GENTAMICIN Available composition GENTING-80 Each ml contains Gentamicin sulphate eq to Gentamicin 40mg PHARMACOLOGICAL CLASSIFICATION Antibiotic MECHANISM OF ACTION Gentamicin is an aminoglycoside antibiotic and has a bactericidal action against many Gram-negative aerobes and against some strains of staphylococci. Aminoglycosides are taken up into sensitive bacterial cells by an active transport process which is inhibited in anaerobic, acidic, or hyperosmolar environments. Within the cell they bind to the 30S, and to some extent to the 50S, subunits of the bacterial ribosome, inhibiting protein synthesis and generating errors in the transcription of the genetic code. The manner in which cell death is brought about is imperfectly understood, and other mechanisms may contribute, including effects on membrane permeability. PHARMACOKINETICS Gentamicin and other aminoglycosides are poorly absorbed from the gastrointestinal tract but are rapidly absorbed after intramuscular injection. Average peak plasma concentrations of about 4 micrograms/ml have been attained in patients with normal renal function 30 to 60 minutes after an intramuscular dose equivalent to gentamicin 1 mg/kg, which is similar to concentrations achieved after intravenous infusion. There may be considerable individual variation. Several doses are required before plasma equilibrium concentrations occur and this may represent the saturation of binding sites in body tissues such as the kidney. Binding of gentamicin to plasma proteins is usually low. Following parenteral use, gentamicin diffuse mainly into extracellular fluids. However, there is little diffusion into the CSF and even when the meninges are inflamed effective concentrations may not be achieved; diffusion into the eye is also poor. Gentamicin diffuse readily into the perilymph of the inner ear. They cross the placenta but only small amounts have been reported in breast milk. The plasma elimination half-life for gentamicin has been reported to be 2 to 3 hours though it may be considerably longer in neonates and patients with renal impairment. Gentamicin do not appear to be metabolised and are excreted virtually unchanged in the urine by glomerular filtration. At steady state at least 70% of a dose may be recovered in the urine in 24 hours and urine concentrations in excess of 100 micrograms/ml may be achieved. However, gentamicin appear to accumulate in body tissues to some extent, mainly in the kidney. Release from these sites is slow and small amounts of Gentamicin may be detected in the urine for up to 20 days or more after administration ceases. Small amounts of gentamicin appear in the bile. INDICATIONS: GENTING is indicated in - Bacterial neonatal sepsis, Bacterial septicemia
- Serious bacterial infections of the central nervous system, meningitis, urinary tract, respiratory tract, gastrointestinal tract, including peritonitis, skin, bone, and soft tissue, including burns
- Suspected or confirmed gram-negative infections
- Treatment of life-threatening infections caused by Pseudomonas aeruginosa in combination with carbenicillin
- Treatment of endocarditis caused by group D streptococci in combination with a penicillin-type drug
- Serious staphylococcal infections, but not the antibiotic of first choice
- Mixed infections caused by susceptible strains of staphylococci and gram-negative organisms
Patient information READ CAREFULLY BEFORE YOU TAKE GENTING Do not take GENTING if you are allergic to GENTING. if you are pregnant or breast feeding ,if treating premature babies ,if you are an elderly patient, if your kidneys are not working properly, if you have diabetes, if you have an ear, hearing or balance disorder, a history of ear infections or if you have been treated with medicines that affect hearing in the past, if you are taking certain other medicines, such as: antibiotics that also affect your kidneys or hearing such as other aminoglycosides, cephalothin and methicillin, medicines used to thin the blood, such as warfarin and phenindione, amphotericin (medicine used to treat fungal infections), neostigmine and pyridostigmine (medicines used in the treatment of muscle weakness) cyclosporin (a medicine that reduces the activity of the body’s immune system), cisplatin (anti-cancer medicine), some diuretics (water tablets), such as ethacrynic acid and furosemide muscle relaxants used during general anaesthesia (such as tubocurarine and succinylcholine) HOW GENTING IS USEDThe dose of GENTING given to you will depend on how serious the infection is, your age, body weight and how well your kidneys are working.The medicine is usually injected into a muscle but may also be injected into a vein in some patients. If it is given into a vein, it can either be given as an injection or dissolved with, e.g. saline or 5% glucose in water and given as a slow injection via a drip (infusion). It will be given daily, with your dose usually divided into two or three separate doses.As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however tell you doctor or pharmacist if you have any concerns.The amount of GENTING in your blood will be measured regularly to check that the correct blood levels have been achieved. Treatment with gentamicin may cause damage to hearing and also to kidney function. In some cases, your doctor may carry out blood tests to check your kidney function before and during treatment with GENTING. Occasionally you may also be asked to take a hearing test to check the drug is not affecting your hearing. SIDE EFFECTS Like all medicines GENTING can have side-effects.If any of the following happen, tell your doctor immediately:severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint. This is a very serious side-effect. You may need urgent medical attention. This very serious side-effect is rare.If you experience any of the following tell your doctor as soon as possible:hearing problems (if you have this side-effect your doctor may need to change your dose or give you other treatments) feeling or being sick , skin rash or development of raised coloured blotches which may be itchy, fever, sore throat , muscle weakness STORAGE Keep out of the reach of children.The ampules/vials should not be stored above 250C.The medicine should not be used after the expiry date printed on the ampule/vial. |