Moclobemide

Registered South African indications:

• Major depression
• Social phobia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Acute confusional state
• Phaeochromocytoma
• Children
• Coadministration with selegiline, linezolid, triptans, pethidine, tramadol, bupropion, dextromethorphan, 5-HT re-uptake inhibitors or other antidepressants (including tricyclic antidepressants)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Psychosis
• Thyrotoxicosis
• History of suicide-related events
• Significant degree of suicidal ideation 
• Bipolar disorders
• Hypertension
• Congenital long QT syndrome
• History of cardiac disorders
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption

Forms avail. in SA and covered in this monograph: tab

Major depression

• Oral (tab): Initial: 300mg/day, in 2-3 divided doses; THEN after 1 week either increase dose to 600mg, dly OR decrease dose to 150mg, dly according to patient response

To be taken after meals

Treatment should be continued for at least 4-6 weeks to determine efficacy. Should be continued for a symptom free period of 4-6 months

Taper dose to discontinue

Social phobia

• Oral (tab): Day 1-3: 300mg/day, in 2 divided doses; Day 4 onwards: 600mg/day, in 2 divided doses

Treatment with 600mg daily should be continued for 6 - 8 weeks in order to assess efficacy. Treatment should be withdrawn in patients not responding after 8 weeks of treatment

To be taken after meals

Taper dose to discontinue

Not established for use in children below 18 years

Pregnancy

• FDA Pregnancy Category Not Rated (NR) 

Breastfeeding

• Caution

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; dose adjustment recommended

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Sleep disorders
• Agitation
• Anxiety
• Restlessness
• Suicidal ideation
• Confusion
• Suicidal behaviours
• Delusions
• Dizziness
• Headache
• Paraesthesia
• Irritability
• Asthenia

Cardiovascular Disorders

• QT prolongation
• Torsade de pointes
• Hypotension
• Flushing

Gastrointestinal Disorders

• Dysgeusia
• Nausea and vomiting
• Dry mouth
• Diarrhoea
• Constipation

Endocrine and Metabolic Disorders

• Decreased appetite
• Hyponatraemia
• Galactorrhoea

Skin and Subcutaneous Tissue Disorders

• Rash
• Oedema
• Pruritus
• Urticaria

Sensory Disorders

• Impaired vision

• Antidepressants
• Opiates
• Sympathomimetics
• QT prolonging agents
• CYP2C19 substrates
• Selegiline
• Linezolid
• Triptans
• Tramadol
• Bupropion
• Dextromethorphan
• Cimetidine
• St. John's wort
• Dextropropoxyphen
• Buspirone

• Hepatic function
• Blood pressure

Moclobemide is an antidepressant that acts on the monoaminergic cerebral neurotransmitter system by reversibly inhibiting monoamine oxidase, primarily type A (RIMA). The metabolism of noradrenaline, dopamine and serotonin is thereby reduced, resulting in increased extracellular concentrations of these neurotransmitters, which relieves the symptoms of depression.

Tablet 150mg

• Depnil (Cipla Life Sciences)

Tablet 300mg

• Depnil (Sandoz)