Eflornithine Topical

This medication is used to slow down the growth of unwanted hair on the face and under the chin in women. It should not be used for hair on other parts of the body. It blocks a certain natural substance (an enzyme) that is needed for hair growth in the skin. This effect slows hair growth and may also make the hair finer and lighter. It does not remove hair or cause the hair to fall out.This drug is not for use in children younger than 12 years.

This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.Apply a thin layer of this medication only to the affected areas of the face and chin, and rub in well. It is usually applied twice daily at least 8 hours apart or as directed by your doctor. Do not apply for at least 5 minutes after hair removal (e.g., plucking, shaving). Do not wash the treated area for at least 4 hours.Wash hands immediately after using this product. This medication is for use on the skin only. Avoid getting the product in your eyes, nose, or mouth. If the medication gets in these areas, rinse immediately with clean water. If this drug gets in your eyes, rinse thoroughly with water and contact your doctor.Wait until the medication has dried completely before applying cosmetics, moisturizers, or sunscreens over the treated areas.This product is not a hair removal product. Continue to use hair removal techniques (e.g., shaving, plucking) while using this medication. If you stop using this product, hair growth will return.You should see some improvement in 4 to 8 weeks. This medication works slowly. Use exactly as directed. Do not use more of this product or use it more often. Your condition will not improve faster, and the risk of side effects will increase. Tell your doctor if your skin becomes red or irritated. Your doctor may direct you to apply the medication only once a day or stop the medication.Tell your doctor if your condition persists or worsens.

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse thoroughly with water and contact your doctor.

Before using eflornithine topical, talk to your doctor if you are taking any other prescription or over-the-counter medications, especially if you are using any other topical preparations. You may not be able to use eflornithine topical, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with eflornithine topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

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 eflornithine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to eflornithine 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

There is no specific information comparing use of eflornithine in children under the age of 12 years with use in other age groups. However, eflornithine is not expected to cause different side effects or problems in older children than it does in adults.

Geriatric

eflornithine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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.

If skin irritation occurs, reduce the frequency of treatments. If irritation continues, stop using the medicine and contact your doctor.

If no improvement is seen after six months of treatment, stop using the medicine and contact your doctor.

If condition gets worse while you use the medicine, stop the medicine and contact your doctor.

Eflornithine interferes with a chemical in hair follicles under the skin, which slows hair growth where the medicine is applied.

Eflornithine topical is used to reduce unwanted facial hair in women.

Eflornithine topical does not permanently remove facial hair or prevent hair growth.

Eflornithine topical may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using eflornithine and call your doctor at once if you have:

• severe irritation of treated skin; or

• redness or crusting around your hair follicles.

Common side effects may include:

• temporary redness, rash, burning, stinging, itching, or tingling;

• acne or red bumps on the skin;

• skin dryness; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of any skin care or hair removal products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not apply more to catch up.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medicines away from children and pets. Do not freeze. Do not use after expiration date.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.