Sitavig Resources for Pharmacists

 

Applying Sitavig

  • Apply one SITAVIG 50mg buccal tablet 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 Strengths

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.

How Sitavig is Supplied/Storage And Handling

Sitavig (acyclovir), 50mg Muco-Adhesive Buccal Tablets are supplied as off-white tablets containing 50mg of acyclovir. Sitavig tablets have a rounded side and a flat side. Sitavig tablets are packaged in blisters (NDC 68712-049-02).

Sitavig should be stored at 20 to 25°C (68 to 77°F) [see USP controlled room temperature]; excursions between 15 and 30°C (59-86°F) permitted at room temperature. Protect from moisture, and keep out of reach of children.

Order Sitavig

For stocking inquiries, please call 1-800-499-4468

WholesalerSITAVIG 50mg
NDC 68712-049-02
ABC10140584 / 321976
BellCo525771
Cardinal/Kinray4990834
Dakota Drug154708
HD Smith376-6474
McKesson 2782282
Morris Dickson298695
NC Mutual Drug138321
Smith Drug Co678730

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.