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  • Edronax
    / Pfizer


    Active Ingredient
    Reboxetine 4 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    60 X 4 mg

    partial basket chart 21196 5149

    Related information


    Dosage

    Use in adults: The recommended therapeutic dose is 4 mg BID (8 mg/day) administered orally. After 3-4 weeks, the dose can be increased up to 10 mg/day in case of incomplete clinical response.
    Use in the elderly (age greater than 65): The recommended therapeutic dose is 2 mg BID (4 mg/day) administered orally. The dose can be increased up to 6 mg/day in case of incomplete clinical response after 3 weeks from starting reboxetine.
    Use in children and adolescents under the age of 18 years: There are no data available on the use of reboxetine in children. Edronax should not be used in the treatment of children and adolescents under the age of 18 years.
    Use in patients with renal or hepatic insufficiency: The starting dose in patients with renal or moderate to severe hepatic insufficiency should be 2 mg BID, which can be increased based on patient tolerance.
    For full details see prescribing information.


    Indications

    Depression and as maintenance therapy in patients initially responding to treatmentt.


    Contra-Indications

    Hypersensitivity to the constituents of the formulation. Pregnancy and lactation.


    Special Precautions

    Since rare cases of seizures have been reported in clinical studies, reboxetine should be given under close supervision to subjects with a history of convulsive disorders and it must be discontinued if the patient develops seizures. Combined usage of MAO inhibitors and reboxetine should be avoided. As with all antidepressants, switches to mania/hypomania have occurred during the clinical studies. Close supervision of bipolar patients is, therefore, recommended. Caution is recommended in patients with current evidence of urinary retention, prostatic hypertrophy, glaucoma and history of cardiac disease. Orthostatic hypotension has been observed with greater frequency at doses higher than the maximum recommended. Close supervision is recommended when administering reboxetine with other drugs known to lower blood pressure. Mydriasis has been reported in association with reboxetine; therefore, caution should be used when prescribing reboxetine to patients with increased intraocular pressure or those at risk of acute narrow-angle glaucoma. Clinical experience with reboxetine in the long-term treatment of elderly patients is, at present, limited. In this population, lowering of mean potassium levels was found starting from week 14; the magnitude of this reduction did not exceed 0.8 mmol/litre and potassium levels never dropped below normal limits.
    Serotonin syndrome: Caution is advisable if Edronax is used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan. In rare cases, serotonin syndrome has been reported in patients using SSRIs/SNRI s concomitantly with serotonergic medicinal products. A combination of symptoms, such as agitation, tremor, myoclonus and hyperthermia may indicate the development of this condition. If this occurs treatment with the SSRI/SNRI and the serotonergic medicinal product should be discontinued immediately and symptomatic treatment initiated.
    Use in children and adolescents under 18 years of age: Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants 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 behavioural development are lacking.
    Use in young adults (18-25 years of age): An additional analysis of pooled data of currently available antidepressants showed an increased risk of suicidal thinking and behavior when compared to placebo in young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Currently, data is insufficient to quantify an increased risk of suicidal thinking and behavior associated with reboxetine treatment. Nevertheless, anyone considering the use of reboxetine in young adults must balance this potential risk with the clinical need.
    Suicide/suicidal thoughts or clinical worsening: Depression is associated with an increased risk of suicidal thoughts, self harm, and suicide (suicide-related events). This 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 in the early stages of recovery. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patient (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present. Pregnancy and lactation.
    For full details see prescribing information.


    Side Effects

    Adverse effects in reboxetine treated patients appear early, tend to diminish with time, and are of mild to moderate severity.
    In placebo-controlled studies of 8 weeks duration or less, adverse events were reported in approximately 80% of reboxetine-treated patients and in approximately 70% of placebo-treated patients. Discontinuation rates for adverse events wereapproximately 9% and 5% for reboxetine-and placebo-treated patients, respectively.
    For full details see prescribing information.


    Drug interactions

    Dipyridamole, propranolol, alprenolol, methadone, lidocaine and other local anesthetics, imipramine, chlorpromazine. CYP3A4 inhibitors such as azole antifungal agents, macrolide antibiotics, such as erythromycin, or fluvoxamine, potassium losing diuretics.


    Pregnancy and Lactation

    Pregnancy: No clinical trial data on exposure to reboxetine during pregnancy are available. However, postmarketing safety data on a very limited number of exposed pregnancies indicate no adverse effects of reboxetine on pregnancy or on the health of the fetus/newborn child. Animal studies in general do not indicate direct or indirect harmful effects with respect to pregnancy, embrynal/fetal development or parturition. Some impairment of growth and development has been noted in rat neonates. Reboxetine should only be used in pregnancy if the potential benefits of treatment to the mother outweigh the possible risks to the developing fetus.
    Women of child-bearing potential: If conception occurs during therapy, treatment is to be discontinued as soon as pregnancy is confirmed to limit foetal exposure to the drug.
    Lactation: Reboxetine is known to be excreted in breast milk. The level of active substance transferred in breast milk is anticipated to be very low, however there is insufficient information to exclude a risk to the nursing infant. The use of reboxetine during breastfeeding can be considered if the potential benefits outweigh the risk for the child.


    Overdose

    In a few cases, doses higher than that recommended were administered to patients (12 to 20 mg/day) for a period ranging from a few days to a few weeks during clinical studies. Treatment-emergent adverse events included postural hypotension, anxiety and hypertension. Elderly might be particularly vulnerable to overdose. In premarketing clinical studies, there were 5 reports of reboxetine overdose alone or in combination with other pharmacologic agents. The amount of reboxetine ingested was 52 mg as the sole agent by 1 patient and 20 mg in combination with other agents by another patient. The remaining 3 patients ingested unknown quantities of reboxetine. All 5 patients recovered fully. There were no reports of ECG abnormalities, coma, or convulsions following overdose with reboxetine alone. In postmarketing experience, there have been few reports of overdose in patients taking reboxetine alone; none of these have proved fatal. Non-fatal overdoses in patients have been reported for patients taking up to 240 mg of reboxetine. One fatal overdose was reported in a patient who ingested reboxetine in combination with amitriptyline (doses unknown). Two cases of self-overdosing with up to 52 mg of reboxetine have been reported. No serious adverse events were observed. In the case of overdose, close supervision including monitoring of cardiac function and vital signs is recommended. General symptomatic supportive and/or emetic measures might be required.


    Manufacturer
    Pfizer Italy
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