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Lomefloxacin | CAS No: 98079-51-7 | GMP-certified suppliers
A medication that treats bacterial respiratory and urinary tract infections, including chronic bronchitis, and provides pre-operative prophylaxis against common uropathogens.
Therapeutic categories
Primary indications
- For the treatment of bacterial infections of the respiratory tract (chronic bronchitis) and urinary tract, and as a pre-operative prophylactic to prevent urinary tract infection caused by: <i>S
- Pneumoniae</i>, <i>H
- Influenzae</i>, <i>S
- Aureus</i>, <i>P
Product Snapshot
- Lomefloxacin is available as oral tablets in film-coated and coated formulations, as well as ophthalmic solution/drops
- It is primarily indicated for bacterial infections of the respiratory and urinary tracts and for pre-operative prophylaxis of urinary tract infections
- The product is approved and available in the US market with additional investigational status
Clinical Overview
Chemically, lomefloxacin belongs to the quinoline carboxylic acid class, characterized by a quinoline ring system substituted with a carboxyl group. Its antimicrobial spectrum encompasses a broad range of gram-negative and gram-positive bacteria. Notable pathogens susceptible to lomefloxacin include Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Pseudomonas aeruginosa, Enterobacter cloacae, Proteus mirabilis, Citrobacter diversus, Staphylococcus saprophyticus, Escherichia coli, and Klebsiella pneumoniae.
Lomefloxacin exerts bactericidal activity by inhibiting bacterial DNA synthesis through selective interference with DNA gyrase and topoisomerase IV enzymes. DNA gyrase is the primary target in gram-negative bacteria, whereas topoisomerase IV predominates in gram-positive species. This dual enzyme inhibition leads to disruption of supercoiling and strand breakage of bacterial chromosome DNA, thereby preventing replication and transcription.
Pharmacokinetic properties include good systemic absorption with distribution to respiratory and urinary tract tissues. Lomefloxacin undergoes hepatic metabolism and renal excretion. It is both a substrate and inhibitor of cytochrome P450 CYP1A2, which may require consideration during polypharmacy. Clinically relevant safety considerations include the potential for photosensitivity reactions and QTc interval prolongation, contra-indicating use in certain susceptible populations. As with other fluoroquinolones, monitoring for tendon toxicity and central nervous system effects is advised.
Lomefloxacin has been approved for use in various markets and is included in systemic antibacterial and fluoroquinolone drug categories. When sourcing the lomefloxacin API, attention should be given to manufacturer compliance with current good manufacturing practices (cGMP) and international pharmacopeial standards to ensure consistent purity, potency, and stability suitable for pharmaceutical formulation.
Identification & chemistry
| Generic name | Lomefloxacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 98079-51-7 |
| UNII | L6BR2WJD8V |
| DrugBank ID | DB00978 |
Pharmacology
| Summary | Lomefloxacin is a fluoroquinolone antibiotic that exerts bactericidal effects by inhibiting bacterial DNA replication and transcription through targeting DNA gyrase and topoisomerase IV. It displays broad-spectrum activity against both gram-negative and gram-positive organisms, including drug-resistant strains. Therapeutically, it is used to treat infections of the respiratory and urinary tracts and as prophylaxis against urinary tract infections in surgical settings. |
|---|---|
| Mechanism of action | Lomefloxacin is a bactericidal fluoroquinolone agent with activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of lomefloxacin results from interference with the activity of the bacterial enzymes DNA gyrase and topoisomerase IV, which are needed for the transcription and replication of bacterial DNA. DNA gyrase appears to be the primary quinolone target for gram-negative bacteria. Topoisomerase IV appears to be the preferential target in gram-positive organisms. Interference with these two topoisomerases results in strand breakage of the bacterial chromosome, supercoiling, and resealing. As a result DNA replication and transcription is inhibited. |
| Pharmacodynamics | Lomefloxacin is a fluoroquinolone antibiotic used to treat chronic bronchitis, as well as complicated and uncomplicated urinary tract infections. It is also used as a prophylactic or preventative treatment to prevent urinary tract infections in patients undergoing transrectal or transurethral surgical procedures. Flouroquinolones such as lomefloxacin possess excellent activity against gram-negative aerobic bacteria such as <i>E.coli</i> and <i>Neisseria gonorrhoea</i> as well as gram-positive bacteria including <i>S. pneumoniae</i> and <i>Staphylococcus aureus</i>. They also posses effective activity against shigella, salmonella, campylobacter, gonococcal organisms, and multi drug resistant pseudomonas and enterobacter. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA gyrase subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | inhibitor |
| DNA topoisomerase 4 subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | inhibitor |
| DNA topoisomerase 2-alpha | Humans | inhibitor |
ADME / PK
| Absorption | Rapid and nearly complete with approximately 95% to 98% of a single oral dose being absorbed. |
|---|---|
| Half-life | 8 hours |
| Protein binding | 10% |
| Metabolism | Minimally metabolized although 5 metabolites have been identified in human urine. 65% appears as the parent drug in urine and 9% as the glucuronide metabolite. |
| Route of elimination | The urinary excretion of lomefloxacin was virtually complete within 72 hours after cessation of dosing, with approximately 65% of the dose being recovered as parent drug and 9% as its glucuronide metabolite. |
| Clearance | * 271 mL/min/1.73 m2 [creatinine clearance of 110 mL/min/1.73 m2] * 31 mL/min/1.73 m2 [creatinine clearance of 0 mL/min/1.73 m2] |
Formulation & handling
- Lomefloxacin is a small molecule quinoline carboxylic acid administered primarily via oral tablets and ophthalmic solutions.
