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Amikacin | CAS No: 37517-28-5 | GMP-certified suppliers
A medication that treats serious Gram-negative bacterial infections, including septicemia, respiratory, urinary tract, and refractory Mycobacterium avium complex lung diseases in patients unresponsive to standard therapy.
Therapeutic categories
Primary indications
- 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
Product Snapshot
- Amikacin is available primarily as an injectable small molecule antibiotic, including injection solutions and liposome inhalation suspension formulations
- It is indicated for the treatment of serious bacterial infections caused by gram-negative organisms, complicated urinary tract infections, and refractory Mycobacterium avium complex lung disease
- Amikacin has regulatory approval in the US, Canada, and EU markets, with certain indications under accelerated or investigational status
Clinical Overview
Clinically, amikacin sulfate injection is indicated for the short-term treatment of serious infections caused by susceptible Gram-negative pathogens. Approved indications include bacterial septicemia, complicated urinary tract infections, respiratory tract infections, central nervous system infections including meningitis, skin and soft tissue infections, intra-abdominal infections, postoperative infections, and burns. Since the drug has nephrotoxic and ototoxic potential, its use is generally reserved for severe infections or cases where less toxic alternatives are ineffective.
A more recent formulation, amikacin liposome inhalation suspension, was approved in 2018 for refractory lung disease due to MAC in patients who do not respond to standard therapy. This approval was based on accelerated criteria measuring sputum culture conversion, with clinical benefit pending further verification.
Pharmacodynamically, amikacin binds irreversibly to bacterial 30S ribosomal subunits, interfering with mRNA binding and tRNA acceptor function. This disruption impairs protein synthesis and produces defective or toxic peptides, resulting in bacterial death. The drug is primarily renally excreted unchanged, with a narrow therapeutic index necessitating careful dosing and monitoring to mitigate nephrotoxicity and ototoxicity risks.
Amikacin demonstrates limited activity against Gram-positive bacteria such as Staphylococcus aureus and is reserved as second-line therapy for severe staphylococcal infections when other agents fail. Susceptibility testing is recommended to guide therapy.
From a sourcing perspective, the procurement of amikacin API should adhere to stringent quality controls, including confirmation of chemical identity (CAS 37517-28-5), purity, absence of contaminants, and compliance with pharmacopeial standards. Given its narrow therapeutic index and narrow safety margin due to potential toxicity, batch-to-batch consistency and reliable supply chain traceability are critical factors in pharmaceutical manufacturing and regulatory compliance.
Identification & chemistry
| Generic name | Amikacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 37517-28-5 |
| UNII | 84319SGC3C |
| DrugBank ID | DB00479 |
Pharmacology
| Summary | Amikacin is an aminoglycoside antibiotic that exerts bactericidal effects by binding to the bacterial 30S ribosomal subunit, disrupting mRNA translation and protein synthesis. It primarily targets aerobic gram-negative bacteria, including Pseudomonas, Acinetobacter, and Enterobacter species, and is also active against certain mycobacteria and gram-positive organisms like Staphylococcus aureus. Its mechanism leads to production of non-functional proteins, inhibiting bacterial growth and viability. |
|---|---|
| Mechanism of action | The primary mechanism of action of amikacin is the same as that for all aminoglycosides. It binds to bacterial 30S ribosomal subunits and interferes with mRNA binding and tRNA acceptor sites, interfering with bacterial growth. This leads to disruption of normal protein synthesis and production of non-functional or toxic peptides. Other actions have been postulated for drugs of this class.[Label,F1949,F1950] Amikacin, as well as the rest of the aminoglycosides, are generally bacteriocidal against gram-positive and gram-negative bacteria. |
