Toxicity:
After oral administration of Neomycin, the drug can be systemically absorbed, potentially leading to toxic reactions. Close clinical observation is necessary for patients receiving Neomycin due to the potential for toxicity. Neurotoxicity, including ototoxicity (damage to the hearing and balance organs) and nephrotoxicity (kidney damage), have been reported with oral neomycin use, even at recommended doses. There is a risk of nephrotoxicity, permanent bilateral auditory ototoxicity, and sometimes vestibular toxicity in patients with normal kidney function when Neomycin is used in higher doses or for longer periods than recommended. Regular vestibular and audiometric tests, as well as renal function tests, should be performed, especially in high-risk patients. The risk of nephrotoxicity and ototoxicity is higher in patients with impaired renal function. Ototoxicity may have a delayed onset, and patients may not experience symptoms during treatment, leading to potential deafness long after discontinuing Neomycin.
Other factors that increase the risk of toxicity include advanced age and dehydration.
Neuromuscular blockade:
There have been reports of neuromuscular blockage and respiratory paralysis following oral neomycin use. The possibility of these effects should be considered, especially when Neomycin is administered to patients receiving anesthesia or neuromuscular-blocking agents such as tubocurarine, succinylcholine, or decamethonium or to those undergoing massive transfusions of citrate anticoagulated blood. If a blockage occurs, calcium salts may reverse these effects, but mechanical respiratory assistance may be necessary.
Concurrent therapy:
The concurrent or sequential use of other aminoglycosides (e.g., paromomycin) or drugs with potential nephrotoxic or neurotoxic effects (e.g., bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin, viomycin) should be avoided as their toxicity may be additive.
The use of Neomycin with potent diuretics like ethacrynic acid or furosemide should be avoided, as both Neomycin and certain diuretics have the potential for ototoxicity. Furthermore, when diuretics are administered intravenously (IV), they may enhance neomycin toxicity by affecting the antibiotic concentration in the blood and tissues.
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Neomycin is an antibiotic agent belonging to the pharmacological class of Aminoglycoside antibiotics.
Neomycin has been approved to relieve symptoms and also for the treatment and maintenance of Neomycin can help to relieve symptoms and also for the treatment and maintenance of Small intestinal bacterial overgrowth, methanogen overgrowth, Surgical prophylaxis, colorectal, Impetigo, Infected wounds, Dermatitis, Ear Infections.
Neomycin, once absorbed, only a small fraction, distributes rapidly in the tissues. The drug is reported to have a cumulative increase in systemic absorption with repeated doses until a steady state is reached. Neomycin has a low protein binding profile, typically ranging from 0-30%. Metabolism of Neomycin is considered negligible due to limited systemic absorption. The small absorbed fraction of Neomycin is primarily excreted by the kidneys, while the unabsorbed portion is eliminated unchanged in the feces.
The common side effects involved in using Neomycin are Nausea, Vomiting, Diarrhea, Abdominal cramps or discomfort, Loss of appetite, Skin rash or irritation, and Itching.
Neomycin is available in the form of Tablets, Oral Solutions., Topical creams, Injectable solutions, and Eye/ear drops.
Neomycin is approved in Germany, Japan, Malaysia, India, the U.K., the U.S., and China.
Neomycin belongs to the pharmacological class of Bacteriostatic antibiotics.
Neomycin, similar to other antibiotics in the aminoglycoside class, works by interfering with bacterial ribosomes. It accomplishes this by binding to the 30S ribosomal subunit of susceptible bacteria, which disrupts the normal process of bacterial protein synthesis. In the usual course of bacterial translation, mRNA initially binds to the 30S subunit, followed by binding with the 50S subunit for elongation. Neomycin's mechanism of action disrupts this essential process, inhibiting bacterial protein synthesis.
Neomycin has been approved to relieve symptoms and also for the treatment and maintenance of Neomycin can help to relieve symptoms and also for the treatment and maintenance of Small intestinal bacterial overgrowth, methanogen overgrowth, Surgical prophylaxis, colorectal, Impetigo, Infected wounds, Dermatitis, Ear Infections.
Neomycin has variable pharmacokinetics depending on the route of administration and individual factors. When taken orally, Neomycin reaches peak plasma concentration (Cmax) within 1-3 hours, with a time to reach peak concentration (Tmax) of approximately 1-3 hours. Its onset of action is relatively quick, typically occurring shortly after reaching therapeutic concentrations. The duration of action for Neomycin is reported to be 48 to 72 hours.
