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Overview
Kanamycin is a antibiotic that is FDA approved for the treatment of shortterm treatment of serious infections caused by susceptible strains of the designated microorganisms like E. coli, Proteus species (both indole-positive and indole-negative), Enterobacter aerogenes, Klebsiella pneumoniae, Serratia marcescens, Acinetobacter species. Common adverse reactions include ototoxicity, nephrotoxicity and neuromuscular blockade.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Kanamycin Injection and other antibacterial drugs, Kanamycin Injection 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.
Kanamycin injection is indicated in the shortterm treatment of serious infections caused by susceptible strains of the designated microorganisms below. Bacteriological studies to identify the causative organisms and to determine their susceptibility to kanamycin should be performed. Therapy may be instituted prior to obtaining the results of susceptibility testing.
Kanamycin may be considered as initial therapy in the treatment of infections where one or more of the following are the known or suspected pathogens: E. coli, Proteus species (both indole-positive and indole-negative), Enterobacter aerogenes, Klebsiella pneumoniae, Serratia marcescens, Acinetobacter species. The decision to continue therapy with the drug should be based on results of the susceptibility tests, the response of the infection to therapy.
In serious infections when the causative organisms are unknown, kanamycin injection, may be administered as initial therapy in conjunction with a penicillin- or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected, consideration should be given to using other suitable antimicrobial therapy in conjunction with kanamycin.
Although kanamycin is not the drug of choice for staphylococcal infections, it may be indicated under certain conditions for the treatment of known or suspected staphylococcal disease. These situations include the initial therapy of severe infections where the organism is thought to be either a Gram-negative bacterium or a staphylococcus, infections due to susceptible strains of staphylococci in patients allergic to other antibiotics, and mixed staphylococcal/Gram-negative infections.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Kanamycin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Kanamycin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Kanamycin in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Kanamycin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Kanamycin in pediatric patients.
Contraindications
A history of hypersensitivity or toxic reaction to one aminoglycoside may also contraindicate the use of any other aminoglycoside, because of the known cross-sensitivity and cumulative effects of drugs in this category.
THIS DRUG IS NOT INDICATED IN LONG-TERM THERAPY (e.g., Tuberculosis) BECAUSE OF THE TOXIC HAZARD ASSOCIATED WITH EXTENDED ADMINISTRATION.
Warnings
Aminoglycosides can cause fetal harm when administered to pregnant women. 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 treatment of pregnant women with other aminoglycosides, the potential for harm exists.
Reproductive studies have been performed in rats and rabbits and have revealed no evidence of impaired fertility or teratogenic effects. Dosages of 200 mg/kg/day in pregnant rats and pregnant guinea pigs led to hearing impairment in the off-spring. There are no well-controlled studies in pregnant women but clinical experience does not include any positive evidence of adverse effects on the fetus. However, if the drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard on the fetus.
Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Kanamycin in the drug label.
Postmarketing Experience
Kanamycin has the potential to induce auditory and sometimes vestibular toxicity, renal toxicity, and neuromuscular blockade.
The risks are higher for patients with a present or past history of renal impairment (especially if hemodialysis is required): for those receiving concomitant or sequential treatment with other ototoxic or nephrotoxic drugs or rapid acting diuretic agents given intravenously (ethacrynic acid, furosemide, and mannitol), and for patients treated for longer periods and/or with higher doses than recommended.
Ototoxicity
Toxic effects of kanamycin on the eighth cranial nerve can result in partially reversible or irreversible bilateral loss of hearing, loss of balance, or both.
Tinnitus or vertigo may or may not be experienced. Cochlear damage is usually manifested initially by small changes in audiometric test results at the high frequencies and may not be associated with subjective hearing loss.
Vestibular dysfunction is usually manifested by nystagmus, vertigo, nausea, vomiting, or acute Meniere’s syndrome.
Nephrotoxicity
Albuminuria, presence of red and white cells, and granular casts; azotemia and oliguria have been reported.
Renal function changes are usually reversible when the drug is discontinued. Renal impairment may be characterized by a rise in serum creatinine and may be accompanied by oliguria, presence of casts, cells, and protein in the urine, by rising levels of BUN or by decrease in creatinine clearance.
Neuromuscular Blockage
Acute muscular paralysis and apnea can occur following treatment with aminoglycoside antibiotics.
Neurotoxicity can occur after intrapleural and interperitoneal instillation of large doses of an aminoglycoside; however, the reaction has followed intravenous, intramuscular, and even the oral administration of these agents.
Other
Some local irritation or pain may follow the intramuscular injection of kanamycin. Other adverse reactions of the drug reported on rare occasions are skin rash, drug fever, headache, paresthesia, nausea, vomiting, and diarrhea.
The “malabsorption syndrome” characterized by an increase in fecal fat, decrease in serum carotene, and fall in xylose absorption, reportedly has occurred with prolonged therapy.
Drug Interactions
There is limited information regarding Kanamycin Drug Interactions in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Kanamycin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Kanamycin during labor and delivery.
Nursing Mothers
Kanamycin is excreted in minute amounts in human milk. Because of the potential for serious adverse reactions from 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
Aminoglycosides should be used with caution in prematures and neonates because of the renal immaturity of these patients and the resulting prolongation of serum half-life of these drugs.
Geriatic Use
There is no FDA guidance on the use of Kanamycin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Kanamycin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Kanamycin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Kanamycin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Kanamycin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Kanamycin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Kanamycin in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Kanamycin in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Kanamycin in the drug label.
Overdosage
In the event of overdosage or toxic reaction, hemodialysis or peritoneal dialysis will aid in the removal of kanamycin from the blood. In the newborn infant, exchange transfusion may also be considered.
