Universal reference book for medicines
Product name: FEVARIN ® (FEVARIN ® )

Active substance: fluvoxamine

Type: Antidepressant

Manufacturer: ABBOTT HEALTHCARE PRODUCTS (Netherlands) manufactured by ABBOTT HEALTHCARE (France)
Composition, form of production and packaging
The tablets covered with a film membrane of
white color, round, biconcave, with a risk on one side, with engraving "291" on both sides of the risks.

1 tab.

fluvoxamine maleate 50 mg

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

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

15 pcs.
- blisters (1) - packs of cardboard.
The tablets covered with a film shell of white color, oval, biconcave, with a risk on one side, with engraving "313" on both sides of the risks.

1 tab.

fluvoxamine maleate 100 mg

Auxiliary substances: mannitol - 303 mg, corn starch - 80 mg, pregelatinized starch - 12 mg, sodium stearyl fumarate - 3.5 mg, silicon dioxide colloid - 1.5 mg.

The composition of the membrane: hypromellose - 5.6 mg, macrogol 6000 - 2 mg, talc - 0.4 mg, titanium dioxide (E171) - 2.1 mg.

15 pcs.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Antidepressant.
Studies on receptor binding have shown that fluvoxamine is a potent inhibitor of serotonin reuptake both in vitro and in vivo with minimal affinity for serotonin receptors. Its ability to bind to? - and? -adrenoceptors, histamine, m-cholinergic receptors or dopamine receptors is insignificant.
Fluvoxamine has a high affinity for?
1- receptors, acting as their agonist.
PHARMACOKINETICS

Suction

After intake of fluvoxamine completely absorbed from the digestive tract.
C max in blood plasma is achieved after 3-8 hours. Absolute bioavailability is 53% after the primary metabolism in the liver. Simultaneous administration of fluvoxamine with food does not affect the pharmacokinetics.
Distribution

The degree of binding to plasma proteins is about 80% (in vitro).
V d - 25 l / kg. C ss in blood plasma is achieved, usually after 10-14 days.
The pharmacokinetics of fluvoxamine after a single dose is linear.
C ss concentration of fluvoxamine is higher than the concentration after a single dose, and this disproportion is more pronounced at higher daily doses.
Metabolism

Fluvoxamine is biotransformed in the liver (mainly by oxidative demethylation) to at least 9 metabolites.
The two main metabolites have little pharmacological activity, the rest are pharmacologically inactive.
Fluvoxamine significantly inhibits cytochrome P450 (CYP) 1A2 and 2C19 isoenzymes, moderately inhibits the isoenzymes CYP2S9, 3A4 and 2D6.

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

Excretion

After taking a single dose, the average T 1/2 from the blood plasma is 13-15 hours, with repeated intake of T 1/2 slightly increases and is 17-22 hours.

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

Pharmacokinetics in special clinical cases

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

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

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

- Depression of a different genesis;

- obsessive-compulsive disorder.

DOSING MODE

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

The recommended initial dose for adults is 50 mg or 100 mg 1 time / day, in the evening.
It is recommended that the dose be gradually increased to an effective level.An 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 over 150 mg should be divided into several doses.
According to official WHO recommendations, treatment with antidepressants should continue for at least 6 months after remission after a depressive episode.

To prevent the recurrence of depression Fevarin ® is recommended to be administered at a dose of 100 mg 1 time / day daily.

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

Obsessive-compulsive disorder (OCD)

The recommended initial dose for adults is 50 mg / day for 3-4 days.
The effective daily dose is usually from 100 to 300 mg. Doses should be increased gradually until an effective daily dose, 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 are recommended to be divided into 2 or 3 doses.
The initial dose for children older than 8 years and adolescents is 25 mg / day for 1 dose.
The maintenance dose is 50-200 mg / day. The maximum daily dose is 200 mg. Doses of more than 100 mg / day are recommended for 2 or 3 doses.
With a good therapeutic response, treatment can be continued with an individually selected daily dose.
If improvement is not achieved after 10 weeks of taking the drug, fluvoxamine treatment should be reviewed. Until now, no systematic studies have been conducted that could answer the question of how long fluvoxamine treatment can be performed, but obsessive-compulsive disorders are chronic, it may be considered advisable to prolong the course of treatment with the drug Fevarin® for more than 10 weeks in patients with adequate therapeutic effect. Selection of the minimum effective maintenance dose should be done individually and with caution. Periodically, it is necessary to re-evaluate the need for treatment. Some clinicians recommend concomitant psychotherapy in patients with a good pharmacotherapy effect.
The withdrawal syndrome after discontinuation of fluvoxamine

