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Neomycin (Neomycin Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets 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.

Suppression of intestinal bacteria : Neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, eg, preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION section).

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.

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.

Hepatic coma : For 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:

  1. Withdraw protein from diet.  Avoid use of diuretic agents.
  2. Give supportive therapy, including blood products, as indicated.
  3. Give Neomycin Sulfate Tablets in doses of 4 to 12 grams of neomycin sulfate per day (eight to 24 tablets) 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.
  4. If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when 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.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op Day 3 : Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op Day 2 : Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at  10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1 : Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m. and 2:00 p.m. Neomycin sulfate (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and  11:00 p.m. No enema

Day of Operation : Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

HOW SUPPLIED

Neomycin Sulfate Tablets, USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as round, off-white, unscored tablets, debossed "500" and "PT".  Supplied as: NDC 39822-0310-5 as Unit dose blister packages of 100 tablets (10 strips of 10 tablets each).  Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].

Dispense in tight containers as defined in the USP/NF.

Manufactured in Canada

Manufactured for:

X-Gen Pharmaceuticals, Inc.

Big Flats, NY 14814

Revised November, 2010

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