Product Name:Amikacin Injection
Nombre del Producto:Amikacina Inyectable
Specification: 500mg/2ml, 100mg/2ml,1g/4ml
Package: 10amps/box, 50amps/box, 100amps/box
Standard: USP & BP& CP
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.
Therapy with amikacin may be instituted prior to obtaining the results of sensitivity testing. Surgical procedures should be performed where indicated.
Consideration should be given to official guidance on the appropriate use of antibacterial Agents.
Posology and method of 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.
Adults and Children over 12 years
The recommended intramuscular or intravenous dosage for adults and adolescents with normal renal function (creatinine clearance ≥50 ml/min) is 15 mg/kg/day which may be administered as a single daily dose or divided into 2 equal doses i.e. 7.5 mg/kg q 12 h. The total daily dose should not exceed 1.5 g. In endocarditis and in febrile neutropenic patients, dosing should be twice daily, as there is not enough data to support once daily dosing.
Children 4 weeks to 12 years
The recommended intramuscular or intravenous (slow intravenous infusion) dose in children with normal renal function is 15-20 mg/kg/day which may be administered as 15-20 mg/kg, once a day; or as 7.5 mg/kg q 12 h. In endocarditis and in febrile neutropenic patients dosing should be twice daily, as there is not enough data to support once daily dosing.
An initial loading dose of 10 mg/kg followed by 7.5 mg/kg q 12 h.
The recommended dose in prematures is 7.5 mg/kg in every 12 hours .
The usual duration of treatment is 7 to 10 days. The total daily dose by all routes of administration should not exceed 15-20 mg/kg/day. In difficult and complicated infections where treatment beyond 10 days is considered, the use of amikacin sulphate injection should be re-evaluated and, if continued, renal, auditory, vestibular function should be monitored, as well as serum amikacin levels.
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.
Special warnings and precautions for use
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. Safety for treatment periods which are longer than 14 days has not been established.