It is necessary to avoid drastic withdrawal of the drug.
When discontinuing treatment with fluvoxamine, the dose should be gradually lowered for a minimum of 1-2 weeks to reduce the risk of withdrawal syndrome. In the case of intolerable symptoms after a dose reduction or after the withdrawal of treatment, consideration may be given to resuming treatment at a previously recommended dose. Later, the doctor may begin to lower the dose, but more gradually.
For hepatic or renal failure, treatment should begin with the lowest dose under strict doctor supervision.

SIDE EFFECT

Some of the side effects observed in clinical trials have often been associated with the disease, rather than the treatment with Fevarin ® .
All reactions are distributed according to organ systems and the frequency of development: often (> 1% and <10%); infrequently (> 0.1% and <1%); rarely (> 0.01% and <0.1%); frequency is unknown.
From the coagulation system: the frequency is unknown - bleeding (eg, gastrointestinal bleeding, gynecological bleeding, ecchymosis, purpura).

On the part of the endocrine system: the frequency is unknown - hyperprolactinaemia, the syndrome of inadequate ADH production.

From the side of metabolism and nutrition: often - anorexia;
frequency is unknown - hyponatremia, weight loss, weight gain.
From the side of the psyche: infrequently - hallucinations, the state of confused consciousness;
rarely - mania; frequency is unknown - suicidal thinking, suicidal behavior.
From the nervous system: often - anxiety, increased excitability, anxiety, insomnia, drowsiness, tremor, headache, dizziness;
infrequently - extrapyramidal disorders, ataxia; rarely convulsions; frequency is unknown - serotonin syndrome, CNS, akathisia / psychomotor agitation, paresthesia, dysgeusia.
From the side of the organ of vision: the frequency is unknown - glaucoma, mydriasis.

From the cardiovascular system: often - a feeling of palpitations, tachycardia;
infrequently - orthostatic hypotension.
From the digestive system: often - abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, nausea, vomiting;
rarely - a violation of liver function (increased activity of liver enzymes).
From the skin and subcutaneous tissues: often - increased sweating;
infrequently - skin reactions of hypersensitivity (including rash, itching, angioedema); rarely photosensitivity reactions.
From the musculoskeletal system: infrequently - arthralgia, myalgia;
frequency unknown - fractures of bones. *
From the urinary system: the frequency is unknown - urination disorders (including urinary retention, urinary incontinence, pollakiuria, nocturia and enuresis).

On the part of the reproductive system: infrequently - violation (delay) of ejaculation;
rarely - galactorrhea; frequency unknown - anorgasmia, menstrual cycle disorders (such as amenorrhea, hypomenorrhea, metrorrhagia, menorrhagia).
General disorders: often - asthenia, malaise;
The frequency is unknown - withdrawal syndrome, including withdrawal syndrome in newborns whose mothers took fluvoxamine during late pregnancy.
* - Epidemiological studies performed mainly involving patients aged 50 years and older showed an increased risk of bone fractures in patients treated with SSRIs and tricyclic antidepressants.
The mechanism of increasing the risk is unknown.
The withdrawal syndrome after discontinuation of fluvoxamine

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

- simultaneous administration with tizanidine and MAO inhibitors (treatment with fluvoxamine can be started 2 weeks after stopping the intake of an irreversible MAO inhibitor, the day after stopping the use of a reversible MAO inhibitor (eg, moclobemide, linezolid) .The time interval between stopping fluvoxamine and initiating therapy any MAO inhibitor should be at least 1 week;

- simultaneous reception with ramelteonom;

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

With caution should prescribe the drug for hepatic and renal failure, seizures in history, epilepsy, patients with a tendency to bleeding (thrombocytopenia), during pregnancy, during lactation, as well as patients of advanced age.

PREGNANCY AND LACTATION

Epidemiological data suggest that the use of selective serotonin reuptake inhibitors (SSRIs) in pregnancy, especially in the last months of pregnancy, may increase the risk of persistent pulmonary hypertension (PLH) in newborns.
The available data show that PLH occurs in approximately 5 cases per 1000 births (in contrast to 1-2 cases per 1000 births, if the mother did not use SSRIs in the last period of pregnancy).
It is not recommended to use fluvoxamine in pregnancy, except when the woman's clinical condition indicates the need for its use.

