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AMIKACIN SOLUTION FOR INJECTION

(Amikacin Sulphate Injection USP 500mg/2ml)

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Composition


Each ml of Injection contains:
Amikacin Sulphate USP
Equivalent to Amikacin 250 mg
Methyl Paraben BP 0.08% w/v
(As Preservative)
Propyl Paraben BP 0.02% w/v
(As Preservative)
Water for Injection BP q.s.


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Indications

Amikacin is indicated in the treatment of the following infections:
1. Urinary tract infection
2. Peritonitis
3. Burns
4. Neonatal infections
5. Respiratory tract infections
6. Meningitis


Dosages and Administration

The recommended dose is 15mg/kg daily divided into two or less commonly, three equal doses. This is usually achieved in adults of 60-70 kg by giving 500 mg every 12 hours as a 30 minute intravenous infusion in a diluent such as 100-200 ml of normal saline or 5% dextrose in water.

Amikacin is concentrated in urine, uncomplicated urinary tract infections can be treated with half the systemic dose (i.e. 250mg every 12 hours).

In newborns, if dosing recommendations for kanamycin are followed, newborn infants less than one week of age and those less than 2000 g could receive 7.5mg/kg every 12 hours while more mature infants could receive as much as 10 mg/kg every 12 hours.

Simple dose schedule for adult of 60-70 kg:

Renal function                          Dose schedule
Normal                                       500mg every 12 h
Mild impairment
i                         500mg every 18 h
Moderate impairment                   500mg every 24 h 
Severe impairment                      250mg every 24 h



Contraindications
A history of hypersensitivity to amikacin is a contraindication for its use. A history of hypersensitivity or serious toxic reactions to aminoglycosides may contraindicate the use of any other aminoglycoside because of the known cross-sensitivities of patients to drugs in this class.

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Presentation

Vial of 500mg/2 ml


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