Product prescribing information for reboxetine detailing indications, dosing, and safety profile for the treatment of depressive illness.
Released f r o m depressionReunited w i t h the w o r l d P Pharmacia &UpJohn Presentation: Tablets containing 4mg reboxetine.Indications: Use in the acute treatment of depressive illness, and maintenance of clinical benefit in patients responsive to treatment.Posology and method of administration: Adults 4 mg b.i.d.(8 mg/day) administered orally.After 3-4 weeks, can increase t o 10 mg/day.Elderly and children Elderly patients have been studied in comparative clinical trials at doses of 2 mg b.i.d., although not in placebo controlled conditions.There is no experience in children and therefore reboxetine cannot be recommended in either of these groups.Renal/Hepatic Insufficiency 2 mg b.i.d. which can be increased based on patient tolerance.Contra-indications: Hypersensitivity to the compound or its constituents.Use in pregnancy/lactation.Special warnings and precautions for use: Close supervision is required for subjects with a history of convulsive disorders and must be discontinued if the patient develops seizures.Avoid concomitant use with MAO-inhibitors.Close supervision of bipolar patients is recommended.Close supervision should be applied in patients with current evidence of urinary retention, glaucoma, prostatic hypertrophy and cardiac disease.At doses higher than the maximum recommended, orthostatic hypotension has been observed with greater frequency.Particular attention should be paid when administering reboxetine with other drugs known to lower blood pressure.Interactions with other medicaments and other forms of interaction: Reboxetine should not be co-administered with macrolide antibiotics, fluvoxamine, azole anti-fungal agents.Caution when co-administered with drugs that have a narrow therapeutic margin and are metabolised by CYP3A4 or CYP2D6 e.g.anti-arrhythmics (flecainide), anti-psychotic drugs and tricyclic anti-depressants.No pharmacokinetic interaction with lorazepam.Reboxetine does not appear to potentiate the effect of alcohol.Pregnancy and lactation: Reboxetine is contraindicated in pregnancy and lactation.Effects on ability to drive and use machines: Reboxetine is not sedative per se.However, as with all psychoactive drugs, caution patients about operating machinery and driving.Undesirable effects: Adverse events occurring more frequently than placebo are: dry mouth, constipation, insomnia, paraesthesia, increased sweating, tachycardia, vertigo, urinary hesitancy/retention, impotence.Overdose: Monitor cardiac function and vital signs.General symptomatic supportive and/or emetic measures might be required.Package and GMS Price: Pack of 60 tablets in blisters £23.50.
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A Alavian Ghavanini (1999) studied this question.
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