AROPAX

What it is

AROPAX contains paroxetine hydrochloride. The 20 mg tablet formulation is an oval, white film-coated tablet.

Approved indications AROPAX 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

AROPAX should be administered once daily in the morning with food. Dosage should be reviewed and adjusted within two or three weeks of initiation and dose changes should occur at intervals of at least one week. In elderly patients, dosing should commence at the adult starting dose and may be increased up to 40 mg daily, but dosing should not exceed 40 mg daily. In patients with severe renal impairment or significant hepatic impairment, dosage should be restricted to the lower end of the dosage range.

Key safety warnings

Young adults aged 18–24 years with Major Depressive Disorder may be at increased risk for suicidal behaviour during treatment with paroxetine, especially during initial treatment (generally the first one to two months). Patients and caregivers should be alerted about the need to monitor for any worsening of condition and the emergence of suicidal ideation or behaviour, and seek medical advice immediately if these symptoms present. Rarely, paroxetine has been associated with akathisia, characterised by an inner sense of restlessness and psychomotor agitation, most likely to occur 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. These potentially life-threatening syndromes are characterised by hyperthermia, rigidity, myoclonus, autonomic instability, and mental status changes. Treatment should be discontinued if such events occur. Bleeding abnormalities of the skin and mucous membranes have been reported with SSRIs. This risk may be potentiated by concurrent use of non-steroidal anti-inflammatory drugs, aspirin or other medicines that affect coagulation. AROPAX should be used with caution in patients concomitantly treated with medicines that increase the risk of bleeding or in patients with a past history of abnormal bleeding. Discontinuation symptoms have been reported when AROPAX has been discontinued, particularly when treatment has been stopped abruptly. The dose should be gradually tapered when discontinuing treatment.

Contraindications

AROPAX is contraindicated in persons known to be hypersensitive to paroxetine or any of its components. AROPAX should not be used in combination with monoamine oxidase inhibitors (including linezolid and methylthioninium chloride) or within two weeks of terminating treatment with MAOIs. Likewise, MAOIs should not be introduced within two weeks of cessation of therapy with AROPAX. AROPAX should not be used in combination with thioridazine or pimozide.

PBS listing

The 20 mg tablet is listed on the PBS with 2 items. The listing is restricted. The ex-manufacturer price is A$5.90.

Regulatory history

AROPAX paroxetine 20 mg tablet was first listed on the ARTG on 15 January 1997.