Acyclovir/Hydrocortisone

Acyclovir/Hydrocortisone topical combination is used to treat the symptoms of herpes simplex virus infection on the lips and around the mouth (cold sores). Although Acyclovir/Hydrocortisone will not cure herpes simplex, it may help the sores to heal faster and relieve some of the pain and discomfort. Acyclovir/Hydrocortisone is an antiviral agent (treats a virus) and hydrocortisone is a steroid (cortisone-like) medicine.

Acyclovir/Hydrocortisone is available only with your doctor's prescription.

• Do not use Acyclovir/Hydrocortisone cream for genital herpes.
• Do not get Acyclovir/Hydrocortisone cream in your eyes or on the inside of your nose or mouth. If Acyclovir/Hydrocortisone cream gets in your eyes, flush them with cool tap water.
• Do not use other skin products such as cosmetics, sunscreen, or lip balm on the cold sore area while you are using Acyclovir/Hydrocortisone cream unless otherwise instructed by your doctor.
• If treated cold sores get worse or if they do not heal within 2 weeks, check with your doctor.
• Acyclovir/Hydrocortisone cream is not a cure for cold sores and it does not prevent the spread of the virus to others. Do not share drinking cups, eating utensils, razors, towels, or toothbrushes. Ask your doctor if you have questions about preventing the spread of cold sores.
• Acyclovir/Hydrocortisone cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your or emergency room right away.
• Acyclovir/Hydrocortisone cream should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acyclovir/Hydrocortisone cream while you are pregnant. It is not known if Acyclovir/Hydrocortisone cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Acyclovir/Hydrocortisone cream, check with your doctor. Discuss any possible risks to your baby.

Usual Adult Dose for Herpes Simplex Labialis

Apply topically 5 times per day for 5 days.

Comments:

-Therapy should be started as early as possible after onset of signs/symptoms (i.e., during prodromal phase or when lesions appear).

Approved

Indication: For the early treatment of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time

Usual Pediatric Dose for Herpes Simplex Labialis

6 years or older: Apply topically 5 times per day for 5 days.

Comments:

-Therapy should be started as early as possible after onset of signs/symptoms (i.e., during prodromal phase or when lesions appear).

Approved

Indication: For the early treatment of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:

-For each dose, apply a sufficient amount of drug to cover the affected area, including the outer margin.

-Avoid unnecessary rubbing of the affected area to prevent aggravating or transferring the infection.

Storage requirements:

-Store at controlled room temperature 20C to 25C (68F to 77F), excursions permitted to 15C to 30C (59F to 86F); do not freeze.

Patient advice:

-Wash hands before and after applying Acyclovir/Hydrocortisone topical.

Use Acyclovir/Hydrocortisone cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Acyclovir/Hydrocortisone cream. Talk to your pharmacist if you have questions about this information.
• Wash and completely dry your hands and the affected area before using Acyclovir/Hydrocortisone cream. Apply a thin layer of Acyclovir/Hydrocortisone cream to the affected area, including the outer margin. Do not rub the cold sore because it may spread to other areas or make the cold sore worse. Wash your hands after using Acyclovir/Hydrocortisone cream.
• Apply Acyclovir/Hydrocortisone cream 5 times every day for 5 days or as directed by your doctor.
• Do not bandage or wrap the area unless directed to do so by your doctor.
• Do not bathe, shower, or swim until 30 minutes after using Acyclovir/Hydrocortisone cream.
• To clear up your infection completely, use Acyclovir/Hydrocortisone cream for the full course of treatment. Keep using it even if you feel better in a few days.
• For best results, use Acyclovir/Hydrocortisone cream at the first sign of a cold sore (tingling, redness, itching, or bump).
• If you miss a dose of Acyclovir/Hydrocortisone cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Acyclovir/Hydrocortisone cream.

This medication contains 2 ingredients: Acyclovir/Hydrocortisone. It is used to treat cold sores/fever blisters caused by a virus (herpes simplex). Acyclovir/Hydrocortisone is an antiviral medication that works by stopping the growth of the virus. Hydrocortisone is a corticosteroid that helps relieve itching, pain, and burning symptoms. This medication can speed up healing of cold sores, but it does not cure herpes or prevent passing the infection to someone else. It also does not prevent cold sores from returning.

How to use Acyclovir/Hydrocortisone topical

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication at the first sign of a cold sore. Wash your hands with soap and water before and after applying this medication. Clean and dry the affected area before applying the medication. Apply a thin layer on the affected area as directed by your doctor, usually 5 times a day (every 3 to 4 hours) for 5 days. Apply enough cream to cover all affected areas. Do not rub the area because it may spread to other areas around your mouth or make your cold sore worse. Do not apply other skin products (including make-up, sunscreen, or lip balm) or cover the affected area with a bandage. To prevent washing off the medication, do not bathe, shower, or swim for 30 minutes after application.

Do not apply this medication in the eyes or nose, inside the mouth, or on the genitals.

Cold sores (herpes) can spread easily. Acyclovir/Hydrocortisone cream does not prevent the spread of herpes. Avoid sharing eating utensils, cups, razors, or towels during an outbreak. Also, try not to touch the cold sore (including kissing), and wash your hands if you do touch the cold sore.

Use this product regularly to get the most benefit from it. Tell your doctor if your condition persists or worsens after 2 weeks.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

See also:
What are the possible side effects of Acyclovir/Hydrocortisone?

Dry/cracked lips, burning, stinging, redness, skin color changes, or dry/flaky skin may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.