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ISOTREX Gel

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.
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