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
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 10/27/2020 | ||
Authorised | 10/27/2020 |
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. |