Why ARESTIN?

ARESTIN (minocycline HCl) Microspheres, 1 mg is a concentrated, locally applied antibiotic that remains active in the pocket for an extended period of time to reduce pocket depth.1 The microspheres release antibiotic over time, targeting bacteria to reduce pocket depth, so gums can heal better than with scaling and root planing (SRP) alone.2


When incorporated into a routine oral maintenance program along with SRP, ARESTIN:

  • Targeted periodontal bacteria to fight infection at 1 month.3*
  • Provided significantly greater pocket depth reduction for up to 3 months vs SRP alone.1†
  • Resulted in reduced pocket depth after 1 month and maintained at 9 months.2†

See additional study data


Without an antibiotic such as ARESTIN, baseline levels of bacteria may return in just a few days, even after SRP.4

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


Fight infection by going deep

In a clinical study, ARESTIN + SRP reduced harmful bacteria by nearly 2x as much as SRP alone.3,5,6* Adding ARESTIN to SRP disrupts the pathogenic progression of periodontitis by specifically targeting the active infection.2


ARESTIN + SRP reduced pocket depth more effectively 
than SRP alone, even in the most susceptible patients2

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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 x 105 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.

‡Subpopulation (n=101) of combined, single-blind, Phase III trial 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. At 9 months, ARESTIN + SRP had a 58% greater therapeutic effect vs. SRP alone in periodontal patients with cardiovascular disease (P≤0.001). 

§Subpopulation (n=271) of combined, 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. At 9 months, ARESTIN + SRP had a 29% greater therapeutic effect vs. SRP alone in smokers (P≤0.001). 

||Subpopulation (n=109) of combined, single-blind, Phase III trial 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. At 9 months, ARESTIN + SRP had a 33% greater therapeutic effect vs. SRP alone in patients over the age of 50 (P≤0.001). 

REFERENCES: 1. 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. 2. ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg. Prescribing Information. OraPharma; Horsham PA: 2015. 3. 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. 4. Socransky SS, Haffajee AD. Dental biofilms: difficult therapeutic targets. Periodontol 2000. 2002;28:12-55. 5. Doherty F, Lessem J, Hanlon A, Rose T. Efficacy of Arestin in perio maintenance patients. J Clin Periodontol. 2003;30(suppl 4):19-100. 6. Grossi SG, Goodson JM, Gunsolley JC, et al. Mechanical therapy with adjunctive minocycline microspheres reduces red-complex bacteria in smokers. J Periodontol. 2007;78(9):1741-1750.

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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 Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information.

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