deep 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 the early stages and after changes dosage.
Patients (and their caregivers) should be warned to monitor for any clinical deterioration, suicidal behavior or suicidal ideation, unusual changes
behavior, and to immediately seek medical advice if such symptoms occur.
Pediatric population
Fluvoxamine should not be used to treat children and adolescents under 18 years of age, except in 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)
A meta-analysis of placebo-controlled clinical trials
of antidepressants in adult patients with psychiatric disorders found an increased risk suicidal behavior with antidepressants compared with placebo in patients under 25 years of age. When prescribing fluvoxamine
the risk of suicide should be weighed against the benefit 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 their usual daily doses. However, increasing
doses of the drug in elderly patients should always be carried out more slowly and with greater caution.
Akathisia/psychomotor agitation
The development of akathisia associated with fluvoxamine is characterized by subjectively unpleasant and painful restlessness. 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.
Impaired liver and/or kidney function
Treatment of patients suffering from liver or kidney failure should begin with low doses, 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 the drug 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 the drug should be discontinued if epileptic seizures occur or their frequency increases.
Rare cases of serotonin syndrome or neuroleptic malignant syndrome-like conditions have been reported and may be associated with fluvoxamine, especially in combination with other serotonergic and/or antipsychotic drugs.
Because these syndromes can lead to potentially life-threatening conditions such as 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 delirium or coma – in such cases, treatment with fluvoxamine should be discontinued and appropriate
symptomatic treatment should be started.
Metabolic and nutritional disorders
How and when using 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 have primarily occurred 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 medications may be required.
The most commonly observed symptom associated with the use of fluvoxamine is nausea, sometimes accompanied by vomiting. This
side effect usually disappears within the first two weeks of treatment.
Visual disturbances
Mydriasis has been reported with SSRIs such as fluvoxamine.
Fluvoxamine should therefore be administered with caution to patients with elevated intraocular pressure or those at increased risk of acute angle-closure glaucoma.
Hematologic 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 to elderly patients and to 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, as well as patients with a history of bleeding or a tendency to bleed (for example,
with thrombocytopenia or coagulation disorders).
Cardiac disorders
Increased risk of QT prolongation/torsade de pointes (TdP) with 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)
Clinical experience with fluvoxamine in conjunction with ECT is limited, so such therapy should be used with caution.
Withdrawal reactions
Withdrawal syndrome may develop when fluvoxamine is stopped. although available data from preclinical and clinical studies have not revealed any dependence on fluvoxamine treatment. The most common symptoms noted in case of drug withdrawal: dizziness, sensory disturbances (including paresthesia, visual disturbance and sensation of electric shock), difficulty falling asleep (including insomnia and vivid dreams), agitation, irritability, confusion, emotional lability, headache, nausea and/or vomiting, diarrhea, sweating, palpitations, tremor and anxiety (see section “Side effects”).
Most of these symptoms are mild or moderate in nature and self-limited, but in some patients they can be severe and/or prolonged. Such 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 in accordance with the patient’s condition (see section “Dosage and Administration”)
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.

Effect on the ability to drive vehicles,
machines
Fluvoxamine, administered to healthy volunteers in doses of up to 150 mg, had no or negligible effect on the ability to drive and operate machines. At the same time, there are reports of drowsiness noted during treatment with fluvoxamine. Therefore, it is recommended
to exercise caution until the individual response to the drug is definitively determined.

Active ingredient

Fluvoxamine

Composition

Composition per tablet:
Active ingredient: fluvoxamine maleate (in terms of anhydrous
substance) 50 mg or 100 mg.
Excipients: mannitol, corn starch, starch
pregelatinized, sodium stearyl fumarate, colloidal silicon dioxide.
Shell composition: hypromellose, titanium dioxide, macrogol (polyethylene glycol
6000), talc.