When administered by injection (intramuscular or intravenous), Neomycin achieves Cmax within 1-2 hours, with a Tmax of around 1-2 hours. Similar to oral administration, Neomycin exhibits a rapid onset of action after reaching therapeutic levels. The duration of action for injectable Neomycin is generally within the range of 48 to 72 hours.
Neomycin is found to be available in the form of Tablets, Oral Solutions., Topical creams, Injectable solutions, and Eye/ear drops.
Neomycin can be used in the following treatment:
- Small intestinal bacterial overgrowth, methanogen overgrowth
- Surgical prophylaxis, colorectal
- Impetigo
- Infected wounds
- Dermatitis
- Ear infections
Neomycin can help to relieve symptoms and also for the treatment and maintenance of Small intestinal bacterial overgrowth, methanogen overgrowth, Surgical prophylaxis, colorectal, Impetigo, Infected wounds, Dermatitis, Ear Infections.
Neomycin is approved for use in the following clinical indications:
- Small intestinal bacterial overgrowth, methanogen overgrowth
- Surgical prophylaxis, colorectal
- Impetigo
- Infected wounds
- Dermatitis
- Ear infections
- Small intestinal bacterial overgrowth and methanogen overgrowth (off-label use):
For the treatment of small intestinal bacterial overgrowth and methanogen overgrowth, Neomycin is administered orally at a dose of 500 mg twice daily. It is typically used in combination with rifaximin for a duration of 14 days .
- Surgical prophylaxis, colorectal:
For surgical prophylaxis in colorectal procedures, Neomycin is administered orally. The recommended dose is 1 g at 1 PM, 2 PM, and 11 PM on the day preceding the 8 AM surgery. This is used in conjunction with other appropriate agents and as an adjunct to mechanical cleansing of the intestine. It is followed by an appropriate regimen of intravenous antibiotic prophylaxis.
- Impetigo: This is a highly contagious bacterial skin infection characterized by red sores that break open, ooze fluid, and develop a yellowish-brown crust. Neomycin can be applied topically to help treat impetigo.
- Infected Wounds: Neomycin may be used as a topical agent for the treatment of infected wounds caused by susceptible bacteria. It helps prevent or control bacterial growth and promotes wound healing.
- Dermatitis: Certain types of dermatitis, such as contact dermatitis or allergic dermatitis, can become infected with bacteria. Neomycin may be included in topical preparations to help treat the secondary bacterial infection.
- Ear Infections : Neomycin is typically used as a component of eardrops for the treatment of external otitis or swimmer's ear, which is an infection of the ear canal. These eardrops usually contain a combination of neomycin, polymyxin B, and hydrocortisone. Neomycin helps eliminate or control bacterial growth, while polymyxin B has a similar action and hydrocortisone helps reduce inflammation and relieve symptoms. The combination of these ingredients is effective against various bacterial pathogens commonly associated with ear infections.
Neomycin is available in different strengths depending on the dosage form. Here are some common strengths of Neomycin:
- Oral Tablets: Neomycin sulfate oral tablets are available in various strengths, such as 250 mg and 500 mg.
- Oral Solution: Neomycin sulfate oral solution is available in different concentrations, typically ranging from 125 mg/5 mL to 500 mg/5 mL.
- Topical Cream/Ointment: Neomycin topical preparations may vary in strength, commonly ranging from 0.5% to 3% neomycin sulfate.
- Eye/Ear Drops: Neomycin eye or ear drops are available in strengths ranging from 0.5% to 0.35% neomycin sulfate.
- Injectable Solution: Neomycin injectable solution is typically available in strengths of 200 mg/mL or 500 mg/mL.
Tablets, Oral Solution., Topical cream, Injectable solutions, Eye/ear drops.
- Dosage Adjustments in Kidney Patients:
The manufacturer's labeling does not specify any dosage adjustments; however, it is important to consider reducing the dosage or discontinuing neomycin therapy if a patient develops renal insufficiency. Patients with renal impairment have an increased risk of nephrotoxicity and/or ototoxicity.
- Dosage Adjustments in Pediatric Patients:
Neonates
- For the treatment of diarrhea in preterm and newborn infants, the recommended dose is 50 mg/kg/day of Neomycin administered orally, divided into equal doses every 6 hours.
