Neo-fradin
Loading...Neo-fradin Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
(see boxed 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 neomycin have not been conducted. If neomycin 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Oral Solution and other antibacterial drugs, Neomycin Sulfate Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
History
There is currently no drug history available for this drug.
Other Information
NEO-FRADIN Oral Solution for oral administration contains neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. The pH range is 5.0 to 7.5. NEO-FRADIN Oral Solution is a clear orange solution with a cherry flavor. Each 5 mL of NEO-FRADIN Oral Solution contains 125 mg of neomycin sulfate (equivalent to 87.5 mg of neomycin).
Inactive ingredients: benzoic acid, FD&C yellow no. 6, cherry flavor, glycerin, methylparaben, proplyparaben, sodium phosphate dibasic heptahydrate, sulfuric acid, and purified water.
Sodium phosphate dibasic heptahydrate and sulfuric acid are used as pH adjusters.
The chemical name for Neomycin is: 0-2, 6-diamino-2, 6-dideoxy-α-D-lucopyranosyl-(1→3)- 0β-D-ribofuranosyl-(1→5)0-[2, 6-diamino-2, 6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine.
Neomycin B is identical except that the -α-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosly.
The molecular weight of Neomycin is 614.67. The structural formula is represented below:
neomycin molecular structure
Sources
Neo-fradin Manufacturers
-
X-gen Pharmaceuticals, Inc.
![Neo-fradin (Neomycin Sulfate) Solution [X-gen Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Neo-fradin | X-gen Pharmaceuticals, Inc.
To minimize the risk of toxicity use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.
Hepatic comaFor use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:
Withdraw protein from diet. Avoid use of diuretic agents.
Give supportive therapy including blood products, as indicated.
Give NEO-FRADIN Oral Solution in doses of four to twelve grams of neomycin sulfate per day in divided doses.
Treatment should be continued over a period of five to six days during which time protein should be returned incrementally to the diet.
If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin sulfate in doses of up to four grams daily may be necessary. The risks for the development of neomycin induced toxicity progressively increase when the treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.
Login To Your Free Account