MedPath

Amikacin

Generic Name
Amikacin
Brand Names
Arikayce, Arikayce liposomal
Drug Type
Small Molecule
Chemical Formula
C22H43N5O13
CAS Number
37517-28-5
Unique Ingredient Identifier
84319SGC3C

Overview

Amikacin is a semi-synthetic aminoglycoside antibiotic that is derived from kanamycin A. Amikacin is synthesized by acylation with the l-(-)-γ-amino-α-hydroxybutyryl side chain at the C-1 amino group of the deoxystreptamine moiety of kanamycin A. Amikacin's unique property is that it exerts activity against more resistant gram-negative bacilli such as Acinetobacter baumanii and Pseudomonas aeruginosa. Amikacin also exerts excellent activity against most aerobic gram-negative bacilli from the Enterobacteriaceae family, including Nocardia and some Mycobacterium (M. avium-intracellulare, M. chelonae, and M. fortuitum). M. avium-intracellulare (MAC) is a type of nontuberculous mycobacteria (NTM) found in water and soil. Symptoms of this disease include a persistent cough, fatigue, weight loss, night sweats, and shortness of breath and the coughing up of blood. Several forms of amikacin are used currently, including an intravenous (IV) or intramuscular (IM) injection. In September 2018, a liposomal inhalation suspension of this drug was approved by the FDA for the treatment of lung disease caused by Mycobacterium avium complex (MAC) bacteria in a small population of patients with the disease who do not respond to traditional treatment.

Background

Amikacin is a semi-synthetic aminoglycoside antibiotic that is derived from kanamycin A. Amikacin is synthesized by acylation with the l-(-)-γ-amino-α-hydroxybutyryl side chain at the C-1 amino group of the deoxystreptamine moiety of kanamycin A. Amikacin's unique property is that it exerts activity against more resistant gram-negative bacilli such as Acinetobacter baumanii and Pseudomonas aeruginosa. Amikacin also exerts excellent activity against most aerobic gram-negative bacilli from the Enterobacteriaceae family, including Nocardia and some Mycobacterium (M. avium-intracellulare, M. chelonae, and M. fortuitum). M. avium-intracellulare (MAC) is a type of nontuberculous mycobacteria (NTM) found in water and soil. Symptoms of this disease include a persistent cough, fatigue, weight loss, night sweats, and shortness of breath and the coughing up of blood. Several forms of amikacin are used currently, including an intravenous (IV) or intramuscular (IM) injection. In September 2018, a liposomal inhalation suspension of this drug was approved by the FDA for the treatment of lung disease caused by Mycobacterium avium complex (MAC) bacteria in a small population of patients with the disease who do not respond to traditional treatment.

Indication

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). Clinical studies have shown amikacin also to be effective in serious, complicated, and recurrent urinary tract infections due to the above organisms. Aminoglycosides, including amikacin, are not indicated in uncomplicated first-time episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics which are less toxic. In September 2018, a new indication with a new dosage route was approved for this drug. Amikacin liposome inhalation suspension was approved for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of patients with the disease who do not respond to conventional treatment (refractory disease). This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6 of treatment. Clinical benefit has not yet been established. Important notes regarding Staphylococcus and Sensitivity testing: Staphylococcus aureus, including methicillin-resistant strains, is the principal Gram-positive organism sensitive to amikacin. The use of amikacin in the treatment of staphylococcal infections should be restricted only to second-line therapy, and should be limited to only those patients suffering from severe infections caused by susceptible strains of staphylococcus species who have failed to show sensitivity to other available antibiotics. Bacteriologic studies should be performed to identify causative organisms and their susceptibilities to amikacin. Amikacin may be used as initial therapy in suspected gram-negative infections and therapy may be initiated before obtaining the results of susceptibility testing.

Associated Conditions

  • Bacterial Peritonitis
  • Bone and Joint Infections
  • Burns
  • Central Nervous System Infections
  • Endophthalmitis
  • Infection caused by staphylococci
  • Infective pulmonary exacerbation of cystic fibrosis
  • Intraabdominal Infections
  • Meningitis, Bacterial
  • Mycobacterium avium complex infection
  • Neonatal Sepsis
  • Nosocomial Pneumonia
  • Postoperative Infections
  • Pulmonary Infections
  • Respiratory Tract Infection Bacterial
  • Sepsis Bacterial
  • Skin and Subcutaneous Tissue Bacterial Infections
  • Tuberculosis (TB)
  • Grade 1, grade 2, grade 3, grade 4 Urinary Tract Infection
  • Severe Bacterial Infections

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/02/05
Phase 4
Recruiting
Asian Institute of Gastroenterology, India
2024/09/19
Phase 2
Not yet recruiting
2024/09/05
Phase 2
Not yet recruiting
2024/02/02
Phase 1
Completed
2023/10/24
Early Phase 1
Active, not recruiting
2023/03/09
Early Phase 1
Recruiting
2022/09/26
Phase 2
Recruiting
2022/02/08
N/A
Recruiting
Antonios Likourezos
2022/01/28
Phase 3
UNKNOWN
Shanghai Zhongshan Hospital
2021/07/02
Phase 4
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Prodigy Innovation, LLC.
70297-996
INTRAMUSCULAR
500 mg in 1 1
5/5/2019
Insmed Incorporated
71558-590
RESPIRATORY (INHALATION)
590 mg in 8.4 mL
2/8/2023
Safrel Pharmaceuticals, LLC.
71309-996
INTRAMUSCULAR
500 mg in 1 1
1/3/2021
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-785
INTRAMUSCULAR, INTRAVENOUS
500 mg in 2 mL
11/17/2022
Qilu Pharmaceutical Co., Ltd.
67184-0569
INTRAMUSCULAR, INTRAVENOUS
250 mg in 1 mL
3/25/2024
Qilu Pharmaceutical Co., Ltd.
67184-0570
INTRAMUSCULAR, INTRAVENOUS
250 mg in 1 mL
3/25/2024
Fresenius Kabi USA, LLC
63323-815
INTRAVENOUS, INTRAMUSCULAR
250 mg in 1 mL
5/31/2023
Hikma Pharmaceuticals USA Inc.
0641-6167
INTRAMUSCULAR, INTRAVENOUS
250 mg in 1 mL
4/7/2023
Hikma Pharmaceuticals USA Inc.
0641-6166
INTRAMUSCULAR, INTRAVENOUS
250 mg in 1 mL
4/7/2023
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-786
INTRAMUSCULAR, INTRAVENOUS
1 g in 4 mL
11/17/2022

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ILDONG AMIKACIN INJECTION 500 mg/2 ml
SIN11944P
INJECTION
500 mg/2 ml
5/21/2002
AKACIN INJECTION 500MG/2ML
SIN15908P
INJECTION, SOLUTION
500mg/ 2mL
3/12/2020

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Amikacin Sulfate and Sodium Chloride Injection
国药准字H20020073
化学药品
注射剂
7/30/2020
Amikacin Sulfate and Sodium Chloride Injection
国药准字H19990323
化学药品
注射剂
5/22/2020
Amikacin Sulfate and Sodium Chloride Injection
国药准字H20020164
化学药品
注射剂
7/24/2024
Amikacin Sulfate and Sodium Chloride Injection
国药准字H20030259
化学药品
注射剂
7/24/2024
Amikacin Sulfate and Sodium Chloride Injection
国药准字H20020163
化学药品
注射剂
7/24/2024
Amikacin Lotion
国药准字H20093352
化学药品
洗剂
10/22/2023
Amikacin Lotion
国药准字H20066180
化学药品
洗剂
8/4/2020
Amikacin Lotion
国药准字H51023304
化学药品
洗剂
12/2/2019
Amikacin Lotion
国药准字H20046092
化学药品
洗剂
6/10/2020
Amikacin Sulfate Injection
国药准字H51023076
化学药品
注射剂
12/2/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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