Acyclovir topical (for the skin) is an antiviral medicine that is used to treat skin symptoms caused by the herpes virus.

Acyclovir topical cream is used to treat cold sores on the lips and face.

Acyclovir topical ointment is used to treat genital herpes lesions.

There is no cure for herpes and acyclovir will not prevent you from developing symptoms in the future.

Acyclovir topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Start using acyclovir as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Wash your hands before and after applying this medicine.

Apply only enough cream to cover the cold sore or tingly area.

Apply only enough ointment to cover the genital lesion(s) completely. Wear a glove or a finger cot or use a cotton swab when applying the ointment to avoid spreading the virus to other body parts and to other people.

Acyclovir topical cream is usually applied 5 times daily for 4 days. Acyclovir topical ointment is usually applied 6 times daily for 7 days. Follow your doctor's dosing instructions very carefully.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Herpes Simplex Labialis:

5% Cream:
Apply to the affected area on face or lips 5 times a day for 4 days
-Initiate therapy as early as possible following onset of signs and symptoms of herpes labialis

Use: For the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.

Usual Adult Dose for Herpes Simplex -- Mucocutaneous/Immunocompromised Host:

5% Ointment:
Apply to affected area every 3 hours, 6 times a day for 7 days
-Therapy should be started as early as possible following onset of signs and symptoms

Comments:
-The dose size per application will vary depending upon the total lesion area; it should approximate a one-half inch ribbon of ointment per 4 square inches of surface area.
-A finger cot or rubber glove should be used when applying ointment to prevent autoinoculation of other body sites and transmission to other persons.

Uses: For the management of initial genital herpes and in limited non-life-threatening mucocutaneous HSV infections in immunocompromised adults.

Usual Adult Dose for Herpes Simplex:

5% Ointment:
Apply to affected area every 3 hours, 6 times a day for 7 days
-Therapy should be started as early as possible following onset of signs and symptoms

Comments:
-The dose size per application will vary depending upon the total lesion area; it should approximate a one-half inch ribbon of ointment per 4 square inches of surface area.
-A finger cot or rubber glove should be used when applying ointment to prevent autoinoculation of other body sites and transmission to other persons.

Uses: For the management of initial genital herpes and in limited non-life-threatening mucocutaneous HSV infections in immunocompromised adults.

Usual Pediatric Dose for Herpes Simplex Labialis:

12 years or older:

5% Cream:
Apply to the affected area on face or lips 5 times a day for 4 days
-Initiate therapy as early as possible following onset of signs and symptoms of herpes labialis

Use: For the treatment of recurrent herpes labialis (cold sores) in pediatric patients 12 years of age or older.

You should not use acyclovir topical if you are allergic to acyclovir or valacyclovir (Valtrex).

Acyclovir topical is not approved for use by anyone younger than 12 years old.

Tell your doctor if you have ever had a weak immune system (caused by disease or by using certain medicine).

It is not known whether this medicine will harm an unborn baby. However, herpes virus can be passed from an infected mother to her baby during childbirth. If you have genital herpes, it is very important to prevent herpes lesions during your pregnancy, so that you do not have a genital lesion when your baby is born.

You should not breastfeed if you have a herpes lesion on or near your breast.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

An overdose of acyclovir topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Keep this medication in the container it came in, with the cap on and tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Never leave this medication in your car in cold or hot weather.

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.

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

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

Avoid getting this medication in your eyes, nose, or mouth. If this does happen, rinse with water. When treating a cold sore, apply the medication only to the outer part of your lips.

Avoid using other medications on the areas you treat with acyclovir topical unless your doctor tells you to.

Using acyclovir topical will not prevent you from passing genital herpes to other people. Herpes infections are contagious and you can infect other people even while you are using acyclovir.

Avoid sexual intercourse or use a latex condom to help keep you from spreading the virus to others. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent the spread of infection.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of acyclovir topical may include:

• dry, cracked, or peeling lips;

• dryness or flaking of treated skin;

• burning, stinging, or itching when the medicine is applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Keep all appointments with your doctor.

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.

• Xerese® (containing Acyclovir, Hydrocortisone)