Xerese

Xerese is part of the drug class:

• Nucleosides and nucleotides excl. reverse transcriptase inhibitors

Acyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection.

Hydrocortisone is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation.

The combination of acyclovir and hydrocortisone topical (for the skin) is used to treat cold sores in people who are at least 12 years old.

This medication will not cure or prevent cold sores caused by herpes, but it can lessen the symptoms of the infection.

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

You should not use this medication if you are allergic to acyclovir (Zovirax) or hydrocortisone.

To make sure you can safely use acyclovir and hydrocortisone topical, tell your doctor if you have a weak immune system (caused by disease by or using certain medicines).

FDA pregnancy category B. Acyclovir and hydrocortisone topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether acyclovir and hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Acyclovir and hydrocortisone topical should not be used on a child younger than 12 years old.

Do not share this medication with other people, even if they have the same symptoms you have.

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 the outer part of your lips.

Do not apply acyclovir and hydrocortisone topical to your genitals.

Do not apply sunscreen, lip balm, or cosmetics to the treated cold sore area.

Herpes infections are contagious and you can infect other people, even while you are being treated with acyclovir and hydrocortisone topical. 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 passing the infection to others.

In the U.S.

• Xerese

Available Dosage Forms:

• Cream

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Xerese, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xerese. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Xerese.

Review Date: October 4, 2017

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

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

Stop using this medicine and call your doctor at once if you have severe burning, stinging, or irritation of treated skin.

Less serious Xerese side effects may include:

• mild burning or tingling after applying the medicine;

• skin dryness or flaking;

• bitter taste in your mouth after applying the medicine; or

• skin redness or discoloration;

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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied acyclovir and hydrocortisone. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.