DrugindexOnline^{2nd edition}

Generic Name: Chloroxylenol/Hydrocortisone/Pramoxine Otic Solution (KLOR-ox-ee-ZIE-len-ole/HIGH-droe-CORE-tih-sone/pram-OX-een)
Brand Name: Examples include Cortane-B and Otozone

Otozone Solution is used for:

Treating certain infections of the outer ear canal that are complicated by inflammation. It is also used to control itching of the ear canal.

Otozone Solution is an antibacterial, steroid, and anesthetic combination. It works by killing bacteria, reducing inflammation, and temporarily relieving itching and pain.

Do NOT use Otozone Solution if:

• you are allergic to any ingredient in Otozone Solution
• you have chickenpox or vaccinia viral infection
• your eardrum is perforated

Contact your doctor or health care provider right away if any of these apply to you.

Before using Otozone Solution:

Some medical conditions may interact with Otozone Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Otozone Solution. Because little, if any, of Otozone Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Otozone Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Otozone Solution:

Use Otozone Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Otozone Solution is only for the ear. Do not get it in your eyes, nose, or mouth. If you get Otozone Solution in the eyes, flush thoroughly with cool water.
• Thoroughly clean and dry the outer ear before using Otozone Solution.
• Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for 5 minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.
• To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
• Wash your hands immediately after using Otozone Solution.
• If you miss a dose of Otozone Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Otozone Solution.

Important safety information:

• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Do not use Otozone Solution for other conditions than the one for which it was prescribed.
• Otozone Solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Caution is advised when using Otozone Solution in CHILDREN; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Otozone Solution while you are pregnant. It is not known if Otozone Solution is found in breast milk. If you are or will be breast-feeding while you use Otozone Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Otozone Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Otozone Solution; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Otozone Solution:

Store Otozone Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Otozone Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Otozone Solution, please talk with your doctor, pharmacist, or other health care provider.
• Otozone Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Otozone Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.