Acyclovir Topical

Acyclovir Topical is a prescription medication used for the treatment of different types of herpes.

• Acyclovir Topical is available under the following different brand names: Zovirax Topical, Sitavig

Adult and pediatric dosage

Topical cream

• 5%

Topical ointment

• 5%

Mucoadhesive buccal tablet

• 50mg (Sitavig)

Herpes Labialis

Adult dosage

• Cream/ointment
  • Apply Topically to lips and around the mouth 5 times per day for 4 days; initiate as soon as possible after first signs and symptoms
• Mucoadhesive buccal tablet
  • Apply one 50 mg buccal tablet as a single dose to the upper gum (canine fossa) region
  • Should be applied within 1 hr after the onset of prodromal symptoms and before the appearance of any signs of Herpes labialis

Pediatric dosage

• Aged below 12 years: Safety and efficacy not established
• Aged below 12 years: As adults, apply cream/ointment Topically to lips and around the mouth 5 times per day for 4 days; initiate as soon as possible after first signs and symptoms

Genital Herpes

Adult dosage

• Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times/day for 7 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Acyclovir Topical include:

• nausea,
• vomiting,
• diarrhea,
• general ill feeling,
• headache, and
• mouth pain while using an acyclovir buccal tablet

Serious side effects of the Acyclovir Topical include:

• easy bruising or bleeding,
• purple or red pinpoint spots under the skin,
• little or no urination,
• painful or difficult urination,
• swelling in the feet or ankles,
• feeling tired, and
• shortness of breath

Rare side effects of the Acyclovir Topical include:

• none

This is not a complete list of side effects and other serious side effects or health problems that may occur due to the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Acyclovir Topical has no noted severe interactions with any other drugs.
• Acyclovir Topical has no noted serious interactions with any other drugs.
• Acyclovir Topical has no noted moderate interactions with any other drugs.
• Acyclovir Topical has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Acyclovir Topical?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acyclovir Topical?”

Cautions

• Not recommended for recurrent infections
• Use caution in immunocompromised patients
• Avoid physical contact when lesions are present
• For external use only; not for use on the eye or inside the mouth

Pregnancy and Lactation

• No available data on use in pregnant women; however, published observational studies over decades of use of acyclovir has not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; systemic exposure of acyclovir following buccal administration is minimal
• Lactation
  • There are no data on the presence of drugs in human milk following buccal administration; there are no data on the effects of drugs on breastfed infants or milk production; systemic exposure following buccal administration is minimal; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from or from the underlying maternal condition