Dibucaine (topical application route)


    Brand Name

    US Brand Name

    Nupercainal


    Description

    Dibucaine is used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

    Dibucaine belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

    This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

    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 on the relationship of age to the effects of dibucaine have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in children are not expected.

    Geriatric

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

    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 at or near the place of application or
    • Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

    Proper Use

    Use this medicine exactly as directed by your doctor or as directed in the package instructions. Do not use it for any other reason without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

    Wash your hands with soap and water before and after using this medicine.

    Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

    This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

    Be careful not to get any of this medicine in your nose, mouth, and especially in your eyes, because it can cause severe eye irritation. If any of the medicine does get on these areas, wash the area with water for at least 15 minutes and check with your doctor right away.

    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 pain and itching caused by minor skin conditions:
        • Adults—Apply to the affected area three or four times a day as needed. The largest amount that may be used in a 24-hour period is 30 grams (g), but much smaller amounts are usually enough.
        • Children 2 years of age and older—Apply to the affected area three or four times a day as needed. Do not use more than 7.5 g in a 24-hour period.
        • Children younger than 2 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.


    Precautions

    If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.

    After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. Dibucaine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

    Stop using this medicine and check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.

    Do not use cosmetics or other skin care products on the treated skin areas.


    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 pain
    • fast or irregular heartbeat
    • tightness in the chest
    • unusual warmth or flushing of skin

    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

    • Diarrhea
    • eye irritation
    • nausea
    • skin irritation
    • vomiting

    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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