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Brand Name(s): Sitavig^®

WHY is this medicine prescribed?

Acyclovir buccal is used to treat herpes labialis (cold sores or fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Acyclovir buccal comes as a delayed-release buccal tablet to apply to the upper gum in the mouth. The delayed-release buccal tablet is usually applied with a dry-finger within 1 hour after cold sore symptoms (itching, redness, burning or tingling) begin, but before the cold sore appears. It is usually taken as a single (one-time) dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use acyclovir exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not chew, crush, suck, or swallow the delayed-release buccal tablets.

You may eat and drink while the tablet is in place. Drink plenty of liquids, if you have a dry mouth while using the delayed-release buccal tablets.

To use buccal acyclovir, follow these steps:

1. Find the area on the upper gum above your left or right incisor teeth (the teeth just to the left and right of your two front teeth) on the side of your mouth with the cold sore.
2. With dry hands, remove one delayed-release tablet from the container.
3. Place the flat side of the tablet on your fingertip. Gently apply the rounded side of the tablet to the upper gum area as high as it will go on your gum above one of your incisor teeth on the side of your mouth with the cold sore. Do not apply it to the inside of the lip or cheek.
4. Hold the tablet in place for 30 seconds.
5. If the tablet does not stick to your gum or if it sticks to your cheek or the inside of your lip, reposition it to stick to your gum. Leave the tablet in place until it dissolves.
6. Do not interfere with the placement of the tablet. Check to see if the tablet is still in place after eating, drinking, or rinsing your mouth.

If the delayed-release buccal tablet comes off within the first 6 hours of application, reapply the same tablet. If it still will not stick, then apply a new tablet. If you accidentally swallow the tablet within the first 6 hours after application, drink a glass of water and place a new tablet on your gum. If the tablet falls off or is swallowed 6 or more hours after application, do not apply a new tablet.

Avoid the following while you are using acyclovir buccal delayed-release tablet:

• Do not touch, or press the buccal tablet after it has been applied.
• Do not chew gum.
• Do not wear upper dentures.
• Do not brush your teeth until it dissolves. If your teeth need to be cleaned while the tablet is in place, rinse the mouth gently.

What SPECIAL PRECAUTIONS should I follow?

Before using acyclovir buccal,

• tell your doctor and pharmacist if you are allergic to acyclovir, valacyclovir (Valtrex), any other medications, milk proteins, or any of the ingredients in acyclovir products. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have any medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using acyclovir buccal, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Acyclovir buccal may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• canker sores
• irritation of the gum

Acyclovir buccal may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 15, 2019.