NARDIL

What it is

NARDIL is phenelzine sulfate, supplied as orange film coated tablets containing 15 mg phenelzine base per tablet. Phenelzine sulfate is a potent inhibitor of monoamine oxidase (MAO). Phenelzine sulfate is a hydrazine derivative.

Approved indications

— Treatment of major depression.

Dosing overview

The usual starting dose of phenelzine sulfate is one tablet (15 mg) three times a day. Dosage should be increased to at least 60 mg per day at a fairly rapid pace consistent with patient tolerance. It may be necessary to increase dosage up to 90 mg per day to obtain sufficient MAO inhibition. Many patients do not show a clinical response until treatment at 60 mg has been continued for at least 4 weeks. After maximum benefit from phenelzine sulfate is achieved, dosage should be reduced slowly over several weeks. Maintenance dose may be as low as one (1) tablet, 15 mg, a day or every other day, and should be continued for as long as required.

Key safety warnings

The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and behaviour whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. The risk is increased in young adults aged 18–24 years, and during the initial treatment period (usually one to two months), patients should be closely monitored for clinical worsening of suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. All patients undergoing treatment with phenelzine sulfate should be closely followed for symptoms of postural hypotension. Hypotensive side effects have occurred in hypertensive as well as normotensive and hypotensive patients. The most serious reactions to phenelzine sulfate involve changes in blood pressure. The most important reaction associated with phenelzine sulfate administration is the occurrence of hypertensive crises, which have sometimes been fatal. These crises are characterised by some or all of the following symptoms: occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea, vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), dilated pupils, and photophobia. All patients should be warned that certain foods, beverages, and medications must be avoided while taking phenelzine sulfate, and for two weeks after discontinuing use. Patients should be warned that the use of these foods, beverages, or medications may cause a reaction characterised by headache and other serious symptoms due to a rise in blood pressure. Development of serotonin syndrome may occur in association with treatment with MAOIs particularly when given in combination with SSRIs and SNRIs, or other serotonergic agents. Symptoms and signs of serotonin syndrome include rapid onset of neuromuscular excitation (hyperreflexia, incoordination, myoclonus, tremor), altered mental status (confusion, agitation, hypomania) and autonomic dysfunction (diaphoresis, diarrhoea, fever, shivering and rapidly fluctuating vital signs).

Contraindications

Phenelzine sulfate should not be used in patients who are hypersensitive to phenelzine sulfate or any of the ingredients listed in the description, with phaeochromocytoma, cerebrovascular disease, congestive heart failure, a history of liver disease, or with abnormal liver function tests. MAO inhibitors including phenelzine sulfate are contraindicated in patients receiving guanethidine. Phenelzine sulfate should not be used in combination with sympathomimetic drugs (including amphetamines, cocaine, methylphenidate hydrochloride, dopamine, adrenaline, noradrenaline and ephedrine) or related compounds (including methyldopa, levodopa, tryptophan, L-tyrosine and phenylalanine), other MAOI, 5HT₁ agonists, dibenzazepine derivative drugs or other antidepressants including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs) or pizotifen. Phenelzine sulfate should not be used in combination with dextromethorphan or with CNS depressants such as alcohol and certain narcotics (including pethidine and propoxyphene).

PBS listing

NARDIL 15 mg tablets are listed on the PBS as one item with restricted access at an ex-manufacturer price of A$188.15.

Regulatory history

NARDIL was first approved on 25 March 2003. The current ARTG registration (462329) for NARDIL phenelzine 15 mg tablet was first listed on 6 November 2024.