Benzoyl peroxide and clindamycin (topical application route)


    Brand Name

    Canadian Brand Name

    Clindoxyl


    Description

    Benzoyl peroxide and clindamycin combination is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean (tiny openings on the skin).

    This medicine is available only with your doctor's prescription.


    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of benzoyl peroxide and clindamycin combination in children younger than 12 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies on the relationship of age to the effects of Duac® gel and Onexton™ gel have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

    No information is available on the relationship of age to the effects of Benzaclin® gel in geriatric patients.

    Breastfeeding

    Substance Name

    Benzoyl Peroxide

    Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

    Substance Name

    Clindamycin

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Erythromycin

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Atracurium
    • Metocurine
    • Tubocurarine

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Stomach or bowel problems (eg, antibiotic-associated colitis, pseudomembranous colitis, regional enteritis, ulcerative colitis), history of—Should not be used in patients with these conditions.

    Proper Use

    It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

    This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

    This medicine should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    To use:

    • Wash your hands with soap and water before and after using this medicine.
    • Before applying this medicine, wash the affected area of your skin with warm water and a mild soap. Rinse well and pat dry.
    • Apply a small amount of the medicine to each affected area of the skin (eg, forehead, chin, cheeks, chest, shoulders), and gently rub it in.

    Do not apply the medicine to your hair or to any colored fabric. This medicine may cause bleaching.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For topical dosage form (gel):
      • For acne:
        • Adults and children 12 years of age and older—
          • Benzaclin®: Apply a thin layer to the affected area(s) of the skin two times a day (morning and evening).
          • Duac®: Apply a thin layer to the affected area(s) of the face once a day, in the evening, or as directed by your doctor.
          • Onexton™: Apply a thin layer to the affected area(s) of the face once a day.
        • Children younger than 12 years of age—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Throw away any unused Duac® gel after 60 days, Benzaclin® gel after 3 months, or Onexton™ after 10 weeks.


    Precautions

    It is important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to use it.

    This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

    This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, such as a hat.

    If you develop severe swelling, trouble breathing, or any allergic reaction to this medicine, check with your doctor right away.

    Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include skin peeling agents.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Dry skin

    Less common

    • Burning, itching, redness, skin rash, swelling, or soreness at the application site
    • flushing or redness of the skin
    • peeling
    • sunburn
    • unusually warm skin

    Incidence not known

    • Chest tightness
    • cough
    • difficulty with swallowing
    • dizziness
    • fast heartbeat
    • hives, itching, skin rash
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • trouble breathing
    • unusual tiredness or weakness

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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