Peel back the cover of the blister pack. Do NOT push the tablet through the packet. Take 1 Sitavig out of the blister pack. When removed from the blister pack, Sitavig must be used right away. Sitavig is round on one side and flat on the other side.
Place the flat side of Sitavig on your dry fingertip. Apply the round side of Sitavig to your upper gum. The flat side will be facing the inside of your lip.
When you apply Sitavig, find the area on your upper gum, just above either the left or the right incisor. The incisor tooth is the tooth just to the right or left of your two front teeth. This is where you should apply Sitavig.
Hold Sitavig in place by applying a slight pressure with your finger on the outside of your upper lip, over the area where Sitavig is placed, for 30 seconds. This will help Sitavig stick to your gum.
Leave the Sitavig tablet in place until it dissolves (tablet needs to be in place for 6 hours, but may take up to 14 hours to dissolve).
Indication & Important Safety Information
Sitavig® (acyclovir) 50 mg buccal tablet is indicated for
the treatment of recurrent herpes labialis (cold sores) in immunocompetent
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.