Generic Name: Antipyrine/Benzocaine/Phenylephrine (an-tee-PYE-reen/BEN-zoe-kane/fen-ill-EF-rin)Brand Name: Examples include Otogesic and Tympagesic

Tympagesic is used for:

Relieving pain in the ear caused by various conditions. It may be used with antibiotics given by mouth to treat middle ear infections.

Tympagesic is an analgesic, anesthetic, and sympathomimetic combination. It works by relieving pressure and reducing inflammation, congestion, pain, and discomfort.

Do NOT use Tympagesic if:

  • you are allergic to any ingredient in Tympagesic or to similar medicines
  • your eardrum is perforated or you have discharge from your ear

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

Before using Tympagesic :

Some medical conditions may interact with Tympagesic . 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
  • if you are allergic to other local anesthetics (eg, lidocaine)
  • if you have asthma, high blood pressure, glaucoma or increased eye pressure, diabetes, heart problems (eg, ischemic heart disease), an enlarged prostate, or an overactive thyroid

Some MEDICINES MAY INTERACT with Tympagesic . However, no specific interactions with Tympagesic are known at this time.

Ask your health care provider if Tympagesic 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 Tympagesic :

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

  • For topical use in the ear canal only. Do not get Tympagesic in the eyes, nose, or mouth. If you get Tympagesic in your eyes, rinse thoroughly with cool water.
  • To use ear drops, 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 several minutes so the medicine can run to the bottom of the ear canal. Moisten a clean cotton plug with Tympagesic and gently insert into the ear canal to prevent medicine from leaking out.
  • To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Do not rinse dropper after use. Keep the container tightly closed.
  • If you miss a dose of Tympagesic , 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 Tympagesic .

Important safety information:

  • Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
  • Tympagesic 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.
  • Use Tympagesic with caution in the ELDERLY; they may be more sensitive to its effects
  • Tympagesic should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tympagesic while you are pregnant. It is not known if Tympagesic is found in breast milk. If you are or will be breast-feeding while you use Tympagesic , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tympagesic :

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); irritation not present when you began using Tympagesic ; redness, itching, blistering, or oozing at the application site.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include anxiety; dizziness; headache; nausea; nervousness; ringing in the ears; sweating; unusually pale or cool skin; vomiting.

Proper storage of Tympagesic :

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

General information:

  • If you have any questions about Tympagesic , please talk with your doctor, pharmacist, or other health care provider.
  • Tympagesic 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 Tympagesic . 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.