Generic Name: acyclovir
Date of Approval: April 12, 2013
Company: BioAlliance Pharma SA
Treatment for: Herpes Labialis (Cold Sores)
FDA Approves Sitavig
The U.S. Food and Drug Administration (FDA) has approved Sitavig (acyclovir) buccal tablets for the treatment of recurring Herpes labialis
Based on proprietary Lauriad® technology, Sitavig comes in the form of a mucoadhesive tablet which the patient places on the gum and which delivers a high concentration of acyclovir directly to the lip, the site of the cold sore infection. In a phase III international study conducted on 775 patients, Sitavig demonstrated a high level of efficacy in terms of healing time with one single tablet containing 50 mg of acyclovir and an excellent tolerance profile.
In addition to its efficacy, Sitavig offers a unique unobtrusive and simple formulation with a single application for the episode's entire duration, representing major advantages for patients suffering from recurrent herpes sores.
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 it is safe and effective in children.
Who should not use Sitavig?
Do not use this medicine 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.
- 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 this medicine will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if this medicine 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.
How should I use Sitavig?
See the detailed Instructions for Use for information about how to use this medicine.
- Use exactly as your healthcare provider tells you to use it.
- Use within one 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 the 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?
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.
Sitavig side effects
The most common side effects 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.
See also: Side effects (in more detail)
How should I store Sitavig?
- Store 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 this medicine 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.
Instructions for Use
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.
- Sitavig should be applied within one hour after you have the first symptom of a cold sore, such as itching, redness, burning, or tingling, and before a cold sore appears.
- The buccal tablet should be applied on the same side of your mouth as the cold sore symptoms.
- The buccal tablet should be applied to your upper gum, just above your incisor tooth.
- It 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 six 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 if the buccal tablet 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 tablet onto your upper gum.
How to apply Sitavig:
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. This is where you should apply the buccal tablet.
Peel back the cover of the blister pack. Take one buccal tablet 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.
Place the flat side of the buccal tablet on your dry fingertip. Apply the round side to your upper gum. The flat side will be facing the inside of your lip.
Hold buccal tablet 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 it stick to your gum.
Leave the buccal tablet in place until it dissolves.