Systemic absorption of neomycin occurs following oral administration and toxic reactions may occur. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use.
Neurotoxicity (including ototoxicity) and nephrotoxicity following the oral use of neomycin sulfate have been reported, even when used in recommended doses. The potential for nephrotoxicity, permanent bilateral auditory ototoxicity and sometimes vestibular toxicity is present in patients with normal renal function when treated with higher doses of neomycin and/or for longer periods that recommended. Serial, vestibular, and audiometric tests, as well as tests of renal function, should be performed (especially in high risk patients).
The risk of nephrotoxicity and ototoxicity is greater in patients with impaired renal function. Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after neomycin has been discontinued.
Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena but mechanical respiratory assistance may be necessary.
Concurrent and/or sequential systemic, oral, or topical use of other aminoglycosides including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin, and viomycin should be avoided because the toxicity may be additive.
Other factors which increase the risk of toxicity are advanced age and dehydration.
The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance neomycin toxicity by altering the antibiotic concentration in serum and tissue .
Systemic absorption occurs following oral administration and toxic reactions may occur. Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Monitor renal and auditory function during therapy. Aminoglycoside-induced ototoxicity is usually irreversible. Neuromuscular blockade and respiratory paralysis have also been reported following administration. Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided .
Available Dosage Forms:
Therapeutic Class: Antibacterial
Chemical Class: Aminoglycoside
Neomycin belongs to the family of medicines called antibiotics. Neomycin topical preparations are used to help prevent infections of the skin. neomycin may be used for other problems as determined by your doctor.
Neomycin topical preparations are available without a 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 neomycin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to neomycin 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.
Studies on neomycin have been done only in adult patients, and there is no specific information comparing use of topical neomycin in children with use in other age groups.
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 or if they cause different side effects or problems in older people. There is no specific information comparing use of topical neomycin in the elderly with use in other age groups.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using neomycin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using neomycin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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.
If you are using neomycin without a prescription, do not use it to treat deep wounds, puncture wounds, serious burns, or raw areas without first checking with your health care professional.
Do not use neomycin in the eyes.
Before applying neomycin, wash the affected area with soap and water, and dry thoroughly.
For patients using the cream form of neomycin:
For patients using the ointment form of neomycin:
After neomycin is applied, the treated area may be covered with a gauze dressing if desired.
To help clear up your infection completely, keep using neomycin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.
The dose of neomycin 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 neomycin. 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.
If you miss a dose of neomycin, apply 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.
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.
If your skin problem does not improve within 1 week, or if it becomes worse, check with your health care professional.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
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.
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