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Acute treatment of depressive illness and for maintaining the clinical improvement in patients initially responding to treatment. The remission of the acute phase of the depressive illness is associated with an improvement in the patient’s quality of life in terms of social adaptation. The onset of the clinical effect is seen after 14 days from the start of treatment.


Hypersensitivity to the constituents of this medicine.

Adverse reactions:

Adverse effects in reboxetine-treated patients appear early, tend to diminish with time and are of mild to moderate severity. In placebo-controlled studies, adverse events were reported in approximately 70% of reboxetine-treated patients and in approximately 60% of placebo-treated patients. Discontinuation rates for adverse events were similar between reboxetine- and placebo-treated patients and were <10%. Adverse events that occurred with statistically greater frequency in reboxetine-treated patients than in placebo-treated patients include: Dry mouth, constipation, insomnia, increased sweating, tachycardia, vertigo, urinary hesitancy/retention and impotence. Impotence was mainly observed in patients treated with doses >8 mg/day. The most relevant between gender difference in adverse event rate was related to the frequency of urinary hesitancy/retention which occurred more often in male patients. The overall frequency (approximately 1%) of serious adverse events in adult reboxetine-treated patients was not different from that found in the placebo-treated population. The only modification in vital signs was an increase in heart rate upon standing. Apart from tachycardia, no consistent changes in electrocardiogram (ECG) tracings were observed during reboxetine treatment in adult patients. In the elderly population, newly observed rhythm disorders (mainly tachycardia) and conduction disorders were apparent in the ECG in approximately 15% of cases. In studies of longer than 8 weeks, newly emergent adverse events were reported in approximately 30% of the reboxetine-treated patients and approximately 25% of the placebo-treated patients. These adverse events were associated with discontinuation rates of 4% and 1%, respectively. Constipation was the only event which was observed more commonly in the reboxetine-treated group. Discontinuation emergent adverse events were infrequent and occurred in approximately 4% of the reboxetine-treated patients and approximately 6% of placebo-treated patients.


In vitro and in vivo studies have shown that reboxetine is not metabolized by CYP-450 2D6. Therefore, no special precautions are necessary for individuals deficient in this enzyme. Likewise, inhibitors of this enzyme eg, fluoxetine and paroxetine, are unlikely to have an effect on reboxetine pharmacokinetics. In vitro studies have shown that reboxetine does not inhibit the activity of the following CYP-450 isozymes: CYP1A2, CYP2C9, CYP2C19 and CYP2E1. At high concentrations, reboxetine inhibits CYP2D6, but the clinical significance of this observation is unknown. In vitro studies show that reboxetine is a very weak inhibitor of CYP3A4. In vitro metabolism studies indicate that reboxetine is metabolized by the CYP3A4 isozyme of CYP-450. Therefore, compounds which modulate the activity of this isozyme, would be expected to increase plasma concentrations of reboxetine.


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 should be discontinued if the patient develops seizures. Combined use of monoamine oxidase inhibitors (MAOI) and reboxetine should be avoided until further data are available. As with all antidepressants, switches to mania/hypomania have occurred. Close supervision of bipolar patients is recommended. The risk of a suicidal attempt is inherent in depression and may persist until significant remission occurs; close patient supervision during initial drug therapy is recommended. Close supervision is recommended in patients with current evidence of urinary retention and glaucoma. 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. Effects on the Ability to Drive or Operate Machinery: Reboxetine is not a sedative. No cognitive or psychomotor impairment has been observed with reboxetine in clinical studies. Use in pregnancy & lactation: There are no adequate and well-controlled studies in pregnant women. Reboxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. While no information on the excretion of reboxetine in maternal milk in humans is available, reboxetine administration is not recommended in women who are breastfeeding. Use in children: There are no data available on the use of reboxetine in children.



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