Indications

Amikin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. It may also be indicated for the treatment of known or suspected staphylococcal disease.

Dosage and Administration

Usage: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 (2 to 3 minutes) or infusion (0.25% over 30 minutes) may be used.

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.The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate.

Precautions & Warning:

1. Patients should be well hydrated during amikacin therapy.

2. Renal Toxicity: Aminoglycosides are potentially nephrotoxic. Renal toxicity is independent of plasma obtained at the peak (C_max). The risk of nephrotoxicity is greater in patients with impaired renal function, and in those who receive higher doses, or in those whose therapy is prolonged.

3. Ototoxicity: The risk of ototoxicity due to aminoglycosides increases with the degree of exposure to either persistently high peak or high trough serum concentrations. Patients developing cochlear or vestibular damage may not have symptoms during therapy to warn them of developing eighth nerve toxicity, and total or partial irreversible bilateral deafness or disabling vertigo may occur after the drug has been discontinued. Aminoglycoside-induced ototoxicity is usually irreversible.

4. Neuromuscular Toxicity

5. Allergic reactions

6. Paediatric use: Aminoglycosides should be used with caution in premature and neonatal infants.

Contraindications:

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

2. 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.

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

4. Hypersensitivity to the active substance or to any of the excipients.

Adverse Reactions:

1. Infections and Infestations: Superinfections or colonisation with resistant bacteria or yeast.

2. Blood and lymphatic system disorders: Anaemia, eosinophilia.

3. Metabolism and nutrition disorders: Hypomagnesaemia.

4. Eye disorders: Blindness, retinal infarction.

5. Vascular disorders: Hypotension.

6. Musculoskeletal, connective tissue and bone disorders: Arthralgia, muscle twitching.

7. General disorders and administration site conditions: Pyrexia.

Storage instructions:

Prior to first use: Do not store above 25° C.

In use: Following dilution in 0.9% sodium chloride and 5% glucose solutions chemical and physical in-use stability has been demonstrated for 24 hours at temperature not above 25° C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8° C, unless dilution has taken place in controlled and validated aseptic conditions.