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FEVARIN is an antidepressant. The mechanism of action is associated with selective inhibition of serotonin reuptake by brain neurons and is characterized by minimal effect on noradrenergic transmission. Fevarin has a weak ability to bind to α- and β-adrenergic receptors, histamine, m-cholinergic receptors, dopamine and serotonin receptors.
- treatment and prevention of depression;
- treatment of symptoms of obsessive-compulsive disorders.
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Dosage and Administration
In the treatment of depression, the recommended initial dose is 50 mg or 100 mg 1 time / day, in the evening. Increasing the dose should be carried out gradually. An effective dose, usually 100 mg / day, is chosen individually depending on the patient's response to treatment. The daily dose can reach 300 mg.
Doses of more than 150 mg / day should be divided into several doses.
In accordance with official WHO recommendations, antidepressant treatment should be continued for at least 6 months after the treatment of a depressive episode.
To prevent recurrence of depression, it is recommended to administer Fevarin in a dose of 100 mg 1 time / day.
When treating obsessive-compulsive disorders, the recommended starting dose is 50 mg / day for 3–4 days. Increasing the dose should be carried out gradually to achieve an effective daily dose, which is usually 100-300 mg. The maximum effective dose for adults is 300 mg / day. Doses up to 150 mg can be taken 1 time / day, preferably in the evening. Doses of more than 150 mg / day are recommended to be divided into 2 or 3 doses.
For children over 8 years old and adolescents, the initial dose is 25 mg / day for 1 reception. Maintenance dose - 50-200 mg / day. The maximum dose is 200 mg / day. Doses of more than 100 mg / day are recommended to be divided into 2 or 3 doses.
With the development of an adequate therapeutic effect, treatment can be continued with an individually selected daily dose. If improvement is not achieved after 10 weeks of treatment, Fevarin should be canceled. Given that obsessive-compulsive disorders are chronic, it may be considered appropriate to extend the course of treatment with Fevarin for more than 10 weeks in patients with an adequate therapeutic effect. Selection of the minimum effective maintenance dose should be done individually and with caution. Some clinicians recommend concomitant psychotherapy in patients with good pharmacotherapy effects.
In case of hepatic or renal insufficiency, treatment should begin with the lowest dose under the strict supervision of a physician.
Fevarin pills should be taken without chewing and washing down with a small amount of water.
Some of the side effects observed during clinical trials were often associated with the disease, and not with the treatment with Fevarin. All reactions are distributed by organ systems and developmental frequency: often (> 1% and 0.1% and 0.01% and
On the part of the blood coagulation system: the frequency is unknown - bleeding (for example, gastrointestinal bleeding, gynecological bleeding, ecchymosis, purpura).
On the part of the endocrine system: the frequency is unknown - hyperprolactinemia, syndrome of inadequate production of ADH.
Metabolism and nutrition: often - anorexia; frequency is unknown - hyponatremia, weight loss, weight gain.
On the mental side: infrequently - hallucinations, a state of confused consciousness; rarely - mania; frequency unknown - suicidal thinking, suicidal behavior.
On the part of the nervous system: often - anxiety, irritability, anxiety, insomnia, drowsiness, tremor, headache, dizziness; infrequently - extrapyramidal disorders, ataxia; rarely seizures; frequency is unknown - serotonin syndrome, MNS, akathisia / psychomotor agitation, paresthesia, dysgeusia.
On the part of the organ of vision: the frequency is unknown - glaucoma, mydriasis.
Since the cardiovascular system: often - a sensation of heartbeat, tachycardia; infrequently - orthostatic hypotension.
On the part of the digestive system: often - abdominal pain, constipation, diarrhea, dry mouth, dyspepsia, nausea, vomiting; rarely - impaired liver function (increased activity of liver enzymes).
On the part of the skin and subcutaneous tissues: often - excessive sweating; infrequently - skin hypersensitivity reactions (including rash, itching, angioedema); rarely photosensitivity reactions.
From the musculoskeletal system: infrequently - arthralgia, myalgia; frequency unknown - bone fractures. *
On the part of the urinary system: the frequency is unknown - urinary 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 is unknown - anorgasmia, menstrual disorders (such as amenorrhea, hypomenorrhea, metrorrhagia, menorrhagia).
General disorders: often - asthenia, malaise; frequency is unknown - drug withdrawal syndrome, including withdrawal syndrome in newborns whose mothers took fluvoxamine in late pregnancy.
* - Epidemiological studies, carried out mainly with the participation of patients aged 50 years and older, showed an increased risk of bone fractures in patients treated with SSRIs and tricyclic antidepressants. The mechanism to increase the risk is unknown.
