Sitavig Educational Brochure

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For more information about cold sores and how to use Sitavig, download this educational brochure (PDF – Adobe Acrobat Reader Required).

Additional resources:

References

  1. Bieber T, et al. Efficacy and Safety of Acyclovir Mucoadhesive Buccal Tablet in Immunocompetent Patients With Labial Herpes (LIP Trial): A Double-Blind, Placebo-Controlled, Self-Initiated Trial. J Drugs Dermatol. 2014;13(7):791-798. View study (link will lead you to the JDD site).
Indication & Important Safety Information
INDICATION
Sitavig® (acyclovir), 50mg Muco-Adhesive Buccal Tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
IMPORTANT SAFETY INFORMATION
  • Sitavig should not be used in patients with known hypersensitivity to acyclovir, milk protein concentrate, or other components of the product.
  • Sitavig has not been studied in pregnant women or in immunocompromised patients and no interaction studies have been performed. Sitavig’s safety and efficacy have not been established in pediatric patients.
  • Sitavig is a Pregnancy Category B product; therefore it should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known if Sitavig is excreted in breast milk; however, systemic absorption is minimal.
  • In a controlled clinical trial Sitavig's most common side effects (greater than or equal to 1%) were: headache (3%), dizziness (1%), lethargy (1%), gingival (gum) pain (1%), aphthous stomatitis (canker sores) (1%), application site pain (1%), application site irritation (1%), erythema (1%) and rash (1%). In the same trial these side effects ranged from 0%-3% for placebo.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch.com or call 1-800-FDA-1088. Click here for Full Prescribing Information.