- Avoid concurrent administration with multivalent ions such as magnesium or aluminum antacids to prevent decreased absorption; separate dosing by several hours.
- Formulations include solid oral dosage forms and aqueous ophthalmic solutions, reflecting stable handling characteristics typical of small molecules.
Regulatory status
| Lifecycle | The API is approaching patent expiry in the US, leading to potential entry of generic products. Market maturity is expected to increase as exclusivity periods end and competition rises. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Lomefloxacin is primarily manufactured by Pharmacia Corp with packaging handled by GD Searle LLC and Unimed Pharmaceuticals Inc., serving the US market. The branded product, Maxaquin, is present in the US but not indicated in EU or other regions. Patent expiry suggests that generic competition may currently exist or emerge in the near term within this market. |
|---|
Safety
| Toxicity | Adverse reactions include peripheral neuropathy, nervousness, agitation, anxiety, and phototoxic events (rash, itching, burning) due to sunlight exposure. |
|---|
- Handle with appropriate personal protective equipment to prevent dermal exposure and potential phototoxic reactions
- Minimize inhalation and ingestion risks due to potential neurotoxic effects such as peripheral neuropathy and central nervous system agitation
- Store away from direct sunlight to maintain compound stability and reduce phototoxic hazard
Lomefloxacin is a type of Quinolones
Quinolones belong to a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs). They are a group of synthetic antibiotics that possess a broad-spectrum activity against various bacterial infections. This technical description will shed light on the key characteristics and applications of quinolones.
Quinolones exhibit potent bactericidal activity by targeting DNA gyrase and topoisomerase IV, which are essential enzymes for bacterial DNA replication and repair. This mechanism of action distinguishes quinolones from other classes of antibiotics, making them effective against both Gram-positive and Gram-negative bacteria.
The versatility of quinolones enables their application in the treatment of a wide range of infections, including respiratory tract infections, urinary tract infections, gastrointestinal infections, skin and soft tissue infections, and sexually transmitted diseases. Furthermore, they have proven efficacy against bacteria resistant to other antibiotics, making them indispensable in clinical practice.
Pharmaceutical companies utilize advanced manufacturing processes to synthesize quinolones with high purity and quality. Stringent quality control measures ensure the safety and efficacy of these APIs, complying with regulatory standards.
Quinolones have revolutionized the field of antibacterial therapy, providing healthcare professionals with potent tools to combat bacterial infections. However, it is crucial to utilize them judiciously to prevent the emergence of antibiotic resistance.
In conclusion, quinolones, as a subcategory of pharmaceutical APIs, possess remarkable antibacterial properties, making them invaluable in the treatment of various infections. Their broad-spectrum activity, mechanism of action, and effectiveness against resistant bacteria make quinolones a crucial component of modern healthcare.
Lomefloxacin (Quinolones), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Lomefloxacin API manufacturers & distributors
Compare qualified Lomefloxacin API suppliers worldwide. We currently have 5 companies offering Lomefloxacin API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Changzhou Lanling | Producer | China | China | CoA, WC | 1 products |
| Corden Pharma | Producer | Germany | Italy | CoA, GMP | 45 products |
| Katayama Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 1 products |
| Nakoda Chemicals | Producer | India | India | CoA, GMP, WC | 6 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 134 products |
When sending a request, specify which Lomefloxacin 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.).
Use the list above to find high-quality Lomefloxacin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
