APO-VENLAFAXINE XR

What it is

APO-VENLAFAXINE XR is a modified release capsule containing venlafaxine hydrochloride, available in strengths of 75 mg and 150 mg. The capsules are intended for oral administration.

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

Dose increments should be made at intervals of approximately two weeks or more, but not less than four days. APO-VENLAFAXINE XR should be taken with food at approximately the same time each day, and each capsule must be swallowed whole with fluid; do not divide, crush, chew or dissolve. Patients with renal and/or hepatic impairment should receive lower doses; the total daily dose should be reduced by 25% to 50% for patients with renal impairment with a glomerular filtration rate of 10 to 70 mL/min. Patients with mild to moderate hepatic impairment should have their dosage reduced by 50%.

Key safety warnings

Patients with major depression may experience worsening of 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 times of dose changes. APO-VENLAFAXINE XR has been associated with akathisia, characterised by subjectively unpleasant restlessness and need to move, most likely occurring within the first few weeks of treatment. 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 such as MAOIs or linezolid. Dose-related increases in blood pressure have been reported; among patients treated with venlafaxine 75 to 375 mg daily in depression studies, 3% experienced sustained hypertension. Regular monitoring of blood pressure is recommended for patients receiving venlafaxine. Cases of hyponatraemia and syndrome of inappropriate antidiuretic hormone secretion may occur with venlafaxine, usually in volume depleted or dehydrated patients, with elderly patients and those taking diuretics at greater risk. Epidemiological studies show an increased risk of bone fractures in patients receiving serotonin reuptake inhibitors including venlafaxine. Abrupt discontinuation or dose reduction of venlafaxine has been associated with discontinuation symptoms including agitation, anxiety, dizziness, nausea, vomiting and sleep disturbance.

Contraindications

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

PBS listing

The information necessary to complete this section (PBS item numbers, restriction type, and ex-manufacturer price) is not available in the provided source documents.

Regulatory history

APO-VENLAFAXINE XR 75 mg modified release capsule (ARTG 286958) and 150 mg modified release capsule (ARTG 286957) were first listed on the ARTG on 23 June 2017 under licence category RE.