AURORIX

What it is

Moclobemide Sandoz (moclobemide) is available as 150 mg and 300 mg film-coated tablets. The 150 mg tablets are beige, oval, film-coated tablets with a score notch on both sides. The 300 mg tablets are white, oval, film-coated tablets 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; this risk must be considered in all depressed patients. Antidepressants increased the risk compared to placebo of suicidality in children, adolescents, and young adults (aged 18–24 years) during initial treatment (generally the first one to two months) in short-term studies of major depression and other psychiatric disorders. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dosage changes, either increases or decreases. 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. Treatment with moclobemide does not necessitate dietary restrictions in patients with normal dietary habits; however, hypertensive patients are advised to avoid large quantities of tyramine-rich food such as ripe cheese. 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; if serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

Contraindications

Moclobemide is contraindicated in 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 with the following drugs is contraindicated: selegiline (L-deprenyl), bupropion, triptans, pethidine, tramadol, dextromethorphan, and linezolid.

PBS listing

The 300 mg tablet is listed on the PBS with 2 items under a restricted restriction scheme, with an ex-manufacturer price of A$10.31. The 150 mg tablet is listed on the PBS with 2 items under a restricted restriction scheme, with an ex-manufacturer price of A$6.81.

Regulatory history

AURORIX moclobemide 150 mg tablets were first registered on the ARTG on 2 August 1991. AURORIX moclobemide 300 mg tablets were first registered on the ARTG on 15 March 1995.