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How ARESTIN works
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ARESTIN (minocycline HCl) Microspheres, 1 mg targets periodontal bacteria to fight infection.1 When incorporated into a routine oral maintenance program along with scaling and root planing (SRP), results were achieved after 1 month, with pocket depth reduction seen at 3 months and maintained at 9 months.1-3*†

The effects of ARESTIN on microorganism overgrowth have not been studied beyond 6 months.

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*Single-blind, randomized, parallel-group study of 127 patients with moderate-to-severe periodontitis who had at least 5 teeth with ≥5 mm pocket depths. Mean RCB numbers at day 30 were reduced from 18.9 x 105 to 9.50 x 105 (50%) by ARESTIN + SRP (p=0.002) and from 19.3 x105 to 14.2 x 105 (26%) by SRP alone (p=0.002).

†In 2 multicenter, investigator-blind, parallel-design studies of 748 patients with generalized moderate to advanced adult periodontitis characterized by a mean probing depth of 5.90 and 5.81 mm, subjects received 1 of 3 treatments: (1) SRP, (2) SRP + vehicle, and (3) SRP + ARESTIN. Retreatment occurred at 3 and 6 months after initial treatment, and any new site with pocket depth ≥5 mm also received treatment. Patients treated with ARESTIN were found to have statistically significantly reduced probing pocket depth compared with those treated with SRP alone or SRP + vehicle at 9 months after initial treatment. ARESTIN vs SRP alone (n=250) p<0.01; ARESTIN vs vehicle + SRP (n=249) p<0.001; ARESTIN + SRP vs vehicle (n=249) p<0.001.

REFERENCES: 1. ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg. Prescribing Information. OraPharma; Bridgewater, NJ. 2. Goodson JM, Gunsolley JC, Grossi SG, et al. Minocycline HCl microspheres reduce red-complex bacteria in periodontal disease therapy. J Periodontol. 2007;78(8):1568-1579. 3. Williams RC, Paquette DW, Offenbacher S, et al. Treatment of periodontitis by local administration of minocycline microspheres: a controlled trial. J Periodontol. 2001;72(11):1535-1544. 

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INDICATION

ARESTIN® (minocycline HCl) Microspheres, 1mg 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 is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines. Hypersensitivity reactions and hypersensitivity syndrome that included, but were not limited to anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis may be present. Swelling of the face, pruritus, fever and lymphadenopathy 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, as well as acute photosensitivity reactions.
  • 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.
  • Tetracyclines, including oral minocycline, have been associated with development of autoimmune syndromes including a lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling. Sporadic cases of serum sickness-like reaction have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy and malaise. In symptomatic patients, diagnostic tests should be performed and ARESTIN treatment discontinued.
  • The use of ARESTIN in an acutely abscessed periodontal pocket or for use in the regeneration of alveolar bone has not been studied.
  • The safety and effectiveness of ARESTIN has not been established in immunocompromised patients or in those with coexistent oral candidiasis. Use with caution if there is a predisposition to oral candidiasis.
  • In clinical trials, the most frequently reported nondental treatment-emergent adverse events were headache, infection, flu syndrome, and pain.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Click here for IMPORTANT SAFETY INFORMATION

  • ARESTIN is contraindicated 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.