Description
Difamilast topical ointment is used to treat mild to moderate atopic dermatitis.
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 difamilast topical ointment in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of difamilast topical ointment in the elderly.
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.
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.
This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, or vagina. Do not apply this medicine to your nipple or areola, if you are breastfeeding. If it does get on these areas, rinse it off right away.
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.
To use the ointment:
- Wash your hands with soap and water before and after you use this medicine.
- Apply a thin layer to the affected area of the skin. Rub it in gently.
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 atopic dermatitis:
- Adults and children 2 years of age and older—Apply to the affected area of the skin 2 times a day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For 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 your or your child's progress at regular visits to make sure this medicine is working properly and to check for any unwanted effects.
If your condition 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:
More common
- Fever
- headache
- muscle aches
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common
- Blistering, burning, crusting, dryness, flaking of the skin
- burning, itching, and pain in hairy areas, pus at the root of hair
- itching, scaling, severe redness, soreness, swelling of the skin
- itchy, raised, round, smooth, skin-colored bumps found on just one area of the body, ooze thick white fluid
Incidence not known
- Swelling at the application site
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.
DRG-80010352
