Dosing & Administration
- 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.
50mg buccal tablets.
Known hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product.
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).
For more information:
- Sitavig [package insert]. Charleston, SC: Cipher Pharmaceuticals US LLC; 2015.
Indication & Important Safety Information
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.