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Neomycin

D06A - Antibiotics for dermatological use ATC D06AX04 Unknown approved 1957 Oral Topical Withdrawn Black-box warning

🧬 Cross-allergy: Aminoglycosides

JFDA label: Cicatrin Cream

⚠ Black-Box Warning
  • Toxicity:
  • Neuromuscular blockade:
  • Concurrent therapy:

Mechanism of Action

Inhibitor of Bacterial 70S ribosome — Bacterial 70S ribosome inhibitor

TargetActionGene / class
Bacterial 70S ribosome efficacy INHIBITOR

Indications

Approved

  • Hepatic coma (portal-systemic encephalopathy)
  • Surgical (perioperative) prophylaxis

Antimicrobial Spectrum

Expected / intrinsic spectrum (EUCAST breakpoints & labels) — not local resistance. Source: openfda-label.

Bacteria

OrganismActivityMIC
Escherichia coli Active
Haemophilus influenzae Active
Pseudomonas aeruginosa Active
Serratia marcescens Active
Staphylococcus aureus Active
Streptococcus pneumoniae Active

Contraindications

Source: Lexicomp

  • Hypersensitivity to the neomycin or any component of the formulation Absolute
  • intestinal obstruction Absolute
  • patients with inflammatory or ulcerative GI disease. Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Nervous system disorders (1)

Very Common Sore mouth

Gastrointestinal disorders (6)

Very Common Anorectal pain · diarrhea · mouth irritation · nausea · rectal irritation · vomiting

Dosing

Source: Lexicomp

Surgical (perioperative) prophylaxis: Oral: Manufacturer's labeling: 1 g at 1 PM, 2 PM, and 11 PM on the day preceding 8 AM surgery as an adjunct to mechanical cleansing of the bowel and oral erythromycin Alternative recommendation: 1 g at 1 PM, 2 PM, and 11 PM on the day preceding 8 AM surgery combined with mechanical cleansing of the large intestine and oral erythromycin or metronidazole, and IV antibiotics on the day of surgery (Bratzler, 2013) Hepatic encephalopathy: Oral: 4 to 12 g daily divided every 4 to 6 hours for 5 to 6 days Chronic hepatic insufficiency: Oral: 4 g daily for an indefinite period
(For additional information see "Neomycin: Pediatric drug information") Surgical (perioperative) prophylaxis: Children and Adolescents: Oral: 15 mg/kg/dose for 3 doses administered over 10 hours (eg, at 1 PM, 2 PM, and 11 PM) on the the day preceding surgery; maximum dose: 1,000 mg; (Bratzler, 2013); used as an adjunct to mechanical cleansing of the intestine and in combination with erythromycin base or metronidazole and perioperative IV antibiotics
Refer to adult dosing.
There are no dosage adjustments provided in manufacturer’s labeling; however, dosage reduction or discontinuation of therapy should be considered if a patient develops renal insufficiency. The risk of nephro- and/or ototoxicity is increased in patients with renal impairment.
There are no dosage adjustments provided in manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

Malabsorption

Small amounts of neomycin are absorbed through intact intestinal mucosa; increases in fecal bile acid excretion and reduction of intestinal lactase activity may occur. Oral doses of >12 g/day produce malabsorption of fats, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Nephrotoxicity

May cause nephrotoxicity; usual risk factors include preexisting renal impairment, concomitant nephrotoxic medications, advanced age and dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually reversible.

Neuromuscular blockade and respiratory paralysis

May cause neuromuscular blockade and respiratory paralysis; especially when given soon after anesthesia or muscle relaxants.

Neurotoxicity

May cause neurotoxicity; symptoms also include numbness, skin tingling, muscle twitching and seizures. Usual risk factors include preexisting renal impairment and concomitant neuro-/nephrotoxic medications. Discontinue treatment if signs of ototoxicity occur; risk of hearing loss continues after drug withdrawal.

Superinfection

Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Disease-related concerns:

Hearing impairment

Use with caution in patients with preexisting vertigo, tinnitus, or hearing loss.

Neuromuscular disorders

Use with caution in patients with neuromuscular disorders, including myasthenia gravis and Parkinson disease.

