INDICATION

ARESTIN® (minocycline HCl) Microspheres, 1mg is indicated as an adjunct to scaling and root planing (SRP) for reduction of pocket depth in adult periodontitis patients. ARESTIN® may be used as part of a periodontal maintenance program, which includes good oral hygiene and SRP.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines.

WARNINGS AND PRECAUTIONS

• ARESTIN should not be used in children, pregnant or nursing women as the use of tetracycline drugs during tooth development may cause permanent discoloration of the teeth.
• Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
• Hypersensitivity reactions and hypersensitivity syndrome included, but were not limited to anaphylaxis, anaphylactoid reaction, angioneurotic edema, urticaria, rash, eosinophilia. Post-marketing cases of anaphylaxis and serious skin reactions such as Stevens-Johnson syndrome and erythema multiforme have been reported with oral minocycline.
• 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-like reaction have presented shortly after oral minocycline use, manifested by fever, rash, arthralgia, lymphadenopathy, and malaise. In symptomatic patients, discontinue use of ARESTIN.
  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.

ADVERSE REACTIONS
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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