Kanamycin Sulfate Injection Meiji

Kanamycin Sulfate Injection Meiji

kanamycin

Manufacturer:

Meiji

Distributor:

DKSH
Full Prescribing Info
Contents
Kanamycin acid sulfate.
Description
Kanamycin is an aminoglycoside antibiotic produced by Streptomyces kanamyceticus. It shows antibacterial activity against gram-positive, gram-negative and acid-fast bacteria, and it is effective in the treatment of various bacterial infections and tuberculosis.
Kanamycin acid sulfate injection meiji 3 ml contains: Kanamycin acid sulfate BP 2000: 1000 mg (potency), sodium metabisulfite NF 19: 2 mg, water for injection USP 24: q.s to 3 ml.
It is a clear, pale yellow sterile solution for injection pH: 6.0-8.5.
Kanamycin acid sulfate BP 2000 is a white powder. It is odorless or has slight odor and a slightly bitter taste. It is freely soluble in water, yet practically insoluble in ethanol, acetone or ether. The molecular formula is C18H36N4O11•H2SO4. The pH of the preparation is 6.0-8.5.
Action
Pharmacology: Antibacterial Activity: Kanamycin has demonstrated a potent inhibitory effect on gram-positive and gram-negative bacteria, and the tubercle bacillus. It has also been proven to be effective against multidrug-resistant staphylococci, E.coli and Klebsiella.
Pharmacokinetics: In vivo pharmacokinetic behavior: Absorption and Excretion: When kanamycin was administered intramsucularly to healthy adults in a single dose of 500 mg (potency) or 1 g (potency), the peak blood concentration was attained 1 hour later. The values were 28 μg/ml and 43.1 μg/ml, respectively, and they gradually decreased thereafter. About 77% of the administered dose was excreted in the urine within first 6 hours.
Side effects: Among 11,224 cases reported by clinicians nationwide, the side effects were manifested in 2,252 cases (20.1%). The major side effects were as follows: Hearing disturbance (8.3%), nerve damage (0.1%), renal impairment (1.4%), hepatic impairment (0.2%), gastrointestinal disorders (2.3%), pain or induration at injection site (1.8%), eruption (0.5%) and eosinophilia (0.7%).
Toxicology: Nonclinical Tests: Acute Toxicity: (see Table.)

