Neomycin Sulfate

Name: Neomycin Sulfate

Warnings

(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.

Clinical pharmacology

Neomycin sulfate is poorly absorbed from the gastrointestinal tract. The small absorbed fraction is rapidly distributed in the tissues and is excreted by the kidney in keeping with the degree of kidney function. The unabsorbed portion of the drug (approximately 97 percent) is eliminated unchanged in the feces.

Growth of most intestinal bacteria is rapidly suppressed following oral administration of neomycin sulfate, with the suppression persisting for 48-72 hours. Nonpathogenic yeasts and occasionally resistant strains of Enterobacter aerogenes (formerly Aerobacter aerogenes) replace the intestinal bacteria.

As with other aminoglycosides, the amount of systemically absorbed neomycin transferred to the tissues increases cumulatively with each repeated dose administered until a steady state is achieved. The kidney functions as the primary excretory path as well as the tissue binding site with the highest concentration found in renal cortex. With repeated dosings, progressive accumulation also occurs in the inner ear. Release of tissue bound neomycin occurs slowly over a period of several weeks after dosing has been discontinued.

Protein binding studies have shown that the degree of aminoglycoside protein binding is low and, depending upon the methods used for testing, this may be between 0 and 30 percent.

Microbiology

In vitro tests have demonstrated that neomycin is bactericidal and acts by inhibiting the synthesis of protein in susceptible bacterial cells. It is effective primarily against gram-negative bacilli but does have some activity against gram-positive organisms. Neomycin is active in vitro against Escherichia coli and the Klebsiella-Enterobacter group. Neomycin is not active against anaerobic bowel flora.

If susceptibility testing is needed, using a 30 mcg disc, organisms producing zones of 16 mm or greater are considered susceptible. Resistant organisms produce zones of 13 mm or less. Zones greater than 13 mm and less than 16 mm indicate intermediate susceptibility.

Indications

Suppression of Intestinal Bacteria: Neomycin sulfate tablets are indicated as adjunctive therapy as party 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

Overdose

Because of low absorption, it is unlikely that acute overdosage would occur with oral neomycin sulfate. However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove neomycin sulfate from the blood.

What should i avoid while taking neomycin (neo-fradin, neo-tab)?

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.

Where can i get more information?

Your doctor or pharmacist can provide more information about neomycin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Stability

Storage

Oral

Tablets

20–25°C in tight container.2

Oral Solution

15–30°C.1

Actions and Spectrum

  • Usually bactericidal.1 2 b

  • Inhibits protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.b

  • Following oral administration, rapidly suppresses growth of most intestinal bacteria; these are replaced by nonpathogenic yeasts and, occasionally, resistant strains of Enterobacter aerogenes.1 2 Suppression persists for 48–72 hours after the dose.1 2

  • In vitro spectrum of activity includes many gram-negative aerobic bacteria and some aerobic gram-positive bacteria.1 2 Inactive against fungi,b viruses,b and most anaerobic bacteria.1 2 b

  • Gram-negative aerobes: Active in vitro against Enterobacter, Escherichia coli, and Klebsiella.1 2

  • Partial cross-resistance occurs between neomycin and other aminoglycosides.b

Neomycin Sulfate Description

Neomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. Structurally, Neomycin Sulfate may be represented as follows:

Chemically, it is O-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→  3)-O-β-D-ribofuranosyl-(1→5)-O-[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-idopyranosyl.

Each tablet contains 500 mg Neomycin Sulfate (equivalent to 350 mg neomycin base).

Inactive Ingredients: Calcium Stearate, Colloidal Silicon Dioxide, Povidone.

Principal display panel

Neomycin Sulfate TABLETS USP, 500 MG

NDC 51991-738-01

Neomycin Sulfate 
Neomycin Sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-738
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Neomycin Sulfate (NEOMYCIN) NEOMYCIN 350 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE  
SILICON DIOXIDE  
POVIDONE, UNSPECIFIED  
Product Characteristics
Color WHITE (OFF WHITE) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code ZYNOVA;01
Contains     
Packaging
# Item Code Package Description
1 NDC:51991-738-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065468 01/03/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Oman Pharmaceutical Products Co. LLC 534770578 MANUFACTURE(51991-738)
Establishment
Name Address ID/FEI Operations
Nutra Med 080274725 PACK(51991-738)
Revised: 03/2017   Breckenridge Pharmaceutical, Inc.
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