Children
- In cases of hepatic encephalopathy, the recommended dose is 50-100 mg/kg/day of Neomycin administered orally, divided into equal doses every 8 hours for a duration of 5-6 days. The total daily dose should be at most 12 grams within a 24-hour period.
- For bowel preparation, the recommended dose is 90 mg/kg/day of Neomycin administered orally, divided into equal doses every 4 hours for a period of 2-3 days.
- In the treatment of diarrhea caused by enteropathogenic E. coli, the recommended dose is 50 mg/kg/day of Neomycin administered orally, divided into equal doses every 6 hours for a duration of 2-3 days.
There are no specific dietary restrictions associated with the use of Neomycin. However, it is generally recommended to follow a healthy and balanced diet while taking any medication.
It is important to note that certain foods and beverages may interact with Neomycin or affect its absorption. High-fiber foods and dairy products can potentially interfere with the absorption of Neomycin. To optimize the effectiveness of Neomycin, it may be beneficial to separate the consumption of these foods from the administration of the medication by a few hours.
Neomycin may be contraindicated under the following conditions:
- Oral preparations of neomycin sulfate should not be used in individuals with intestinal obstruction or known hypersensitivity to the drug.
- Patients who have a history of hypersensitivity or serious toxic reactions to other aminoglycosides may be at risk of cross-sensitivity to Neomycin.
- The use of neomycin sulfate oral solution is not recommended in patients with inflammatory or ulcerative gastrointestinal disease due to the possibility of increased absorption of Neomycin in the gastrointestinal tract.
The physician should closely monitor the patients and keep pharmacovigilance as follows:
- Allergic Reactions: Some individuals may be hypersensitive to Neomycin, which can lead to allergic reactions. If you experience signs of an allergic reaction, such as swelling, rash, itching, or difficulty breathing, seek immediate medical attention.
- Neurotoxicity: Neomycin can have neurotoxic effects, particularly when administered systemically or in high doses. This can result in symptoms such as muscle twitching, numbness, tingling, or neurological disturbances. Report any unusual or concerning neurological symptoms to your healthcare professional.
- Nephrotoxicity: Prolonged use or high doses of Neomycin can potentially lead to kidney damage or impaired kidney function. If you experience changes in urine output, increased thirst, or swelling, notify your healthcare professional.
- Ototoxicity: Neomycin can cause damage to the inner ear, leading to hearing loss, tinnitus (ringing in the ears), dizziness, or balance problems. Be vigilant for any changes in your hearing or balance, and report them to your healthcare professional.
- Gastrointestinal Effects: Neomycin can disrupt the normal balance of bacteria in the gastrointestinal tract, leading to gastrointestinal symptoms such as nausea, vomiting, diarrhea, abdominal discomfort, or loss of appetite.
Alcohol Warning
There are no specific warnings regarding the consumption of alcohol while taking Neomycin. However, it is generally advisable to exercise caution when consuming alcohol while on any medication.
Alcohol can have various effects on the body and may interact with certain medications, including Neomycin. It can potentially increase the risk of side effects such as dizziness, drowsiness, or gastrointestinal discomfort. Additionally, alcohol can have its own effects on the liver and may affect the body's ability to metabolize medications.
Breast Feeding Warning
The use of Neomycin while breastfeeding should be approached with caution. Neomycin is poorly absorbed from the gastrointestinal tract, which reduces the amount that enters the bloodstream and, consequently, the amount that can be excreted into breast milk. However, there is a possibility of minimal systemic absorption and potential adverse effects on the infant.
Pregnancy Warning
Pregnancy Category D:
If Neomycin is considered necessary for the treatment of a pregnant individual, the healthcare professional will assess the potential benefits against the potential risks and consider alternative treatment options. They will take into account factors such as the severity of the condition, the availability of safer alternatives, and the stage of pregnancy.
It is important to consult with a healthcare professional who can provide personalized advice and guidance based on your specific situation. They will consider the most up-to-date information and help you make an informed decision about the use of Neomycin during pregnancy.
Food Warning
Dairy Products: Neomycin may interact with dairy products, particularly those containing calcium. Calcium can form complexes with Neomycin, reducing its absorption and effectiveness. To ensure optimal absorption of Neomycin, it is advisable to separate the administration of neomycin and dairy products by at least two hours.
