ALLEGRON

What it is

ALLEGRON contains nortriptyline hydrochloride 10 mg or 25 mg as the active ingredient in tablet form. The 10 mg tablets are white to off white, round, biconvex, uncoated tablets debossed 'NM' on one side and '10' on the other side, whilst the 25 mg tablets are white to off white, round, biconvex, uncoated tablets debossed 'NM' on one side and '25' on the other side.

Approved indications

— Major depression.

Dosing overview

The usual adult dose is 25 mg 3 or 4 times daily; dosage should begin at a low level and be increased as required. Doses above 100 mg per day are not recommended. For elderly patients, the dose is 25 to 50 mg per day, in divided doses. Lower than usual dosages are recommended for elderly patients and adolescents. ALLEGRON is not recommended for children.

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 emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. 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 treatment or at the time of dose changes. Patients with cardiovascular disease should be given nortriptyline only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia and strokes have occurred. Nortriptyline is contraindicated during the acute recovery period after myocardial infarction. Because of its anticholinergic activity, nortriptyline should be used with great caution in patients with glaucoma or a history of urinary retention. Patients with a history of seizures should be followed closely when ALLEGRON is administered, since this drug is known to lower the convulsive threshold. Nortriptyline may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly. Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicide attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation. The patient should be informed that the response to alcohol may be exaggerated.

Contraindications

The use of nortriptyline or other tricyclic antidepressants concurrently with a monoamine oxidase (MAO) inhibitor is contraindicated. Hyperpyretic crises, severe convulsions and fatalities have occurred when similar tricyclic antidepressants were used in such combinations. It is advisable to have discontinued the MAO inhibitor for at least two weeks before treatment with nortriptyline is started. Patients hypersensitive to nortriptyline should not be given the drug.

PBS listing

ALLEGRON 25 mg tablet is listed on the PBS with a restriction status of restricted and an ex-manufacturer price of A$4.46. The 10 mg tablet is also listed with a restriction status of restricted and an ex-manufacturer price of A$3.55.

Regulatory history

ALLEGRON 10 mg tablet was first listed on the ARTG on 5 September 1991, and the 25 mg tablet was first listed on 17 October 1995. The current product information for NortriTABS was revised on 11 May 2020.