Venlafaxine XR-WGR

What it is

Venlafaxine XR-WGR contains venlafaxine hydrochloride. Each modified release capsule contains venlafaxine 75 mg or 150 mg. The 75 mg capsules are peach opaque hard capsules, and the 150 mg capsules are dark orange hard capsules.

Approved indications

— 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 once daily, which may be increased to 150 mg per day after two weeks if further clinical improvement is required, and if needed can be increased up to 225 mg once daily. For panic disorder, the recommended dose is 75 mg once daily, and treatment should be started with 37.5 mg per day for the first 4 to 7 days before increasing to 75 mg once daily. Patients with panic disorder not responding to 75 mg per day may benefit from dose increases to a maximum of 225 mg per day, with increases made in increments of 75 mg at intervals of approximately 2 weeks or more, but not less than 4 days.

Key safety warnings

Patients with major depression may experience worsening of their depression and emergence of suicidal ideation and behaviour, and 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. Pooled analyses showed that antidepressants increase the risk of suicidality in children, adolescents and young adults aged 18 to 24 years, but short-term studies did not show an increase in risk in adults beyond the age of 24 years, with a reduction in risk in adults aged 65 years and older. Serotonin syndrome, a potentially life threatening condition, may occur with venlafaxine treatment, particularly with concomitant use of other serotonergic drugs, MAOIs or reversible MAOIs such as moclobemide, and with antipsychotics or dopamine antagonists. Dose-related increases in blood pressure have been reported in some patients, with 3% of patients treated with venlafaxine 75 to 375 mg per day experiencing sustained hypertension. It is recommended that patients receiving venlafaxine have regular monitoring of blood pressure. Cases of QTc prolongation, torsade de pointes, ventricular tachycardia and sudden death have been reported during post-marketing use, with the majority of reports occurring in association with overdose or in patients with other risk factors for QTc prolongation. Abrupt discontinuation, dose reduction or tapering has been associated with the appearance of new symptoms including agitation, anxiety, confusion, nausea, vomiting, dizziness and headache.

Contraindications

Venlafaxine XR-WGR is contraindicated in patients with hypersensitivity to venlafaxine or any excipients in the formulation. Venlafaxine XR-WGR 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, and at least 7 days should be allowed after stopping Venlafaxine XR-WGR before starting a MAOI.

PBS listing

Information regarding PBS listing status, strength range, item count, restriction type and ex-manufacturer price is not contained in the provided source documents.

Regulatory history

Venlafaxine XR-WGR 75 mg and 150 mg modified release capsules were first listed on the ARTG on 17 May 2017, with the 225 mg strength added on 9 August 2018.