DEPTRAN

What it is

DEPTRAN is doxepin (as hydrochloride), available in capsule strengths of 10 mg and 25 mg, and tablet strengths of 50 mg and 75 mg. DEPTRAN is a dibenzoxepin psychotherapeutic agent. The clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses so that deactivation of noradrenaline by reuptake into the nerve terminals is prevented.

Approved indications

— For the treatment of major depression.

Dosing overview

The optimum oral dose depends on the severity of the condition and the individual patient's response. The dose varies from 30 mg to 300 mg daily, and is usually administered in a three times daily regimen. When the optimum dose has been reached, it may be given as a single daily dose up to a maximum of 150 mg. For patients where the presenting symptoms are mild, it is advisable to initiate treatment at a dose of 30 mg daily; a good clinical response is obtained in many of these patients at a daily dose of 30 to 50 mg. For the majority of patients with moderate or severe symptoms, it is recommended that treatment commences with an initial dose of not more than 75 mg daily in divided doses. Optimal antidepressant effect may not be evident for two to three weeks whereas the antianxiety effect should be evident sooner.

Key safety warnings

Therapeutic doses of tricyclic antidepressants have the potential to cause cardiac arrhythmias, and effects on cardiac conduction are dose related. Caution should be exercised in the use of DEPTRAN in patients with cardiac disease. The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. This risk must be considered in all depressed patients. 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. 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 dose changes, either increases or decreases. The pupillary dilation that occurs following use of many antidepressant drugs including doxepin may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. The concomitant use of doxepin with buprenorphine may result in serotonin syndrome, a potentially life-threatening disorder. If concomitant treatment with buprenorphine is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The 50 mg and 75 mg tablets are indicated only for the maintenance treatment of major depression. The 50 mg and 75 mg tablets should not be used in acutely ill patients where there is a risk of suicide. There is an increased risk of completed suicide by overdose with the 50 mg and 75 mg tablets compared with the 10 mg and 25 mg capsules.

Contraindications

Doxepin must not be used in patients with hypersensitivity to tricyclic antidepressants, doxepin, or any of the inactive ingredients. Doxepin must not be used in patients with glaucoma or tendency to urinary retention, particularly in older patients.

Regulatory history

DEPTRAN 50 mg tablets were first listed on the ARTG on 20 September 1991. DEPTRAN 75 mg tablets were first listed on 19 October 1992. DEPTRAN 25 mg capsules were first listed on 2 July 1997. DEPTRAN 10 mg capsules were first listed on 17 December 2018.