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|Aurodex Otic

ANTIPYRINE AND BENZOCAINE (Otic)

Some commonly used brand names are:

In the U.S.—

• A/B Otic
• Allergen
• Analgesic Otic
• Antiben
• Auralgan
• Aurodex
• Auroto
• Dolotic
• Ear Drops
• Otocalm

In Canada—

• Auralgan
• Earache Drops

Generic name product may be available in the U.S.

Another commonly used name for antipyrine is phenazone . Another commonly used name for benzocaine is ethyl aminobenzoate .

Category

• Analgesic-anesthetic, otic
• Cerumen removal adjunct

Description

Antipyrine and benzocaine (an-tee-PYE-reen and BEN-zoe-kane) combination is used in the ear to help relieve the pain, swelling, and congestion of some ear infections. It will not cure the infection itself. An antibiotic will be needed to treat the infection. This medicine is also used to soften earwax so that the earwax can be washed away more easily.

In the U.S., this medicine is available only with your doctor"s prescription. In Canada, this medicine is available without a prescription. However, your doctor may have special instructions on the proper dose for your ear problem. This medicine is available in the following dosage form:

• Otic
• Otic solution (ear drops) (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For antipyrine and benzocaine combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to antipyrine or benzocaine or other local anesthetics. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although studies on effects in pregnancy have not been done in either humans or animals, this medicine has not been reported to cause problems in humans.

Breast-feeding—It is not known whether this medicine passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Infants, especially infants up to 3 months of age, may be especially sensitive to the effects of the benzocaine in this combination medicine. This may increase the chance of side effects. However, this medicine is not expected to cause different side effects or problems in older children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of antipyrine and benzocaine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medical problems—The presence of other medical problems may affect the use of antipyrine and benzocaine combination. Make sure you tell your doctor if:

• Your ear is draining—The chance of unwanted effects may be increased

Proper Use of This Medicine

You may warm the ear drops to body temperature (37 °C or 98.6 °F) by holding the bottle in your hand for a few minutes before applying the drops.

To use:

• Lie down or tilt the head so that the affected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. (For young children and other patients who cannot stay still for 5 minutes, try to keep the ear facing up for at least 1 or 2 minutes.) A sterile cotton plug may be moistened with a few drops of this medicine and gently placed at the ear opening for no longer than 5 to 10 minutes to help keep the medicine from leaking out. If you have any questions about this, check with your doctor.
• To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear).
• Do not rinse the dropper after use . Wipe the tip of the dropper with a clean tissue and keep the container tightly closed.

If you are using this medicine to help remove earwax, the ear should be flushed with warm water after you have used this medicine for 2 or 3 days. This is usually done by your doctor. If you have been directed to flush the ear out yourself, make sure that you have learned how to do it correctly. Follow the instructions carefully.

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 amounts of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

• For otic dosage form (ear drops):
  • Adults and children:
    • For ear pain caused by an infection—Use enough medicine to fill the entire ear canal every one or two hours until the pain is relieved.
    • For softening earwax before removal—Use enough medicine to fill the entire ear canal three times a day for two or three days.

Missed dose—If you miss a dose of this medicine, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects may mean that you are having an allergic reaction to the medicine. Stop using the medicine right away if any of them occur. Check with your doctor if any of the following effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 07/14/1995

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