Aurorix Special Precautions

General: Suicide/Suicidal thoughts or clinical worsening: Depressive disorders are 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 when treatment is initiated.
Other psychiatric conditions for which moclobemide is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may occur together with depressive disorders (episodes of major depression). For this reason, 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 behavior, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts. They 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 behaviour with antidepressants compared to placebo in patients less than 25 years old.
As with other antidepressants, treatment may exacerbate the schizophrenic symptoms of depressive patients with schizophrenic or schizoaffective psychoses. If possible, therapy with long-acting neuroleptics should be continued in such patients.
Generally during therapy with moclobemide, special dietary restrictions are not necessary. Since hypersensitivity to tyramine may exist in some patients, all patients should be advised to avoid the consumption of large amounts of tyramine-rich food.
Suicidality on Children and Adolescent: Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Suicidal thoughts, self-harm and suicide (suicide-related events) are known be associated with the conditions for which moclobemide is prescribed, but a possible increase in the risk of such events in patients treated with antidepressants can not be excluded. Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need. The indication(s) approved in paediatric for the particular drug should be clearly stated/included.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose adjustment. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber immediately if these symptoms present.
When treating patients with schizophrenic or schizoaffective psychoses, exacerbation of schizophrenic symptoms may occur. If somehow possible, treatment with long-term neuroleptics should be continued in these patients.
In pharmacological studies, moclobemide has shown a slight potential only for interactions with tyramine. In contrast to a therapy with irreversible monoaminoxidase inhibitors, the interactions occurring with tyramine rich food under treatment with moclobemide are clinically insignificant under normal conditions and when the product is taken after the meals. However, as a precaution it is recommended that all patients avoid eating large amounts of tyramine rich food (such as old mature cheese).
In predisposed patients, hypersensitivity reactions manifesting themselves in symptoms including rash, oedema or dyspnoea may occur.
There are theoretical pharmacological grounds for supposing that drugs that inhibit monoamine oxidase may provoke hypertensive reaction in patients with thyrotoxicosis or pheochromocytoma. As experience with moclobemide in this population group is lacking, caution should be exercised with regard to prescribing moclobemide.
In patients receiving moclobemide, additional drugs that enhance serotonin, such as many other antidepressants, particularly in multiple-drug combinations, should be given with caution. Due to the increased risk of serious undesirable effects, concomitant administration of moclobemide and clomipramine should be avoided (see Interactions).
Concomitant administration of moclobemide and buprenorphine containing products may result in serotonin syndrome, a potentially life-threatening condition (see Interactions).
If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Concomitant administration of moclobemide and dextromethorphan (may be contained in medicines used to treat colds, for instance), is not recommended (see Interactions).
Particular caution should be exercised when moclobemide is co-administered with herbal products containing St. John’s wort (Hypericum) as this may increase the serotonin serum concentration.
Insomnia or nervousness or jitteriness at the beginning of treatment with moclobemide can justify a dose reduction or temporary symptomatic treatment. In case of occurrence of mania or hypomania, or the onset of early symptoms of those reactions (grandiosity, hyperactivity (including increased speech), reckless impulsivity), treatment with moclobemide shall be interrupted and alternative treatment should be initiated.
Excipient information: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take moclobemide.
Effects on the ability to drive and use machines: In general, reactivity will not be impaired. The individual reaction should, however, be monitored in particular during early treatment.