ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg is indicated as an adjunct to scaling and root planing (SRP) procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN® may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.
IMPORTANT SAFETY INFORMATION
ARESTIN® should not be used in any patient who has a known sensitivity to minocycline or tetracyclines. The use of drugs of the tetracycline class during tooth development may cause permanent discoloration of the teeth, and therefore should not be used in children or in pregnant or nursing women. 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®. In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome and pain.
*Two single-blind, Phase III trials comparing ARESTIN® + SRP to SRP alone and SRP + placebo (n=748). SRP was performed for all groups at baseline. ARESTIN® or vehicle was administered to periodontal pockets ≥5 mm in the adjunctive therapy groups at baseline, 3 months, and 6 months. Efficacy was evaluated over 9 months.
REFERENCES: 1. ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg. Prescribing Information. Horsham, PA: OraPharma, Inc.; 2011. 2. Eke PI, Dye B. Assessment of self-report measures for predicting population prevalence of periodontitis. J Periodontol. 2009;80(9):1371-1379.