Elaxine SR

What it is

ELAXINE SR is a modified release capsule formulation containing venlafaxine as the hydrochloride salt, available in strengths of 37.5 mg, 75 mg, 150 mg or 225 mg. ELAXINE SR capsules release venlafaxine from mini-tablets within the capsule via diffusion through a coating that is not pH dependent.

Approved indications ELAXINE SR is indicated for the treatment of:

— Major Depression, including prevention of relapse and recurrence where appropriate — Generalised Anxiety Disorder — Social Anxiety Disorder — Panic Disorder, including prevention of relapse

Dosing overview

For major depression, generalised anxiety disorder and social anxiety disorder, the usual recommended dose is 75 mg per day given once daily. After two weeks, the dose may be increased to 150 mg per day if further clinical improvement is required, and if needed, this can be increased up to 225 mg given once daily. For panic disorder, the recommended dose is 75 mg once daily, with treatment started at 37.5 mg per day for the first 4 to 7 days, after which the dose is increased to 75 mg once daily. ELAXINE SR should be taken with food at approximately the same time each day, and each capsule must be swallowed whole with fluid.

Key safety warnings

Patients with major depression may experience worsening of their depression and emergence of suicidal ideation and behaviour. Antidepressants may have a role in inducing worsening of depression and emergence of suicidality in certain patients during early phases of treatment. As improvement may not occur during the first few weeks or more of treatment, patients should be monitored appropriately and observed closely for clinical worsening and suicidality, especially at the beginning of treatment or at the time of dose changes. Dose-related increases in blood pressure have been reported in some patients treated with venlafaxine. Among patients treated with 75 to 375 mg per day of modified release venlafaxine in depression studies, 3% experienced sustained hypertension, whilst among patients treated with 37.5 to 225 mg per day in GAD studies, 0.5% experienced sustained hypertension. It is recommended that patients receiving venlafaxine have regular monitoring of blood pressure. Serotonin syndrome, a potentially life threatening condition, may occur with venlafaxine treatment, particularly with concomitant use of other serotonergic drugs including SSRIs, SNRIs, amphetamines, triptans, opioids, and drugs that impair metabolism of serotonin including MAOIs and reversible MAOIs. ELAXINE SR should not be used in combination with monoamine oxidase inhibitors (MAOIs) or reversible MAOIs, or within 14 days of discontinuing treatment with a MAOI. At least 7 days should be allowed after stopping ELAXINE SR before starting a MAOI. Cases of serious reactions, such as potentially life-threatening serotonin syndrome, have been reported in patients receiving an SNRI in combination with MAOIs and RIMA, and in patients who have recently discontinued an SNRI and have been started on a MAOI. Cases of hyponatraemia and/or the Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) may occur with venlafaxine, usually in volume-depleted or dehydrated patients. Elderly patients, patients taking diuretics and patients who are otherwise volume depleted, may be at greater risk for this event. Seizures have been reported with venlafaxine therapy and in overdose. ELAXINE SR should be introduced with care in patients with a history of seizure disorders.

Contraindications

ELAXINE SR is contraindicated in patients with hypersensitivity to venlafaxine or any excipients in the formulation. ELAXINE SR should not be used in combination with monoamine oxidase inhibitors (MAOIs) or reversible MAOIs (e.g. moclobemide, linezolid and intravenous methylene blue), or within 14 days of discontinuing treatment with a MAOI.

Regulatory history

ELAXINE SR 37.5 mg, 75 mg and 150 mg were first listed on the ARTG on 17 May 2017, and ELAXINE SR 225 mg was first listed on 9 August 2018.