"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
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Patient Counseling Information
Patients should be informed that SITAVIG is not a cure for cold sores.
See FDA-approved patient labeling (Patient Information and Instructions for Use).
Instructions for Use
Read the Instructions for Use that comes with SITAVIG before you start using it. Talk to your doctor or pharmacist if you have any questions.
SITAVIG should be applied to the area of the upper gum above the incisor tooth. SITAVIG tablets should not be crushed, sucked, chewed or swallowed.
If it comes out before 6 hours have gone by, reapply it. If this does not work then a new tablet should be applied. It should not be applied to the inside of the lip or cheek.
- Tablet should be applied on the same side of the mouth as the herpes labialis symptoms.
- Do not remove SITAVIG if it sticks to your upper gum. If SITAVIG does not stick or falls off of your upper gum within the first 6 hours that you apply it, place it back onto your upper gum. If it still does not stick, replace it with a new SITAVIG tablet.
- Do not re-apply SITAVIG if it falls out or you swallow it after it has been in place 6 hours or longer.
- If you swallow SITAVIG within the first 6 hours of applying it, drink a glass of water and place a new SITAVIG tablet onto your upper gum.
Patients may experience adverse reactions including headache, and application site pain.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Systemic exposure following buccal administration of acyclovir is minimal. Results from previous studies of carcinogenesis, mutagenesis and fertility for acyclovir are not included in the full prescribing information for SITAVIG due to the minimal exposure that results from buccal administration. Information on these studies following systemic exposure is available in the full prescribing information for acyclovir products approved for oral and parenteral administration.
Use In Specific Populations
Pregnancy Category B
No studies with SITAVIG have been performed in pregnant women. Systemic exposure of acyclovir following buccal administration of SITAVIG is minimal. SITAVIG should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
There are no adequate and well-controlled studies of systemic acyclovir in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy between 1984 and 1999 followed 749 pregnancies in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximated that found in the general population. However, the size of the registry was insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.
Animal reproduction studies have not been conducted with SITAVIG. Acyclovir was not teratogenic in the mouse, rabbit or rat at exposures greatly in excess of human exposure.
Labor and Delivery
SITAVIG should not be administered during labor and delivery as there is no experience with SITAVIG.
It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following buccal administration is minimal.
After oral administration of acyclovir, concentrations have been documented in breast milk in 2 women and ranged from 0.6 to 4.1 times the corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day.
There is no experience with SITAVIG in nursing mothers. SITAVIG should be administered to a nursing mother with caution.
Safety and effectiveness of SITAVIG in pediatric patients have not been established. The ability of pediatric patients to comply with the application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.
Clinical studies of SITAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
The safety of SITAVIG has not been studied in immunocompromised subjects.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/29/2013
Additional Sitavig Information
Report Problems to the Food and Drug Administration
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