Dosing & Administration

sitavig-tablet-diagram

Applying Sitavig

  • SITAVIG 50mg buccal tablet should be applied as a single dose to the upper gum (canine fossa) region.
  • SITAVIG should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labialis.
  • Instruct patients not to crush, chew, suck or swallow tablets.

Dosage Forms and Strengthssitavig-prescription-tear-pad

50mg buccal tablets.

Contraindications1

Known hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product.

Adverse Reactions

Most common adverse reactions (≥1%) are: headache and application site pain. For more information, please view Sitavig Full Prescribing Information (PDF — Adobe Acrobat Reader Required).

 

Additional resources:

 

For more information:

References

  1. Sitavig [package insert]. Charleston, SC: Cipher Pharmaceuticals US LLC; 2015.
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.