AMIRA

What it is

AMIRA contains moclobemide and is available in 150 mg and 300 mg film-coated tablets.

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 medicine. AMIRA 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 (generally the first one to two months) in short-term studies of major depression and other psychiatric disorders. As improvement may not occur during the first few weeks or more of treatment, 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. 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. A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed that 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. 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.

Contraindications

AMIRA 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 of moclobemide is contraindicated with selegiline (L-deprenyl), bupropion, triptans, pethidine, tramadol, dextromethorphan, and linezolid.

PBS listing

No source document provides information about PBS listing status, strength details, item numbers, restriction type, or ex-manufacturer price for AMIRA.

Regulatory history

AMIRA 150 mg and AMIRA 300 mg film-coated tablets were first listed on the ARTG on 29 September 2017.