What happens if I overdose Neo-Fradin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include change in urination frequency or amount of urine.
Proper storage of Neo-Fradin solution:
Store Neo-Fradin solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Neo-Fradin solution out of the reach of children and away from pets.
Overdose of Neo-Fradin in details
Because of low absorption, it is unlikely that acute overdosage would occur with oral Neo-Fradin. However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
Hemodialysis will remove Neo-Fradin from the blood.
What should I avoid while taking Neo-Fradin?
If you are being treated for hepatic coma, avoid eating foods that are high in protein. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.
Neo-Fradin warnings
Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions.
The risk of hearing loss continues after drug withdrawal.
Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of Neo-Fradin have not been conducted. If Neo-Fradin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
What should I discuss with my healthcare provider before taking Neo-Fradin?
Some medical conditions may interact with Neo-Fradin solution. 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 have diarrhea, a stomach infection, nerve damage, muscle weakness, Parkinson disease, kidney problems, or are dehydrated
Some MEDICINES MAY INTERACT with Neo-Fradin solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Penicillin because it may decrease Neo-Fradin solution's effectiveness
- Cephalosporins (eg, cephalexin), cyclosporine, fludarabine, loop diuretics (eg, furosemide), methoxyflurane, or nitrosoureas (eg, carmustine) because the risk of side effects such as kidney damage and hearing loss may be increased
- Anticoagulants (eg, warfarin), digoxin, loop diuretics (eg, furosemide), methotrexate, methoxyflurane, nondepolarizing muscle relaxants (eg, vecuronium), polypeptide antibiotics (eg, actinomycin), succinylcholine, or vancomycin because their actions and the risk of their side effects may be increased by Neo-Fradin solution
- Digoxin or methotrexate because their effectiveness may be decreased by Neo-Fradin solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Neo-Fradin solution 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.
Neo-Fradin precautions
General
Prescribing Neo-Fradin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibiotics, use of oral Neo-Fradin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.
Neo-Fradin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of Neo-Fradin.
Cross-allergenicity among aminoglycosides has been demonstrated.
Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
Small amounts of orally administered Neo-Fradin are absorbed through intact intestinal mucosa.
There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of Neo-Fradin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.
An oral Neo-Fradin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
Orally administered Neo-Fradin increases fecal bile acid excretion and reduces intestinal lactase activity.
Information for The Patient
Patients should be counseled that antibacterial drugs including Neo-Fradin tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Neo-Fradin tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Neo-Fradin tablets or other antibacterial drugs in the future.
Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.
Laboratory Tests
Patients with renal insufficiency may develop toxic Neo-Fradin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve (eighth cranial nerve) function.
Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.
Drug Interactions
Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of Neo-Fradin.
Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance Neo-Fradin’s nephrotoxicity and/or ototoxicity and potentiate Neo-Fradin’s neuromuscular blocking effects.
Oral Neo-Fradin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.
Oral Neo-Fradin may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed with Neo-Fradin to evaluate carcinogenic or mutagenic potential or impairment of fertility.
Pregnancy Category D
Nursing Mothers
It is not known whether Neo-Fradin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and efficacy of oral Neo-Fradin in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, Neo-Fradin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.
What happens if I miss a dose of Neo-Fradin?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "neomycin". http://www.drugbank.ca/drugs/DB00452 (accessed September 17, 2018).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