Pregnancy

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 after the use of fluvoxamine in late pregnancy have been described.
Some newborns after exposure to SSRIs in the third trimester of pregnancy experienced feeding and/or breathing difficulties, seizure disorders, unstable body temperature, hypoglycemia, tremor, 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 the reproductive function of males and females, increases the risk of intrauterine fetal death and reduces fetal body weight at doses exceeding
the maximum recommended dose for humans by approximately 4 times.
In addition, an increase in the incidence of perinatal mortality in puppies was observed in pre- and postnatal studies. The significance of these data in humans is unknown.
Fluvoxamine should not be given to patients who are planning pregnancy
unless the patient’s clinical condition warrants the use of fluvoxamine.

Contraindications

-simultaneous 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 taking a reversible MAO inhibitor
(for example, moclobemide, linezolid).

The time interval between stopping fluvoxamine and starting
therapy with any MAO inhibitor should be at least one week,
simultaneous use with the drug ramelteon (see section “Interaction
with other drugs”);

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

With caution

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

Side Effects

Some side effects observed in clinical trials were often related to the disease and not to treatment with fluvoxamine.
All reactions are distributed according to organ system and frequency of development: often from > 1/100 to 1/1000 to 1/10000 to < 1/1000,
frequency not established (available data do not allow us to determine frequency).
Disorders with blood and lymphatic system: frequency not established – bleeding (for example, gastrointestinal bleeding, gynecological bleeding, ecchymosis, purpura).
Endocrine system disorders: frequency not established – hyperprolactinemia, syndrome of inadequate production of antidiuretic hormone.
Metabolic and nutritional disorders: often – anorexia; frequency not established – hyponatremia, weight loss, weight gain.
Mental disorders: uncommon – hallucinations, state of confusion, aggressiveness; rarely – mania; frequency not established – suicidal thinking, suicidal behavior (see section “Special instructions”).
Nervous system disorders: often – anxiety, increased excitability, restlessness, insomnia, drowsiness, tremor, headache,
dizziness; uncommon – extrapyramidal disorders, ataxia; rarely – convulsions; frequency not established – serotonin syndrome, malignant
neuroleptic syndrome, akathisia/psychomotor agitation, paresthesia, dysgeusia.
Visual disorders: frequency not established – glaucoma,
mydriasis.
Heart disorders: often – palpitations/tachycardia.
Vascular disorders: infrequently – orthostatic hypotension.
Gastrointestinal tract disorders: often – abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, nausea, vomiting.
Liver disorders: rarely – dysfunction (increased activity of liver enzymes).
Skin and subcutaneous tissue disorders: often – increased sweating; uncommon – skin hypersensitivity reactions (including rash, itching, angioneurotic edema); rarely – photosensitivity reactions.
Disorders of the musculoskeletal and connective tissue: uncommon – arthralgia, myalgia; frequency not established – bone fractures**. Renal and urinary tract disorders: frequency not established – urinary disorders (including urinary retention, urinary incontinence, pollakiuria, nocturia and enuresis).
Genital and breast disorders: uncommon – disturbance
(delay) of ejaculation; rarely – galactorrhea; frequency not established – anorgasmia, menstrual disorders (such as amenorrhea, hypomenorrhea, metrorrhagia, menorrhagia).
General disorders: often – asthenia, malaise; frequency not established—drug withdrawal syndrome, including withdrawal syndrome in neonates whose mothers took fluvoxamine in late pregnancy.
* – Nausea, sometimes accompanied by vomiting, is the most commonly
observed side effect associated with fluvoxamine treatment.
The incidence usually decreases during the first two weeks
of use drug.
** – Epidemiological studies performed primarily on patients aged 50 years and older have shown an increased risk of bone fractures in patients receiving SSRIs and tricyclic antidepressants. The mechanism for the increased risk is unknown.
Withdrawal syndrome after discontinuation of fluvoxamine
Discontinuation of fluvoxamine (especially abrupt) often leads to the development of withdrawal syndrome. The most common symptoms noted in case of drug withdrawal: dizziness, sensory disturbances (including paresthesia, visual disturbance and electric shock sensation), sleep disturbances (including insomnia and vivid dreams), agitation, irritability, confusion, emotional lability, headache, nausea and/or vomiting, diarrhea, sweating, sensation palpitations, tremors and
anxiety (see section “Special instructions”.)
Most of these symptoms are mild or moderate and self-limiting, but in some patients they can be severe and/or prolonged. For this reason, if treatment with fluvoxamine is no longer required, it is recommended to gradually reduce the dose until the drug is completely discontinued (see section “Dosage and Administration” and “Special Instructions”).
Children
During a 10-week placebo-controlled study in children and adolescents with OCD, adverse events such as insomnia, asthenia,
excitability, hyperkinesia, somnolence and dyspepsia were more common. manifested in patients receiving the drug compared with patients
receiving placebo. Serious adverse events in this study included agitation and hypomania.
Seizures in children and adolescents have been reported outside of clinical
studies.

