How does this medication work? What will it do for me?

Clascoterone topical cream belongs to the class of medications called anti-androgens. This medication is used to treat acne vulgarisfor adolescents and adults 12 years of age and over.

While it is not clearly understood how clascoterone works to treat acne, this class of medications can reduce the production of oils from the sebaceous glands. Decreased oil production may help prevent skin pores from becoming blocked.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each gram of white-to-almost-white cream, contains 10 mg of clascoterone. Nonmedicinal ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, DL- alpha tocopherol (vitamin E), mineral oil, mono- and di- glycerides, polysorbate 80, propylene glycol, and water.

How should I use this medication?

Clascoterone is applied to the skin to treat acne twice daily, in the morning and evening.

To use this cream, wash your hands, then gently cleanse and dry the skin. Apply a thin layer of cream to the entire area of skin that is prone to developing acne. No more than 1 gram of cream should be applied each dosing time. One-half gram of cream is equal to the amount of cream squeezed along the index finger from the tip of the finger to the first joint. When spread on the skin, 1 gram should cover the size of an adult face.

Avoid areas near the lips, eyes, mouth, corners of the nose, or other soft tissues inside the mouth or nose. This cream should not be applied to skin that is cut, scraped, has eczema, or is sunburnt.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double amount to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Any cream that remains 1 month after first opening the tube should be safely discarded. Unopened tubes should be kept for a maximum of 180 days after receiving them from your pharmacy.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you are allergic to clascoterone or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • skin irritation at the area of application (e.g., itching, burning, redness, peeling, dryness, or change of hair colour)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • effects caused by decreased adrenal gland function:
    • altered mental state
    • depression
    • memory problems
    • menstrual changes
    • nausea
    • stomach pain
    • unexplained tiredness
    • unexplained weight loss
    • vomiting
    • weakness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body’s organs, including how your body responds to injury or stress. Clascoterone may cause your adrenal gland to function improperly if it is applied over a large area of the body, corticosteroid products are used, or the area you are treating is covered with a dressing that doesn’t allow the skin to be exposed to air. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

Skin irritation: Some people may experience temporary skin irritation, especially in the early weeks of treatment. If excessive reactions occur, and the skin becomes extremely red, swollen, thinned, or dry, stop taking the medication and contact your doctor.

Avoid using irritating or drying soaps and cleansers while using this cream. Products containing large amounts of alcohol, astringents, spices, or lime should be avoided if possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: It is not known if clascoterone passes into breast milk. If you are breast-feeding and using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children younger than 12 years of age.

What other drugs could interact with this medication?

There may be an interaction between clascoterone and any of the following:

  • topical or oral corticosteroids (e.g., hydrocortisone, prednisone)

If you are using any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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