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USP DI Vol. II - ANTIPYRINEAND BENZOCAINE (Otic)

ANTIPYRINEAND 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 inthe 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 treatthe infection. This medicine is also used to soften earwax so that the earwaxcan 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, yourdoctor 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 benzocainecombination, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic 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 notbeen done in either humans or animals, this medicine has not been reportedto cause problems in humans.

Breast-feeding?It is not known whether this medicine passes intothe 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 usingthis 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 combinationmedicine. This may increase the chance of side effects. However, this medicineis not expected to cause different side effects or problems in older childrenthan it does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of antipyrine and benzocaine in the elderly with use in otherage groups, this medicine is not expected to cause different side effectsor problems in older people than it does in younger adults.

Other medical problems?The presence of other medical problems may affectthe use of antipyrine and benzocaine combination. Make sure you tell yourdoctor if:

  • Your ear is draining?The chance of unwanted effects may beincreased

Proper Use of This Medicine

You may warmthe ear drops to body temperature (37 ?C or 98.6 ?F) by holding thebottle 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. Gentlypull the earlobe up and back for adults (down and back for children) to straightenthe ear canal. Drop the medicine into the ear canal. Keep the ear facing upfor about 5 minutes to allow the medicine to coat the ear canal. (For youngchildren and other patients who cannot stay still for 5 minutes, try to keepthe ear facing up for at least 1 or 2 minutes.) A sterile cotton plug maybe moistened with a few drops of this medicine and gently placed at the earopening for no longer than 5 to 10 minutes to help keep the medicine fromleaking 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 dropperto any surface (including the ear).
  • Do not rinse the dropper after use. Wipethe tip of the dropper with a clean tissue and keep the container tightlyclosed.

If you are using this medicine to help remove earwax, the ear should beflushed 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 theear 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 differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average amounts of this medicine. If your dose isdifferent, 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 tofill the entire ear canal every one or two hours until the pain is relieved.
      • For softening earwax before removal?Use enough medicine tofill 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 assoon as you remember. However, if it is almost time for your next dose, skipthe 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 surethat any discarded medicine is out of the reach of children.

Side Effects of This Medicine

Alongwith its needed effects, a medicine may cause some unwanted effects. The followingside 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 doctorif any of the following effects continue or are bothersome:

Itching, burning, redness, or oozing sores in the ear

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


Revised: 07/14/1995