Interaction

MAO inhibitors
Fluvoxamine should not be used in combination with MAO inhibitors,
linezolid due to the risk of developing serotonin syndrome (see
Contraindications),
The effect of fluvoxamine on the oxidative process of other drugs
Fluvoxamine can inhibit the metabolism of drugs,
metabolized by certain cytochrome isoenzymes P450
In vitro and in vivo studies have shown fluvoxamine to be a potent inhibitor of the cytochrome P450 1A2 and P450 2C19 isoenzymes and, to a lesser extent, the cytochrome P450 2C9, P450 2D6 and P450 34 isoenzymes.
Drugs that are significantly metabolized by these isoenzymes are slower are excreted 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 concomitantly with fluvoxamine. Careful monitoring of plasma concentrations, effects or side effects is required, and dosage adjustments of these drugs are required if necessary. This is especially significant for drugs that have a narrow therapeutic index.
Ramelteon
When taking fluvoxamine 100 mg twice daily for 3 days before co-administering ramelteon 16 mg, the AUC value for ramelteon increased approximately
190-fold and the Cmax value increased approximately 70-fold compared to these parameters when administered with ramelteon alone.
Drugs with a narrow therapeutic range
Patients concomitantly taking fluvoxamine and drugs with a narrow therapeutic range 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
dosage adjustment of these drugs is recommended.
Tricyclic antidepressants and antipsychotics
With simultaneous use of fluvoxamine, increased concentrations of tricyclic antidepressants (for example, clomipramine,
imipramine, amitriptyline) and antipsychotics (for example, clozapine, olanzapine, quetiapine), which are significantly metabolized, were observed isoenzyme of
cytochrome P4501A2. 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.
Instances of increased plasma concentrations
Concomitant use of fluvoxamine and ropinirole may increase
the plasma concentration of ropinirole, thereby increasing the risk of
overdose. In such cases, monitoring is recommended, or, if necessary, a dose reduction or discontinuation of ropinirole during treatment with fluvoxamine.
When fluvoxamine interacts 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 using fluvoxamine in combination with warfarin, a significant increase in the concentrations of warfarin in the blood plasma and prolongation of
prothrombin time were observed.
Cases of increased incidence of side effects
Isolated cases of cardiotoxicity were reported with the simultaneous 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, insomnia, are observed.
Cytochrome P450 3A4 isoenzyme
Terfenadine, astemizole, cisapride, sildenafil: in combination therapy with fluvoxamine concentrations terfenadine, astemizole or cisapride in plasma may increase, increasing the risk of QT prolongation/torsade de pointes (TdP). Therefore, fluvoxamine should not
be administered concomitantly with these drugs.
Glucuronidation
Fluvoxamine has no effect on the plasma concentration of digoxin.
Renal excretion
Fluvoxamine has no effect on the plasma concentration of atenolol.
Pharmacodynamic interactions
In case of concomitant use of fluvoxamine with serotonergic drugs (such as triptans, tramadol, selective serotonin reuptake inhibitors and St. John’s wort preparations) may enhance the serotonergic effects of fluvoxamine (see “Special Instructions”)
Fluvoxamine has been used in combination with lithium preparations to treat severe 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 kind of combination pharmacotherapy should be carried out with caution.
With the simultaneous use of indirect anticoagulants and fluvoxamine, the risk of developing hemorrhages may increase. Such patients should be under medical supervision.

