Neomycin Sulfate 500 mg Tablet

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

NEOMYCIN - ORAL

(nee-oh-MY-sin)

COMMON BRAND NAME(S): Mycifradin

WARNING: This medication can rarely cause serious kidney problems and nerve damage, resulting in permanent hearing loss (including deafness or decreased hearing) and balance problems. These serious side effects may occur even in people without kidney problems and taking usual doses. Hearing problems may occur long after neomycin has been stopped. The risk is increased if you are older, already have kidney disease, or if you have a severe loss of body water (dehydration). Your risk is also increased if you receive high doses, or with longer use of this medication. Careful monitoring by your doctor (which may include hearing, kidney, and urine tests) will reduce the risk of these side effects. Avoid other medications that may increase your risk for these serious side effects if taken together with neomycin (See also Drug Interactions section). Tell your doctor right away if you notice any signs of these serious side effects, including: ringing/roaring sounds in the ears, hearing loss, dizziness, or an unusual decrease in the amount of your urine. Severe muscle and breathing problems may also rarely occur.

USES: This medication is used to decrease the risk of infection after certain intestinal surgeries. Neomycin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria in the intestines. Neomycin may also be used along with a special diet to treat a certain serious brain problem (hepatic encephalopathy). This condition is caused by too much of a certain natural substance (ammonia). Normally, the liver gets rid of ammonia, but liver disease can cause too much ammonia to build up in the body. This medication helps treat encephalopathy by killing certain intestinal bacteria that make ammonia. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

HOW TO USE: Take this medication by mouth exactly as prescribed by your doctor. To decrease the risk of infection after intestinal surgery, take this medication as directed by your doctor, usually for 3 or 4 doses the day before surgery. Carefully follow your doctor\'s directions for any diet restrictions and using this medication or other products before surgery. For treating hepatic encephalopathy, take this medication as directed by your doctor, usually four times a day for 5 to 6 days. The dosage is based on your medical condition and response to treatment. To decrease your risk of hearing loss and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more often, or take it for a longer time than prescribed. The manufacturer recommends that this medication should not be taken for longer than 2 weeks during each treatment period. If you are taking this medication for hepatic encephalopathy, take it at evenly spaced times for the best effect. To help you remember, take it at the same times each day. Tell your doctor if your condition lasts or gets worse.

SIDE EFFECTS: See also Warning section. Nausea, vomiting, and diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. 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: difficulty walking, numbness/tingling, muscle twitching or weakness, seizure. 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.

PRECAUTIONS: Before taking neomycin, tell your doctor or pharmacist if you are allergic to it; or to other aminoglycoside antibiotics (such as tobramycin); 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: hearing problems (including deafness, decreased hearing), intestinal problems (including blockage, swelling, ulcers), kidney problems, myasthenia gravis, Parkinson\'s disease. High doses or longer use of neomycin may cause your body to not properly absorb some foods, nutrients (such as iron, Vitamins A and B-12), and drugs (such as digoxin, warfarin). Consult your doctor for more details. Neomycin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using neomycin before having any immunizations/vaccinations. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Newborn and premature babies may be more sensitive to the side effects of this drug, especially hearing problems. This medication is not recommended for use during pregnancy. Although there have been reports of harm in babies born to women using similar drugs, the risk for harm may not be the same with this drug. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. However, many doctors consider breastfeeding safe while using this medication. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Precautions section. 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 health care professional. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Other medications that may affect the kidneys or hearing may increase the risk of kidney damage or hearing loss if taken with neomycin. Some examples include: amikacin, tobramycin, amphotericin B, cidofovir, cisplatin, polymyxin B, cephalosporins such as cephaloridine, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, among others.

OVERDOSE: 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.

NOTES: Do not share this medication with others. Lab and/or medical tests (such as hearing tests, kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you are taking this drug before a scheduled surgery to prevent infection and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, continue taking your dosing schedule as directed and ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up. If you are taking this drug to treat hepatic encephalopathy and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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 July 2023. Copyright(c) 2023 First Databank, Inc.