Refissa | Tretinoin Cream while Breastfeeding

It is recommended to breastfeed exclusively for six months and then while introducing to other food sources extend it to twelve months. In this duration most mothers will need help of some sort of medication, It could be for short term like could and flue or it could be something chronic like Arthritis or Diabetes and here comes the question of safety of medication in use. In this post we will figure out what is Refissa | Tretinoin Cream and whether its safe to use Refissa | Tretinoin Cream while nursing or not.

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Tretinoin Cream, USP (Emollient) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs (see bullet 3 for populations in which effectiveness has not been established). TRETINOIN CREAM, USP (EMOLLIENT) DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. Tretinoin Cream, USP (Emollient) 0.05% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. Tretinoin Cream, USP (Emollient) 0.05% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sunlight avoidance program alone. The effectiveness of Tretinoin Cream, USP (Emollient) 0.05% in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of Tretinoin Cream, USP (Emollient) 0.05%. Thus the effectiveness and safety of Tretinoin Cream, USP (Emollient) 0.05% in these populations are not known at this time. Neither the safety nor the effectiveness of Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established. Neither the safety nor the efficacy of using Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (see WARNINGS section.)

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness on the face with Tretinoin Cream, USP (Emollient) may be postponed in nursing mothers until after completion of the nursing period.