| Pharmacodynamics | Amikacin is an aminoglycoside antibiotic. Aminoglycosides bind to the bacteria, causing misreading of t-RNA, leaving bacteria unable to synthesize proteins vital to their growth. Aminoglycosides are useful mainly in the treatment infections involving aerobic, Gram-negative bacteria, such as Pseudomonas, Acinetobacter, and Enterobacter. In addition, some mycobacteria, including the bacteria that cause tuberculosis, are susceptible to aminoglycosides. Infections caused by Gram-positive bacteria can also be treated with aminoglycosides, however, other antibiotics may be more potent and less toxic to humans.[Label,F1949] |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S12 | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Rapidly absorbed after intramuscular administration. Rapid absorption occurs from the peritoneum and pleura. Poor oral and topical absorption. Poorly absorbed from bladder irrigations and intrathecal administration.[F1954,Label] The bioavailability of this drug is expected to vary primarily from individual differences in nebulizer efficiency and airway pathology. Following IM administration of a single dose of amikacin of 7.5 mg/kg in adults with normal renal function, peak plasma amikacin concentrations of 17-25 micrograms/mL are attained within 45 minutes to 2 hours. Following IV infusion of the same dose given over 1 hour peak plasma concentrations of the drug average 38 micrograms/mL immediately following the infusion, 5.5 micrograms/mL at 4 hours, and 1.3 micrograms/mL at 8 hours. |
|---|---|
| Half-life | The plasma elimination half-life of amikacin is usually 2-3 hours in adults with normal renal function and is reported to range from 30-86 hours in adults with severe renal impairment. |
| Protein binding | The protein binding of amikacin in serum is ≤ 10%. |
| Metabolism | Amikacin's structure has been altered to reduce the possible route of enzymatic deactivation, thus reducing bacterial resistance. Many strains of Gram-negative organisms resistant to gentamicin and tobramycin have shown to be sensitive to amikacin in vitro. |
| Route of elimination | This drug is eliminated by the kidneys. In adults with normal renal function, 94-98% of a single IM or IV dose of amikacin is excreted unchanged by glomerular filtration in the kidney within 24 hours. Amikacin can be completely recovered within approximately 10-20 days in patients with normal, healthy renal function. In patients with impaired renal function, the clearance of amikacin is found to be decreased; the more severe the impairment, the slower the clearance. The interval between doses of amikacin should be adjusted according to the level of renal impairment. Endogenous creatinine clearance rate and serum creatinine which have a high correlation with serum half-life of amikacin, may be used as a guide for dosing. |
| Volume of distribution | * 24 L (28% of body weight healthy adult subjects). Following administration of usual dosages of amikacin, amikacin has been found in bone, heart, gallbladder, and lung tissue. Amikacin is also distributed into bile, sputum, bronchial secretions, and interstitial, pleural, and synovial fluids. |
| Clearance | The mean serum clearance rate is about 100 mL/min and the renal clearance rate is 94 mL/min in subjects with normal renal function. |
Formulation & handling
- Amikacin is a small molecule aminoglycoside antibiotic predominantly formulated for parenteral administration including intramuscular, intravenous, and intraperitoneal routes.
- It exhibits high water solubility and requires careful handling to maintain stability in aqueous injectable solutions.
- Topical and respiratory inhalation formulations are also available, indicating the need for appropriate formulation strategies for non-invasive delivery routes.
