Hypersensitivity Reactions Hypersensitivity reactions that included, but were not limited to anaphylaxis, angioneurotic edema, urticaria, rash, swelling of the face and pruritus have been reported with the use of ARESTIN® . Some of these reactions were serious. Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens- Johnson syndrome and erythema multiforme have been reported with oral minocycline. Autoimmune Syndromes Tetracyclines, Including oral minocycline, have been associated with the development of autoimmune syndromes including a Lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling. Sporadic cases of serum sickness have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. No further treatment with ARESTIN® should be administered to the patient. The use of ARESTIN® in an acutely abscessed periodontal pocket has not been studied and is not recommended. While no overgrowth by opportunistic microorganisms, such as yeast, were noted during clinical studies, as with other antimicrobials, the use of ARESTIN® may result in overgrowth of nonsusceptible microorganisms including fungi. The effects of treatment for greater than 6 months has not been studied. ARESTIN® should be used with caution in patients having a history of predisposition to oral candidiasis. The safety and effectiveness of ARESTIN® has not been established for the treatment of periodontitis in patients with coexistent oral candidiasis. ARESTIN® has not been clinically tested in immunocompromised patients (such as those immunocompromised by diabetes, chemotherapy, radiation therapy, or infection with HIV). If superinfection is suspected, appropriate measures should be taken, ARESTIN® has not been clinically tested in pregnant women. ARESTIN® has not been clinically tested for use in the regeneration of alveolar bone, either in preparation for or in conjunction with the placement of endosseous (dental) implants or in the treatment of failing implants. Carcinogenicity, Mutagenicity, Impairment of Fertility Dietary administration of minocycline In long-term tumorlgenldty studies In rate resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia In rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Minocycline demonstrated no potential to cause genetic toxicity in a battery of assays which included a bacterial reverse mutation assay (Ames test), an in vitro mammalian cell gene mutation test (L5178Y/TK+- mouse lymphoma assay), an in vitro mammalian chromosome aberration test, and an in vivo micronucleus assay conducted in ICR mice. Fertility and general reproduction studies have provided evidence that minocycline impairs fertility in male rats. Teratogenic Effects Pregnancy Category D. (See WARNINGS.) Labor and Delivery The effects of tetracyclines on labor and delivery are unknown. Nursing Mothers Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions In nursing Infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the Importance of the drug to the mother. (See WARNINGS.) Pediatric Use Since adult periodontitis does not affect children, the safety and effectiveness of ARESTIN® in pediatric patients cannot be established. Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.