This medication is used to relieve pain, congestion, and swelling caused by middle ear inflammation (acute otitis media). This medication is also used to help remove earwax. This product contains 2 main medications. Benzocaine is a topical anesthetic that helps to numb the pain. Antipyrine is an analgesic that helps to decrease the pain and inflammation. This product may also contain glycerin, which helps to soften the earwax, and/or zinc acetate, which helps to protect the skin.
How to use Ear Drops 5.4 %-1.4 %
Use this medication exactly as directed by your doctor.
An antibiotic medication may sometimes be prescribed along with this medication if you also have an infection.
To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person insert the drops if possible. To lower the risk of dizziness, hold the container in your hand for a few minutes to warm it. To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted for about 2 minutes, or insert a soft cotton plug if so directed. You may be instructed by your doctor to moisten the cotton plug with this medication. Repeat for the other ear if so directed. Do not rinse the dropper. Replace the cap after use.
If you are using this medication to help remove earwax, gently rinsing the ear with warm water or using a soft rubber bulb after 2 to 3 days of treatment may help remove any remaining earwax. Consult your doctor or pharmacist about the safe use of an ear bulb.
Do not use in the eye.
Do not use this medication if it is brown or contains particles.
Inform your doctor if your condition lasts after a few days of treatment or if it gets worse.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: burning/stinging/redness/new pain in or around the ears.
This medication has rarely caused a very serious (possibly fatal) blood disorder (methemoglobinemia). This effect is more likely if you have breathing problems, certain diseases of the blood, or if you smoke (see also Precautions section). The symptoms of this disorder may occur within minutes to a couple of hours after using this medication. Stop using this medication and get medical help right away if you develop any symptoms of methemoglobinemia, including: pale/bluish/gray skin, unusual tiredness, shortness of breath, fast heartbeat, dizziness, headache, confusion.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using this medication, tell your doctor or pharmacist if you are allergic to antipyrine, benzocaine, or other ingredients in this product (such as glycerin, zinc acetate); or to other ester-type anesthetics (such as procaine, tetracaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: ear injuries/surgery (such as hole in the eardrum), certain blood disorders (G6PD deficiency, pyruvate kinase deficiency, hemoglobin-M disease, NADH-methemoglobin reductase deficiency), breathing problems (such as asthma, bronchitis, emphysema, smoking history).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
This medication has been prescribed for your current condition only. Do not use it later for another ear problem unless told to do so by your doctor. A different medication may be necessary in that case.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and heat. Keep bottle tightly closed. Do not freeze. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
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