Kanamycin Sulphate Meiji

Kanamycin sulfate.

Each vial contains kanamycin sulfate 0.5, 1 or 2 g (potency).
Kanamycin sulfate is a hygroscopic white powder and readily soluble in water. Its pH in an aqueous solution of 50 mg (potency)/mL is 6-7.5.
It is reported that kanamycin monosulfate has the molecular formula of C₁₈H₃₆N₄O₁₁·H₂SO₄·H₂O and is composed of desoxystreptamine, 6-deoxy-6-amino-D-glucose and another aminohexose kanosamine.

Microbiology: Kanamycin is a water-soluble, basic antibiotic discovered from the culture broth of a new species of Actinomyces, Streptomyces kanamyceticus.
Kanamycin is active against both in vitro and in vivo gram-positive and gram-negative bacteria as well as acid-fast bacteria (Mycobacterium tuberculosis). It strongly inhibits the growth of these bacteria and exerts a powerful protective effect against infections due to them. Kanamycin has been proven, under the experiments with mice, rats, dogs, cats, goldfishes and monkeys, to be a substance of less acute and chronic toxicity.
Kanamycin shows no cross-resistance with other antibiotics commonly used. Staphylococcus, Escherichia coli and Shigella which have developed resistance to other antibiotics are sensitive to kanamycin. Mycobacterium tuberculosis resistant to one or more of streptomycin, PAS and INH also responds to kanamycin.
It often exerts a favourable effect on infections due to Pseudomonas aeruginosa and Proteus vulgaris, so far considered to be intractable.
Pharmacokinetics: Absorption and Excretion: Kanamycin given IM attains the peak concentration in serum in about an hr, distributed in various organs and is excreted principally through the kidneys, about 50% in urine in 24 hrs.
Toxicology: The LD₅₀ of IV kanamycin in mice, rats and rabbits is 200-300 mg (potency)/kg of body weight and that of intraperitoneal or SC injection in mice is about 1700 mg (potency)/kg.
Kanamycin is free from delayed or chronic toxicity. The mice and rats tolerated 400 mg (potency)/kg SC daily in 30 days and 355 mg (potency)/kg in 6 weeks, respectively.
Kanamycin given to dogs SC 100 mg (potency)/kg once daily for 3 months and IM 15 mg (potency)/kg once daily for 60 days caused no disturbances in hepatorenal and hematopoietic functions nor any other undesirable side reactions.

Respiratory Tract Infections Due to Staphylococcus, Pneumococcus, Streptococcus viridans and Haemophilus influenzae: Pharyngitis, bronchitis, tonsillitis, bronchopneumonia, pneumonia, pertussis.
Urinary Tract Infections Due to Staphylococcus, Escherichia coli, Pseudomonas aeruginosa and Proteus vulgaris: Acute and chronic cystitis, acute pyelitis, urethritis, etc.
Gonococcal Infections: Acute and chronic urethritis, epididymitis, cystitis, cervicitis, etc.
Gastrointestinal Infections: Bacillary dysentery, acute diarrhea.
Suppurative Infections Due to Staphylococcus, Pneumococcus and Pseudomonas aeruginosa: Impetigo, phlegmon, lymphadenitis, abscess, mastitis, otitis media, osteomyelitis, carbuncle, postoperative infections, etc.
Adnexitis, Weil's disease.
Prophylactic use for postoperative infections.
Pulmonary tuberculosis, urinary tuberculosis, genital tuberculosis of the lymph node, bone and joint tuberculosis.

For parenteral use, Kanamycin Sulphate Meiji is dissolved in Water for Injection. The amount of solvent to be added to 0.5-g (potency), 1-g (potency) or 2-g (potency) vials to obtain the desired concentrations are shown in the following table. The solution is so stable as to retain its potency at room temperature, but it is preferable to use immediately after preparation. (See table.)


Click on icon to see table/diagram/image


IM Administration: Treatment of Tuberculosis: For adults, usually a daily dose of 2 g (potency) kanamycin is administered by IM injection in 2 equally divided doses (morning and evening) twice a week. Otherwise, 1 g (potency) once daily is administered 3 days a week. Kanamycin Sulphate Meiji should be locally applied when necessary.
Kanamycin sulphate Meiji 0.5-0.75 g (potency) is, however, administered as a single dose to elderly patients (>60 years). The dose should be decreased for children and patients with a very small body weight.
In principle, Kanamycin Sulphate Meiji should be used in combination with other antituberculous drugs.
Other Infections: Usually, a daily dose of 1-2 g (potency) kanamycin is injected IM to adults in 1 or 2 equally divided doses. For children, 30-50 mg (potency)/kg of body weight daily is injected IM in 1 or 2 equally divided doses.
Local application should be conducted when necessary.
The dose may be adjusted according to the age of patients and severity of symptoms.
Local Injection: For lymph node tuberculosis, local injection is effective in combination with IM administration. In this case, 1 g (potency) is dissolved in 6 mL of Water for Injection and about 0.7 mL [100 mg (potency)] of the solutions at a time SC injected into the chin or upper sternocleidomastoid for the injected site.
Inhalation Therapy: It is effective in combination with IM administration. In this case, 1 g (potency) is dissolved in 9.2 mL of water for injection, and 1-3 mL of the solutions is given 1-3 times a day with a nebulizer.
Ear Bath: For stubborn, chronic, purulent otitis media, ear bath is effective in combination with IM administration. In this case, 1 g (potency) is dissolved in 5 mL of Water for Injection and 0.6 mL [100 mg (potency)] of the solutions at a time are given by the usual ear bath.

There is no evidence that kanamycin is contraindicated; nevertheless, it is ineffective against the infections due to insusceptible pathogens. Hypersensitivity to kanamycin.

Kanamycin should be administered by or under the supervision of a physician. Where Kanamycin Sulphate Meiji treatment is prolonged, audiometric test should be made.
Particular care is essential for patients with renal and hearing impairment, intestinal ulcer, poor oral and parenteral nutrition.
Use in pregnancy & lactation: Caution is also necessary when administered in elderly and pregnant and lactating women.

Caution is also necessary when administered in pregnant and lactating women.

Kanamycin produces no significant side reactions in the treatment of acute infections. Rarely, loose feces, local pain, headache, numbness and urinary casts are encountered, which are all mild, seldom necessitating cessation of medication. These reactions disappear by suspending the administration.
Rarely, ototoxicity, nephrotoxicity, deafness, vitamins K and B deficiency may occur. Infrequently, gastrointestinal disorders occur.

Use with blood substitute or diuretics aggravate ototoxicity and nephrotoxicity. Respiratory depression with muscle relaxants.

Prepare Kanamycin Sulphate Meiji solution using water for injection and avoid combined use with other agents since they may cause coloring or loss of potency.
For repeated injections, the site of injection should be rotated.
Kanamycin aqueous solution is essentially transparent and colorless. A slightly colored solution seldom prepared can be used safely.
The aqueous solution may be stored at room temperature but it is advisable to use immediately after preparation.

The injection may be stored at room temperature and should be used in 5 years after the month of assay approval.

Aminoglycosides

J01GB04 - kanamycin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.

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