Sitavig

What is Sitavig used for?

Sitavig is a prescription medicine that is used to treat cold sores.

Description

SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see Clinical
Pharmacology  . 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 C 8H 11N 5O 3 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.

Before taking Sitavig, tell your doctor:

• If you are allergic to Sitavig; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• 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 Sitavig 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 things I need to know or do while I take Sitavig?

• Tell all of your health care providers that you take Sitavig. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine will not cure cold sores. If you have questions, talk with the doctor.
• Do not give Sitavig to younger children. The chance of choking may be raised.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Sitavig while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Sitavig best taken?

Use Sitavig as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use within 1 hour after the first signs of a cold sore. Put on the same side of the mouth as the cold sore.
• Dry your hands and place the tablet in your mouth above the incisor tooth between the upper cheek and gum. Leave the tablet in place until it dissolves.
• Do not swallow whole. Do not chew, break, or crush.
• Do not suck on this product.
• Do not remove the tablet from the tablet pack until you are ready to put in Sitavig. Put in the tablet right away after opening the blister pack. Do not store the removed tablet for future use.
• You may eat and drink when using Sitavig. Avoid doing things that may knock the tablet loose like chewing gum, touching the tablet, wearing upper dentures, and brushing your teeth.
• If your mouth gets dry when using Sitavig, drink more liquids.
• If the drug does not stick or falls out within the first 6 hours, put the same tablet back in. If you cannot do this, put in a new tablet.
• If the drug is swallowed within the first 6 hours, drink a glass of water and put in a new tablet.
• If the drug falls out or is swallowed after the first 6 hours, you do not need to re-apply a tablet.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses or extra doses.

What are the side effects of Sitavig that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where Sitavig is used.

What are some other side effects of Sitavig?

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:

• Headache.
• 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sitavig?

• Store at room temperature. Do not freeze.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL