Penciclovir (Topical)

Penciclovir is part of a group of medicines known as antivirals. Antivirals are used to treat infections caused by viruses, typically targeting a specific type or group of virus infections.

Topical penciclovir is used to treat the symptoms of herpes simplex virus infections around the mouth (cold sores). While topical penciclovir will not cure herpes simplex, it may help reduce pain and discomfort and may help the sores heal more quickly.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There is no specific information comparing the use of topical penciclovir in children with its use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. So, it may not be clear if they work the same way they do in younger adults. There is no specific information comparing the use of penciclovir in older adults with its use in other age groups. However, this medicine has been used in some older patients and has not been found to cause different side effects or other problems compared to younger adults.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there might be an interaction. In such cases, your doctor may want to adjust the dose, or other precautions may be needed. Let your healthcare professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Immune system problems—It is not known if this medicine will work properly in patients with these issues.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Mild pain, burning, or stinging

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache

Less common

• Change in sense of taste
• decreased sensitivity of skin, particularly to touch
• redness of the skin
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Denavir

Available Dosage Forms:

• Cream

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

This medicine should only be used on the lips or face.

Penciclovir is best used as soon as possible after the symptoms of herpes infection (for example, pain, burning, or blisters) begin to appear.

Do not use this medicine in or near the eyes.

Do not use this medicine inside the mouth or nose or on other internal parts of the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (cream): For herpes simplex infection (cold sores): Adults—Apply to the affected area(s) of the skin every two hours, while awake, for four days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.