Acyclovir Buccal Tablets
Name: Acyclovir Buccal Tablets
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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 68712-049-02).
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.
Distributed By: Cipher Pharmaceuticals U.S. LLC.,Charleston, SC 29401. Revised: April 2017
Acyclovir absorption and systemic exposure following application of SITAVIG are minimal. Overdose is therefore unlikely [see CLINICAL PHARMACOLOGY] .
Symptomatic and supportive care is the basis for management.
(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-thecounter medicines, vitamins, or herbal supplements.
How should I use SITAVIG?
See the detailed Instructions for Use for informationabout 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.
INSTRUCTIONS FOR USE
(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.
- 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.
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).
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.
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).
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.
Uses of Acyclovir Buccal Tablets
- It is used to treat cold sores.
What do I need to tell my doctor BEFORE I take Acyclovir Buccal Tablets?
- If you have an allergy to acyclovir, valacyclovir, or any other part of this medicine (acyclovir buccal tablets).
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have a milk allergy.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some other side effects of Acyclovir Buccal Tablets?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Pain where it was placed.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.