Cortane-B (otic)

Cortane-B (otic)

Cortane-B (otic)

What is Cortane Botic?

Hydrocortisone is a steroid. It reduces the effects of chemicals in the body that cause inflammation.

Pramoxine is a topical anesthetic. It works by interfering with the pain signals sent by nerves to the brain.

Cortane-B (for the ear) is a combination medicine used to treat infections in the ear canal and to relieve symptoms of itching or swelling. Cortane-B does not treat inner ear infections (also called middle ear infections).

The FDA has not approved the medical use of this product to treat ear infections. Cortane-B should not be taken in place of medications prescribed by your doctor.

Cortane-B may also be used for purposes not listed in this medication guide.

Cortane-Botic Side Effects

If necessary, get emergency medical helpSigns of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects from using this drug in the ears is low, side effects may occur if hydrocortisone is absorbed into your bloodstream.

Steroid medications that are absorbed through the skin in your ears can cause steroid side effects throughout the body, such as:thinning skin, easy bruising, changes in the shape or location of body fat (especially on the face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Stop using this medication and call your doctor immediately if you experience severe burning or other irritation after using the ear drops.

Common side effects may include a slight stinging or burning sensation upon first use.

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

Warnings

The FDA has not approved the medical use of this product to treat ear infections.

You should not use Cortane-B if you have a hole in your eardrum (ruptured eardrum) or if you also have chickenpox or cowpox.

Before you take this medicine

You should not use this medicine if you are allergic to chloroxylenol, hydrocortisone or pramoxine or if you have:

• a hole in your eardrum (ruptured eardrum); or

• Chickenpox or cowpox.

To make sure this medicine is safe for you, tell your doctor if you have:

• an inner ear infection;

• severe ear pain;

• hearing problems; or

• Fever.

It is not known whether Cortane-B will harm an unborn child. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether this medicine passes into breast milk or whether it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Do not give this medicine to a child without medical advice. Children may absorb larger amounts of this medicine through the ear canal and may be at higher risk of side effects.

How should I use Cortane-Botic?

Follow all instructions on your prescription label. Do not use Cortane-B in larger or smaller amounts or for longer than recommended.

For best results, remove earwax and other debris before using this medicine. Ask your doctor about safe methods for removing earwax.

How to use the ear drops:

• Lie down or tilt your head with your ear up. Open the ear canal by gently pulling your ear back or pulling the earlobe downward when giving this medicine to a child.

• Hold the pipette upside down over your ear and drip the correct number of drops into the ear.

• Remain lying down or with your head tilted for at least 5 minutes. You can use a small piece of cotton to plug the ear and prevent the medicine from leaking out.

• Another method of use is to insert a small piece of gauze into your ear and then drip in enough medicine to saturate the gauze in the ear canal.

• Leave the gauze in your ear for at least 24 hours and keep it moist by adding a few drops of the medicine to the cotton every 4 hours.

• After removing the gauze, you can apply the drops directly into your ear three to four times a day. Only use the number of drops prescribed by your doctor.

• Follow your doctor's instructions about how long to use Cortane-B ear drops.

Do not touch the dropper tip or place it directly in your ear. Contamination may occur. Wipe the tip with a clean cloth, but do not wash it with soap or water.

Call your doctor if your symptoms do not improve after 10 days of treatment.

Do not use Cortane-B to treat any ear condition that has not been checked by your doctor.

Store at room temperature, protected from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for the next scheduled dose. Do not take extra medicine to make up for a missed dose.

What happens if I overdose?

An overdose of Cortane-B is not expected to be dangerous. Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222 if someone accidentally swallows the medication.

What should I avoid when using Cortane-Botic?

This medicine is for use in the ear only. Avoid getting the medicine in your eyes, mouth, nose, or lips. If this medicine gets into or on these areas, rinse with water.

Do not use other ear medications unless your doctor tells you to.

What other drugs will affect Cortane-Botic?

Other medications you take orally or inject are unlikely to have an effect on Cortane-B in the ears. But many medications can interact with each other. Tell each of your healthcare providers about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal products.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.