Collagenase (topical application route)


    Brand Name

    US Brand Name

    Santyl


    Description

    Collagenase topical is used to clean skin ulcers and severe burns.

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

    This product is available in the following dosage forms:

    • Ointment

    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 collagenase topical in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    No information is available on the relationship of age to the effects of collagenase topical in geriatric patients.

    Breastfeeding

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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:

    • Infection, active—Use with caution. May make this condition worse.

    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. Do not use this medicine to treat a skin problem your doctor has not examined.

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

    To use:

    • Wash your hands with soap and water before and after using this medicine.
    • Before applying this medicine, gently cleanse the wound with normal saline solution, or as directed by your doctor.
    • Apply a thin layer to the affected areas of the skin and gently rub it in.
    • You may apply this medicine directly to the wound or to a sterile gauze pad. You may cover your wound with the sterile gauze pad applied with this medicine.

    Do not put cosmetics or skin care products on the treated skin. Tell your doctor if you are using soaps, antiseptic creams, or solutions.

    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 (ointment):
      • For cleaning of skin ulcers and severe burns:
        • Adults— Apply a thin layer to the affected area(s) of the skin once a day or as needed.
        • Children—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.


    Precautions

    It is important that your doctor check your progress at regular visits to see if the medicine is working properly.

    If your skin problem does not improve or if it becomes worse, check with your doctor.


    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:

    Incidence not known

    • Chest tightness
    • difficulty with swallowing
    • dizziness
    • fast heartbeat
    • fever
    • hives, itching, skin rash
    • hoarseness
    • irritation
    • joint pain, stiffness, or swelling
    • redness of the skin
    • swelling of the eyelids, face, lips, hands, or feet
    • trouble breathing

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Redness around the wound area

    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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