Sitivig

These highlights do not include all the information needed to use SITAVIG safely and effectively.  See full prescribing information for SITAVIG.

SITAVIG (acyclovir) buccal tablets 50mg

Initial U.S. Approval:  1982

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.

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.

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.

Important:
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.

Adverse Reactions

Patients may experience adverse reactions including headache, and application site pain.

SITAVIG (SIT-a-vig) (acyclovir) buccal tablets

Read the Instructions for Use that comes with SITAVIG before you start using it. Talk to your healthcare provider or pharmacist if you have any questions.

Important:
• SITAVIG should be applied within 1 hour after you have the first symptom of a cold sore, such as itching, redness, burning, or tingling, and before a cold sore appears.
• SITAVIG should be applied on the same side of your mouth as the cold sore symptoms.
• SITAVIG should be applied to your upper gum, just above your incisor tooth.
• SITAVIG should not be applied to the inside of your lip or your cheek.
• If SITAVIG does not stick to your upper gum or falls off of your upper gum within the first 6 hours after you apply it, the same tablet should be placed back onto your upper gum right away. If this SITAVIG tablet does not stay in place, apply another SITAVIG tablet to your upper gum.  
• 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.

How to apply Sitavig

Step 1:  Before you apply SITAVIG, find the area on your upper gum, just above either the left or the right incisor.  The incisor tooth is the tooth just to the right or left of your two front teeth (See Figure A).  This is where you should apply SITAVIG. 

Figure A

Step 2:

Peel back the cover of the blister pack. Take 1 SITAVIG out of the blister pack. When removed from the blister pack, SITAVIG must be used right away. SITAVIG is round on one side and flat on the other side (See Figure B).

Figure B

Step 3: Place the flat side of SITAVIG on your dry fingertip. Apply the round side of SITAVIG to your upper gum (See Figure C). The flat side will be facing the inside of your lip.

Figure C

Step 4: Hold SITAVIG in place by applying a slight pressure with your finger on the outside of your upper lip, over the area where SITAVIG is placed, for 30 seconds. This will help SITAVIG stick to your gum (See Figure D).

Figure D

Step 5: Leave the SITAVIG tablet in place until it dissolves.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured By:
      Farméa
      10 rue Bouché Thomas
      ZAC d’orgemont
      49 000 Angers - France

Distributed By:

      Innocutis Holdings LLC

      Charleston SC  29401

       1-800-449-4468

       www.innocutis.com

       www.sitavig.com

U.S. Pat. No.: 8,592,434 and
additional patents pending.
©2013 Innocutis Holdings, LLC
Issued: April/2013