EXTINE

What it is

EXTINE contains paroxetine hydrochloride 20 mg per tablet. The tablet is oval, white, and film-coated, with "X | T" marked on one side.

Approved indications EXTINE is indicated in the treatment of:

— Major depression and for the prevention of relapse of depressive symptoms — Obsessive Compulsive Disorder and for the prevention of relapse of OCD — Panic Disorder and for the prevention of relapse of Panic Disorder — Social Anxiety Disorder/Social Phobia — Generalised Anxiety Disorder — Posttraumatic Stress Disorder

Dosing overview

EXTINE should be administered once daily in the morning with food. Dosing varies by indication:

In elderly patients, increased plasma concentrations may occur; dosing should commence at the adult starting dose and may be increased up to 40 mg daily, not exceeding 40 mg daily. In patients with severe renal or hepatic impairment, dosage should be restricted to the lower end of the range. EXTINE is not indicated for children or adolescents under 18 years of age.

Key safety warnings

Young adults aged 18–24 years with Major Depressive Disorder may be at increased risk for suicidal behaviour during treatment, especially during the first one to two months. Patients and caregivers should monitor for worsening of condition, development of new symptoms, and emergence of suicidal ideation or thoughts of self-harm, and seek medical advice immediately if these occur. Rarely, EXTINE may cause akathisia, characterised by an inner sense of restlessness and psychomotor agitation such as inability to sit or stand still, most likely within the first few weeks of treatment. On rare occasions, serotonin syndrome or neuroleptic malignant syndrome-like events may occur, particularly when given with other serotonergic or neuroleptic drugs; treatment should be discontinued if such events occur and supportive symptomatic treatment initiated. Bleeding abnormalities of the skin and mucous membranes have been reported with EXTINE; this risk may be increased by concurrent use of NSAIDs, aspirin, or other medicines affecting coagulation. Discontinuation symptoms including dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, tremor, confusion, sweating, headache and diarrhoea may occur when treatment is discontinued; these symptoms are generally mild to moderate and self-limiting, usually resolving within two weeks, though in some cases they may be prolonged.

Contraindications

EXTINE is contraindicated in patients with known hypersensitivity to paroxetine or any component of the tablets. It should not be used with monoamine oxidase inhibitors (including linezolid and methylthioninium chloride) or within two weeks of terminating MAOI treatment. EXTINE should not be used in combination with thioridazine or pimozide.

Regulatory history

EXTINE (paroxetine hydrochloride 20 mg) was first listed on the ARTG on 26 July 2006.