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

Some infants after SSRI in the third trimester of pregnancy experienced difficulties in feeding and / or breathing, convulsive disorders, unstable body temperature, hypoglycemia, tremor, muscle tone disorders, increased nervous reflex excitability syndrome, cyanosis, irritability, lethargy, drowsiness, nausea, difficulties with falling asleep and continuous crying, which may require a longer hospitalization.

Fluvoxamine penetrates into breast milk in small amounts.
In this regard, the drug should not be used during lactation.
Fluvoxamine should not be given to patients who plan pregnancy, unless the clinical condition of the patient requires the administration of fluvoxamine.

Experimental studies of reproductive toxicity in animals have shown that fluvoxamine affects the reproductive function of males and females, increases the risk of fetal death and reduces fetal body weight in doses exceeding the maximum recommended doses for humans by approximately 4 times.
In addition, there was an increase in the incidence of perinatal mortality of puppies in pre- and postnatal studies. The significance of this data for a person is unknown.
APPLICATION FOR FUNCTIONS OF THE LIVER

With renal failure, treatment should be started with the lowest dose under strict doctor supervision.

With caution should prescribe the drug for kidney failure



APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In liver failure, treatment should begin with the lowest dose under strict doctor control.

With caution should prescribe the drug for liver failure



APPLICATION FOR CHILDREN

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

In the treatment of obsessive-compulsive disorders, the initial dose for children older than 8 years and adolescents is 25 mg / day for 1 dose.
The maintenance dose is 50-200 mg / day. The maximum daily dose is 200 mg. Doses of more than 100 mg / day are recommended for 2 or 3 doses.
APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients.

SPECIAL INSTRUCTIONS

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

Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide attempts (suicidal behavior).
This risk persists until the state of significant improvement. Since the improvement may not occur during the first few weeks of treatment or longer, patients should be carefully monitored until such an improvement occurs.
In clinical practice, an increased risk of suicide in the early stages of recovery is widespread.

Other mental disorders for which fluvoxamine is prescribed may also be associated with an increased risk of suicidal behavior.
In addition, these conditions can accompany deep depression. Therefore, patients with other mental disorders should be carefully monitored.
It is known that patients with a history of suicidal behavior or who are largely suicidal in thinking, have a greater risk of suicidal thoughts or suicidal attempts before starting treatment and should be carefully observed during treatment.

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

It is necessary to warn patients (and caregivers) about the need to monitor any clinical deterioration, suicidal behavior or suicidal thoughts, unusual behavioral changes, and immediately seek the advice of a specialist if such symptoms occur.