Withdrawal after discontinuing fluvoxamine
Discontinuation of fluvoxamine (especially abrupt) often leads to the development of withdrawal syndrome. For this reason, if treatment with fluvoxamine is no longer required, it is recommended to gradually reduce the dose until the drug is completely discontinued.
- simultaneous use with tizanidine;
- simultaneous use with MAO inhibitors (the interval between the withdrawal of the MAO inhibitor and the start of treatment with Fevarin should be at least 2 weeks);
- children's age up to 8 years;
- Hypersensitivity to fluvoxamine maleate or to other components of the drug.
Fluvoxamine cannot be used in combination with MAO inhibitors, including linezolid, because of the risk of developing serotonin syndrome.
Fluvoxamine can inhibit the metabolism of drugs that are metabolized by certain cytochrome P450 isoenzymes. In vitro and in vivo studies have shown a potent inhibitory effect of fluvoxamine on the cytochrome P450 1A2 and 2C19 isoenzymes and, to a lesser extent, on the cytochrome P450 isoenzymes 2C9, 2D6 and 3A4.
Drugs that are largely metabolized by these isoenzymes are more slowly excreted and may have higher plasma concentrations, when used concurrently with fluvoxamine. Such drugs should be prescribed in a minimum dose or reduce the dose to the minimum with simultaneous use with fluvoxamine. Careful observation of plasma concentrations, effects or side effects is required, as well as dose adjustment of these drugs, if necessary. This is especially important for drugs that have a narrow therapeutic range.
When taking the drug Fevarin 100 mg 2 times / day for 3 days before simultaneous use of the drug ramelteon at a dose of 16 mg, the AUC value for ramelteon increased approximately 190 times, and the Cmax value increased approximately 70 times compared with these parameters when prescribing one ramelteon.
Patients taking both fluvoxamine and narrow therapeutic range drugs that are metabolized exclusively or with a combination of cytochrome P450 isoenzymes inhibiting fluvoxamine (such as takrin, theophylline, methadone, mexiletine, phenytoin, carbamazepine, and cyclosporine) should be carefully monitored. If necessary, recommended dose adjustment of these drugs.
With the simultaneous use of fluvoxamine, there was an increase in the concentration of tricyclic antidepressants (for example, clomipramine, imipramine, amitriptyline) and neuroleptics (for example clozapine, olanzapine, quetiapine), which are largely metabolized by the cytochrome P450 1A2 isoenzyme.Therefore, if treatment with fluvoxamine is started, a reduction in the dose of these drugs should be considered.
With simultaneous use with fluvoxamine benzodiazepines undergoing oxidative metabolism, such as triazolam, midazolam, alprazolam and diazepam, it is possible to increase their concentration in plasma. The dose of these benzodiazepines should be reduced while taking fluvoxamine.
With simultaneous use of fluvoxamine and ropinirole, plasma concentration of ropinirole may increase, thus increasing the risk of an overdose. In such cases, it is recommended to control, or, if necessary, reduce the dose or cancel ropinirole at the time of treatment with fluvoxamine.
The interaction of fluvoxamine with propranolol showed an increase in plasma concentrations of propranolol. In this regard, it is possible to recommend a dose reduction of propranolol in the case of simultaneous use with fluvoxamine.
When fluvoxamine was used in combination with warfarin, a significant increase in plasma concentrations of warfarin and prolongation of prothrombin time was observed.
It was reported on isolated cases of cardiotoxicity with simultaneous use of fluvoxamine and thioridazine.
While taking fluvoxamine, plasma caffeine concentration may increase. Thus, patients who consume large amounts of caffeine-containing beverages should reduce their intake for the period of fluvoxamine, and when adverse effects of caffeine are observed, such as tremor, heartbeat, nausea, anxiety, insomnia.
When combined with fluvoxamine, concentrations of terfenadine, astemizole, or cisapride in the blood plasma may increase, increasing the risk of prolonged QT / paroxysmal ventricular tachycardia of the pirouette type. Therefore, fluvoxamine should not be administered with these drugs.
Fluvoxamine has no effect on plasma digoxin concentration.
Fluvoxamine has no effect on plasma atenolol concentration.
In the case of combined administration of fluvoxamine with serotonergic drugs (such as triptans, tramadol, selective serotonin reuptake inhibitors and drugs of Hypericum perforatum), serotonergic effects of fluvoxamine may be enhanced.
Fluvoxamine was used in combination with lithium preparations to treat severely ill patients responding 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 combined pharmacotherapy should be carried out with caution.
With the simultaneous use of indirect anticoagulants and fluvoxamine may increase the risk of hemorrhage. Such patients should be supervised by a physician.
