Isotrex is indicated for the topical treatment of mild to moderate acne vulgaris, characterised by papules and pustules.

Dosage and Administration

Isotrex is for topical application only.

The skin should be washed and dried before application of the gel. Isotrex should be applied sparingly once or twice daily, in the morning or before retiring, using enough medication to cover the entire affected area.

Patients should be advised that 6-8 weeks of treatment may be required before a therapeutic effect is observed.

Paediatric Use

The safety and efficacy of Isotrex has not been established in children since acne vulgaris rarely presents in this age group.

Elderly Patients

There are no specific recommendations. Acne vulgaris does not present in the elderly.

Side Effects

In normal use, Isotrex may cause stinging, burning or irritation. Local erythema and peeling at the site of application may occur.

If undue irritation occurs, treatment should be interrupted temporarily and resumed once the reaction subsides. If irritation persists, treatment should be discontinued. Reactions will normally resolve on discontinuation of therapy.

Drug Interactions

Concomitant topical medication should be used with caution during therapy with Isotrex . Particular caution should be exercised when using preparations containing a peeling agent (for example, sulphur, resorcinol, benzoyl peroxide) or abrasive cleaners.

It may be advisable to rests a patient's skin until the effects of previously used peeling agents subside before initiating Isotrex therapy.

Overdosage

Acute overdosage of Isotrex has not been reported to date. Accidental ingestion of Isotrex resulting in overdosage of isotretinoin could be expected to induce symptoms of hypervitaminosis A. These include severe headaches, nausea or vomiting, drowsiness, irritability and pruritus.

Storage

Isotrex should be stored at temperatures not exceeding 25 C (77 F).