The development of akathisia associated with the administration of 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. An increase in the dose of the drug in patients with such symptoms may worsen their condition.
Care should be taken when prescribing patients with a history of seizures.
Avoid the administration of fluvoxamine in patients with unstable epilepsy, and patients with stable epilepsy should be closely monitored. Treatment with the drug Fevarin ® should be discontinued if epileptic seizures occur or their frequency increases.
There are rare cases of the development of a serotonergic syndrome or a condition similar to the NSH, which may be associated with the administration of fluvoxamine, especially in combination with other serotonergic and / or neuroleptic drugs.
These syndromes can lead to potentially life-threatening conditions manifested by hyperthermia, rigidity of muscles, myoclonus, lability of the autonomic nervous system with possible rapid changes in vital parameters (including pulse, respiration, BP), changes in mental status, including confusion, irritability, extreme agitation, reaching to delirium or coma. Therefore, in such cases, Fevarin ®should be discontinued and appropriate symptomatic treatment initiated.
As with other selective serotonin reuptake inhibitors, in rare cases, hyponatremia may occur, which is reversed after the withdrawal of fluvoxamine.
Some cases were caused by the syndrome of insufficient ADH secretion. In most cases, these cases were observed in elderly patients.
Control over the level of glucose in the blood (eg, hyperglycemia, hypoglycemia, impaired glucose tolerance) may be impaired, especially in the early stages of treatment.
In the case of the appointment of the drug Fevarin ® to patients with diabetes in history, it may be necessary to correct the dose of hypoglycemic drugs.
The most commonly observed symptom associated with the use of the drug Fevarin ® is nausea, sometimes accompanied by vomiting.
This side effect is usually disappears within the first 2 weeks of treatment.
Reported cases of mydriasis with SSRIs such as fluvoxamine. Therefore, in patients with elevated intraocular pressure or patients at-risk of acute angle-closure glaucoma fluvoxamine should be used with caution.
There are reports of intradermal hemorrhage such as ecchymosis and purpura and other hemorrhagic manifestations (e.g., gastro-intestinal or gynecological bleeding bleeding) observed with the use of selective serotonin reuptake inhibitors. Caution must be exercised in the appointment of these drugs in elderly patients and in patients concomitantly receiving drugs acting on platelet function (eg atypical antipsychotics and phenothiazines, most tricyclic antidepressants, aspirin, NSAIDs) or drugs that increase the risk of bleeding, as well as in patients with a history of bleeding or prone to bleeding (e.g., thrombocytopenia or coagulation disorders).
Increased risk of lengthening QT / paroxysmal ventricular tachycardia type "pirouette" interval in combination therapy with fluvoxamine with terfenadine and astemizole, or cisapride, due to the increased concentration of the latter in the blood plasma. Therefore, fluvoxamine should not be administered with these drugs.
Fluvoxamine can cause a slight decrease in heart rate (2-6 u. / Min).
Clinical experience with fluvoxamine on the background of ECT is limited, therefore such therapy should be done with caution.
Upon termination of fluvoxamine may develop withdrawal symptoms, although the evidence of pre-clinical and clinical studies have not revealed the abuse of fluvoxamine treatment. The most common symptoms noted in the case of cancellation of the product: dizziness, sensory disturbances (including paraesthesia, visual disturbances, and the feeling of electric shock), disorders of sleep (including insomnia and vivid dreams), agitation, irritability, confusion, emotional lability, headache, nausea and / or vomiting, diarrhea, sweating, palpitations, tremor and anxiety. Most of these symptoms are mild to moderate in nature and are stopped on their own, but in some patients they may be severe and / or prolonged.These symptoms usually occur within the first few days after stopping treatment. For this reason, it recommended to gradually reduce the dose of fluvoxamine to the complete abolition in accordance with the patient's condition.
Fluvoxamine should be used with caution in patients with mania / hypomania in history. With the development of the patient's manic phase should discontinue the use of fluvoxamine.
Treatment of patients with hepatic or renal insufficiency should begin with drug administration at a low dose, such patients require a strict medical control. In rare cases, treatment with fluvoxamine can lead to an increase in liver enzymes, which is often accompanied by appropriate clinical symptoms; in such cases, Luvox ®should be discontinued.
The data obtained in the treatment of elderly patients and younger patients showed no clinically relevant differences between them are usually applied daily doses. However, increasing doses of the drug in elderly patients should always be done slowly and with great care.
A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behavior with antidepressants compared to placebo in patients younger than 25 years. In the appointment of fluvoxamine should be related to the risk of suicide and benefit from its use.
Use in Pediatrics

Fluvoxamine should not be used for the treatment of children and adolescents under 18 years except for patients with obsessive-compulsive disorder. Due to lack of clinical experience the use of fluvoxamine in children for the treatment of depression can not be recommended. In clinical studies conducted in children and adolescents due to suicidal-behavior (suicide attempts and thoughts), and hostility (mainly aggression, oppositional behavior and anger) were more frequent in patients treated with antidepressants compared to placebo. If, based on clinical need a decision to treat is accepted, the patient must be installed carefully monitored for appearance of suicidal symptoms.
In addition, long-term data on the safety of children and adolescents concerning growth, development and formation of cognitive behavior, no.
Impact on the ability to drive vehicles and manage mechanisms

When applied in healthy volunteers Luvox ® at doses up to 150 mg have no or insignificant effect on the ability to drive the car and control the machines. At the same time there are reports of sleepiness notes during treatment with fluvoxamine. Therefore, until the final determination of the individual response to the drug, patients are advised to exercise caution during the occupation of potentially hazardous activities.
OVERDOSE

Symptoms: The most typical nausea, vomiting, diarrhea, drowsiness, dizziness. There are reports of cardiac disorders (tachycardia, bradycardia, hypotension), liver problems, seizures, coma.
Fluvoxamine has a great breadth of therapeutic dose. So far, cases of death related to overdose of fluvoxamine, occurred very rarely. Most registered dosage adopted one patient was 12 g (the patient was cured). More serious complications were observed in cases of deliberate overdose of fluvoxamine with concurrent pharmacotherapy.
Treatment:gastric lavage, which should be performed as soon as possible after taking the drug; symptomatic therapy. In addition, it is recommended multiple administration of activated charcoal, osmotic laxatives assignment if necessary.
There is no specific antidote. Forced diuresis or dialysis are ineffective.
DRUG INTERACTION

