ENLAFAX-XR

What it is

ENLAFAX-XR contains venlafaxine hydrochloride , which is a modified release formulation that releases the active constituent venlafaxine hydrochloride from tablets within the capsule . The medicine is available in 75 mg and 150 mg strengths .

Approved indications

— Major depression, including prevention of relapse and recurrence where appropriate. — Generalised anxiety disorder. — Social anxiety disorder. — Panic disorder, including prevention of relapse.

Dosing overview

ENLAFAX-XR should be taken with food, at approximately the same time each day . Each capsule must be swallowed whole with fluid and should not be divided, crushed, chewed or dissolved .

Key safety warnings

Patients with major depression may experience worsening of depression and emergence of suicidal ideation, and antidepressants may have a role in inducing such worsening during early phases of treatment; patients should be monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes . Pooled analyses showed that antidepressants increase the risk of suicidality in children, adolescents and young adults (ages 18 to 24 years) with major depression and other psychiatric disorders . Serious reactions, such as potentially life-threatening serotonin syndrome characterised by neuromuscular excitation, altered mental status and autonomic dysfunction, have been reported in patients receiving an SNRI in combination with monoamine oxidase inhibitors and reversible MAOIs, and in patients who have recently discontinued an SNRI and started a MAOI . 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 in pre-marketing depression studies, 3% experienced sustained hypertension . Patients receiving venlafaxine should have regular monitoring of blood pressure . Venlafaxine has been associated with akathisia, characterised by subjectively unpleasant restlessness and need to move, most likely to occur within the first few weeks of treatment . Discontinuation effects are well known with antidepressants and sometimes can be protracted and severe; abrupt discontinuation or dose reduction of venlafaxine has been associated with agitation, anorexia, anxiety, confusion, dry mouth, fatigue, paraesthesia, vertigo, hypomania, nausea, vomiting, dizziness, convulsion, headache, diarrhoea, sleep disturbance, insomnia, somnolence, sweating and nervousness . When venlafaxine at a dose of 75 mg per day or greater has been administered for more than one week, it is recommended that the dose be tapered gradually to minimise the risk of discontinuation symptoms . SNRIs may cause symptoms of sexual dysfunction, and there have been reports of long-lasting sexual dysfunction where symptoms have continued despite discontinuation of SNRIs .

Contraindications

Hypersensitivity to venlafaxine or any excipients in the formulation . ENLAFAX-XR should not be used in combination with monoamine oxidase inhibitors or reversible MAOIs (such as moclobemide, linezolid and intravenous methylene blue), or within 14 days of discontinuing treatment with a MAOI; similarly, at least 7 days should be allowed after stopping ENLAFAX-XR before starting a MAOI .

Regulatory history

ENLAFAX-XR 75 mg and 150 mg modified release capsules were first registered on the Australian Register of Therapeutic Goods on 30 April 2009 .