Consumer Information for: VALISONE-G

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

VALISONE-G is used to treat inflamed skin (dermatosis) that may be infected by bacteria.

VALISONE-G contains an antibacterial ingredient called gentamicin, and it should be used exactly as directed by your healthcare professional.

What it does

VALISONE-G contains two medicines that work together in different ways:

  • Betamethasone 17-valerate is used to relieve swelling, redness, and itching
  • Gentamicin sulfate is a topical antibacterial agent to prevent and treat infection.
    • When it should not be used

  • If you are allergic to any of the ingredients in VALISONE-G (see “What are the ingredients in VALISONE-G?”) or the materials of the container.
  • If you have viral diseases including chicken pox, herpes simplex, and vaccinia, and in tuberculosis of the skin.
  • In or near the eyes.

    • To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VALISONE-G. Talk about any health conditions or problems you may have, including if:
  • Your condition gets worse or you have any other skin reactions or infections.
  • You use other medicines that contain steroids.
  • You are pregnant or planning to get pregnant.
  • You are breast-feeding or plan to breast-feed.
    • What the medicinal ingredient is

    Betamethasone Valerate USP and Gentamicin Sulfate USP.

    What the non-medicinal ingredients are

    Cream: Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Monobasic Sodium Phosphate, Phosphoric Acid, Polyethylene Glycol 1000 Monocetyl Ether, Purified Water, Sodium Hydroxide, and White Petrolatum.
    Ointment: White Petrolatum.

    What dosage form it comes in

    Cream or ointment.

    Warnings and precautions

    Using too much VALISONE-G may increase your chance of experiencing side effects. See “What are possible side effects from using VALISONE-G?”, below.

    Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

    Proper use of this medication

    How to take VALISONE-G

  • Apply a thin film of VALISONE-G (cream or ointment) to completely cover the affected area two or three times daily.
  • Although you may feel better early in treatment, VALISONE-G should be used exactly as directed.
  • Misuse or overuse of VALISONE-G could lead to the growth of bacteria that will not be killed by gentamicin. This means that VALISONE-G or other medicines that contain gentamicin may not work for you in the future.
  • Do not share your medicine.

    • Usual dose

    Apply two or three times daily.

    Overdose

    Using this drug for longer than recommended, can lead to medical conditions, such as Cushing’s disease or adrenal suppression.

    If you think you have taken too much VALISONE-G, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

    Missed Dose

    If you forget to use VALISONE-G as directed, apply it as soon as possible, then go back to your regular schedule.

    Side effects and what to do about them

    Common side effects when used with occlusive dressings

  • softening and breaking down of skin
  • secondary infection
  • thinning of skin
  • stretch marks
  • heat rash

    • Less common side effects include

  • burning, itching, dryness
  • inflammation around hair and mouth
  • excessive hair growth
  • acne
  • skin discoloration

    • Serious side effects, how often they happen and what to do about them
    Symptom / effect Talk to your healthcare professional
    Only if severe    		 Talk to your healthcare professional
    In all cases    		 Stop taking drug and get immediate medical help
    Allergic reaction : rash, hives     ✔
    Adrenal effects: Fatigue, increased urination / thirst, problems controlling blood sugar levels, weakness, weight loss.   ✔  

    If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

    How to store

    Store at 15 to 30°C.
    Keep out of reach and sight of children.

    Reporting side effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    More information

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this consumer medication information by visiting the Health Canada website; (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by calling 1-800-361-4261.

    • This leaflet was prepared by Valeant Canada LP.

    Last Revised: August 1, 2018

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