). After stopping treatment with 5-HT re-uptake inhibitors a time period equal to 4 - 5 half lives of the drug or any active metabolite should elapse between stopping therapy and starting therapy with Manerix. Manerix should not be co-administered with dextromethorphan, contained in many proprietary cough medicines, as isolated cases of severe central nervous system adverse reactions have been reported after co-administration.
Manerix should not be administered to children for the time being as clinical experience in this category is lacking. 4. Special warnings and precautions for use 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. Manerix is a reversible inhibitor of monoamine oxidase type A (RIMA). It causes less potentiation of tyramine than traditional irreversible MAOIs, and therefore Manerix does not generally necessitate the special dietary restrictions required for these irreversible MAOIs.
However, as a few patients may be especially sensitive to tyramine, all patients should be advised to avoid the consumption of large amounts of tyramine rich food (mature cheese, yeast extracts and fermented soya bean products). 5 Interaction with other medicinal products and other forms of interaction).
g. a benzodiazepine). The sedative should only be used for a maximum of 2 to 3 weeks. If a depressive episode is treated in bipolar disorders, manic episodes can be provoked. Due to the lack of clinical data, patients with concomitant schizophrenia or schizo- affective organic disorders should not be treated with Manerix.
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.
Theoretical pharmacological considerations indicate that MAO inhibitors may precipitate a hypertensive reaction in patients with thyrotoxicosis. As experience with Manerix in this population group is lacking, caution should be exercised before prescribing Manerix.
5 Interaction with other medicinal products and other forms of interaction). 5). If concomitant treatment with buprenorphine 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.
Hypersensitivity may occur in susceptible individuals. Symptoms may include rash and oedema. 8 Undesirable effects), and should be considered in all patients who develop drowsiness, confusion or convulsions while taking an antidepressant.
St John’s Wort (Hypericum) – containing phytotherapeutic products should be used with care in combination with moclobemide as this may increase the serotonin concentration. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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. Other psychiatric conditions for which Manerix is prescribed can also be associated with an increased risk of suicide-related events.
In addition, these conditions may be co- morbid with major depressive disorder. 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-related events, 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, and 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.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or […]