Pregnancy and Lactation
Epidemiological data suggest that the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, especially in the last months of pregnancy, may increase the risk of persistent pulmonary hypertension (PLH) of the newborn. The available data show 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 during the last stages of pregnancy).
It is not recommended to use fluvoxamine during pregnancy, except in cases where the clinical condition of the woman indicates the need for its use.
Individual cases of withdrawal syndrome in newborns after using fluvoxamine at the end of pregnancy have been described.
Some newborns after exposure to SSRIs in the third trimester of pregnancy had difficulty feeding and / or breathing, convulsive disorders, unstable body temperature, hypoglycemia, tremor, muscle tone disorders, increased neuro-reflex excitability syndrome, cyanosis, irritability, lethargy, drowsiness, nausea, difficulty falling asleep and continuous crying, which may require longer hospitalization.
Fluvoxamine penetrates into breast milk in small quantities. In this regard, the drug should not be used during lactation.
Fluvoxamine should not be prescribed to patients who are planning a pregnancy, except in cases where the clinical condition of the patient requires the appointment 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 intrauterine fetal death and reduces the body weight of the fetus in doses exceeding the maximum recommended doses for humans approximately 4 times. In addition, there was an increase in the frequency of perinatal puppy mortality in pre- and postnatal studies. The significance of this data for humans is unknown.
As with the use of other psychotropic drugs, during treatment with Fevarin, it is not recommended to consume alcohol.
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide attempts (suicidal behavior). This risk persists to significant improvement. As 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, an increasing 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 may be accompanied by a deep depression. Therefore, patients with other mental disorders should be closely monitored.
It is known that patients with a history of suicidal behavior or who are significantly suicidal thinking have a greater risk of suicidal thoughts or suicidal attempts before treatment and should be carefully observed during treatment.
Careful observation of patients, especially those at high risk, must accompany drug therapy especially in its early stages and after dose changes.
Patients (and their caregivers) should be warned of the need to monitor any clinical deterioration, suicidal behavior or suicidal thoughts, unusual behavioral changes, and immediately consult a specialist if any of these symptoms occur.
The development of akathisia associated with taking 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.
Care must be taken when prescribing the drug to patients with a history of convulsions. Fluvoxamine should be avoided in patients with unstable epilepsy, and patients with stable epilepsy should be closely monitored. Treatment with the drug Fevarin must be stopped if epileptic seizures occur or their frequency increases.
Rare cases of the development of a serotonergic syndrome or a condition similar to ZNS, which may be associated with fluvoxamine, are described, especially in combination with other serotonergic and / or neuroleptic drugs. 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 (including pulse, respiration, blood pressure), changes in mental status, including confusion, irritability, extreme agitation, reaching delirium or coma.Therefore, in such cases, Fevarin should be canceled and appropriate symptomatic treatment should begin.
As with the use of other selective serotonin reuptake inhibitors, in rare cases, the occurrence of hyponatremia, which undergoes reverse development, after the withdrawal of fluvoxamine may occur. Some cases were caused by the syndrome of insufficient secretion of ADH. Mostly these cases were observed in elderly patients.
The control of blood glucose levels (i.e. hyperglycemia, hypoglycemia, impaired glucose tolerance) may be impaired, especially in the early stages of treatment. In the case of prescribing the drug Fevarin to patients with diabetes mellitus in history, a dose adjustment of hypoglycemic drugs may be required.
The most commonly observed symptom associated with the use of Fevarin is nausea, sometimes accompanied by vomiting. This side effect usually disappears during the first 2 weeks of treatment.
Cases of mydriasis have been reported with SSRIs such as fluvoxamine. Therefore, fluvoxamine should be administered with caution to patients with elevated intraocular pressure or patients at high risk of acute angle-closure glaucoma.
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. Care must be taken when prescribing these medicines in elderly patients and patients simultaneously receiving drugs that act on platelet function (for example, atypical antipsychotics and phenothiazines, many tricyclic antidepressants, acetylsalicylic acid, NSAIDs) or drugs that increase the risk of bleeding, as well as patients with a bleeding history or prone to bleeding (for example, with thrombocytopenia or impaired coagulation).
Increased risk of lengthening the QT / paroxysmal ventricular tachycardia type "pirouette" with combination therapy with fluvoxamine with terfenadine or astemizole or cisapride, due to the increased concentration of the latter in plasma. Therefore, fluvoxamine should not be prescribed with these drugs.
Fluvoxamine may cause a slight decrease in heart rate (2-6 beats / min).
The clinical experience with fluvoxamine with ECT is limited, so this therapy should be carried out with caution.