Regulatory status
| Lifecycle | The API is in a mature phase in the US market with initial patents expiring between 2024 and 2026, while additional patents extend exclusivity until 2034-2035. The API is also marketed in Canada and the EU, where patent statuses may differ. |
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| Markets | US, Canada, EU |
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Supply Chain
| Supply chain summary | Amikacin is manufactured by multiple originator companies with a presence in the US, Canada, and the EU, supported by several branded products marketed under the Amikacin Sulfate name. The supply landscape includes a variety of established manufacturers and packagers, indicating a well-supported global distribution network. Patent expirations range from 2024 through 2035, suggesting ongoing protection for some formulations, while earlier expiry dates may allow for existing or forthcoming generic competition in certain markets. |
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Safety
| Toxicity | **Oral (LD50):** 6000 mg/kg (Mouse) [MSDS]. No antidote for toxicity is currently available. This drug is only 20% dialyzable; however, this is variable based on the type hemodialysis filter used. **Nephrotoxicity** Mild and reversible nephrotoxicity may be observed in 5 - 25% of patients. Amikacin accumulates in the proximal renal tubular cells. Tubular cell regeneration occurs despite continued drug exposure. Toxicity most commonly occurs several days following initiation of therapy. Amikacin may exacerbate pre-existing renal disease. **Ototoxicity** May cause irreversible ototoxicity. Ototoxicity appears to be correlated to cumulative exposure. Drug accumulation in the endolymph and perilymph of the inner ear causes irreversible damage to hair cells of the cochlea or summit of ampullar cristae in the vestibular complex. High- frequency hearing is lost first with progression leading to loss of low-frequency hearing. Further toxicity may lead to retrograde degeneration of the 8th cranial (vestibulocochlear) nerve. Vestibular toxicity may cause vertigo, nausea, vomiting, dizziness, and loss of balance.[F1949,Label] **Neuromuscular blockade** In addition to the above, amikacin may exacerbate neuromuscular blockade, however, this is less common.[Label,L4680] **Use in Pregnancy** Category D. Gentamicin and other aminoglycosides are known to cross the placenta. There is evidence of selective uptake of gentamicin by the fetal kidney resulting in damage to immature nephrons. Eighth cranial nerve damage has also been reported after in-utero exposure to some of the aminoglycosides. Because of the chemical similarity, all aminoglycosides should be considered potentially nephrotoxic and ototoxic to the developing fetus. Therapeutic blood amikacin levels in the mother do not equate with safety for the fetus. In reproductive toxicity studies in mice and rats, no effects on fertility or fetal toxicity were observed. **Use in Lactation** It is not known whether amikacin is excreted in breast milk. Since the possible harmful effect on the infant is not known, it is recommended that if nursing mothers must be given amikacin, the infants should not be breastfed during therapy. |
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- Exposure to the API may cause dose-dependent nephrotoxicity, with tubular accumulation and reversible proximal renal tubular cell damage observed in preclinical and clinical data
- Irreversible ototoxicity is associated with cumulative exposure
- Drug accumulation in inner ear fluids can damage cochlear hair cells and the vestibular system
Amikacin is a type of Aminoglycosides
Aminoglycosides are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in combating bacterial infections. These powerful antibiotics are primarily used to treat severe infections caused by gram-negative bacteria. Aminoglycosides are characterized by their unique chemical structure, consisting of amino sugars and a glycosidic bond.
These antibiotics exert their therapeutic effects by inhibiting bacterial protein synthesis, leading to the disruption of essential cellular functions in the bacteria. This mechanism of action makes aminoglycosides highly effective against a wide range of bacteria, including those that have developed resistance to other classes of antibiotics.
Key examples of aminoglycosides include gentamicin, amikacin, and tobramycin. These drugs are typically administered intravenously or intramuscularly to ensure optimal absorption and distribution throughout the body. Due to their limited oral bioavailability, aminoglycosides are not commonly administered orally.
Although aminoglycosides possess potent antimicrobial properties, they are associated with some potential adverse effects, including nephrotoxicity and ototoxicity. Regular monitoring of kidney function and therapeutic drug monitoring are often recommended during aminoglycoside therapy to minimize the risk of these complications.
In summary, aminoglycosides are an important subcategory of pharmaceutical APIs that have significant therapeutic value in the treatment of severe bacterial infections. Their unique mechanism of action and broad spectrum of activity make them valuable tools in the fight against antibiotic-resistant bacteria.
Amikacin (Aminoglycosides), classified under Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Amikacin API manufacturers & distributors
Compare qualified Amikacin API suppliers worldwide. We currently have 5 companies offering Amikacin API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CoA, GMP, USDMF | 36 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| K. Sevantilal & Co. | Producer | India | India | CoA | 8 products |
| Qilu Tianhe | Producer | China | China | CoA, JDMF, USDMF, WC | 16 products |
| Zhejiang Jinhua Conba | Producer | China | China | CoA, USDMF, WC | 6 products |
When sending a request, specify which Amikacin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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