Renal impairment

Use with caution in patients with preexisting renal insufficiency; dosage modification required. Concurrent drug therapy issues:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Dosage form specific issues:

Benzyl alcohol and derivatives

Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling. Other warnings/precautions:

Parenteral administration

More toxic than other aminoglycosides when given parenterally; do not administer parenterally.

Surgical irrigation

Do not use as surgical irrigation due to significant systemic absorption of the drug.

Pregnancy & Lactation

Pregnancy

FDA category D

Animal reproduction studies have not been conducted. Aminoglycosides cross the placenta. Aminoglycosides may cause fetal harm if administered to a pregnant woman. There are several reports of total irreversible bilateral congenital deafness in children whose mothers received another aminoglycoside (streptomycin) during pregnancy. Although serious side effects to the fetus/infant have not been reported following maternal use of all aminoglycosides, a potential for harm exists. Large oral doses may cause malabsorption of some nutrients in the mother.

Lactation

It is not known if neomycin is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. As a class, aminoglycosides are expected to be poorly distributed into breast milk, limiting systemic exposure to a nursing infant. In general, modification of bowel flora may occur with any antibiot

LactMed: monitor the infant.

Monitoring

Clinical pearlSerum creatinine/BUN at baseline and periodically during chronic therapy; audiometry in symptomatic patients

Chemistry & Properties

2D structure
FormulaC23H46N6O13
Molecular weight614.6 g/mol
IUPAC name(2R,3S,4R,5R,6R)-5-amino-2-(aminomethyl)-6-[(1R,2R,3S,4R,6S)-4,6-diamino-2-[(2S,3R,4S,5R)-4-[(2R,3R,4R,5S,6S)-3-amino-6-(aminomethyl)-4,5-dihydroxyoxan-2-yl]oxy-3-hydroxy-5-(hydroxymethyl)oxolan-2-yl]oxy-3-hydroxycyclohexyl]oxyoxane-3,4-diol
CAS1404-04-2
PubChem CID8378
InChIKeyPGBHMTALBVVCIT-VCIWKGPPSA-N
logP-9.0 (XLogP -9.0)
Polar surface area353.0 Ų
H-bond acceptors / donors19 / 13
SMILESC1C(C(C(C(C1N)OC2C(C(C(C(O2)CN)O)O)N)OC3C(C(C(O3)CO)OC4C(C(C(C(O4)CN)O)O)N)O)O)N

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantNo

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP3 (Inhibitor)OATP1B1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)

Drug–drug interactions (100+, DDInter)

Interacting drugSeverityManagement
Atracurium major
Bacitracin major
Botulinum Toxin Type B major
Botulinum toxin type A major
Bumetanide major
Capreomycin major
Cidofovir major
Cisatracurium major
Colistimethate major
Deferasirox major
Diatrizoate major
Doxacurium major
Etacrynic acid major
Everolimus major
Foscarnet major
Furosemide major
Gallium nitrate major
Human Rho(D) immune globulin major
Human botulinum neurotoxin A/B immune globulin major
Human cytomegalovirus immune globulin major
Human immunoglobulin G (intravenous and subcutaneous) major
Human immunoglobulin G (intravenous) major
Inotersen major
Iodipamide major
Iodixanol major
Iohexol major
Iopamidol major
Iopromide major
Iothalamic acid major
Ioversol major
Ioxilan major
Magnesium sulfate major
Mannitol major
Metocurine major
Mivacurium major
Pancuronium major
Pipecuronium major
Polymyxin B major
Rapacuronium major
Rocuronium major

Showing 40 of 100+.

Registered Products (33)

