Sitavig
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults (1).
SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
History
There is currently no drug history available for this drug.
Other Information
SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see Clinical
Pharmacology (12.3)]. Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has a molecular formula of C8H11N5O3 and a molecular weight of 225. The structural formula is shown in Figure 1.
Acyclovir drug substance is a white or almost white crystalline powder. SITAVIG contains 50 mg of acyclovir, USP and the following inactive
ingredients: hypromellose, USP; milk protein concentrate; sodium lauryl sulfate, NF; magnesium stearate, NF; microcrystalline cellulose,
NF; povidone, USP; colloidal silicon dioxide, NF.
Sources
Sitavig Manufacturers
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Innocutis Holdings, Llc
![Sitavig (Acyclovir) Tablet, Delayed Release [Innocutis Holdings, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sitavig | Innocutis Holdings, Llc
Application of one SITAVIG 50 mg buccal tablet as a single dose to the upper gum (canine fossa) region (2.1). SITAVIG should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labailis. Do not crush, chew, suck or swallow tablets (2.2)2.1 Basic Dosing Information
One SITAVIG 50 mg buccal tablet should be applied as a single dose to the upper gum region (canine fossa).
2.2 Administration Instructions
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 (12.3)]. 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 situation 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 Counseling Information (17)]. SITAVIG does not need to be reapplied if the tablet falls out or is swalloed after the first 6 hours
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