Click on icon to see table/diagram/image

Subacute and Chronic Toxicities: Kanamycin administered intramuscularly to dogs in a dose of 100 mg (potency) per kg once daily (except Saturdays and Sundays) for 6 months caused no abnormalities in the blood, urine, or hepatoral examinations, or in the light microscopic histological findings. However, kanamycin administered to dogs intramuscularly in a dose of 200 mg (potency) per kg under the same conditions caused proteinuria and hematuria within 2 to 3 weeks as well as a decrease in PSP and a rise in NPN.
Concentration in Tissues: Kanamycin administered intramuscularly to rabbits was transferred well to the kidneys and lungs.
Indications/Uses
Susceptible Bacteria: Staphylococcus, Gonococcus, E. coli, Mycobacterium tuberculosis, Proteus sp., Enterobacter aerogenes, Klebsiella, Acinetobacter (Mima-Herellea).
It is indicated for the treatment of infection caused by the previously mentioned susceptible organisms of skin, mucous membrane, lymph nodes, bones, respiratory tracts, genito-urinary tracts, pulmonary tuberculosis and extra-pulmonary tuberculosis.
Dosage/Direction for Use
Treatment of Tuberculosis: For adults, intramuscular injection of 2 g (potency)/day in 2 equally divided doses (morning and evening) is usually employed twice a week. Otherwise, 1 g (potency) once daily is administered three days a week.
0.5 to 0.75 g (potency) is, however, administered as a single dose to elderly patients (over 60 years old). The dose should be decreased for children and patients with a very small body weight.
In principle, kanamycin should be used in combination with other antituberculous drugs.
Other Infections: Generally, for adults 1 to 2 g (potency) daily is injected intramuscularly in 1 or 2 equally divided doses. For children, 30-50 mg (potency) per kg of body weight daily is intramuscularly injected in 1 or 2 equally divided doses or as prescribed by physicians.
Contraindications
Patients with a history of hypersensitivity to aminoglycoside antibiotics such as streptomycin, kanamycin, gentamicin and fradiomycin, or bacitracin.
Warnings
Do not use this drug in patients with known hypersensitivity.
This drug may cause an auditory nervous system disorders or hearing difficulty or hearing impairment.
This drug has toxic with renal. Patients who have renal function disorder and pediatric should use carefully and reduce dose administration.
Pregnant women should not use this drug.
Discontinue drug and consult the physician immediately if patient has a rash or a similar cold symptoms.
Discontinue drug and consult the physician if patient has any sign or symptom of fever, rash, the epidermis to separate from the dermis and the mucus membranes such as mouth, throat nose, reproductive organs and conjunctivitis because it may be Stevens-Johnson Syndrome (SJS).
Special Precautions
Avoid using or using with careful dosage in patients with or having close-relatives with hearing impairment caused by Streptomycin or any other hearing impairment.
Administer carefully to the following patients:
Patients with renal impairment.
Elderly patients.
Orally poorly nourished or parenterally nourished patients, elderly patients and patients in poor general health. (Sufficient observation should be performed because vitamin K deficiency may develop.)
Use In Pregnancy & Lactation
Newborns may incur eight nerve damage; therefore, the drug should be administered to women with known or suspected pregnancy only when the benefit of the administration is judged to outweigh the risk.
It is advisable to avoid breast-feeding during administration since kanamycin is transferred into human breast milk.
Side Effects
Nervous system: Damage to the eight nerve, causing such problems as tinnitus, hearing difficulty and vertigo (mainly cochlear damage), may occur; therefore, sufficient observation should be performed. It is advisable to discontinue administration if these symptoms have appeared. Particular care should be taken when use of kanamycin is unavoidable.
Kidneys: Sufficient observation should be performed, since renal impairment may rarely occur. Discontinue administration if any abnormality of the kidneys has been detected.
Shock: Sufficient observation should be performed, since shock symptoms may rarely occur. Discontinue the drug and give an appropriate treatment if oppression of the chest, dyspnea, palpitation, a decrease in blood pressure, etc, occur.
Hypersensitivity: Discontinue the drug if hypersensitivity reactions such as eruption, occur. When readministration is necessary (for tuberculosis, etc), desensitization should be performed.
Avitaminosis: Vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc) and vitamin B group deficiency (glossitis, stomatitis, anorexia, neuritis, etc) may rarely occur.
Others: Headache or numbness of the lips may rarely occur.
Drug Interactions
Since kanamycin may aggravate the renal toxicity of such blood substitutes as dextran, it is advisable to avoid concomitant use with such agents.
Respiratory depression due to a neuromuscular blocking effect may occur; therefore, particular care should be taken when combining kanamycin with anesthetics or muscle relaxants.
Combined use with ethacrynic acid or furosemide (intravenous injection, in particular) may aggravate the renal and auditory toxicities; therefore, it is advisable to avoid concomitant use of kanamycin with these diuretics.
Caution For Usage
Precautions in Application: Pay special attention to the following points in order to avoid damage to tissues and nerves when conducting intramuscular injection: Avoid injection to innervated sites.
Repeated injections to the same site should be avoided. Special care should be taken in newborns, premature infants, infants and children.
If acute pain or blood reflux occurs at the time of insertion of a needle, withdraw it immediately and administer the injection to a different site.
In principle, avoid mixed injection with other drugs.
In case of local use, avoid continuous, prolonged administration.
Storage
Store below 30°C.
MIMS Class
ATC Classification
J01GB04 - kanamycin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.
Presentation/Packing
Inj (amp) 1 g x 10's, (vial) 1 g x 1's, 10's. 5 g x 1's, 10's.
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