Uses

This product is a combination of 2 medications: fusidic acid and betamethasone valerate. It is used to treat certain skin conditions (types of eczema) when bacterial infection is also present. Betamethasone is a medium-strength corticosteroid used on the skin to reduce the swelling, itching, and redness that can occur in these types of conditions. Fusidic acid is an antibiotic that works by stopping the growth of certain bacteria. This medication should be used short-term (up to 2 weeks) to treat eczema with bacterial infection. Using any antibiotic when it is not needed can cause it to not work for future infections.

How To Use

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.

This medication is for use on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands before applying the medication. Clean and dry the affected area. Apply a thin film of the medication to the affected area and gently rub in as directed by your doctor, usually 2 times daily. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.

After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in these areas, rinse with plenty of water.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Tell your doctor if your condition lasts or gets worse after 2 weeks.

Side Effects

Stinging, burning, itching, irritation, dryness, swelling, or redness of the skin may occur when this medication is first applied to the skin. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

Tell your doctor right away if you have any serious side effects, including:

• stretch marks
• skin thinning/discoloration
• acne
• extreme/unwanted hair growth
• small red bumps on the skin (folliculitis)

Using this medication for a long time or for repeated times may result in a new infection (such as fungal infection). Contact your doctor if you notice signs of a new infection.

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur:

• unusual/extreme tiredness
• weight loss
• headache
• swelling ankles/feet
• increased thirst/urination
• vision problems

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.

Precautions

Before using this product, tell your doctor or pharmacist if you are allergic to fusidic acid or betamethasone valerate; or to other corticosteroids (such as hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• poor blood circulation
• diabetes
• immune system problems

Do not use this product to treat an area of skin that has a fungal infection, infection not related to eczema, or skin condition related to tuberculosis or syphilis. It should also not be used to treat skin conditions such as rash around the mouth, red flushed facial skin (rosacea), or rash after receiving a vaccine.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, similar medications pass into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

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.

Some products that may interact with this drug are:

• other corticosteroids (including skin products such as hydrocortisone, products taken by mouth such as prednisone)

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless your doctor tells you to. A different medication may be needed in those cases.

If you are using this medication for a longer time or over a large area of skin, lab and/or medical tests (such as adrenal function) may be done. Keep all medical and lab appointments.

Tell all your doctors that you use or have used this medication.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Discard any remaining product 3 months after opening the tube. Consult your pharmacist or local waste disposal company.