Pronunciation:

nee-oh-MYE-sin

Brand Names:

• Neo-Fradin

Dosage Forms:

• Tablet
• Solution

Warnings:

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 .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Aminoglycoside

Uses of This Medicine:

Oral neomycin is used to help lessen the symptoms of hepatic coma, a complication of liver disease. In addition, it may be used with another medicine before any surgery affecting the bowels to help prevent infection during surgery.

Neomycin is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Damage to hearing, sense of balance, and kidneys is more likely to occur in premature infants and neonates, who are more sensitive than adults to the effects of neomycin.

Older adults—

Serious side effects, such as damage to hearing, sense of balance, and kidneys may occur in elderly patients, who are usually more sensitive than younger adults to the effects of neomycin.

Breast-feeding—

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.

Other 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

• Alcuronium
• Aspirin
• Atracurium
• Cidofovir
• Cisatracurium
• Colistimethate Sodium
• Decamethonium
• Doxacurium
• Emtricitabine
• Ethacrynic Acid
• Fazadinium
• Foscarnet
• Furosemide
• Gallamine
• Hexafluorenium
• Methotrexate
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Rapacuronium
• Rocuronium
• Sorafenib
• Tacrolimus
• Tenofovir Alafenamide
• Tubocurarine
• Vecuronium

Using this medicine 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.

• Bumetanide
• Digoxin
• Semaglutide

Other interactions—

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:

• Blockage of the bowel

• Eighth-cranial-nerve disease (loss of hearing and/or balance)—Oral neomycin may increase the chance of hearing loss and/or balance problems

• Kidney disease—Patients with kidney disease may have an increased chance of side effects

• Myasthenia gravis or
• Parkinson's disease—Patients with myasthenia gravis or Parkinson's disease may have an increased chance of developing muscular weakness

• Ulcers of the bowel—Patients with ulcers of the bowel may have an increased chance of side effects since more neomycin may be absorbed by the body

Proper Use of This Medicine:

This medicine may be taken on a full or empty stomach.

For patients taking the oral liquid form of neomycin:

• Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Keep taking this medicine for the full time of treatment. Do not miss any doses.

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 oral dosage forms (solution, tablets):
  • For patients in a coma from liver disease:
    • Adults and teenagers—1 to 3 grams every six hours for five or six days.
    • Children—Dose is based on body size (not weight) and must be determined by your doctor. That dose is given every six hours for five or six days.
  • For cleaning the bowel before surgery:
    • Adults and teenagers—1 gram every hour for four hours, then 1 gram every four hours for the rest of a twenty-four hour period; or 1 gram nineteen hours before surgery, 1 gram eighteen hours before surgery, and 1 gram nine hours before surgery.
    • Children—Dose is based on body weight. The usual dose is 14.7 milligrams (mg) per kilogram (kg) (6.7 mg per pound) of body weight every four hours for 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.

Side Effects of This Medicine:

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:

Rare

Any loss of hearing

clumsiness

diarrhea

difficulty in breathing

dizziness

drowsiness

greatly decreased frequency of urination or amount of urine

increased amount of gas

increased thirst

light-colored, frothy, fatty-appearing stools

ringing or buzzing or a feeling of fullness in the ears

skin rash

unsteadiness

weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Irritation or soreness of the mouth or rectal area

nausea or vomiting

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.