"The U.S. Food and Drug Administration (FDA) along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multi-state outbreak of Cyclospora infections. We are moving quickly to learn as much as"...
- Patient Information:
Details with Side Effects
Hepatic coma (portal-systemic encephalopathy)
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.
DOSAGE AND ADMINISTRATION
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.
For use as an adjunct in the management of hepatic coma, the recommended dose is 4-12 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.
NEO-FRADIN Oral Solution is available as a clear orange solution with a cherry flavor in 16 fl. oz bottles containing 125 mg of neomycin sulfate (equivalent to 87.5 mg of neomycin) per five mL.
NDC 39822-0330-5 for 16 fl. oz.
Store at controlled room temperature 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Manufactured for: X-Gen Pharmaceuticals, Inc. Revised November 2011
Last reviewed on RxList: 9/4/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Neo-Fradin Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.