Sitavig Patient Counseling Information
Treating cold sores successfully requires patients’ clear understanding of the condition and how to use Sitavig properly. The resources below are intended to help educate your patients.
Additional cold sore resources:
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.
Sitavig® (acyclovir), 50mg Muco-Adhesive Buccal Tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
- 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.