When discontinuation of fluvoxamine, the development of withdrawal syndrome is possible, although the available data of preclinical and clinical studies have not revealed the occurrence of dependence on fluvoxamine treatment. The most frequent symptoms noted in case of drug withdrawal are: dizziness, disturbed sensitivity (including paresthesias, visual disturbance and sensation of shock), disturbed 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 or moderately pronounced and stop themselves, but in some patients they can be severe and / or prolonged. Similar symptoms usually occur during the first few days after stopping treatment. For this reason, it is recommended that the dose of fluvoxamine be gradually reduced before complete withdrawal according to the patient’s condition.
Fluvoxamine should be used with caution in patients with a history of mania / hypomania. With the development of the patient manic phase should stop the use of fluvoxamine.
Treatment of patients with hepatic or renal insufficiency should begin with the appointment of the drug in a low dose, such patients require strict medical supervision. In rare cases, treatment with fluvoxamine can lead to an increase in liver enzyme activity, which is most often accompanied by relevant clinical symptoms; in such cases, Fevarin should be abolished.
The data obtained in the treatment of elderly patients and younger patients, indicate the absence of clinically significant differences between the commonly used daily doses. However, increasing doses of the drug in elderly patients should always be carried out more slowly and with greater caution.
A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders revealed an increased risk of suicidal behavior when taking antidepressants compared with placebo in patients younger than 25 years. When prescribing fluvoxamine, the risk of suicide should be correlated with the benefits of its use.
Symptoms: the most characteristic are nausea, vomiting, diarrhea, drowsiness, dizziness. There are reports of cardiac abnormalities (tachycardia, bradycardia, arterial hypotension), abnormal liver function, convulsions, coma.
To date, more than 300 reports of Fevarin’s deliberate overdose have been reported. The highest recorded dose was 10 g (the patient was cured as a result of symptomatic therapy). More serious complications were observed in cases of deliberate overdose of Fevarin against the background of concomitant pharmacotherapy.
Treatment: gastric lavage, which should be carried out as soon as possible after taking the drug; conduct symptomatic therapy. In addition, repeated administration of activated carbon is recommended. There is no specific antidote. Forced diuresis or dialysis is impractical.
- Brand name: Fevarin
- Active ingredient: Fluvoxamine
- Dosage form: Pills
- Manufacturer: Abbott
- Country of Origin: USA
- Missing data perspectives of the fluvoxamine data set: a review
- The Effect of Chronic Fluvoxamine Treatment on Overnight Melatonin Secretion in Medicated Chronic Schizophrenic Patients
- Effectiveness of Fluvoxamine and Paroxetine in Major Depressives with Psychotic Features
- A comparison of fluvoxamine, fluoxetine, sertraline and paroxetine examined by observational cohort studies
- Comparison of fluvoxamine, imipramine, and placebo in the treatment of outpatients with panic disorder
- Open trial of fluvoxamine in the treatment of bulimia nervosa
- Voltammetric Behavior of Fluvoxamine Using Square-Wave and Adsorptive Stripping Square-Wave Techniques. Determination in Pharmaceutical Products
- Bioavailability of fluvoxamine given with and without food
- Pharmacokinetics of fluvoxamine maleate after increasing single oral doses in healthy subjects
- Automated analysis of fluvoxamine in rat plasma using a column-switching system and ion-pair high-performance liquid chromatography
- High performance liquid chromatographic determination of fluvoxamine in human plasma
- Determination of fluvoxamine concentration in plasma by reversed-phase liquid chromatography
- Determination of fluvoxamine in rat plasma by HPLC with pre-column derivatization and fluorescence detection using 4-fluoro-7-nitro-2,1,3-benzoxadiazole
- Fluvoxamine treatment in veterans with combat-related post-traumatic stress disorder
- A double-blind clinical trial of fluvoxamine and imipramine in patients with primary depression
- Aggravation of food-related behavior in an adolescent with Prader-Willi syndrome treated with fluvoxamine and fluoxetine
- Cognition and depression: the effects of fluvoxamine, a sigma-1 receptor agonist, reconsidered
- Differences in clinical effect and tolerance between fluvoxamine and paroxetine: A switching study in patients with depression
- Fluvoxamine is ineffective in the treatment of enuresis in children and adolescents: an open-label pilot study
- Fluvoxamine in obsessive-compulsive disorder: similar efficacy but superior tolerability in comparison with clomipramine
- Fluvoxamine augmentation in risperidone-resistant schizophrenia: an open trial
- Fluvoxamine as effective as clomipramine against symptoms of severe depression: results from a multicentre, double-blind study
- Possible predictors of response to fluvoxamine for depression