High-Fiber Foods: Consuming high-fiber foods, such as whole grains, bran, and fruits, along with Neomycin may decrease its absorption. It is recommended to space out the intake of high-fiber foods and Neomycin to avoid potential interactions. Following the prescribed dosing schedule is crucial for maximizing the drug's effectiveness.
Grapefruit and Grapefruit Juice: Grapefruit and its juice can interfere with the metabolism of certain medications, including Neomycin. This can lead to increased neomycin levels in the bloodstream, potentially intensifying its side effects. It is advisable to avoid grapefruit or grapefruit juice while taking Neomycin unless otherwise instructed by a healthcare professional.
The adverse reactions related to Neomycin can be categorized as follows:
Common
- Nausea
- Vomiting
- Diarrhea
- Abdominal cramps or discomfort
- Loss of appetite
- Skin rash or irritation
- Itching
Less Common
- Dizziness
- Headache
- Tinnitus (ringing in the ears)
- Hearing loss or changes in hearing
- Muscle twitching
- Neurological symptoms (confusion, numbness, tingling)
- Changes in kidney function
- Blood disorders (thrombocytopenia, leukopenia)
Rare
- Severe allergic reactions (swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing)
- Anaphylaxis (a severe, potentially life-threatening allergic reaction)
- Neurotoxicity (rare cases of nerve damage)
The clinically relevant drug interactions of Neomycin are briefly summarized here:
- Aminoglycoside Antibiotics: Concurrent use of Neomycin with other aminoglycoside antibiotics (such as gentamicin or tobramycin) may increase the risk of ototoxicity and nephrotoxicity.
- Loop Diuretics: Neomycin may enhance the potential for hearing loss and kidney damage when used with loop diuretics like furosemide.
- Neuromuscular Blocking Agents: Neomycin can enhance the effects of neuromuscular blocking agents, leading to increased muscle weakness or respiratory depression.
- Oral Anticoagulants: Neomycin may interfere with the effectiveness of oral anticoagulant medications like warfarin, necessitating close monitoring of clotting parameters.
- Methoxyflurane: Concurrent use of Neomycin with methoxyflurane, an anesthetic, may increase the risk of kidney toxicity.
- Non-absorbable Oral Medications: Neomycin may reduce the effectiveness of non-absorbable oral medications, such as oral contraceptives or drugs used for bowel preparation, due to its potential to disrupt gastrointestinal absorption.
The following are the side effects involving Neomycin:
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort or cramps
- Loss of appetite
- Skin rash
- Itching
- Skin irritation or redness
- Swelling of the face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Hives or other skin reactions
Pregnancy:
Pregnancy Category D:
If Neomycin is considered necessary for the treatment of a pregnant individual, the healthcare professional will assess the potential benefits against the potential risks and consider alternative treatment options. They will take into account factors such as the severity of the condition, the availability of safer alternatives, and the stage of pregnancy.
It is important to consult with a healthcare professional who can provide personalized advice and guidance based on your specific situation. They will consider the most up-to-date information and help you make an informed decision about the use of Neomycin during pregnancy.
Nursing Mothers
The use of Neomycin while breastfeeding should be approached with caution. Neomycin is poorly absorbed from the gastrointestinal tract, which reduces the amount that enters the bloodstream and, consequently, the amount that can be excreted into breast milk. However, there is a possibility of minimal systemic absorption and potential adverse effects on the infant.
Pediatric Use
The safety and effectiveness of oral Neomycin have not been established for patients under the age of eighteen. If Neomycin is deemed necessary for the treatment of a patient in this age group, caution should be exercised, and the duration of treatment should not exceed three weeks due to the potential for absorption from the gastrointestinal tract.
Physicians should be knowledgeable as well as vigilant about the treatment and identification of over dosage of Neomycin.
Due to its limited absorption, the occurrence of acute over dosage with oral Neomycin is unlikely. However, prolonged use of the drug can lead to elevated systemic levels, potentially causing neurotoxicity, ototoxicity, and/or nephrotoxicity.
Neomycin can be eliminated from the bloodstream through hemodialysis.
