Sitavig Acyclovir

Get an overview of SITAVIG (acyclovir tablet, delayed release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Sitavig can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Sitavig.

Drug Basics

Brand Name: Sitavig

Generic Name: ACYCLOVIR

Drug Type: HUMAN PRESCRIPTION DRUG

Route: BUCCAL

Dosage Form: TABLET, DELAYED RELEASE

Data Current As Of: 2018-10-05

indications & usage

SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults (1).

drug interactions

Due to low dose and minimal systemic absorption of SITAVIG, drug interactions are unlikely (7).

See 17 for PATIENT COUNSELING INFORMATION AND FDA-Approved Patient Labeling

Revised: 10/2015

indications & usage

SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.

drug interactions

No interaction studies have been performed with SITAVIG. Acyclovir is primarily eliminated unchanged in the urine via active tubular secretion. Drugs administered concomitantly that compete with tubular secretion may increase acyclovir plasma concentrations. However, due to the low dose and minimal systemic absorption of SITAVIG, systemic drug interactions are unlikely.

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.

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.

patient information

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


What is SITAVIG?
SITAVIG is a prescription medicine used to treat cold sores (herpes labialis) in adults with normal immune systems.
It is not known if SITAVIG is safe and effective in children.

Who should not use SITAVIG?
Do not use SITAVIG if you are allergic to:
acyclovir or any of the ingredients in SITAVIG. See the end of this leaflet for a complete list of ingredients in SITAVIG.
milk protein concentrate

Before using SITAVIG, tell your healthcare provider about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if SITAVIG will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SITAVIG passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.

H ow should I use SITAVIG?
See the detailed Instructions for Use for information about how to use SITAVIG.
Use SITAVIG exactly as your healthcare provider tells you to use it.
Use SITAVIG 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.
You may eat and drink while using SITAVIG.
Do not crush, chew, suck, or swallow SITAVIG tablets.
SITAVIG will slowly dissolve over time while in your mouth and should be left in place.
Gently rinse your mouth with water to clean your teeth while SITAVIG is in place.
Drink more liquids if your mouth becomes dry while using SITAVIG.


What should I avoid while using SITAVIG?
You should avoid activities that may prevent SITAVIG from sticking to your gum, including: touching or pressing SITAVIG
after you apply it, wearing upper dentures, chewing gum, and brushing your teeth during the treatment day.

What are the possible side effects of SITAVIG?
The most common side effects of SITAVIG include: headache and pain where SITAVIG is applied.
These are not all the possible side effects of SITAVIG. Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.


How should I store SITAVIG?
Store SITAVIG between 68°F to 77°F (20°C to 25°C). Keep SITAVIG tablets dry.

Keep SITAVIG and all medicines out of the reach of children.

General information about the safe and effective use of SITAVIG
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use
SITAVIG for a condition for which it was not prescribed. Do not give SITAVIG to other people, even if they have the same
symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about
SITAVIG that is written for health professionals.

What are the ingredients in SITAVIG?
Active ingredient: acyclovir
Inactive ingredients: hypromellose, milk protein concentrate, sodium lauryl sulfate, magnesium stearate,microcrystalline cellulose, povidone, colloidal silicon dioxide.


Manufactured By: Farméa,10 rue Bouché Thomas, ZAC d’orgemont, 49 000 Angers - France

For more information call 1-800-499-4468.

This Patient Information has been approved by the U.S. Food and DrugAdministration. Issue: April/2013 Reference ID: 3292406

instructions for use

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

Fig A.jpg


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

Fig B.jpg


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

Fig C.jpg

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

Fig D.jpg


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:

      Cipher Pharmaceuticals U.S. LLC

      Charleston, SC  29401

       1-800-449-4468

       www.cipherpharma.com

       www.sitavig.com


U.S. Pat. No.: 8,592,434, 8,747,896 and 8,791,127.
©2013 Cipher Pharmaceuticals U.S. LLC
Revised: 10/2015                                                                                                      SIT-PI-0417

Sitavig Box 1015 CR.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. 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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