Kantrex

IV Incompatibilities

Do not mix with other drugs

IV Preparation

For adults, IV infusions are prepared by adding 500 mg of kanamycin to 100-200 mL of usual IV infusion fluid such as NS or D5W or by adding 1 g of the drug to 200-400 mL of diluent

IV/IM Administration

Administer by deep IM injection, or IV infusion

May administer by intraperitoneal instillation, irrigation, or inhalation

Infuse over 30-60 min

Storage

Store <40°C, preferably between 15-30°C

Protect from freezing

Kanamycin sulfate is an aminoglycoside antibiotic produced by Streptomyces kanamyceticus. It is C18H36N4O11 • 2H2SO4.D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl • (1→6)-O- [6-amino-6-deoxy-α-D-glucopyranosyl- (1→4)]-2-deoxy, sulfate 1:2 (salt). It consists of two amino sugars glycosidically linked to deoxystreptamine.

Kanamycin Injection, USP, sterile solution for parenteral administration, contains respectively; kanamycin sulfate 75 mg, 500 mg, and 1.0 g; sodium bisulfite, an antioxidant, 0.099%, 0.66%, and 0.45%; and sodium citrate, 0.33% 2.2%, and 2.2% with pH of each dosage form adjusted to 4.5 with sulfuric acid.

Vial headspace contains nitrogen.

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.

Kanamycin is in a group of drugs called aminoglycosides (a-MEEN-oh-GLY-koe-sides). It fights bacteria in the body.

Kanamycin is used to treat serious infections caused by bacteria.

Kanamycin may also be used for other purposes not listed in this medication guide.

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 Blockade

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.

Read the entire FDA prescribing information for Kantrex (Kanamycin)

In the U.S.

• Kantrex

Available Dosage Forms:

• Solution

Therapeutic Class: Antitubercular

Chemical Class: Aminoglycoside

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of kanamycin injection in children. However, this medicine should be used with caution in premature and newborn infants.

Geriatric

No information is available on the relationship of age to the effects of kanamycin injection in geriatric patients. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving kanamycin injection.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ataluren

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Atracurium
• Cholera Vaccine, Live
• Cidofovir
• Cisatracurium
• Colistimethate Sodium
• Decamethonium
• Doxacurium
• Ethacrynic Acid
• Fazadinium
• Foscarnet
• Furosemide
• Gallamine
• Hexafluorenium
• Lysine
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Rapacuronium
• Rocuronium
• Succinylcholine
• Tubocurarine
• Vecuronium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bumetanide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Sulfite allergy, history of—This medicine contains sodium bisulfite which may cause an allergic reaction in patients with these conditions.

• Kidney disease, severe or
• Muscle problems (e.g., infant botulism) or
• Myasthenia gravis (severe muscle weakness) or
• Nerve problems or
• Parkinson's disease—Use with caution. May make these condition worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of this medicine from the body.

Patients treated with aminoglycosides by any route should be under close clinical observation because of the potential toxicity associated with their use. As with other aminoglycosides, the major toxic effects of kanamycin sulfate are its action on the auditory and vestibular branches of the eighth nerve and the renal tubules. Neurotoxicity is manifested by bilateral auditory toxicity which often is permanent and, sometimes, by vestibular ototoxicity. Loss of high frequency perception usually occurs before there is noticeable clinical hearing loss and can be detected by audiometric testing. There may not be clinical symptoms to warn of developing cochlear damage. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching, and convulsions. The risk of hearing loss increases with the degree of exposure to either high peak or high trough serum concentrations and continues to progress after drug withdrawal.

Renal impairment may be characterized by decreased creatinine clearance, the presence of cells or casts, oliguria, proteinuria, decreased urine specific gravity, or evidence of increasing nitrogen retention (increasing BUN, NPN, or serum creatinine).

The risks of severe ototoxic and nephrotoxic reactions are sharply increased in patients with impaired renal function and in those with normal renal function who receive high doses or prolonged therapy.

Renal and eighth nerve function should be closely monitored, especially in patients with known or suspected reduced renal function at the onset of therapy, and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Serum concentrations of parenterally administered aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. Urine should be examined for decreased specific gravity, increased excretion of protein and the presence of cells or casts. Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained when feasible in patients old enough to be tested, particularly high risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug.

Neuromuscular blockade with respiratory paralysis may occur when kanamycin sulfate is instilled intraperitoneally concomitantly with anesthesia and muscle-relaxing drugs. Neuromuscular blockade has been reported following parenteral injection and the oral use of aminoglycosides. The possibility of the occurrence of neuromuscular blockade and respiratory paralysis should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular-blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate-anticoagulated blood. If blockage occurs, calcium salts may reduce these phenomena but mechanical respiratory assistance may be necessary.

The concurrent and/or sequential systemic, oral, or topical use of kanamycin and other potentially nephrotoxic, and/or neurotoxic drugs, particularly polymyxin B, bacitracin, colistin, amphotericin B, cisplatin, vancomycin, and all other aminoglycosides (including paromomycin) should be avoided because the toxicity may be additive. Other factors which may increase patient risk of toxicity are advanced age and dehydration.

Kanamycin sulfate should not be given concurrently with potent diuretics (ethacrynic acid, furosemide, meralluride sodium, sodium mercaptomerin, or mannitol). Some diuretics themselves cause ototoxicity, and intravenously administered diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.

Kanamycin sulfate is an aminoglycoside antibiotic produced by Streptomyces kanamyceticus. It is C18H36N4O11• 2H2SO4.D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl • (1→6)-O- [6-amino-6-deoxy-α-D-glucopyranosyl- (1→4)]-2-deoxy, sulfate 1:2 (salt). It consists of two amino sugars glycosidically linked to deoxystreptamine.

Kanamycin Injection, USP, sterile solution for parenteral administration, contains respectively; kanamycin sulfate 75 mg, 500 mg, and 1.0 g; sodium bisulfite, an antioxidant, 0.099%, 0.66%, and 0.45%; and sodium citrate, 0.33% 2.2%, and 2.2% with pH of each dosage form adjusted to 4.5 with sulfuric acid.

Vial headspace contains nitrogen.

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 Blockade

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.