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) 50 mg buccal tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
Sitavig® (acyclovir) 50 mg buccal tablet is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
- 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.
Please see Full Prescribing Information.