DRUG PROFILE

GENERIC NAME:

Amikacin

BRAND NAMES:

Arikayce

MECHANISM OF ACTION:

The primary mechanism of action of amikacin is the same as that for all aminoglycosides. It
binds to bacterial 30S ribosomal subunits and interferes with mRNA binding and tRNA acceptor sites,
interfering with bacterial growth. This leads to disruption of normal protein synthesis and production of
non-functional or toxic peptides. Other actions have been postulated for drugs of this class.Label,6,7
Amikacin, as well as the rest of the aminoglycosides, are generally bacteriocidal against gram-positive
and gram-negative bacteria.

INDICATIONS:

The amikacin sulfate injection is indicated in the short-term treatment of serious bacterial
infections due to susceptible strains of gram-negative bacteria, including Pseudomonas species,
Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-
Enterobacter-Serratia species, as well as Acinetobacter (Mima-Herellea) species.Clinical studies have
shown amikacin sulfate injection to be effective in bacterial septicemia (including neonatal sepsis); in
serious infections of the respiratory tract, bones and joints, central nervous system (including
meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and
postoperative infections (including post-vascular surgery).

CONTRAINDICATIONS:

Generally not indicated for long-term therapy because of ototoxicity (damage to the ear) and
nephrotoxicity (damage to kidney cells).

Diarrhea from an infection with Clostridium difficile bacteria,Low amount of calcium in the
blood,Dehydration,A type of movement disorder called parkinsonism,Myasthenia gravis, a skeletal
muscle disorder,Ringing in the ears,Disorder of nerve that controls hearing and balance,Decreased
kidney function,Sensation of spinning or whirling,Pregnancy.

SIDE EFFECTS

Musculoskeletal- Muscle weakness (due to blocking of signals from the nerves to the muscles).

Eye and ENT- Hearing loss and loss of balance.

Genitourinary- Reduced urine volume, protein in urine, increased serum creatinine, urinary casts, red
and white blood cells in urine and high level of nitrogen waste in blood (azotemia).

Miscellaneous- Decreased serum magnesium.

ADVERSE EFFECTS:
OTOTOXICITY: Auditory or vestibular damage

NEPHROTOXICITY: Takes the form of acute tubular nephrosis.

NEUROMUSCULAR BLOCKAGE: reduction of Calcium and acetylcholine release

Allergic reactions

DRIG DRUG INTERACTIONS:

It decreases the excretion rate of Amikacin which could result in a higher serum level if given with
Abacavir,Aceclofenac,Acemetacin, Acetaminophen,Acetyldigtoxin, Acetylsalicylic acid,Aclidinum etc.

The risk or severity of nephrotoxicity and hypocalcemia can be increased when Amikacin is combined
with Alendronic acid.

Bleeding may be increased by Acenocoumarol.

The risk of severity of NEPHROTOXICITY and Hypocalcemia can be increased with Alendronic Acid.

DRUG FOOD INTERACTIONS:

It should not be used at or around the time of eating food or eating certain types of food since
interactions may occur. Using alcohol or tobacco with this may also cause interactions to occur.

DOSAGE FORM AVAILABLE:

Tablet and vial are available

DOSE ( ADULT AND PEDIATRIC):

INTRAVENOUS ADMINISTRATION:

FOR ADULTS:

The recommended dosage for adults, children and older infants with normal renal function is 15
mg/kg/day divided into 2 or 3 equal doses administered at equally-divided intervals i.e., 7.5 mg/kg q12h
or 5 mg/kg q8h. Treatment of patients in the heavier weight classes should not exceed 1.5 gram/day.

FOR NEWBORNS:

When amikacin is indicated in newborns it is recommended that a loading dose of 10 mg/kg be

administered initially to be followed with 7.5 mg/kg every 12 hours.The usual duration of treatment is 7
to 10 days. It is desirable to limit the duration of treatment to short term whenever feasible. The total
daily dose by all routes of administration should not exceed 15 mg/kg/day.

Patients 50 years of age and older or those with prolonged treatment (greater than 3 weeks) should be
given lower daily doses (10 mg/kg/day).