amikacin (oral inhalation)

Action and Spectrum

Amikacin attaches to the 30S ribosomal subunits of bacteria and disrupts tRNA acceptor sites and mRNA binding, which stops the growth of bacteria. This results in the creation of poisonous or non-functional peptides and the disturbance of regular protein synthesis.  

Gram-positive and gram-negative bacteria are typically susceptible to the bactericidal effects of amikacin and the other aminoglycosides. 

Drug Interaction

Adverse Reaction

Frequency defined:  

>10% 

Diarrhea (13%) 

Nausea (12%) 

Fatigue (16%) 

Vomiting (7%) 

Asthenia (16%) 

Bronchospasm (29%) 

Chronic obstructive pulmonary disease (15%) 

Hemoptysis (18%)  

1%-10%: 

Skin rash (6%) 

Chest discomfort (5%) 

Weight loss (7%) 

Oral candidiasis (4%) 

Anxiety (5%) 

Balance impairment (1%) 

Dizziness (6%) 

Tinnitus (8%) 

Hypersensitivity pneumonitis (3%)  

Frequency not defined:  

Genitourinary nephrotoxicity 

Anaphylaxis 

Black Box Warning

It is linked to a higher chance of respiratory adverse effects including bronchospasm, hypersensitivity pneumonitis, and worsening of preexisting lung conditions that have required hospitalization. 

Contraindication / Caution

Contraindication: 

Hypersensitivity 

Caution: 

Anaphylaxis reactions 

Nephrotoxicity 

Ototoxicity 

Pregnancy / Lactation

Pregnancy consideration: Amikacin can be assigned under pregnancy category N. amikacin can be considered for the treatment of maternal infection. 

Lactation: No data available regarding the excretion of amikacin in breast milk.  

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or the later trimester. 
• Category B: There is no evidence of risk to the fetus found in animal reproduction studies and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women. 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh risks over benefits. These category drugs should be prohibited for pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

To penetrate bacterial cells, bactericidal aminoglycoside disturbs the general structure of the cell wall. 

It binds to the 30S ribosomal subunit in target bacteria causes disruption and inhibition of protein synthesis. 

When bacteria bind to aminoglycosides, t-RNA is misread, which prevents the bacteria from synthesizing proteins that are essential for growth.

Adminstartion

It is used as only in oral inhalation from. 

Use the Lamira Nebulizer System exclusively for nebulization administration. 

If the patient also takes a bronchodilator, advise them to take it before inhaling amikacin liposomes. 

Patients with known hyperreactive airway illness, chronic obstructive lung disease, asthma, or bronchospasm may benefit from pretreatment with short-acting selective beta-2 agonists. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: amikacin (oral inhalation) 

Why do we use amikacin (oral inhalation)? 

Amikacin is indicated for Mycobacterium avium complex (MAC) lung disease in patients who do not have negative sputum cultures after receiving a multidrug background regimen for at least six months. 

It is mainly classified as an aminoglycoside antibiotic.