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Arikayce Kit (AMIKACIN)
Amikacin works by binding to bacterial ribosomes, inhibiting protein synthesis and ultimately killing the bacteria.
Arikayce Kit (Amikacin) is a small molecule aminoglycoside antibacterial drug originally developed by Apothecon and currently owned by the same company. It was FDA-approved in 1981 for various bacterial infections, including those caused by Klebsiella pneumoniae and Serratia. As an off-patent medication, it is available from multiple generic manufacturers. Arikayce Kit has a short half-life of 2.4 hours and zero bioavailability, requiring intravenous administration. It is used to treat a range of bacterial infections, including pneumonia, meningitis, and septicemia.
At a glance
| Generic name | AMIKACIN |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Aminoglycoside Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1981 |
Mechanism of action
Mechanism of Action. Amikacin, an aminoglycoside, binds to the prokaryotic ribosome, inhibiting protein synthesis in susceptible bacteria. It is bactericidal in vitro against Gram-positive and Gram-negative bacteria.
Approved indications
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial infection due to Serratia
- Bacterial meningitis
- Bacterial meningitis due to Gram-negative bacteria
- Bacterial pneumonia
- Bacterial septicemia
- Bacterial urinary infection
- Burn Wound Infections
- Cholangitis
- Complicated Bacterial Peritonitis
- Complicated Proteus UTI
- Complicated UTI with Pseudomonas Aeruginosa
- Complicated Urinary Tract Infection due to Acinetobacter
- Complicated Urinary Tract Infections
- Diverticulitis of gastrointestinal tract
- Enterobacter Meningitis
- Enterobacter Pneumonia
- Escherichia coli meningitis
- Escherichia coli urinary tract infection
- Gram-Negative Aerobic Bacillary Pneumonia
Boxed warnings
- WARNINGS Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established. Neurotoxicity, manifested as vestibular and permanent bilateral auditory ototoxicity, can occur in patients with preexisting renal damage and in patients with normal renal function treated at higher doses and/or for periods longer than those recommended. The risk of aminoglycoside-induced ototoxicity is greater in patients with renal damage. High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions. The risk of hearing loss due to aminoglycosides increases with the degree of exposure to either high peak or high trough serum concentrations. Patients developing cochlear damage may not have symptoms during therapy to warn them of developing eighth-nerve toxicity, and total or partial irreversible bilateral deafness may occur after the drug has been discontinued. Aminoglycoside-induced ototoxicity is usually irreversible. Aminoglycosides are potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high doses or prolonged therapy. Neuromuscular blockade and respiratory paralysis have been reported following parenteral injection, topical instillation (as in orthopedic and abdominal irrigation or in local treatment of empyema), and following oral use of aminoglycosides. The possibility of these phenomena should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate-anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena, but mechanical respiratory assistance may be necessary. Renal and eighth-nerve function should be closely monitored especially in patients with known or suspected renal impairment at the onset of therapy and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Serum concentrations of amikacin should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels and prolonged peak concentrations above 35 micrograms per mL. Urine should be examined for decreased specific gravity, increased excretion of proteins, and the presence of cells or casts. Blood urea nitrogen, serum creatinine, or creatinine clearance should be measured periodically. Serial audiograms should be obtained where feasible in patients old enough to be tested, particularly high risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears, and hearing loss) or nephrotoxicity requires discontinuation of the drug or dosage adjustment. Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. Other factors that may increase risk of toxicity are advanced age and dehydration. The concurrent use of amikacin with potent diuretics (ethacrynic acid, or furosemide) should be avoided since diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue.
Common side effects
- Dysphonia
- Cough
- Bronchospasm
- Hemoptysis
- Musculoskeletal pain
- Upper airway irritation
- Ototoxicity
- Fatigue/asthenia
- Exacerbation of underlying pulmonary disease
- Diarrhea
- Nausea
- Headache
Drug interactions
- ampicillin
- atracurium
- bumetanide
- carbenicillin
- cidofovir
- cisatracurium
- doxacurium
- ethacrynic acid
- foscarnet
- furosemide
- gallamine
- metocurine
Key clinical trials
- Early Versus Late Stopping of Antibiotics in Children With Cancer and High-risk Febrile Neutropenia (PHASE4)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin (PHASE2)
- Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
- Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex (PHASE3)
- Clinical Outcomes of Inhaled Amikacin in Ventilator Associated Pneumonia (PHASE4)
- Antibiotic Dosing in Pediatric Intensive Care
- Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO) (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Arikayce Kit CI brief — competitive landscape report
- Arikayce Kit updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI