Levofloxacin Infusion
Description:
Levofloxacin Infusion is a sterile, nonpyrogenic solution for intravenous use. Each 100 mL of solution contains:
Levofloxacin: 500 mg
Sodium Chloride: 0.9% (for isotonicity)
Water for Injection (q.s. to 100 mL)
Clinical Pharmacology:
Levofloxacin is a broad-spectrum fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination. It is effective against a range of gram-positive and gram-negative bacteria.
Indications and Usage:
Levofloxacin Infusion is indicated for the treatment of infections caused by susceptible strains of the following bacteria:
Community-acquired pneumonia
Hospital-acquired pneumonia
Chronic bronchitis exacerbations
Urinary tract infections (UTIs)
Skin and skin structure infections
Sinusitis
Intra-abdominal infections
Dosage and Administration:
Administer by intravenous infusion over 60-90 minutes. The dosage depends on the type and severity of the infection:
Community-acquired pneumonia: 500 mg every 24 hours for 7-14 days.
Chronic bronchitis exacerbations: 500 mg every 24 hours for 7-10 days.
Urinary tract infections: 250-500 mg every 24 hours for 7-10 days.
Skin infections: 500 mg every 24 hours for 7-14 days.
Sinusitis: 500 mg every 24 hours for 7-14 days.
Intra-abdominal infections: 500 mg every 24 hours for 7-14 days.
Contraindications:
Known hypersensitivity to levofloxacin or any other fluoroquinolone.
History of tendon disorders related to fluoroquinolone use.
Concurrent use with tizanidine (risk of increased sedation and hypotension).
Warnings and Precautions:
Tendon Damage: Risk of tendinitis and tendon rupture, especially in the elderly and those on corticosteroids.
CNS Effects: May cause seizures or increase the risk of seizures in patients with a history of seizures.
QT Interval Prolongation: Monitor ECG in patients with a history of QT prolongation or on medications that prolong the QT interval.
Hepatic Impairment: Use with caution in patients with liver disease.
Adverse Reactions:
Common side effects:
Nausea
Diarrhea
Headache
Dizziness
Insomnia
Serious adverse reactions:
Tendon rupture
Seizures
QT prolongation
Hepatotoxicity
Severe allergic reactions (anaphylaxis)
Drug Interactions:
Antacids: May reduce the absorption of levofloxacin.
CYP450 Enzyme Inhibitors: May increase the risk of levofloxacin-related side effects.
Theophylline: May increase the risk of theophylline toxicity.
Use in Specific Populations:
Pregnancy: Category C. Use only if the benefits outweigh the risks.
Lactation: Levofloxacin is excreted in breast milk; use with caution.
Pediatric Use: Safety and efficacy not established in children under 18 years.
Geriatric Use: Dose adjustment may be necessary due to renal function impairment.
Storage:
Store at controlled room temperature (20° to 25°C or 68° to 77°F). Do not freeze. Protect from light.
How Supplied:
Levofloxacin Infusion is supplied in 100 mL single-dose containers.
Manufactured by:Shijiazhuang No.4 Pharmaceutical Co.,Ltd.
Shijiazhuang No. 4 Pharmaceutical Co., Ltd., as one of the leading manufacturers in Chinese pharmaceutical industry and a well-known brand, has a business history of seventy years. The company principally specializes in R & D, manufacture and sales of wide types of drugs mainly including intravenous infusion.
The production lines have achieved full automation control and information control in the production process and logistics process and reached international advanced level by integrating the world's leading equipment and technology.
With product quality as its life, the Company always organizes production in strict accordance with GMP requirements, establishes and implements superior service concepts and measures and provides guarantee for the health of the majority of patients at home and abroad with excellent quality products and services.
The Company has a powerful R&D team and made a number of achievements in scientific research and undertaken many major scientific and technological innovation projects and industrialization projects by firmly grasping the pulse of pharmaceutical development, increasing new product development investment and accelerating the pace of technological innovation.
Large volume injection is the key products, tablets, capsules, small volume injection and other forms are manufactured also. Recently API has been put into production and sales. There are more than ten international advanced production lines for the large volume injection, its production scale, technology level, brand influence and economic benefit are on the forefront of domestic counterparts, and it has become one of China's top 100 pharmaceutical industry enterprises and China's top 10 chemical and pharmaceutical industry preparation export-oriented excellent enterprise brands for many consecutive years.
The products are radiated to all provinces, autonomous regions and municipalities in China and also exported to many overseas markets, including more than 80 countries in Asia, Americas, Europe, Oceania, Africa and other continents, and it has become one of the main export enterprises of infusion products.
Audited Supplier 
){kind=link}