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Fevarin (Fluvoxaminum, Fluvoxamine) - Antidepressant. Studies on the receptor binding showed that fluvoxamine is a potent inhibitor of serotonin reuptake both in vitro, and in vivo with minimal affinity for the serotonin receptors. Its ability to bind α- and .beta.-adrenergic receptors, histamine, m-cholinergic receptors or dopamine receptors insignificant.

Fluvoxamine has a high affinity for the σ1-receptor, acting as their agonist.

Testimony:

  • Depression different genesis;
  • Obsessive-compulsive disorder.

Contraindications:

  • Simultaneous reception with tizanidine and MAO inhibitors (treatment with fluvoxamine can be started 2 weeks after discontinuation of an irreversible MAO inhibitor, on the following day after discontinuation of a reversible MAO inhibitor (eg moclobemide, linezolid) The time interval between discontinuation of fluvoxamine and initiation of therapy. any MAO inhibitor should be at least 1 week;
  • Simultaneous reception with ramelteon;
  • Hypersensitivity to the active substance or to any component of the drug.

Precautions should be prescribed the drug for liver and kidney failure, a history of seizures, epilepsy, patients with a tendency to bleeding (thrombocytopenia), pregnancy, lactation, as well as elderly patients.

Pregnancy and breast-feeding:

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 (PPH) newborns. Available data show that PPH occurs in about 5 cases per 1000 births (as opposed to 1-2 cases per 1000 births if the mother has not applied the SSRIs in the last stages of pregnancy).

We do not recommend the use of fluvoxamine during pregnancy except in cases where the clinical condition of the woman points to the need for its use.

some cases of neonatal withdrawal of fluvoxamine after use in late pregnancy were described.

Some infants after exposure to SSRIs in the III trimester of pregnancy have been difficult feeding and / or breathing, seizure disorders, unstable body temperature, hypoglycemia, tremor, disorders of muscle tone, increased neuro-reflex excitability syndrome, cyanosis, irritability, lethargy, drowsiness, nausea, difficulty falling asleep and continuous crying, which may require a longer hospital stay.

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

Fluvoxamine should not be used in patients who are planning a pregnancy, except in cases where the patient's clinical condition requires the appointment of fluvoxamine.

Experimental studies of reproductive toxicity in animals have shown that fluvoxamine affect reproductive function in males and females, increases the risk of fetal death and reduced the fetal body weight at doses exceeding the maximum recommended human dose of approximately 4 times. In addition, the observed increase in the incidence of perinatal puppies mortality in the pre- and postnatal studies. The significance of these data for humans is unknown.

Special instructions:

As with other psychotropic drugs during treatment with Fevarin is not recommended to consume alcohol.

Depression is associated with an increased risk of suicidal thoughts, self harm and attempted suicide (suicidal behavior). This risk persists until significant improvement. As improvement may not occur during the first few weeks of treatment or longer, patients should be closely monitored until such improvement.

In clinical practice widely increased risk of suicide at the early stages of recovery.

Other mental disorder for which treatment is prescribed fluvoxamine, may also be associated with an increased risk of suicidal behavior. Also, these states can accompany major depression. Therefore, patients with other psychiatric disorders should be monitored carefully.

It is known that patients with a history of suicidal behavior or substantially exhibiting suicidal ideation, before treatment are at greater risk of suicidal thoughts or suicide attempts, and should be monitored closely during treatment.

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

It is necessary to warn patients (and caregivers of them) on the need to keep track of any clinical deterioration, suicidal behavior or suicidal thoughts and unusual changes in behavior, and immediately seek the advice of a specialist with the appearance of symptoms.

The development of akathisia associated with taking fluvoxamine, characterized subjectively unpleasant and painful anxiety. The need to move often accompanied by an inability to sit or stand still. The development of such a condition is most likely in the first few weeks of treatment. Increasing the dose of the drug in patients with such symptoms may worsen their condition.

Caution should be exercised when administering the drug to patients with seizures in history. Destination fluvoxamine should be avoided in patients with unstable epilepsy, and with stable epilepsy patients should be closely monitored. Treatment with Fevarin should be discontinued if there are seizures or their frequency increases.

