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  • Favoxil
    / Perrigo


    Active Ingredient
    Fluvoxamine Maleate 50 mg, 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    60 x 50 mg

    partial basket chart 9007 6049

    Tablets

    30 X 100 mg

    partial basket chart 9006 6048

    Related information


    Dosage

    Depression
    Adults:
    The recommended dose is 100 mg daily. Patients should start on 50 or 100 mg, given as a single dose in the evening. Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 300 mg a day. Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
    Children/adolescents: Favoxil should not be used in children and adolescents under the age of 18 years for the treatment of major depressive episode. The efficacy and safety of Favoxil have not been established in the treatment of pediatric major depressive episode. 2
    Obsessive compulsive disorder
    Adults:
    The recommended dose is between 100-300 mg daily. Patients should start at is 50 mg per day. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 300 mg a day. Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses. If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. While there are no systematic studies to answer the question of how long to continue fluvoxamine treatment, OCD is a chronic condition and it is reasonable to consider continuation beyond 10 weeks in responding patients. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. The need for treatment should be reassessed periodically. Some clinicians advocate concomitant behavioral psychotherapy for patients who have done well on pharmacotherapy. Long-term efficacy (more than 24 weeks) has not been demonstrated in OCD.
    Children/adolescents: In children over 8 years and adolescents there is limited data on a dose of up to 100 mg b.i.d for 10 weeks. The starting dose is 25 mg per day. Increase every 4-7 days in 25 mg increments as tolerated until an effective dose is achieved. The maximum dose in children should not exceed 200 mg/day. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.
    Withdrawal symptoms seen on discontinuation of fluvoxamine: Abrupt discontinuation should be avoided. When stopping treatment with fluvoxamine, the dose should be gradually reduced over a period of at least one or two weeks in order to reduce the risk of withdrawal reactions. (If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
    Hepatic or renal insufficiency: Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored.
    For full details see prescribing information.


    Indications

    Depression, obsessive compulsive disorders.


    Contra-Indications

    Should not be taken in combination with monoamine oxidase inhibitors (MAOI). Treatment with fluvoxamine can be initiated: two weeks after discontinuation of an irreversible MAOI, or one day after the discontinuation of a reversible MAOI (e.g. moclobemide). At least one week should elapse between discontinuation of fluvoxamine and initiation of therapy with any MAOI. Known hypersensitivity to any component of the product.


    Special Precautions

    Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). The risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase again in the early stages of recovery. Other psychiatric conditions for which fluvoxamine are prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behavior with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behavior or thoughts and unusual changes in behavior and to seek medical advice immediately if these symptoms present.
    Pediatric population: Fluvoxamine should not be used in the treatment of children and adolescents under the age of 18 years except for patients with Obsessive Compulsive Disorder. Suicide-related behaviors (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behavior and anger) were more frequently observed in clinical trials among children and adolescents treated with an antidepressant compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioral development are lacking.
    Geriatric population: Data in elderly subjects give no indication of clinically significant differences in normal daily dosages compared to younger subjects. However, upward dose titration should be done more slowly in the elderly, and dosing should always be done with caution.
    Renal and hepatic impairment: Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored. Treatment with fluvoxamine has rarely been associated with an increase in hepatic enzymes, generally accompanied by clinical symptoms. In such cases treatment should be discontinued. Withdrawal symptoms seen on discontinuation of fluvoxamine treatment Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt. In clinical trials, adverse events seen on treatment discontinuation occurred in approximately 12% of patients treated with fluvoxamine, which is similar to the incidence seen in patients taking placebo. The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction. The most commonly reported reactions in association with withdrawal of the product include: dizziness, sensory disturbances (including paresthesia, visual disturbances and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation and anxiety, irritability, confusion, emotional instability, nausea and/or vomiting and diarrhea, sweating and palpitations, headache and tremor. Generally these symptoms are mild to moderate; however in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore advised that fluvoxamine should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient’s needs.
    Psychiatric Disorders: Fluvoxamine should be used with caution in patients with a history of mania/hypomania. Fluvoxamine should be discontinued in any patient entering a manic phase.
    For full details see prescribing information.


    Side Effects

    Adverse reactions, observed in clinical studies at frequencies listed below, are often associated with the illness and are not necessarily related to treatment.
    For full details see prescribing information.


    Drug interactions

    The serotonergic effects of fluvoxamine may be enhanced when used in combination with other serotonergic agents (including triptans, SSRIs and St. John’s Wort preparations) Fluvoxamine has been used in combination with lithium in the treatment of severely ill, drug-resistant patients. However, lithium (and possibly also tryptophan) enhances the serotonergic effects of fluvoxamine. The combination should be used with caution in patients with severe, drug-resistant depression. In patients on oral anticoagulants and fluvoxamine, the risk for hemorrhage may increase and these patients should therefore be closely monitored. As with other psychotropic drugs patients should be advised to avoid alcohol use while taking fluvoxamine.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: Epidemiological data have suggested that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies occur. Reproduction toxicity studies in animals revealed treatment related increases in embryotoxicity (embryofetal death, fetal eye abnormalities). The relevance to humans is unknown. The safety margin for reproductive toxicity is unknown. Fluvoxamine should not be used during pregnancy unless the clinical condition of the woman requires treatment with fluvoxamine. Isolated cases of withdrawal symptoms in the newborn child have been described after the use of fluvoxamine at the end of pregnancy. Some newborns experience feeding and/ or respiratory difficulties, seizures, temperature instability, hypoglycemia, tremor, abnormal muscle tone, jitteriness, cyanosis, irritability, lethargy, somnolence, vomiting, and difficulty in sleeping and constant crying after third trimester exposure to SSRIs and may require prolonged hospitalization.
    Lactation: Fluvoxamine is excreted via human milk in small quantities. Therefore, the drug should not be used by women who breast-feed.
    Fertility: Reproductive toxicity studies in animals have shown that fluvoxamine impairs male and female fertility. The safety margin for this effect was not identified. The relevance of these findings to humans is unknown. Animal data have shown that fluvoxamine may affect sperm quality. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far. Fluvoxamine should not be used in patients attempting to conceive unless the clinical condition of the patient requires treatment with fluvoxamine.


    Overdose

    Symptoms: Symptoms include gastro-intestinal complaints (nausea, vomiting and diarrhea), somnolence and dizziness. Cardiac events (tachycardia, bradycardia, and hypotension), liver function disturbances, convulsions and coma have also been reported. Fluvoxamine has a wide margin of safety in overdose. Since market introduction, reports of death attributed to overdose of fluvoxamine alone have been extremely rare. The highest documented dose of fluvoxamine ingested by a patient is 12 gram. This patient recovered completely. Occasionally, more serious complications were observed in cases of deliberate overdose of fluvoxamine in combination with other drugs.
    Treatment: There is no specific antidote to fluvoxamine. In case of overdose the stomach should be emptied as soon as possible after tablet ingestion and symptomatic treatment should be given. The repeated use of medicinal charcoal, if necessary accompanied by an osmotic laxative, is also recommended. Forced diuresis or dialysis is unlikely to be of benefit.


    Manufacturer
    Perrigo Israel
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