Penciclovir Topical

Penciclovir is a prescription medication used for the treatment of recurrent herpes labialis (cold sores) in adults and children aged 12 years or older.

• Penciclovir is available under the following different brand names: Denavir

Common side effects of Penciclovir include:

• application site reactions (such as redness, burning, stinging, numbness, rash, pain, itching, skin discoloration, or hives)
• changes in the sense of taste
• headache
• swollen mouth or throat

Serious side effects of Penciclovir include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• severe skin redness, itching, rash, or pain after applying the medicine

Rare side effects of Penciclovir include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of 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.

Adult and pediatric dosage

Cream

• 1%

Herpes simplex labialis (cold sores)

Adult dosage

• Apply at the first onset of symptoms (tingling, swelling, etc.) apply every 2 hours while awake for 4 days

Pediatric dosage

• Children younger than 12 years: Safety and efficacy not established
• Children older than 12 years: At first onset of symptoms apply every 2 hours while awake for 4 days

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

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.

• Penciclovir has no noted severe interactions with any other drugs
• Penciclovir has no noted serious interactions with any other drugs
• Penciclovir has no noted moderate interactions with any other drugs
• Penciclovir 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 healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Use gloves to apply because may inoculate other areas
• External use only
• Effects in immunocompromised patients not established
• For use on herpes labialis on the lips and face
• Not for use in mucous membranes not recommended
• Not for use in or near eyes
• Lesions that do not improve or that worsen on therapy should be evaluated for secondary bacterial infection

Pregnancy and Lactation

• Drug is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug
• Lactation
  • Drug is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in the exposure of a child to the drug