Described rare cases of serotonin syndrome or condition, such NMS, which may be associated with taking fluvoxamine, especially in combination with other serotonergic and / or neuroleptic drugs. These syndromes may result in potentially life-threatening condition, manifested by hyperthermia, muscle rigidity, myoclonus, lability of the autonomic nervous system with possible rapid changes in vital parameters (including pulse, respiration, blood pressure), mental status changes, including confusion, irritability, extreme agitation that extends to delirium or coma. Therefore, in such cases, Fevarin should start and cancel corresponding symptomatic treatment.

As with other selective serotonin reuptake inhibitors, in rare cases may cause hyponatremia, which is subjected to reverse development, after the abolition of fluvoxamine. Some cases have been caused by the syndrome of inadequate secretion of ADH. In general, these cases were observed in elderly patients.

It may be broken control of blood glucose levels (i.e., hyperglycemia, hypoglycemia, impaired glucose tolerance), especially in the early stages of treatment. In the case of the appointment of the drug Luvox patients with diabetes mellitus history, you may need correction of dose of hypoglycemic drugs.

The most frequently observed symptom associated with the use of the drug Fevarin, 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, patients with elevated intraocular pressure in patients or groups of high-risk acute angle-closure glaucoma fluvoxamine should be used with caution.

There are reports of such intradermal hemorrhages as ecchymosis and purpura and other hemorrhagic manifestations (eg, gastrointestinal bleeding or gynecological bleeding) was observed with 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, acetylsalicylic acid, NSAIDs) or drugs that increase the risk of bleeding, as well as in patients with bleeding history or prone to bleeding (eg, thrombocytopenia or coagulation disorders).

Increased risk of lengthening QT / paroxysmal ventricular tachycardia type "pirouette" interval therapy in combination with fluvoxamine terfenadine or astemizole cisapride or in connection with the recent increase in plasma concentration. Therefore, fluvoxamine should not be administered with these drugs.

Fluvoxamine may cause a slight decrease in heart rate (2-6 beats. / Min).

Experience of clinical application of 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 preclinical and clinical studies revealed no occurrence of the treatment with fluvoxamine. 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 cessation of treatment. For this reason, it recommended to gradually reduce the dose of fluvoxamine to the complete abolition in accordance with the condition of the patient.

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 start with the appointment of the drug at a low dose, these patients require strict medical supervision. In rare cases, treatment with fluvoxamine may lead to an increase in liver enzymes, which is often accompanied by corresponding clinical symptoms; in such cases, Fevarin should be abolished.

The data obtained in the treatment of elderly patients and younger patients showed no clinically relevant differences between them are usually used in 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 the benefits of its application.

Suggested Use:

Fluvoxamine tablets should be taken orally, without chewing, drinking water. A tablet may be divided into two equal parts.

depression

The recommended starting dose for vzroslyhsostavlyaet 50 mg or 100 mg 1 time / day, evening. Recommended doses of a gradual increase to a level effective. The effective daily dose is usually 100 mg, selected individually depending on the patient's response to treatment. The daily dose may reach 300 mg. Daily doses greater than 150 mg should be distributed on several stages.

In accordance with the official WHO recommendations antidepressant treatment should continue for at least 6 months after remission of depressive episodes.

For the prevention of relapse of depression Fevarin is recommended to be administered in a dose of 100 mg 1 time / day every day.

Due to 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 starting dose for adults is 50 mg / day for 3-4 days. The effective daily dose is usually from 100 to 300 mg. Dosages should be increased gradually until the effective daily dose should not exceed 300 mg in adults. Doses up to 150 mg can be taken once a day, preferably at night. Daily doses greater than 150 mg is recommended to distribute on 2 or 3 doses.

The initial dose for children over 8 years and adolescents of 25 mg / day for 1 admission. The maintenance dose - 50-200 mg / day. The maximum daily dose is 200 mg. Doses of 100 mg / day is recommended to distribute on 2 or 3 doses.

