COMPOSITION Isotrex Gel contains isotretinoin 0,05 g per 100 g, and butylated hydroxytoluene as antioxidant.
PHARMACOLOGICAL CLASSIFICATION A 13.12 Acne preparations
PHARMACOLOGICAL ACTION Isotretinoin is structurally and pharmacologically related to Vitamin A which regulates epithelial cell growth and differentiation.
The pharmacological action of isotretinoin remains to be fully elucidated. When used systemically it suppresses sebaceous gland activity and reduces sebum production; it also affects comedogenesis, suppresses Propionibacterium acnes and reduces inflammation.
When applied topically the mode of action of isotretinoin is probably comparable with its stereoisomer, tretinoin. Tretinoin stimulates mitosis in the epidermis and reduces intercellular cohesion in the stratum corneum; it contests the hyperkeratosis characteristic of acne vulgaris and aids desquamation, preventing the formation of lesions. Tretinoin also mediates and increased production of less cohesive epidermal sebaceous cells, this appears to promote the initial expulsion and subsequent prevention of comedones.
INDICATIONS Isotrex Gel is indicated in the treatment of mild to moderate inflammatory and non-inflammatory acne vulgaris.
CONTRA INDICATIONS Isotrex Gel should not be used in patients with known hypersensitivity to any of the ingredients. Isotrex Gel should not be used in patients with a personal or family history of cutaneous epithelioma.
WARNINGS Pregnancy and lactation
Oral tretinoin has been shown to be teratogenic in a wide variety of animals.
Limited animal data urge caution in the use of preparations containing tretinoin during the first trimester of pregnancy.
In the case of an eventual pregnancy, the patient should inform her doctor. Therefore, it may be concluded that cutaneous administration of tretinoin to pregnant women should not pose a significant hazard, although, as with all medicines, its use should be avoided during pregnancy unless the benefits outweighs any potential risk to the foetus. It is not known whether tretinoin is excreted in animal or human milk. Because many medicines are excreted in human milk, caution should be exercised when applying topical tretinoins to nursing women. In this event the product should not be used on the chest.
DOSAGE AND DIRECTIONS FOR USE Apply Istorex Gel sparingly over the whole affected area once or twice daily. Patients should be advised that 6-8 weeks of treatment may be required before a therapeutic effect is observed.
SIDE EFFECTS AND SPECIAL PRECAUTIONS In normal use, Isotrex Gel may cause stinging, burning or irritation, 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.
Contact with the mouth, eyes and mucous membranes and with abraded or eczematous skin should be avoided; the product should not be applied to the angles of the nose. Application to sensitive areas of skin, such as the neck, should be made with caution.
Exposure to sunlight of areas treated with Isotrex Gel should be avoided or minimised. When exposure to strong sunlight cannot be avoided a sunscreen product and protective clothing should be used. Patients with sunburn should not use Isotrex Gel due to the possibility of increased sensitivity to sunlight. The use of sunlamps should be avoided during treatment. Concomitant topical medication may cause a cumulative irritant effect during therapy with Isotrex Gel. Other topical preparations should be used with caution during treatment. Particular caution should be exercised when using preparations containing a peeling agent (for example benzoyl peroxide) or abrasive cleansers.
KNOWN SYMPTOMS OF OVERDOSE AND PRECAUTIONS OF ITS TREATMENT Acute overdosage of Isotrex Gel has not been reported to date. Accidental ingestion of Isotrex Gel 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.
IDENTIFICATION Isotrex Gel is a soft greenish yellow clear gel with an odour of ethanol.
PRESENTATION Aluminium tube of 30 g, fitted with a screw cap. The tube is presented in a carton with a package leaflet.
STORAGE INSTRUCTIONS Store below 25°C
Keep out of reach of children
REGISTRATION NUMBER 29/13.12/0027
NAME AND BUSINESS ADDRESS OF THE APPLICANT Stiefel Laboratories (SA) (Pty) Ltd
1 Rembrandt Plaza
cnr. Lister/Heine Roads