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) 50 mg buccal tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
IMPORTANT SAFETY INFORMATION
  • Sitavig® (acyclovir) 50 mg buccal tablet should not be used in patients with known hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product.
  • Sitavig has not been studied in immunocompromised patients. No interaction studies have been performed. Sitavig’s safety and efficacy have not been established in pediatric patients.
  • There are no available data on Sitavig use in pregnant women. However, published observational studies over decades of use of acyclovir have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. It is not known if Sitavig is excreted in breast milk; however, systemic exposure following buccal administration of acyclovir is minimal. Before administration, discuss if the patient is lactating or planning to breastfeed.
  • The possibility of viral resistance to acyclovir should be considered in patients who fail to respond or experience recurrent viral shedding during therapy.
  • In a controlled clinical trial, the most common side effects (greater than or equal to 1%) for Sitavig 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 (redness) (1%), and rash (1%). In the same trial, these side effects ranged from 0% to 3% for placebo.
You are encouraged to report negative side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see Full Prescribing Information.