If a good therapeutic response, treatment can be continued with the help of individualized daily dose. If no improvement is achieved after 10 weeks of treatment, treatment with fluvoxamine should be reconsidered. Until now, there was no organized system of research that could answer the question of how long can be carried out treatment with fluvoxamine, but obsessive-compulsive disorders are chronic, can be considered expedient to prolong the course of treatment Fevarin over 10 weeks in patients with adequate therapeutic effect. Selection of the minimum effective maintenance dose should be individually and with caution. Periodically it needs to re-evaluate the need for treatment. Some clinicians recommend carrying out concomitant therapy in patients with good effect of pharmacotherapy.

Drug interactions:

Fluvoxamine can 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. In in vitro and in vivo studies show a strong inhibitory effect of fluvoxamine on the cytochrome P450 isoenzyme 1A2 and 2C19, and to a lesser extent by cytochrome P450 isozymes 2C9, 2D6 and 3A4.

Drugs which are metabolized to a great extent these isozymes, displayed slower and can have higher blood plasma concentrations, if the simultaneous application of fluvoxamine. Such drugs should be administered at a minimum dose or reduce the dose to the minimum while the use of fluvoxamine. Careful observation of the plasma concentrations, effects or side effects, and correction dose of these preparations, if necessary. This is particularly important for drugs that have a narrow therapeutic range.

Before the drug Luvox 100 mg 2 times / day for 3 days before the simultaneous application of the preparation of ramelteon at a dose of 16 mg, AUC value for ramelteon increased about 190 times, and the value Cmaxuvelichilos approximately 70 times compared to these parameters when assigning one ramelteon.

Patients simultaneously receiving fluvoxamine, and drugs with a narrow therapeutic range, is metabolized solely or a combination of cytochrome P450 isoenzymes, inhibiting fluvoxamine (such as tacrine, theophylline, methadone, mexiletine, phenytoin, carbamazepine and ciclosporin) should be carefully monitored. If necessary, dose adjustment is recommended that these drugs.

With simultaneous use of fluvoxamine observed increase in concentrations of tricyclic antidepressants (such as clomipramine, imipramine, amitriptyline) and neuroleptics (for example clozapine, olanzapine, quetiapine), which largely metabolized by cytochrome P450 isoenzyme 1A2. In this regard, if treatment is started fluvoxamine should be considered reduced doses of these drugs.

In an application with fluvoxamine benzodiazepines undergoing oxidative metabolism, such as triazolam, midazolam, alprazolam and diazepam, may increase their concentration in plasma. The dosage of these benzodiazepines should be reduced at the time of 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 necessary, dose reduction or cancellation of ropinirole during treatment with fluvoxamine.

When interacting with fluvoxamine propranolol was an increase in the plasma concentration of propranolol. In connection with this reduction can be recommended dose of propranolol in the case of simultaneous application with fluvoxamine.

When applied in combination with fluvoxamine was observed a significant increase warfarin warfarin plasma concentrations and prolonged prothrombin time.

It was reported a few cases of cardiotoxicity, while the use of fluvoxamine and thioridazine.

While receiving fluvoxamine plasma concentrations of caffeine may increase. Thus, patients who consume large amounts of beverages containing caffeine should reduce their consumption while taking fluvoxamine, and when there are adverse effects of caffeine, such as tremor, palpitations, nausea, restlessness, insomnia.

In combination therapy with fluvoxamine concentrations of terfenadine, astemizole, or cisapride 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 effect on plasma concentration of digoxin.

Fluvoxamine has no effect on the plasma concentration of atenolol.

When combined with fluvoxamine serotonergic drugs (such as triptans, tramadol, selective serotonin reuptake inhibitors and drugs Hypericum perforatum) may increase serotonergic effects of fluvoxamine.

Fluvoxamine was used in combination with lithium preparations for the treatment of patients with severe, poorly responsive to pharmacotherapy. 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 a doctor's supervision.

Packaging:

  • Comes in original packaging. Item is brand new and unopened.

Storage:

  • Keep away from direct sunlight.
  • Keep locked and away from children.
  • Store in dry place at room temperature.
  • Do not exceed storage temperature higher than 25 C

Important notice- the outer box design may vary before prior notice!

 

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