MOCLOBEMIDE-WGR

What it is

Moclobemide-WGR is available as 150 mg and 300 mg film-coated tablets.

Approved indications

— Treatment of major depression.

Dosing overview

Moclobemide-WGR therapy should be initiated in two divided daily doses, with a recommended initial daily dose of 300 or 450 mg and a recommended dose range of 300–600 mg/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-WGR 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, and 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. Concomitant administration of moclobemide-WGR and buprenorphine-containing products may result in serotonin syndrome, a potentially life-threatening condition, and 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, and if serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms. A major depressive episode may be the initial presentation of bipolar disorder, treating such an episode with an antidepressant alone can increase the likelihood of precipitation of a mixed/manic episode in patients at risk of bipolar disorder, and patients should be adequately screened to determine if they are at risk for bipolar disorder prior to initiating treatment. Moclobemide-WGR is usually well tolerated, with no adverse event occurring at an increased frequency of more than 5% compared to placebo, and the following transient effects have been observed: sleep disturbances, dizziness, nausea, dry mouth and headache.

Contraindications

Moclobemide-WGR is contraindicated in acute confusional states and serotonin syndrome. Known hypersensitivity to the drug is a contraindication. Co-administration of moclobemide-WGR with clomipramine should be avoided in clinical practice due to the risks of increased incidence of adverse effects. Co-administration is contraindicated with selegiline (L-deprenyl), bupropion, triptans, pethidine, tramadol, dextromethorphan and linezolid.

Regulatory history

Moclobemide-WGR 150 mg and 300 mg film-coated tablets were first listed on the ARTG on 4 May 2020.