AMIKACIN INJECTION BP
Composition
– Amikacin Injection BP is available in concentrations of 25mg/ml, 50mg/ml, 125mg/ml, and 250mg/ml.
– Each ml contains Amikacin Sulphate equivalent to 25mg, 50mg, 125mg, or 250mg, along with Methyl Paraben (0.1% w/v), Propyl Paraben (0.02% w/v), and Water for Injection.
Clinical Pharmacology
Pharmacodynamics
– Amikacin is a semi-synthetic aminoglycoside antibiotic effective against a broad spectrum of Gram-negative organisms and some Gram-positive organisms.
– It acts bactericidally by irreversibly binding to the 30S ribosomal subunit, inhibiting protein synthesis.
Pharmacokinetics
– Amikacin is rapidly absorbed after intramuscular injection, achieving peak plasma concentrations of about 20 mg/ml one hour after a 500 mg dose.
– It has a plasma elimination half-life of 2-3 hours in adults with normal renal function, with 94-98% excreted unchanged by glomerular filtration within 24 hours.
Indications and Usage
– Amikacin is indicated for treating hospital-acquired pneumonia, complicated urogenital tract infections, complicated intra-abdominal infections, endocarditis (in combination with other antibiotics), infected burns, and bacteraemia associated with these infections.
– It may also be used for managing neutropenic patients with suspected bacterial infections.
Contraindications
– Amikacin is contraindicated in patients with known allergies to amikacin or any formulation component, and those with a history of hypersensitivity to aminoglycosides.
– It should not be administered to patients with myasthenia gravis due to the risk of neuromuscular transmission impairment.
Drug Interactions
– Concurrent use with other neurotoxic, ototoxic, or nephrotoxic agents should be avoided due to potential additive effects.
– The risk of ototoxicity increases when used with rapidly acting diuretics.
– Caution is advised when administering aminoglycosides with beta-lactam antibiotics due to potential inactivation.
Warnings and Precautions
– Amikacin may cause severe hypersensitivity reactions, particularly in individuals with sulfite sensitivity.
– Neuromuscular toxicity, including respiratory paresis, has been reported, especially in patients receiving anesthetics or neuromuscular blockers.
– Patients with renal insufficiency or pre-existing hearing damage should be monitored closely due to the risk of nephrotoxicity and ototoxicity.
Side Effects
– Common side effects include nephrotoxicity and ototoxicity, with the risk increasing in patients with impaired renal function or those receiving prolonged therapy.
– Other adverse effects may include superinfection, anemia, hypersensitivity reactions, and gastrointestinal disturbances.
Dosage and Administration
– The recommended dose for adults with normal renal function is 15mg/kg/day, either as a single daily dose or divided into multiple doses.
– For neonates, an initial dose of 10mg/kg followed by 7.5mg/kg every 12 hours is recommended.
– Dosage adjustments are necessary for patients with renal impairment.
Pregnancy and Lactation
– Amikacin can cross the placenta and may cause fetal harm; therefore, it should be used during pregnancy only if clearly needed.
– It is unknown if amikacin is excreted in human milk, and caution is advised when administering to breastfeeding mothers.
Storage Conditions
– Amikacin should be stored in a cool, dark place and kept out of reach of children.