Crisaborole topical

Crisaborole comes as an ointment to apply to the skin. It is usually applied twice a day. Use crisaborole at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use crisaborole exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

The ointment is only for use on the skin. Be careful not to get crisaborole ointment in your eyes, mouth, or vagina.

To use the ointment, follow these steps:

1. Wash your hands with soap and water.
2. Be sure that the skin in the affected area is dry.
3. Apply a thin layer of crisaborole ointment to all affected areas of your skin. Rub the ointment into your skin gently and completely.
4. Wash your hands with soap and water to remove any leftover crisaborole ointment. Do not wash your hands if you are treating them with crisaborole ointment. If a caregiver has applied the ointment, they should wash their hands after applying the ointment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Keep this medication in the tube it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Pregnancy

There are no available data in pregnant women to inform the drug-associated risk for major birth defects and miscarriage

Crisaborole is systemically absorbed

Animal studies

• No adverse developmental effects observed with oral administration in pregnant rats and rabbits during organogenesis at doses up to 5 and 3 times, respectively, the maximum recommended human dose (MRHD)

Lactation

Unknown if distributed in human breast milk

Crisaborole is systemically absorbed

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use crisaborole topical if you are allergic to it.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether crisaborole topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Crisaborole topical is not approved for use by anyone younger than 2 years old.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

It is not likely that other drugs you take orally or inject will have an effect on topically applied crisaborole. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, mouth, or vagina, rinse with water.

Apply a thin layer to the affected skin.

Wash your hands after applying this medicine, unless you are using it to treat eczema on your hands.

Crisaborole topical is usually applied twice daily. Follow your doctor's dosing instructions.

Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use.

An overdose of crisaborole topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next dose. Do not use extra medicine to make up the missed dose.