BrandForm / strengthPackAgentCitizen (JOD)
Atasorb-N Suspension Suspension , 3 g 60 ml Hikma Pharmaceuticals Co.Ltd/Jordan 0.500
Cicatrin Cream Cream 3300 IU, 250 IU 15 g tube Suleiman Tannous & Sons Co. Ltd 0.740
Betaval-N Ointment Ointment (as 17-valerate) 0.1 %, ( as sulphate) 0.5 % 15 g tube The Arab Pharmaceutical Manufactruing Co. 0.760
Betaval-N Cream Cream 0.1 %, 0.5 % 15 g tube pack varies The Arab Pharmaceutical Manufactruing Co. 0.810
NEOBACIN SKIN OINT. Ointment (as Neomycin Sulfate)5 mg, (as Bacitrain Zinc)250 IU 15 g tube Dar Al Dawa Development and Investment Co Ltd/Jordan 0.810
Cicatrin Powder Powder 3300 IU, 250 IU 15 g Suleiman Tannous & Sons Co. Ltd 0.830
Detroz Solution 0.35 %, 0.1 % 5 ml Dar Al Dawa Development and Investment Co Ltd/Jordan 0.850
Otosporin Ear / Drops Eye/Ear Drops 10 mg/ml, 3400 IU, 10000 IU 5 ml Suleiman Tannous & Sons Co. Ltd 0.940
multicin Z center oint. Ointment 3.5 mg, 5000 IU, 400 IU 15 g tube pack varies MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 0.970
BANEOCIN Powder Powder 250 IU, 5000 IU 10 g Nabulsi Drug Store 1.040
Betaval-N Ointment Ointment (as 17-valerate) 0.1 %, (as sulphate) 0.5 % 30 g tube The Arab Pharmaceutical Manufactruing Co. 1.100
Detroz-P Injection 1 mg/ml, 3500 IU/ml, 6000 IU/ml 5 ml Dar Al Dawa Development and Investment Co Ltd/Jordan 1.140
Cebemyxine e/o Ophthalmic Ointment 1000000 IU, 430000 IU 5 g tube Petra Drug Store 1.320
Betaval-N Cream Cream 0.1 %, 0.5 % 30 g tube pack varies The Arab Pharmaceutical Manufactruing Co. 1.350
kenacin cream Cream 100000 IU, 0.1 %, 0.025 %, 0.25 % 15 g tube pack varies MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 1.370
kenacin oint Ointment 100000 IU, 0.1 %, 0.025 %, 0.25 % 15 g tube pack varies MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 1.370
Panderm Cream Cream 10.000000 IU/100 g, 0.025 g/100 g, 0.25 g/100 g, 0.1 g/100 g 15 g tube pack varies Professional Drug Store 1.420
petralar N cream. Cream 0.25 mg/g, 3.50 mg/g 15 g tube MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 1.500
petralar N oint. Ointment 0.25 mg/g, 3.50 mg/g 15 g tube MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 1.500
Kenaphil Cream Cream 0.326 g/tube, 0.00375 g/tube, 0.055161 g/tube, 0.015 g/tube 15 g tube PHILADELPHIA PHAEMACEUTICALS.COMP/JORDAN 1.510
multicin z center powder Powder (as Sulphate)3.5 mg/g, (as Sulphate)5000 IU/g, (as zinc)400 IU/g 15 g MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 1.560
BANEOCIN OINT Ointment 250 IU/g, 5000 IU/g 20 g tube Nabulsi Drug Store 1.600
Menaderm Cream Cream 0.025 %, 0.5 % 30 g tube pack varies ORIENT DRUG STORE CO 1.670
Menaderm Lotion Lotion 0.025 %, 0.5 % 30 g pack varies ORIENT DRUG STORE CO 1.670
Neopred-P eye ear drops Ophthalmic Solution 10000 IU, 5 mg, 5 mg 10 ml Amman Pharmaceutical Industries Co 1.800
multicin Z center oint. Ointment 3.5 mg, 5000 IU, 400 IU 30 g tube pack varies MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 1.840
Neodex Eye/Ear drops Ophthalmic Solution 5 mg, 1 mg 10 ml Amman Pharmaceutical Indusries 1.910
Maxitrol Eye Drops Ophthalmic Solution 1 mg/ml, 6.000 IU/ml, 3.500 IU/ml 5 ml The Jordan Drugstore Co 2.460
Panderm Cream Cream 10.000000 IU/100 g, 0.025 g/100 g, 0.25 g/100 g, 0.1 g/100 g 30 g tube pack varies Professional Drug Store 2.480
Synalar-N cream Cream 0.025 %, 0.5 % 15 g tube Nabulsi Drug Store 3.200
Synalar-N ointment Ointment 0.025 %, 0.5 % 15 g tube Nabulsi Drug Store 3.200
Polygynax 12 Ovules Ovule 100000 IU, 35000 IU, 35000 IU 12 Quality Drug Store 4.710
Multisol Aerosol 150 gm Cream 500.000 IU, 150.000 IU, 40.000 IU 150 gm MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 7.320