Kanamycin is a water soluble and basic antibiotic discovered by Dr. Hamao Umezawa and others, National Institute of Health of Japan, in 1955.
Kanamycin was isolated from the culture broth of a new Streptomyces species, Streptomyces Kanamyceticus.
Kanamycin is active both in vitro and in vivo against gram-positive and gram-negative bacteria as well as acid-fast bacteria (Mycobacterium tuberculosis). It inhibits strongly the growth of these bacteria and exerts a powerful protective effect against the infections due to them. Kanamycin was proved, under the experiments with mice, rats, dogs, cats, goldfishes and monkeys, to be a substance of less acute and chronic toxicity.
KANAMYCIN Sulfate "Meiji" has been made available to the world by Meiji Seika Kaisha, Ltd., which carried on the production research of this epoch-making antibiotic from the beginning, confirming the marked therapeutic effect in the clinical trials subject to several hundred of patients.
KANAMYCIN Sulfate "Meiji" contains 0.5 g (base), 1 g (base ), 2 g (base) of Kanamycin Sulfate in a container and is prepared conforming to the Minimum Requirements of Antibiotic Products for the national assay
DESCRIPTION AND ADVANTAGE
Physical and Chemical Properties. This preparation is a white powder of Kanamycin Sulfate. It is hygroscopic and readily soluble in water. Its pH in an aqueous solution of 50 mg (base) per ml is 6.0 to 7.5. It is reported that Kanamycin Mono sulfate has the molecular formula of C18H36N4O11H2SO4, H2O and is composed of desoxystreptamine, 6-deoxy-6-amino D-glucose and another aminohexose (kanosamine).
Pharmacology. The LD50 of intravenous Kanamycin in mice, rats and rabbits is 200 to 300 mg (base) per kg of body weight and that of intra peritoneal of subcutaneous injection in mice is about 1.700 mg (base) per kg.
Kanamycin is free from delayed or chronic toxicity. The mice tolerated 400 mg (base) per kg in 30 days subcutaneously every day, and rats 355 mg (base) per kg in 6 weeks.
Kanamycin given to dogs subcutaneously 100 mg (base) per kg once daily for 3 months and intramuscularly 150 mg (base) per kg once daily for 60 days caused no disturbances in hepatorenal and hematopoietic functions nor any other undesirable side reaction.
There appeared no toxic sign in monkeys received the continuous administration of 200 mg (base) per kg daily for 50 days.
Antimicrobial Activity and Resistance. Kanamycin is an amynoglycoside group antibiotic which activity is as bactericide, effective against gram negative bacteria including Mycobacterium tuberculosis (acid fast bacteria). Kanamycin activity against gram positive bacteri including Streptococcal is very small.
Kanamycin shows no cross-resistance with other antibiotics commonly used.
Mycrobactcrium tuberculosis resistant to one or more of Streptomycin. PAS and INH also responds to Kanamycin.
Absorption and Excretion. Kanamycin given intramuscularly attains the peak concentration in serum about 1 hour later, distributes in various organs and is excreted principally through the kidney about 50% in urine by 24 hours.
The blood concentration of Kanamycin following intramuscular administration are illustrated in the figure.
Blood concentration of KANAMYCIN Sulfate "Meiji" following a single intramuscular administration (Department of Urology, Tokyo University)
INDICATION
- Kanamycin is used for serious infection caused by Escherichia coli, Klebsiella pneumonia, Enterobacter aerogenes, Proteus vulgaris such as:
- Septicemia
- Respiratory tract infection
- Meningitis
- Intra abdominal infection (such as Peritonitis)
- Complicated urinary tract infection
- Although Kanamycin is not drug of choice for Staphylococcal infection but Kanamycin can be indicated for theraphy of Staphylococcal infection if Penicillin or other less toxic drugs is contraindicated and sensitivity test and clinical consideration support the use of Kanamycin.
- Kanamycin can be used as "second line" drug of the treatment of tuberculosis.
- Kanamycin can be used for the treatment of Gonococcal infection resistant to Penicillin.
- Kanamycin can be used for early treatment of serious infections if the causative organism is not yet identify between Staphylococcal and gram - negative bacteria or mixed organism.
