Benzotic

In the U.S.

• A/B Otic
• Aurodex
• Auroto
• Benzotic
• Dec-Agesic A.B.
• Dolotic

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic, Local

Pharmacologic Class: NSAID

Chemical Class: Pyrazolone

Antipyrine and benzocaine 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 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 this medicine, the following should be considered:

Allergies

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

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.

Geriatric

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.

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

This section provides information on the proper use of a number of products that contain antipyrine and benzocaine. It may not be specific to Benzotic. Please read with care.

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

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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:

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

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.