| Customization: | Available |
|---|---|
| Type: | Gentamicin Injection |
| Material: | for Oral Administration |
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Indications:
Gentamicin injection is indicated for the following conditions, when caused by susceptible organisms;
1.Urinary tract infections; (Not indicated for the treatment of uncomplicated urinary tract infections).
2.Systemic infections, e.g. Septicaemia, peritonitis;
3.Bone and soft-tissue infections, e.g. osteomyelitis, wound and soft-tissue infections;
4.Infected burns;
5.Infections of the respiratory tract e.g. Pneumonia.
Contra-indications:
Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of the known cross-sensitivity of patients to drugs in this class.
Adverse Effects:
It can produce irreversible, cumulative ototoxicity affecting both the cochlea (manifest as hearing loss of higher tones) and more common, the vestibular system (manifest as dizziness and vertigo). Concurrent use of an anti-emetic eg. dimenhydrinate may mask the early symptoms of vestibular ototoxicity.
Reversible nephrotoxicity may occur and acute renal failure has been reported, often in association with the concurrent administration of other nephrotoxic agents eg. other aminoglosides, vancomycin, some cephalosporins, or potentially ototoxic agents such as ethacrynic acid.
Renal impairment is usually mild, although acute tubular necrosis and interstitial nephritis have occurred. Decreased glomerular filtration rate is usually seen only after several days, and may even occur after therapy has been discontinued.
Aminoglycosides possess a neuromuscular blocking action and respiratory depression and muscular paralysis have been reported and care is required when another neuromuscular blocking agent is given concomitantly. Neurotoxicity has occurred, both peripheral neuropathies and central symptoms including encephalopathy, confusion, lethargy, hallucinations, convulsions and central depression.
Cross-sensitivity may occur between aminoglycosides. Hypersensitivity reactions, anaphylactic reactions and endotoxic shock has been reported. Infrequent effects reported include blood dyscrasias, purpura, nausea and vomiting, stomatitis, and signs of liver dysfunction eg.increased serum aminotransferase values and increased serum-bilirubin concentrations. Great care is required in patients with myasthenia gravis, parkinsonism and other conditions characterised by muscle weakness.
It is desirable to determine dosage requirements by individual monitoring.
Dosage should be adjusted to avoid peak plasma concentrations above 10 to 20 µg/mL, or trough concentrations exceeding 2 µg/ml. Monitoring is important in patients receiving high doses or prolonged courses, in infants and the elderly and in patients with renal failure.
Use of aminoglycosides during pregnancy may damage the 8th cranial nerve of the foetus.
Storage instructions:
Store below 25ºC. Protect from moisture. Keep out of reach of children.
| Testing terms | Standards | Results |
| pH | 3.0~5.5 | 5.0 |
| Quantity | Not less than the marked capacity | Complies |
| Foreign matter | Not detected | Not detected |
| Gentamicin C component | C1:25%~50%:Cla:10%~35%;C2a+C2 25%~55% |
C1:25.2%;Cla:24.3%;C2a+C2:50.4% |
| Bacterial endotoxins | Not more than 7.1EU per ml of Gentamicin. | Complies |
| Sterility | Complies | Complies |
| Assay | 97.0%-110.0% | 99.8% |
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