- This drug is not to be used for early stage of uncomplicated urinary tract infection, except if the causative organism are sensitive to Kanamycin and not sensitive to other less toxic antibiotics
- Kanamycin is not effective against Pseudomonas aeruginosa bacteria.
- This drug is not used for early of uncomplicated urinary tract infection, except if the causative organism are sensitive to Kanamycin and not sensitive to other less toxic antibiotic.
ADMINISTRATION AND RECOMMENDED DOSAGE
For parenteral used. KANAMYCIN Sulfate "Meiji" is dissolved in water for injection. The amount of solvent to be added to 0.5 g (base), 1 g (base) or 2 g (base) vial 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 is preferable to use soon after preparation.
Intramuscular administration
The solutions of 150 to 400 mg (base) per ml are usually employed
Adult:
Acute infection:
15 mg (base) per kg body weight per day is injected in 1 or 2 divided doses.
Above dosage should be adjusted according to patient condition and disease.
doses deep into the muscle.
Children:
15 mg (base) per kg body weight per day in 1 or 2 divided doses,
Above dosage should be adjusted according to patient condition and disease.
Dilution Table
Solvent
added to
|
0.5 g
vial
|
4.6 ml
|
3.6 ml
|
2.9 ml
|
2.1 ml
|
1.6 ml
|
0.9 ml
|
1 g
vial
|
9.2 ml
|
7.2 ml
|
5.8 ml
|
4.2 ml
|
3.2 ml
|
1.7 ml
| |
2 g
vial
|
-
|
-
|
-
|
8.4 ml
|
6.4 ml
|
3.4 ml
| |
Potency of
Kanamycin per ml
|
100 mg
|
125 mg
|
150 mg
|
200 mg
|
250 mg
|
400 mg
| |
PRECAUTION
Patients receiving the drug should be carefully observed for sign of eight nerve damage. It is desirable to discontinue the treatment immediately when the toxic effects appear. If administration of the drug is unavoidable, the drug should he administered under carefull observation. Observation should be done to renal function, audiogram, before and during treatment to the patient with renal damage. Old patient, patient with tinnitus or vertigo and patient used ototoxic before, should be carefully observed due to possibility of eight nerve damage. In pregnancy, should be used with caution.
SIDE EFFECTS
Administration of Kanamycin may cause impairment of the auditory portion of the eight nerve (mainly cochlear function damage) with sign such as tinnitus, hearing difficulty and vertigo. Nephrotoxic effect may be seen in some patients. If the sign of renal damage occur, the drug should be discontinued. Administration of the drug may cause transient headache and numbness of lips, neurotoxicity, nephrotoxicity, eosinophilia, rash, pruritis, fever, paresthesia.
CONTRA INDICATIONS
The drug should be discontinued if a hypersensitivity reaction occurs. In patients with hypersensitive to one of aminoglycoside group, such as: Fradiomycin, Streptomycin, dihydrostreptomycin, Kanamycin, Gentamycin, the drug should be avoided. In pregnant patient the drug should be administered under careful observation because of the possibility of inducing a damage to the eight nerve of new born.
INTERACTIONS
Concurrent administration of blood substitute such as dextran and sodium alginate with Kanamycin should be avoided because of the possibility of the intensifying effect of these nephrotoxic drugs. The drug should he administered carefully when it is necessary to combine with anesthetics or muscular relaxant. since the combinations with such drugs may cause respiratory depression due curare action.
STORAGE AND DURATION OF EFFICACY
The preparation may be stored at room temperature and should be used before expiration date stated on the label.
HOW SUPPLIED
KANAMYCIN Sulfate "Meiji" is supplied in a vial containing of 0.5 g (base), 1 g (base) or 2 g (base) as Kanamycin Sulfate
KANAMYCIN Sulfate "Meiji" 0.5 g (Base) / vial Reg. No. DKL7415300l44Bl
KANAMYCIN Sulfate "Meiji" 1 g (Base) / vial Reg. No. DKL72l5300144A2
KANAMYCIN Sulfate "Meiji" 2 g (Base) / vial Reg. No. DKL7815300144Cl
HARUS DENGAN RESEP DOKTER
PT MEIJI INDONESIAN PHARMACEUTICAL INDUSTRIES
BANGIL - PASURUAN, JAWA TIMUR - INDONESIA
Licensed by
MEIJI SEIKA KAISHA, LTD,
TOKYO, JAPAN
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