Product Description
Description
Amikacin is a semisynthetic aminoglycoside antibiotic derived from kanamycin. Amikacin occurs as a white, crystalline powder and is sparingly soluble in water.The injection consists of the sulfate salt.
Amikacin Injection is a sterile clear, colourless solution, free from specks, lint, or other visible evidence of contamination. Each 2 mL vial contains amikacin sulfate equivalent to amikacin activity 100 mg (100,000 L.U.).Pharmacokinetics Absorption
powder and is sparingly soluble in water. The injection consists of the sulfate salt.
Pharmacokinetics
Absorption
Following IM administration of a single dose of amikacin of 7.5 mg/kg in adults with normal renal function, peak plasma amikacin concentrations of 17-25 micrograms/mL are attained within 45 minutes to 2 hours.
Following IV infusion of the same dose given over 1 hour peak plasma concentrations of the drug average 38micrograms/mL immediately following the infusion, 5.5 micrograms/mL at 4 hours, and 1.3 micrograms/mL at 8 hours.
Distribution
Following administration of usual dosages of amikacin, amikacin has been found in bone, heart, gallbladder, and lung tissue. Amikacin is also distributed into bile, sputum, bronchial secretions, and interstitial, pleural, and synovial fluids.
Elimination
The plasma elimination half-life of amikacin is usually 2-3 hours in adults with normal renal function and is reported to range from 30-86 hours in adults with severe renal impairment.
In adults with normal renal function,94-98%of a single IM or IV dose of amikacin is excreted unchanged by glomerular filtration within 24 hours. The drug may be completely recovered within approximately 10-20 days in patients with normal renal function. Terminal elimination half-lives of greater than 100 hours have been reported in adults with normal renal function following repeated IM or IV administration of the drug.
In patients with impaired renal function, the clearance of amikacin is decreased; the more severe the impairment, the slower the clearance. Therefore, the interval between doses should be adjusted according to the degree of renal impairment. Endogenous creatinine clearance rate and serum creatinine which have high correlation with serum haff-life of amikacin, may be used as a guide for this purpose (see Dossge and Administration - Impaired Renal Function).
Indications
Amikacin Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria, (see Microbiology).
Staphylococcus aureus, including methicillin-resistant strains is the principal Gram-positive organism sensitive to amikacin.
The use of amikacin in the treatment of staphylococcal infections should be restricted to second-line therapy,and should be confined to patients suffering from severe infections caused by susceptible strains of stapylococcus who have failed to respond or are allergic to other available antibiotics.
Amikacin Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.
In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately and at different sites because in-vitro mixing of the two drugs causes inactivation of amikacin.
Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intra-abdominal organs, post-operative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.
Contraindications
Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to amikacin, any constituents of the injection (see Description ) or in patients who may have subclinical renal or eighth nerve damage induced by prior administration of nephrotoxic and/or ototoxic agents, as the toxicity may possibly be additive.
Pregnancy (see Use in Pregnancy) ; Lactation (see, Use in Lactation).
Use in Pregnancy
Category D. Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of gentamicin by the foetal kidney resulting in damage (probably reversible) to immature nephrons, Eighth cranial nerve damage has also been reported following in-utero exposure to some of the aminoglycosides. Because of the chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the foetus. It should also be noted that therapeutic blood levels in the mother do not equate with safety for the foetus.
Use in Lactation
It is not known whether amikacin is excreted in breast milk. Since the possible harmful effect on the infant is not known, it is recommended that if nursing mothers must be given amikacin, the infants should not be breast fed during therapy.
Interactions with Other Drugs
Potent dluretics:
If possible, do not give amluacin in corjunction with atheorynic acid, frusemede or other potert dureics which may themsees cause ooloxicity or enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
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