AMIKACIN 500, 100-EXIR
Ampoule AMIKACIN 250, 100 mg/ml ( 2ml )
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Indications And Usage
Indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established
Instruct patients using a bronchodilator (‘reliever’) to first use the bronchodilator following the bronchodilator leaflet for use information before using ARIKAYCE.
Pre-treatment with short-acting selective beta-2 agonists should be considered for patients with known hyperreactive airway disease, chronic obstructive pulmonary disease, asthma, or bronchospasm
contraindicated in patients with a known hypersensitivity to any aminoglycoside
Hypersensitivity Pneumonitis, Hemoptysis, Bronchospasm, Exacerbation of Underlying Pulmonary Disease, Anaphylaxis and Hypersensitivity Reactions, Ototoxicity, Nephrotoxicity, Neuromuscular Blockade, Embryo-Fetal Toxicity.
Side-effects of amikacin are similar to those of other aminoglycosides. Kidney damage and ototoxicity (which can lead to hearing loss) are the most important effects, occurring in 1–10% of users. The nephro-toxicity and ototoxicity are thought to be due to aminoglycosides' tendency to accumulate in the kidneys and inner ear
Amikacin can cause neurotoxicity if used at a higher dose or for longer than recommended
Amikacin causes nephrotoxicity (damage to the kidneys), by acting on the proximal renal tubules
Pregnancy and lactation
|This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.|
Renal and liver Impairment
Adverse reactions specifically associated with overdose of amikacin have not been identified. Acute toxicity should be treated with immediate withdrawal of amikacin, and baseline tests of renal function should be undertaken.