Amikacin GPO

Amikacin GPO





Full Prescribing Info
Amikacin sulfate.
Each 2 ml contains Amikacin Sulfate equivalent to Amikacin 250 and 500 mg, respectively.
Pharmacology: Amikacin is a semisynthetic aminoglycoside antibiotic derived from Kanamycin A. It has the advantage of not being inactivated by the same enzymes that render other aminoglycosides inactive against resistant organisms. It is active against some gram-positive and many gram-negative aerobic bacteria including Staph. aureus, E.coli, Ps. aeruginosa, Acenitobacter, Proteus spp. and Serratia.
Amikacin is rapidly and completely absorbed following IM administration. Peak plasma concentration is attained within 0.5 to 1.5 hours following IM administration and 15 to 30 minutes after end of IV infusion. The drug distributes to most extracellular fluid and does not cross the blood-brain barrier in therapeutically adequate concentrations in adults. Small improvement in penetration with inflamed meninges. Higher levels are achieved in the CSF of newborns than in adults. Most of the drug is excreted unchanged in urine with the elimination half-life of about 2 to 4 hours.
Amikacin crosses the placenta and small amounts appears in breast milk.
Treatment of serious infections caused by susceptible organisms eg. bone and joint infections, skin and soft tissue infections (including burn wound infections), respiratory tract infections, bacterial septicemia, intra-abdominal infections, urinary tract infections, and CNS infections, mainly in neonates.
Dosage/Direction for Use
IM administration or IV infusion,
Neonates: Initially 10 mg per kg body weight, then 7.5 mg per kg body weight every twelve hours.
Older infants, children, and adults: 5 mg per kg body weight every eight hours; or 7.5 mg per kg body weight every twelve hours, for seven to ten days, but not to exceed 1.5 g daily for more than ten days.
Amikacin is contraindicated in patients who are hypersensitive to aminoglycosides.
It is not recommended for use in infant, in pregnant and nursing woman.
Special Precautions
It may cause auditory and vestibular toxicity, hearing loss may occur and may progress to deafness.
Because of its nephrotoxicity, amikacin should be used with caution and in reduced dose in patient with impaired renal function and in children.
Use In Pregnancy & Lactation
It is not recommended for use in pregnant and nursing woman.
Side Effects
The following signs of ototoxicity, nephrotoxicity, and neurotoxicity are not uncommon, including ringing or any loss of hearing, unsteadiness, dizziness, increased or decreased frequency of urination or amount of urine, increased thirst, loss of appetite, nausea and vomiting.
Drug Interactions
Concurrent use of amikacin and other potentially ototoxic, nephrotoxic, or neurotoxic drugs (eg, other aminoglycosides, capreomycin, methoxyflurane, polymyxins, general anesthetics and opioid analgesics) should be avoided.
Extemporaneous admixtures with other drugs are not recommended since incompatibilities may occur.
MIMS Class
ATC Classification
J01GB06 - amikacin ; Belongs to the class of other aminoglycosides. Used in the systemic treatment of infections.
Inj (vial) 250 mg/2 mL x 10 x 1's. 500 mg/2 mL x 10 x 1's.
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