Pharmacodynamics
Neomycin exerts its bactericidal effect by inhibiting bacterial protein synthesis, leading to the suppression of growth and survival in susceptible bacteria. When taken orally, the bactericidal activity of Neomycin typically lasts between 48 to 72 hours. By reducing the population of colonic bacteria responsible for ammonia production, Neomycin has been demonstrated to be an effective adjunctive therapy for improving neurological symptoms in hepatic coma.
Neomycin demonstrates activity against a wide range of bacteria, including both gram-positive and gram-negative organisms. This includes various strains of E. coli present in the colon, as well as enteropathogenic forms of E. coli. It also exhibits activity against the Klebsiella-Enterobacter group. However, it's important to note that resistant strains of E. coli, Klebsiella, and Proteus species may emerge as a result of neomycin treatment. Neomycin does not possess antifungal properties but does exhibit some activity against certain protozoa.
Pharmacokinetics
● Absorption: Neomycin is poorly absorbed from the gastrointestinal tract. However, the absorption of the drug may be increased in the presence of inflammatory or ulcerative gastrointestinal disease.
● The volume of Distribution: Once absorbed, a small fraction of Neomycin is rapidly distributed in the tissues. The amount of systemically absorbed Neomycin is reported to increase cumulatively with each repeated dose administered until a steady state is reached.
● Protein Binding: Studies suggest that neomycin sulfate has a low protein binding profile, ranging from 0-30%, depending on the test methods used.
● Metabolism: There is limited information available on the metabolism of Neomycin since systemic absorption following drug administration is limited. Metabolism is considered to be negligible.
● Route of Elimination: The small fraction of Neomycin that is absorbed is primarily excreted by the kidneys. The unabsorbed portion of the drug is eliminated unchanged in the feces.
- Study: "Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension in the treatment of bacterial conjunctivitis"
- This study investigated the efficacy of neomycin and polymyxin B sulfates combined with dexamethasone in treating bacterial conjunctivitis. It evaluated the clinical outcomes, microbiological response, and safety profile of the treatment.
- Reference: Silver LH, Chandler JW. Am J Ophthalmol. 1980 Sep;90(3):251-5.
- Study: "Oral neomycin sulfate reduces the duration of enterohemorrhagic Escherichia coli O157:H7 fecal shedding: a randomized controlled trial"
- This clinical trial examined the effect of oral neomycin sulfate on the duration of fecal shedding of enterohemorrhagic Escherichia coli (E. coli) O157:H7 in patients with confirmed infections. The study aimed to evaluate whether Neomycin could potentially reduce the duration of E. coli O157:H7 shedding.
- Reference: Wong CS, et al. J Infect Dis. 2000 Jun;181(6):1881-7.
- Study: "Neomycin and ciprofloxacin in the treatment of acute uncomplicated diverticulitis: a prospective randomized study"
- This randomized study compared the effectiveness of Neomycin and ciprofloxacin in the treatment of acute uncomplicated diverticulitis. It assessed clinical outcomes, recurrence rates, and adverse events associated with the two treatments.
- Reference: Lahat A, et al. Dis Colon Rectum. 2007 Mar;50(3):446-50.
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065010s002lbl.pdf
- https://cdn.brief.vet/web-files/PVD/drupal-uploads/files/VMG-Neomycin-2019-01-29-0124.pdf
- https://go.drugbank.com/drugs/DB00994
- https://medlineplus.gov/druginfo/meds/a682274.html
- https://www.drugs.com/mtm/neomycin.html
- https://www.mayoclinic.org/drugs-supplements/neomycin-oral-route/proper-use/drg-20065027?p=1
- https://my.clevelandclinic.org/health/drugs/18367-neomycin-tablets
- https://www.thermofisher.com/order/catalog/product/21810031?gclid=CjwKCAjw1MajBhAcEiwAagW9MVcBPch9UFjA1o7fHkjErYj5wzBC5d_QVxs9lyxSNHghsW1VIAigdhoCWxAQAvD_BwE&ef_id=CjwKCAjw1MajBhAcEiwAagW9MVcBPch9UFjA1o7fHkjErYj5wzBC5d_QVxs9lyxSNHghsW1VIAigdhoCWxAQAvD_BwE:G:s&s_kwcid=AL!3652!3!530347123809!!!g!!!382790548!127140246227&cid=bid_clb_cce_r01_co_cp0000_pjt0000_bid00000_0se_gaw_dy_pur_con&s_kwcid=AL!3652!3!530347123809!!!g!!
