Neomycin Sulfate label

Neomycin Sulfate

Neomycin Sulfate Recall

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Side Effects & Adverse Reactions

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.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets USP and other antibacterial drugs, Neomycin Sulfate Tablets USP 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).

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.

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History

There is currently no drug history available for this drug.

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Other Information

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:

Chemical Structure

Chemical Structure

C23H46N6O13·2 H2SO4 MW 614.67

Chemically, it is 0-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→3)-0-β-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 a-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl.

Inactive Ingredients: Calcium Stearate, Povidone.

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Neomycin Sulfate Manufacturers

  • Major Pharmaceuticals
    Neomycin Sulfate | Major Pharmaceuticals
    No Recall

    Neomycin Sulfate | Major Pharmaceuticals

    Neomycin Sulfate | Major Pharmaceuticals

    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:

    Withdraw protein from diet. Avoid use of diuretic agents. Give supportive therapy, including blood products, as indicated. Give Neomycin Sulfate Tablets in doses of 4-12 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. 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.

  • Hi Tech Pharmacal Co Inc
    Neomycin Sulfate | Hi Tech Pharmacal Co Inc
    No Recall

    Neomycin Sulfate | Hi Tech Pharmacal Co Inc

    Neomycin Sulfate | Hi Tech Pharmacal Co 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 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:

    Withdraw protein from diet.  Avoid use of diuretic agents. Give supportive therapy, including blood products, as indicated. Give Neomycin Sulfate Tablets in doses of 4-12 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. 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.

  • Stat Rx Usa Llc
    Neomycin Sulfate | Stat Rx Usa Llc
    No Recall

    Neomycin Sulfate | Stat Rx Usa Llc

    Neomycin Sulfate | Stat Rx Usa Llc

    Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

  • Stat Rx Llc Usa
    Neomycin Sulfate | Stat Rx Llc Usa
    No Recall

    Neomycin Sulfate | Stat Rx Llc Usa

    Neomycin Sulfate | Stat Rx Llc Usa
    DOSAGE AND ADMINISTRATION

    One to two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

    Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

    FOR TOPICAL OPHTHALMIC USE ONLY.


  • Breckenridge Pharmaceutical, Inc.
    Neomycin Sulfate | Breckenridge Pharmaceutical, Inc.
    No Recall

    Neomycin Sulfate | Breckenridge Pharmaceutical, Inc.

    Neomycin Sulfate | Breckenridge Pharmaceutical, 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 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:

    Withdraw protein from diet. Avoid use of diuretic agents. Give supportive therapy, including blood products, as indicated. Give Neomycin Sulfate Tablets USP 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. 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.

  • X-gen Pharmaceuticals, Inc.
    Neomycin Sulfate | X-gen Pharmaceuticals, Inc.
    No Recall

    Neomycin Sulfate | X-gen Pharmaceuticals, Inc.

    Neomycin Sulfate | 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 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:

    Withdraw protein from diet.  Avoid use of diuretic agents. Give supportive therapy, including blood products, as indicated. 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. 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.

  • Golden State Medical Supply, Inc.
    Neomycin Sulfate | Golden State Medical Supply, Inc.
    No Recall

    Neomycin Sulfate | Golden State Medical Supply, Inc.

    Neomycin Sulfate | Golden State Medical Supply, 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 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:

    Withdraw protein from diet. Avoid use of diuretic agents. Give supportive therapy, including blood products, as indicated. Give Neomycin Sulfate Tablets USP 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. 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.

  • Teva Pharmaceuticals Usa Inc
    Neomycin Sulfate | Teva Pharmaceuticals Usa Inc
    No Recall

    Neomycin Sulfate | Teva Pharmaceuticals Usa Inc

    Neomycin Sulfate | Teva Pharmaceuticals Usa 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 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:

    Withdraw protein from diet. Avoid use of diuretic agents. Give supportive therapy, including blood products, as indicated. 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. 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.

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