Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Reboxetine is indicated for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment.
Reboxetine is for oral use.
The recommended therapeutic dose is 4 mg twice a day (b.i.d.) i.e.8 mg/day administered orally. The full therapeutic dose can be given upon starting treatment. After 3-4 weeks, this dose can be increased to 10 mg/day in case of incomplete clinical response. The maximum daily dose should not exceed 12 mg/day. The minimum effective dose has not yet been established.
Elderly patients have been studied in clinical trials at doses of 2 mg b.i.d. However, safety and efficacy have not been evaluated in placebo-controlled conditions. Therefore, as for other antidepressants that have not been studied in placebo-controlled conditions, reboxetine cannot be recommended.
Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4).
The starting dose in patients with renal or hepatic insufficiency should be 2 mg b.i.d which can be increased based on patient tolerance.
The acute toxicity studies carried out in animals indicate a very low toxicity, with a wide safety margin with respect to the pharmacologically active doses. Clinical signs and cause of death were related to CNS stimulation (mainly convulsive symptoms).
In a few cases doses higher than those recommended were administered to patients (12 mg to 20 mg/day) for a period ranging from a few days to some weeks during clinical studies: newly reported complaints include 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).
In case of overdose, monitoring of cardiac function and vital signs is recommended. General symptomatic supportive and/or emetic measures might be required.
3 years.
Do not store above 25°C.
The tablets are contained either in amber glass, type III, bottle, closed with an aluminium pilfer-proof screw cap equipped with a polyethylene undercap or in aluminium-PVDC/PVC-PVDC opaque blisters.
Each pack contains: 10, 20, 50, 60, 100, 120, and 180 tablets in blisters; and 60 tablets in glass bottles.
Multipacks of 3x60, 5x60 and 10x60 tablets in blisters; and 3x60, 5x60 and 10x60 tablets in glass bottles.
Not all pack sizes may be marketed.
No special requirements.
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