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Kantrex

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Kantrex

Kantrex

INDICATIONS

Kanamycin is indicated in the short term 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, and the important additional concepts contained in the WARNING box above.

In serious infections when the causative organisms are unknown, KANTREX (kanamycin) 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.

DOSAGE AND ADMINISTRATION

Kanamycin Injection may be given intramuscularly or intravenously. The patient's pretreatment body weight should be obtained for calculation of the correct dosage. The dosage of an aminoglycoside in obese patients should be based on an estimate of the lean body mass. The status of renal function should be determined by measurement of serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) level is much less reliable for this purpose. Renal function should be reassessed frequently during therapy.

It is desirable to measure both peak and trough serum concentrations intermittently during therapy since both concentrations are used to determine the adequacy and safety of the dose and to adjust the dosage during treatment. Peak serum concentrations (30 to 90 minutes after injection) above 35 g per mL and trough concentrations (just prior to the next dose) above 10 g per mL should be avoided.

Intramuscular Route

Inject deeply into the upper outer quadrant of the gluteal muscle. The recommended dose for adults or children is 15 mg/kg/day in two equally divided dosages administered at equally divided intervals; ie, 7.5 mg/kg q 12h. If continuously high blood levels are desired, the daily dose of 15 mg/kg may be given in equally divided doses every 6 or 8 hours. Treatment of patients in the heavier weight classes, ie, 100 kg, should not exceed 1.5 g/day.

In patients with impaired renal function, it is desirable to follow therapy by appropriate serum assays. If this is not feasible, a suggested method is to reduce the frequency of administration in patients with renal dysfunction. The interval between doses may be calculated with the following formula:

Serum creatinine (mg/100 mL) x 9 = Dosage Interval (in hours); eg, if the serum creatinine is 2 mg, the recommended dose (7.5 mg/kg) should be administered every 18 hours. Changes in creatinine concentration during therapy would, of course, necessitate changes in the dosage frequency.

It is desirable to limit the duration of treatment with kanamycin to short term. The usual duration of treatment is 7 to 10 days. Total daily dose by all routes of administration should not exceed 1.5 g/day. If longer therapy is required, measurement of kanamycin peak and trough serum concentrations is particularly important as a basis for determining the adequacy and safety of the dose. These patients should be carefully monitored for changes in renal, auditory, and vestibular function. Dosage should be adjusted as needed. The risks of toxicity multiply as the length of treatment increases.

At the recommended dosage level, uncomplicated infections due to kanamycin-susceptible organisms should respond to therapy in 24 to 48 hours. If definite clinical response does not occur within 3 to 5 days, therapy should be stopped and the antibiotic susceptibility pattern of the invading organism should be rechecked. Failure of the infection to respond may be due to resistance of the organism or to the presence of septic foci requiring surgical drainage.

Intravenous Administration

The dose should not exceed 15 mg/kg per day and must be administered slowly. The solution for intravenous use is prepared by adding the contents of a 500-mg vial to 100 to 200 mL of sterile diluent such as Normal Saline or 5% Dextrose in Water, or the contents of a 1.0-g vial to 200 to 400 mL of sterile diluent. The appropriate dose is administered over a 30- to 60-minute period. The total daily dose should be divided into 2 or 3 equally divided doses.

In pediatric patients the amount of diluent used should be sufficient to infuse the kanamycin sulfate over a 30- to 60-minute period.

Kanamycin Injection, USP should not be physically mixed with other antibacterial agents but each should be administered separately in accordance with its recommended route of administration and dosage schedule.

Intraperitoneal Use

(Following exploration for established peritonitis or after peritoneal contamination due to fecal spill during surgery.)

Adults: 500 mg diluted in 20 mL sterile distilled water may be instilled through a polyethylene catheter sutured into the wound at closure. If possible, instillation should be postponed until the patient has fully recovered from the effects of anesthesia and muscle-relaxing drugs (see duration of treatment statement above and WARNING box). Serum levels should be carefully monitored during treatment.

Aerosol Treatment

250 mg 2 to 4 times a day. Withdraw 250 mg (1.0 mL) from a 500-mg vial and dilute it with 3 mL Physiological Saline and nebulize. Serum levels should be carefully monitored during treatment.

Other Routes of Administration

KANTREX (kanamycin) Injection in concentrations of 0.25 percent (2.5 mg/mL) has been used as an irrigating solution in abscess cavities, pleural space, peritoneal and ventricular cavities. Possible absorption of KANTREX (kanamycin) by such routes must be taken into account and dosage adjustments should be arranged so that a maximum total dose of 1.5 g/day by all routes of administration is not exceeded. Serum levels should be carefully monitored during treatment.

PEDIATRIC DOSAGE GUIDE FOR KANTREX (kanamycin) PEDIATRIC INJECTION, 75 MG/2 ML—AMOUNT PER 24 HOURS TO BE GIVEN IN DIVIDED DOSES

Weight In Pounds Weight In Kilograms Daily Dosage In Milligrams Daily Dosage In Milliliters
2.2 1.00 15.0 0.4
2.8 1.25 18.8 0.5
3.3 1.50 22.5 0.6
3.9 1.75 26.2 0.7
4.4 2.00 30.0 0.8
5.0 2.25 33.8 0.9
5.5 2.50 37.5 1.0
6.0 2.75 41.2 1.1
6.6 3.00 45.0 1.2
7.7 3.50 52.5 1.4
8.8 4.00 60.0 1.6
9.9 4.50 67.5 1.8
11.0 5.00 75.0 2.0

Stability

Occasionally, some vials may darken during the shelf life of the product, but this does not indicate a loss of potency.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever container and solution permit.

HOW SUPPLIED

KANTREX INJECTION (Kanamycin Injection, USP)

NDC 0015-3503-20–1 g per 3 mL

This product contains dry natural rubber.

APOTHECON®. Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08543, USA. Distributed by: Geneva Pharmaceuticals, Inc. Dayton, NJ 08810, USA. FDA Rev date: 9/17/2001

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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