Drugs Details

Drugs Info of Neo-Fradin, Neo-Tab
Drugs Details
  • Drugs Type  : Multum
  • Date : 24th Feb 2015 03:07 am
  • Brand Name : Neo-Fradin, Neo-Tab
  • Generic Name : neomycin (Pronunciation: nee oh MY sin)
Descriptions

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, diatomaceous earth, 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-Dlucopyranosyl-(1→3)- 0β-D-ribofuranosyl-(1→5)0-[2, 6-diamino-2, 6-dideoxyα-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:

 

Neo-Fradin (Neomycin sulfate) Structural Formula Illustration

What are the possible side effects of neomycin (Neo-Fradin, Neo-Tab)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • hearing problems, ringing in your ears, or a feeling of fullness in the ears;
  • spinning sensation, nausea, feeling like you might pass out;
  • loss of balance or coordination, trouble walking;
  • numbness or tingly feeling under your skin;
  • muscle twitching, seizure (convulsions);
  • urinating less than...

Read All Potential Side Effects and See Pictures of Neo-Fradin »

This monograph has been modified to include the generic and brand name in many instances.

Indications

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 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 4-12 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 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.
  4. 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.

How Supplied

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

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The most common adverse reactions to oral neomycin are nausea, vomiting, and diarrhea. The “Malabsorption Syndrome” characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity, and neuromuscular blockage have been reported ( see BOXED WARNINGS AND PRECAUTIONS section).

Read the Neo-Fradin (neomycin sulfate) Side Effects Center for a complete guide to possible side effects

Learn More »

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 neomycin ( see BOXED WARNINGS).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin's nephrotoxicity and/or ototoxicity and potentiate neomycin's neuromuscular blocking effects.

Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorourcil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral neomycin may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Read the Neo-Fradin Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

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.

Precautions

General

Prescribing Neomycin Sulfate Oral Solution 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 neomycin may result in overgrowth of non-susceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Neomycin 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 neomycin.

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 neomycin are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with the oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral neomycin 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.

Oral administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Laboratory Tests

Patients with renal insufficiency may develop toxic neomycin 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with neomycin to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

( see WARNINGS section)

Nursing Mothers

It is not known whether neomycin 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 neomycin in patients less than eighteen years of age have not been established. If treatment of a patient less than eighteen years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed three weeks because of the absorption from the gastrointestinal tract.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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

Hemodialysis will remove neomycin from the blood.

ContrainDications

Neomycin sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin.

Neomycin sulfate oral solution is contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients should be counseled that antibacterial drugs including Neomycin Sulfate Oral Solution should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Neomycin Sulfate Oral Solution is 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 Neomycin Sulfate Oral Solution or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects of the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Neo-Fradin, Neo-Tab

Generic Name: neomycin (Pronunciation: nee oh MY sin)

  • What is neomycin (Neo-Fradin)?
  • What are the possible side effects of neomycin (Neo-Fradin)?
  • What is the most important information I should know about neomycin (Neo-Fradin)?
  • What should I discuss with my healthcare provider before taking neomycin (Neo-Fradin)?
  • How should I take neomycin (Neo-Fradin)?
  • What happens if I miss a dose (Neo-Fradin)?
  • What happens if I overdose (Neo-Fradin)?
  • What should I avoid while taking neomycin (Neo-Fradin)?
  • What other drugs will affect neomycin (Neo-Fradin)?
  • Where can I get more information?

What is neomycin (Neo-Fradin)?

Neomycin is an antibiotic that fights bacteria in the body.

Neomycin is used to reduce the risk of infection during surgery of your intestines. Neomycin is also used to reduce the symptoms of hepatic coma.

Neomycin may also be used for purposes not listed in this medication guide.

Neomycin 500 mg-TEV

round, white, imprinted with BL, 18

What are the possible side effects of neomycin (Neo-Fradin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • hearing problems, ringing in your ears, or a feeling of fullness in the ears;
  • spinning sensation, nausea, feeling like you might pass out;
  • loss of balance or coordination, trouble walking;
  • numbness or tingly feeling under your skin;
  • muscle twitching, seizure (convulsions);
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • swelling, weight gain, feeling short of breath;
  • weak or shallow breathing; or
  • severe stomach cramps, diarrhea that is watery or bloody.

