CLOBEMIX

What it is

Moclobemide Sandoz is available as 150 mg film-coated tablets , and 300 mg film-coated tablets . The 150 mg tablets are beige, oval, and film-coated with a score notch on both sides . The 300 mg tablets are white, oval, and film-coated with a score notch on both sides .

Approved indications

— Treatment of major depression.

Dosing overview

Moclobemide therapy should be initiated in two divided daily doses, with a recommended initial daily dose of 300 or 450 mg . The recommended dose range is 300–600 mg per day . The dose should not be raised until after the first week, as bioavailability increases during this period . Treatment should continue for at least 4–6 weeks in order to assess the efficacy of the drug . Moclobemide should be taken after meals . In patients with severely impaired hepatic metabolism, the daily dose should be reduced to half or one third of the dose to reach the usual plasma level . No dosage adjustments are necessary in elderly patients .

Key safety warnings

The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Antidepressants increased the risk compared to placebo of suicidality in children, adolescents, and young adults aged 18–24 years during initial treatment in short-term studies of major depression and other psychiatric disorders . Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults over 24 years of age, and there was a reduction in risk with antidepressants compared to placebo in adults 65 years or older . Families and caregivers of children and adolescents being treated with antidepressants should be informed about the need to monitor these patients for the emergence of agitation, irritability, unusual changes in behaviour and other symptoms, as well as the emergence of suicidality, and it is particularly important that monitoring be undertaken during the initial few months of treatment or at times of dose increase or decrease . A major depressive episode may be the initial presentation of bipolar disorder, and treating such an episode with an antidepressant alone can increase the likelihood of precipitation of a mixed or manic episode in patients at risk of bipolar disorder . Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder and depression . Concomitant administration of moclobemide and buprenorphine-containing products may result in serotonin syndrome, a potentially life-threatening condition . Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms .

Contraindications

Contraindications include known hypersensitivity to the drug, acute confusional states, and serotonin syndrome . Co-administration of moclobemide with clomipramine should be avoided in clinical practice due to the risks of increased incidence of adverse effects . Co-administration of moclobemide with selegiline, bupropion, triptans, pethidine, tramadol, dextromethorphan, and linezolid is contraindicated .

Regulatory history

CLOBEMIX moclobemide was first registered on the Australian Register of Therapeutic Goods on 19 April 2012, with ARTG entries 184084 (150 mg film-coated tablet) and 184085 (300 mg film-coated tablet) .