Description
Crisaborole topical is used to treat mild to moderate atopic dermatitis (eczema).
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of crisaborole ointment in children. However, safety and efficacy have not been established in children younger than 3 months of age.
Geriatric
Appropriate studies on the relationship of age to the effects of crisaborole ointment have not been performed in the geriatric population. No geriatric-specific problems have been documented to date.
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 of the skin at or near the place of application or
- Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.
Proper Use
It is very important that you use this medicine only as directed by your doctor. 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 unwanted side effects or skin irritation.
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, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
To use the ointment:
- Wash your hands with soap and water before and after using this medicine.
- Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
- Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
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 mild to moderate atopic dermatitis:
- Adults and children 3 months of age and older—Apply a thin layer to the affected area of the skin 2 times a day. Your doctor may adjust your dose (apply once a day) as needed.
- Children younger than 3 months of age—Use and dose must be determined by your doctor.
- For mild to moderate atopic dermatitis:
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 very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
This medicine may cause serious allergic reactions, including contact urticaria. Check with your doctor right away if you or your child have a skin rash, severe itching, burning, redness, stinging, swelling, or irritation on the skin where the medicine is applied.
Do not use cosmetics or other skin care products on the treated 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:
Less common
- Burning, pain, redness, stinging, swelling, or skin irritation where the medicine is applied
- difficulty with breathing or swallowing
- fast heartbeat
- hives or welts, itching, or skin rash
- swelling of the face, throat, or tongue
Incidence not known
- Blistering, crusting, dryness, flaking, scaling, or soreness of the skin
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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