AMIKACIN SULFATE INJECTION 500MG/2ML

AMIKACIN SULFATE INJECTION 500MG/2ML

  • Documents: GMP,COPP,CTD

AMIKACIN SULFATE INJECTION 500MG/2ML

Indications:

Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species. Although amikacin is not the drug of choice for infections due to staphylococci, at times it may be indicated for the treatment of known or suspected staphylococcal disease. These situations include: the initiation of therapy for severe infections when the organisms suspected are either Gram-negative or staphylococci, patients allergic to other antibiotics, and mixed staphylococcal/Gram-negative infections.

Dosage and Administration:

Amikacin sulphate injection may be given intramuscularly or intravenously.

Amikacin should not be physically premixed with other drugs, but should be administered separately according to the recommended dose and route.

The patient's pre-treatment bodyweight should be obtained for calculation of correct dosage.

For most infections the intramuscular route is preferred, but in life-threatening infections, or in patients in whom intramuscular injection is not feasible, the intravenous route, either slow bolus or infusion may be used.

Precautions & Warning:

Patients should be well hydrated during amikacin therapy.

Caution should be applied to patients with pre-existing renal insufficiency, pre-existing hearing or vestibular damage and diminished glomerular filtration. Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use.

If therapy is expected to last seven days or more in patients with renal impairment, or 10 days in other patients, a pre-treatment audiogram should be obtained and repeated during therapy.

Contra-indications:

Amikacin sulphate injection is contraindicated in patients with known allergy to amikacin or any component of the formulation.

A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any aminoglycoside because of the known cross sensitivities of patients to drugs in this class.

Aminoglycosides may impair neuromuscular transmission, and should not be given to patients with myasthenia gravis.

Drug interactions:

The concurrent or serial use of other neurotoxic, ototoxic or nephrotoxic agents.

Cephalosporins.

Potent diuretics

Beta-lactam antibiotics (In Vitro)

Bisphosphonates.

Platinum compounds.

Thiamine (vitamin B1)

Anaesthetics or muscle-relaxing drugs

Indomethacin

Storage instructions:

.Do not store above 25°C.