An Antibiotic to Go Beyond the Limitations of Routine Teeth Cleaning

FULL PRESCRIBING INFORMATION

TO ORDER, PLEASE CONTACT CUSTOMER SERVICE AT 1-866-ARESTIN.

Our flagship product, ARESTIN (minocycline HCl) 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. Clinical studies show that ARESTIN plus SRP achieves greater pocket depth reduction than SRP alone.1

Using advanced microsphere technology, ARESTIN provides sustained release of minocycline, a broad-spectrum antibiotic that targets infection. Currently, ARESTIN is the leading locally administered antibiotic (LAA) for the treatment of periodontitis.2,3

Clinical trial data demonstrate clear benefits from active treatment with ARESTIN plus SRP when indicated to2:

  • Target the microorganisms associated with a periodontal infection
  • Significantly reduce pocket depth compared to SRP alone
  • Help restore a state of periodontal health
  • Help restore a healthy balance of bacteria

ARESTIN should not be used in any patient who has a known sensitivity to minocycline or tetracyclines.

REFERENCES: 1. Bland PS, Goodson JM, Gunsolley JC, Grossi SG, Otomo-Corgel J, et al. Association of antimicrobial and clinical efficacy: periodontitis therapy with minocycline microspheres. JIAP. 2010;12(1):11-19. 2. ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg. Prescribing Information. OraPharma; Bridgewater, NJ. 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.

ARESTIN INDICATION & IMPORTANT SAFETY INFORMATION

INDICATIONARESTIN® (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.

REFERENCES: 1. Bland PS, Goodson JM, Gunsolley JC, Grossi SG, Otomo-Corgel J, et al. Association of antimicrobial and clinical efficacy: periodontitis therapy with minocycline microspheres. JIAP. 2010;12(1):11-19. 2. ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg. Prescribing Information. OraPharma; Bridgewater, NJ. 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.