Less serious side effects may include:

  • mild nausea, vomiting; or
  • mild diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Neo-Fradin (neomycin sulfate) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about neomycin (Neo-Fradin)?

You should not take this medicine if you are allergic to neomycin or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

You should not take neomycin if you have ulcerative colitis, Crohn's disease, a blockage in your intestines, or other inflammatory bowel disease.

Do not use neomycin if you are pregnant. It could harm the unborn baby.

Before you take neomycin, tell your doctor if you have kidney disease, myasthenia gravis, or Parkinson's disease.

Never take neomycin in larger amounts than recommended, or for longer than 2 weeks. High doses or long-term use of neomycin can cause serious kidney problems, or hearing loss that may not be reversible. The longer you take neomycin, the more likely you are to develop these serious side effects.

To be sure this medication is not causing harmful effects, your kidney function, and your nerve and muscle function will need to be tested often. You may also need hearing tests. Neomycin can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.

Neomycin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using neomycin, tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

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.

Side Effects Centers
  • Neomycin Sulfate
  • Neo-Fradin

Patient Detailed How Take

What should I discuss with my healthcare provider before taking neomycin (Neo-Fradin)?

You should not take this medicine if you are allergic to neomycin or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

You should not take neomycin if you have ulcerative colitis, Crohn's disease, a blockage in your intestines, or other inflammatory bowel disease.

To make sure you can safely take neomycin, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • myasthenia gravis; or
  • Parkinson's disease.

FDA pregnancy category D. Do not use neomycin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether neomycin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using neomycin.

How should I take neomycin (Neo-Fradin)?

Never take neomycin in larger amounts than recommended, or for longer than 2 weeks. High doses or long-term use of neomycin can cause serious kidney problems, or hearing loss that may not be reversible. The longer you take neomycin, the more likely you are to develop these serious side effects. Follow the directions on your prescription label.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Neomycin will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your kidney function, and your nerve and muscle function will need to be tested often. You may also need hearing tests. Neomycin can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.

If you are taking neomycin for hepatic coma, your treatment may also include a special diet. It is very important to follow the diet plan created for you by your doctor. You should become very familiar with the list of foods you should avoid to help control your condition.

If you need surgery, tell the surgeon ahead of time that you are using neomycin. Neomycin can interact with certain medicines that may be given during surgery.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

Side Effects Centers
  • Neomycin Sulfate
  • Neo-Fradin

Patient Detailed Avoid Taking

What happens if I miss a dose (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.

What happens if I overdose (Neo-Fradin)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking neomycin (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.

What other drugs will affect neomycin (Neo-Fradin)?

Neomycin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using neomycin, tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before you take neomycin, tell your doctor if you are using any other antibiotics, such as

  • amikacin (Amikin)
  • amphotericin-B (Amphotec);
  • bacitracin (Baci IM);
  • colistimethate (Coly Mycin M);
  • gentamicin (Garamycin);
  • kanamycin (Kantrex);
  • paromomycin (Humatin, Paromycin);
  • polymyxin B sulfate;
  • penicillin V (PC Pen VK);
  • streptomycin;
  • tobramycin (Nebcin, Tobi); or
  • vancomycin (Vancocin, Vancoled).

Tell your doctor about all other medicines you use, especially:

  • cisplatin (Platinol);
  • digoxin (digitalis, Lanoxin, Lanoxicaps);
  • methotrexate (Rheumatrex, Trexall);
  • vitamin B-12;
  • antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or tenofovir (Viread);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • a botulism toxin medication (Botox, Dysport, Myobloc, Xeomin, and others); or
  • a diuretic (water pill) such as bumetanide (Bumex), ethacrynic acid (Edecrin), furosemide (Lasix), or torsemide (Demadex).

This list is not complete and other drugs may interact with neomycin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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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