"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.
DOSAGE AND ADMINISTRATION
Basic Dosing Information
One SITAVIG 50 mg buccal tablet should be applied as a single dose to the upper gum region (canine fossa).
SITAVIG should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labialis lesions. The tablet should be applied with a dry finger immediately after taking it out of the blister. The tablet should be placed to the upper gum just above the incisor tooth (canine fossa) and held in place with a slight pressure over the upper lip for 30 seconds to ensure adhesion. For comfort the rounded side should be placed to the upper gum, but either side of the tablet can be applied. Tablet should be applied on the same side of the mouth as the herpes labialis symptoms.
Once applied, SITAVIG stays in position and gradually dissolves during the day. [See CLINICAL PHARMACOLOGY]. In addition,
- SITAVIG should not be crushed, chewed, sucked or swallowed.
- Food and drink can be taken normally when SITAVIG is in place. Avoid any situations which may interfere with adhesion of the tablet such as chewing gum, touching or pressing the tablet after placement, wearing upper denture, and brushing teeth. If the teeth need to be cleaned while the tablet is in place, rinse the mouth gently. Drink plenty of liquids in the case of dry mouth.
- If SITAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet cannot be repositioned, a new tablet should be placed.
- If SITAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied. [see PATIENT INFORMATION].
- SITAVIG does not need to be reapplied if the tablet falls out or is swallowed after the first 6 hours
Dosage Forms And Strengths
SITAVIG is a buccal tablet containing 50 mg of acyclovir. SITAVIG tablets are round, off-white tablets, with a rounded side and a flat side. The tablets are marked with an “AL21” on the flat side.
Storage And Handling
SITAVIG 50 mg buccal tablets are supplied as off-white tablets containing 50 mg of acyclovir. SITAVIG tablets have a rounded side and a flat side. SITAVIG tablets are packaged in blisters (NDC XXXXXX).
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.
Manufactured By: Farméa, 10 rue Bouché Thomas, ZAC d'orgemont, 49 000 Angers -France. Issue: April/2013This 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
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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