Isotrex is used for the topical treatment of acne vulgaris.
Special
precautions
Isotrex is intended for external use only and should be kept away from eyes, nose, mouth, and other mucous membranes because of its irritant effect. Do not apply to eyelids or to the skin at the corners of the eyes and mouth. Avoid the angles of the nose and nasolabial fold.
Topical use may induce severe local erythema and peeling at the site of application. If the degree of local irritation warrants, patients should be directed to use the medication less frequently, discontinue use temporarily or discontinue use altogether. Pregnancy: Topical isotretinoin should be used by women of childbearing years only after contraceptive counseling. It is recommended that topical isotretinoin should not be used by pregnant women. There have been rare reports of birth defects among babies born to women exposed to topical tretinoin during pregnancy. Lactation: It is not known whether isotretinoin is excreted in human milk. Nevertheless, a decision should be made whether to discontinue the drug taking into account the importance of the drug to the mother.
Side
effects
During clinical trials, 4 of 171 patients treated with isotretinoin 0.05% gel discontinued use because of irritation. Most patients experienced some erythema (109 of 171) or peeling (104 of 171). Some patients experienced severe erythema (7 of 171) or peeling (4 of 171). Transient burning, stinging, itching, or scaling was also reported.