Overdose

Symptoms: the most characteristic symptoms include gastrointestinal disorders (nausea, vomiting and diarrhea), drowsiness and dizziness. In addition, there are reports of cardiac abnormalities (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 prescription of osmotic laxatives. Forced diuresis or dialysis are not effective.

Recommendations for use

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 mg or 100 mg
(once, in the evening). After 3-4 weeks from the start of therapy, the dose should
be reviewed and adjusted in accordance with clinical experience
use of the drug. It is recommended to gradually increase the dose to
effective.
The effective daily dose, usually 100 mg, is selected
individually depending on the patient’s response to treatment. Daily dose
can reach 300 mg. Daily doses above 150 mg are recommended to be distributed
for 2 or 3 doses. Selection of the minimum effective maintenance dose
should be done with caution on an individual basis.
In accordance with official WHO recommendations, treatment
Antidepressants should be continued for at least 6 months
remission after a depressive episode. To prevent relapse of depression
It is recommended to take 100 mg of the drug once a day, daily.
Children
Due to the lack of clinical experience, fluvoxamine is not recommended for use
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 per day
within 3-4 days. The effective daily dose is usually from
100 mg to 300 mg. Doses should be increased gradually until effective
daily dose, which should not exceed 300 mg in adults. Doses up to 150 mg
can be taken once a day, preferably in the evening. Daily doses over
150 mg is recommended to be divided into 2 or 3 doses.
If there is a good therapeutic response to the drug, treatment can be continued
using an individually selected daily dose. If there is no improvement
achieved after 10 weeks, treatment with fluvoxamine should be reconsidered.
Until now, no systematic research has been organized that could
answer the question of how long treatment with fluvoxamine can last,
however, obsessive-compulsive disorders are chronic,
and therefore it may be considered appropriate to prolong treatment with fluvoxamine
beyond 10 weeks in patients who have responded well to this drug. Selection
the minimum effective maintenance dose should be carried out
with caution on an individual basis. Periodically it is necessary to renew
assess the need for treatment. Some clinicians recommend
conducting concomitant psychotherapy in patients who responded well
for pharmacotherapy. Long-term effectiveness (more than 24 weeks) was not
confirmed.
Children over 8 years old and teenagers
In children over 8 years of age and adolescents, data on use at a dose of more than 100 mg two
times a day for 10 weeks are limited. Initial dose for children
over 8 years and adolescents is 25 mg/day per dose, preferably
before bed. The dose should be increased by 25 mg to the permissible dose every 4-7 days
until the effective daily dose is reached. The effective dose is usually
from 50 to 200 mg/day, the maximum dose in children should not exceed 200 mg/day.
Daily doses over 50 mg are recommended to be divided into 2 doses, while
if the two doses received are not the same, the larger dose should be taken at bedtime.
Withdrawal syndrome after stopping the use of fluvoxamine
Abrupt withdrawal of the drug should be avoided. Upon termination of treatment
fluvoxamine should be gradually reduced in dose over at least 1-2 days
weeks to reduce the risk of withdrawal syndrome (see section “Side effects”
and “Special Instructions”), In case of intolerable symptoms
after dose reduction or after treatment discontinuation, you may consider
resuming treatment at the previously recommended dose. Later, the doctor may again
start reducing the dose, but more gradually.
Patients with hepatic or renal failure should be treated
start with low doses under strict medical supervision.

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use after the expiration date stated on the package.

Manufacturer

Rapharma JSC, Russia