Neomycin Sulfate

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Overview

What is Neomycin Sulfate?

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

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

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What does Neomycin Sulfate look like?

What are the available doses of Neomycin Sulfate?

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What should I talk to my health care provider before I take Neomycin Sulfate?

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How should I use Neomycin Sulfate?

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 epidimiology and susceptibility patterns may contribute to the empiric selection of therapy.

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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.

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What interacts with Neomycin Sulfate?

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What are the warnings of Neomycin Sulfate?

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What are the precautions of Neomycin Sulfate?

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What are the side effects of Neomycin Sulfate?

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What should I look out for while using Neomycin Sulfate?

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 preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

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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.

What might happen if I take too much Neomycin Sulfate?

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.

How should I store and handle Neomycin Sulfate?

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09Neomycin 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 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature].Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, NY 14814Distributed by:Hi-Tech Pharmacal Co. Inc.Amityville, NY 11701Revised October, 2009REV. 565:02 10/09

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Neomycin sulfate is poorly absorbed from the normal 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%) 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 (formerly ) 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 the 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%.

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In vitro

in vitro

Escherichia coli

Klebsiella

Enterobacter

If susceptibility testing is needed, using a 30 msg 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.

Non-Clinical Toxicology

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 preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

(see

):

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.

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrtoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin ).

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 sulfate's neuromuscular blocking effects.

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

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

Prescribing neomycin sulfate tablets 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 nonsusceptible 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 malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

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

The most common adverse reactions to oral neomycin sulfate 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 ( ).

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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