TARGETED PRESCRIPTION COLD SORE TREATMENT¹

Fewer Recurrences. More Freedom.

Cold sores are a sore subject for many, which is why Sitavig (acyclovir), 50mg Muco-Adhesive Buccal Tablet is such a breakthrough in the world of prescription cold sore treatment. Sitavig is a single-dose, prescription-strength treatment that may stop cold sores before they start, which means fewer outbreaks and a lot more freedom.¹

Sitavig works by delivering a concentrated dose of prescription cold sore medication that stays localized at the site of viral replication in the mouth. In clinical trials, patients who applied prescription Sitavig within one hour of the first sign of an outbreak experienced significant relief from their cold sore symptoms in just 3.5 days — and completely healed within 5.5 days.¹* Plus, on average, patients treated with Sitavig went 105 days longer between cold sore outbreaks compared to patients treated with a placebo.¹*

The freedom to live your life — with fewer cold sores.¹

Knowledge is freedom when it comes to cold sores. Know your triggers and stop cold sore outbreaks before they happen¹ — so you have the freedom to get on with your life. What will you have more freedom to do with fewer cold sore outbreaks?

Additional cold sore resources:

Disclaimer

*Data on the incidence and delay of the next recurrence need further confirmation as they were obtained on a subset of patients.

 

References

  1. Bieber T, Chosidow O, Bodsworth N, Tyring S, Hercogova J, Bloch M, Davis M, Lewis M, Boutolleau D, Attali P and the LIP Study Group. Efficacy and safety of acyclovir mucoadhesive buccal tablet in immunocompetent patients with labial herpes (LIP): 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).
  2. Ward DB Jr. Can We Change the Course of Herpes Simplex Labialis? 2015. Practical Dermatology, Clinical Insights (7):1-2.
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.