Uses

This medication is used to treat skin infections. This product contains betamethasone valerate, a medium-strength anti-inflammatory corticosteroid that helps reduce swelling, redness, and itching. It also contains gentamicin, an aminoglycoside antibiotic that works by stopping the growth of bacteria.

This medication treats only bacterial skin infections. It will not work for other types of skin infections (such as infections caused by fungi, viruses). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How To Use

This medication is for use on the skin only. Do not use it on the face, groin, or underarms unless directed to do so by your doctor. Wash your hands before using. Clean and dry the affected area as directed. Then apply a small amount of medication in a thin layer on the skin and rub in gently, usually 2 to 3 times a day or as directed by your doctor. Wash your hands after use, unless you are using this product to treat the hands.

Do not bandage, cover, or wrap the treated area unless you are instructed to do so by your doctor.

Do not use large amounts of this medication or apply this more often or for a longer period than directed. Your condition will not clear faster, but the risk of side effects may be increased.

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wipe off the medication and rinse thoroughly with water. Caution is advised if you are using this medication near the eyes because doing so may worsen or cause increased pressure in the eyes (glaucoma). Ask your doctor for more information.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition persists or worsens.

Side Effects

Burning, redness, irritation, or dryness of the skin may occur. If any of these effects persist or worsen, 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 any of these unlikely but serious side effects occur:

• stretch marks
• skin thinning/discoloration
• acne
• extreme/unwanted hair growth
• "hair bumps" (folliculitis)

Rarely, use of this medication for prolonged or repeated periods may result in other types of skin infections (such as fungal or other bacterial infections). Contact your doctor if you notice any unusual skin symptoms or if your condition does not improve.

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, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction:

• 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 betamethasone or gentamicin; or to corticosteroids (such as dexamethasone, prednisone); or to aminoglycoside antibiotics (such as amikacin, neomycin, tobramycin); 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
• a weakened immune system

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 not known whether this medication passes 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 (such as 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 aminoglycoside antibiotics (such as amikacin, neomycin, tobramycin)
• other corticosteroids (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 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. 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 another infection unless your doctor tells you to.

Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

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

Missed Dose

If you miss a dose, apply the medication 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.

Storage

Store at room temperature away from heat with the cap tightly closed. Keep all medicines 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. Consult your pharmacist or local waste disposal company.