Fluvoxamine should not be used in combination with MAO inhibitors, including linezolid, due to the risk of serotonin syndrome.
Fluvoxamine can inhibit the metabolism of drugs which are metabolized by cytochrome P450 isozymes defined. The in vitro and in vivo studies show a strong inhibitory effect of fluvoxamine on cytochrome P450 isoenzymes 1A2 and 2C19 and to a lesser extent on the isozymes of cytochrome P450 2C9, 2D6 and 3A4.
Drugs which are metabolized to a great extent these isozymes, displayed slower and may have higher concentrations in plasma, in the case of simultaneous application of fluvoxamine. Such preparations should be used in minimal dose or dose reduction to a minimum while the use of fluvoxamine. It requires careful monitoring of plasma concentrations, effects or side effects, and correction dose of these preparations, if desired. This is especially important for drugs that have a narrow therapeutic range.
When receiving the drug Luvox ® 100 mg of 2 times / day for 3 days before the simultaneous application of ramelteon drug at a dose of 16 mg, AUC value for ramelteon increased about 190 times, and the value C maxincreased approximately 70 times compared to these parameters when assigning one ramelteon.
Patients concurrently taking fluvoxamine and drugs with a narrow therapeutic range, are metabolized exclusively or a combination of isoenzymes of cytochrome P450 inhibitory fluvoxamine (such as tacrine, theophylline, methadone, mexiletine, phenytoin, carbamazepine, and cyclosporine) should be monitored carefully. If necessary, a correction is recommended dose of these drugs.
With simultaneous use of fluvoxamine observed increase in concentrations of tricyclic antidepressants (e.g. clomipramine, imipramine, amitriptyline) and neuroleptics (for example clozapine, olanzapine, quetiapine), which is largely metabolized by cytochrome P450 isoenzyme 1A2. In this regard, if treatment is started fluvoxamine should be considered a reduced dose of these drugs.
While the use of fluvoxamine benzodiazepines undergoing oxidative metabolism, such as triazolam, midazolam, alprazolam and diazepam, may increase their plasma concentrations. The dose of the benzodiazepine to be reduced at the time of receiving fluvoxamine.
With simultaneous use of fluvoxamine and ropinirole can rise in plasma concentration of ropinirole, thus increasing the risk of overdose. In such cases, control, or, if appropriate, dose reduction or elimination of ropinirole during treatment with fluvoxamine.
In the interaction with fluvoxamine propranolol propranolol showed an increase in plasma concentrations. In connection with this it is possible to recommend propranolol dose reduction in case of the simultaneous application of fluvoxamine.
When applied in combination with fluvoxamine warfarin showed a significant increase of warfarin plasma concentrations and prolonged prothrombin time.
It was reported a few cases of cardiotoxicity, while the use of fluvoxamine and thioridazine.
During fluvoxamine plasma concentrations of caffeine may increase. Thus, patients who consume large amounts of beverages containing caffeine should reduce their consumption during receiving fluvoxamine, and when there are adverse effects of caffeine, such as tremor, palpitations, nausea, anxiety, insomnia.
In combination therapy with fluvoxamine concentration terfenadine, astemizole, or cisapride in plasma may increase, increasing the risk of lengthening the interval QT / paroxysmal ventricular tachycardia type "pirouette". Therefore, fluvoxamine should not be administered with these drugs.
Fluvoxamine has no influence on the concentration of digoxin in plasma.
Fluvoxamine has no effect on the plasma concentration of atenolol.
When combined with fluvoxamine serotonergic agents (such as triptans, tramadol, selective serotonin reuptake inhibitor medication and Hypericum perforatum) may increase serotonergic effects fluvoxamine.
Fluvoxamine used in combination with lithium therapy for the treatment of severe patients respond poorly to drug therapy. It should be noted that lithium (and possibly also tryptophan) enhances the serotonergic effects of the drug, and therefore such combination pharmacotherapy must be carried out with care.
With simultaneous use of anticoagulants and fluvoxamine may increase the risk of hemorrhage. These patients should be under the supervision of a physician.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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