FLUOTEX

What it is

FLUOTEX contains fluoxetine hydrochloride 20 mg per capsule. It is an antidepressant for oral administration; capsules should be swallowed whole.

Approved indications FLUOTEX is indicated for treatment of:

— Major depression — Obsessive Compulsive Disorder (OCD) — Premenstrual Dysphoric Disorder (PMDD) as defined by DSM-IV criteria

Dosing overview

This medicine is only available as a 20 mg capsule and therefore only appropriate for use in patients prescribed ≥ 20 mg fluoxetine. For patients requiring treatment with lower doses of fluoxetine, fluoxetine dispersible tablets are available in other brands. The full antidepressant effect may be delayed until 4 weeks of treatment or longer. A lower or less frequent dosage should be used in patients with hepatic impairment and should also be considered for patients, such as the elderly, with concurrent disease or on multiple medications.

Key safety warnings

The risk of suicide attempt is inherent in depression and other psychiatric disorders and may persist until significant remission occurs. As with other antidepressants, isolated cases of suicidal ideation and suicidal behaviours have been reported during fluoxetine therapy or early after treatment discontinuation. This risk must be considered in all depressed patients. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes, either increases or decreases. Development of serotonin syndrome may occur in association with treatment with SSRIs and SNRIs, particularly when given in combination with MAOIs or other serotonergic agents. Symptoms and signs of serotonin syndrome include rapid onset of neuromuscular excitation (hyperreflexia, incoordination, myoclonus, tremor), altered mental status (confusion, agitation, hypomania) and autonomic dysfunction (diaphoresis, diarrhoea, fever, shivering and rapidly fluctuating vital signs). QT prolongation can occur with fluoxetine treatment. Fluoxetine should be used with caution in patients with conditions such as congenital long QT syndrome; acquired long QT syndrome (e.g. due to concomitant use of a drug that prolongs the QT); a family history of QT prolongation; or other clinical conditions that predispose to arrhythmias (e.g. hypokalemia or hypomagnesemia) or increased exposure to fluoxetine (e.g., hepatic impairment). During premarketing testing of more than 5,600 U.S. patients given fluoxetine, approximately 4% developed a rash and/or urticaria. Among these cases, almost a third were withdrawn from treatment because of the rash and/or systemic signs or symptoms associated with the rash. In patients with diabetes, fluoxetine may alter glycaemic control. Hypoglycaemia has occurred during therapy with fluoxetine and hyperglycaemia has developed following discontinuation of the drug. Insulin and/or oral hypoglycaemic dosage may need to be adjusted when therapy with fluoxetine is instituted or discontinued.

Contraindications

FLUOTEX is contraindicated in patients known to be hypersensitive to fluoxetine or any of the other ingredients in the formulation. Fluoxetine should not be used in combination with a MAOI (selective, reversible or irreversible), or within a minimum of 14 days of discontinuing therapy with a MAOI. Concomitant use in patients taking pimozide is contraindicated. Fluoxetine is contraindicated in combination with metoprolol used in cardiac failure.

PBS listing

FLUOTEX 20 mg capsule is listed on the PBS with 2 items under restricted access. The ex-manufacturer price is A$3.50.

Regulatory history

FLUOTEX 20 mg capsules (sponsored by Arrotex Pharmaceuticals) were registered on the ARTG on 23 February 2017 under licence category RE.