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Composition

Inj 10 mg/20 mg/40 mg/80 mg/160 mg: Per amp: Gentamicin (as sulphate) 10 mg(2 .ml amp)/20 mg(2 ml amp)/ 40 mg(1 ml amp)/80 mg(2 ml amp)/160 mg(2 ml amp).

Indications & Dosage

Gram-positive bacterial endocarditis or HACEK endocarditis (in combination with other antibacterials): BY IM INJ, OR BY SLOW IV INJ, OR BY IV INF: Adult: 1 mg/kg every 12 hours, IV injection to be administered over at least 3 minutes, daily dose may be further divided Septicaemia, Meningitis and other CNS infections, Respiratory tract infection, Biliary tract infection, Acute pyelonephritis, Endocarditis, Bone infection Pneumonia in hospital patients, Adjunct in listerial meningitis Prostatitis: BY IM INJ, OR BY SLOW IV INJ, OR BY IV INF: Adult: 3-5 mg/kg daily in 3 divided doses, divided doses to be given every 8 hours, IV injection to be administered over at least 3 minutes. Children: 2-2.5 mg/kg every 8 hr. Infants/Neonates: 2.5 mg/kg every 8 hr. 1 week or less: 2.5 mg/kg every 12 hr. BY IV INF: Adult: Initially 5-7 mg/kg, subsequent doses adjusted according to serum-gentamicin concentration, to be given in a once daily dose regimen. Surgical prophylaxis: BY SLOW IV INJ: Adult: 1.5 mg/kg, IV injection to be administered over at least 3 minutes, administer dose up to 30 minutes before the procedure, dose may be repeated every 8 hours for high-risk procedures; up to3 further doses may be given. Surgical prophylaxis (including joint replacement surgery): BY IV INF: Adult: 5 mg/kg for 1 dose, administer dose up to30 minutes before the procedure.

Administration

Administer by deep IM route if possible. Slower absorption and lower peak concentrations, probably due to poor circulation in the atrophic muscle, may occur following IM injection; in paralysed patients, suggest IV route. Administer other antibiotics at least 1 hour before or 1 hour after gentamicin.

Compatibility

Stable in dextran 40, D5W, 010W, mannitol20%, LR, NS. Incompatible with fat emulsion 10%.

Stability

Stored between 2C-30C, but refrigeration is not recommended. For reconstituted solution (IV infusion mix in NS or D5W solution) are stable for 24 hours at room temperature and refrigeration.

Contraindications

Myasthenia gravis (aminoglycosides may impair neuromuscular transmission).

Precautions

To avoid excessive dosage in obese patients, use ideal weight for height to calculate dose and monitor serum amikacin concentration closely. Care must be taken with dosage, caution in conditions characterized by muscular weakness (aminoglycosides may impair neuromuscular transmission), renal impairment, infants, elderly, obesity. Ensure adequate hydration; if possible, dehydration should be corrected before starting an aminoglycoside, if possible, parenteral treatment should not exceed 7 days. Monitor serum levels as vestibular toxicity and nephrotoxicity may occur if serum levels exceed 10 microgram/ ml.

Interactions

Neuromuscular blocking drugs, anaesthetic, ethacrynic acid, furosemide.

Pregnancy

Avoid, use only when no safer alternative available

Lactation

Caution advised, avoid

Side Effects

Auditory damage, impaired neuromuscular transmission, irreversible ototoxicity, nephrotoxicity, signs of liver dysfunct, transient myasthenic syndrome in patients with normal neuromuscular function with large doses given during surgery, vestibular damage. Rare: Antibiotic-associated colitis, electrolyte disturbances, hypocalcaemia, hypokalaemia, hypomagnesaemia on prolonged therapy, nausea, peripheral neuropathy, stomatitis, vomiting, Blood disorders, CNS effects, convulsions, encephalopathy, rash