sparfloxacin Tablets 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Pakistan
GMP approvals
WHO
Manufacturer #20897
This company is a prominent player in the pharmaceutical industry, specializing in both human and animal health products. Their diverse portfolio includes branded generics, biologics, injectables, personal hygiene items, and consumer products. They boast a state-of-the-art GMP-compliant facility and have established subsidiaries to focus on specific areas like carbapenem injectables and consumer goods. The company is recognized for its commitment to quality, evidenced by certifications such as ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018. They have a strong presence in regions like the EU, North America, Asia, and the Middle East. Key therapeutic areas include infectious diseases and mental health, with principal dosage forms encompassing oral solutions, tablets, injectables, and topical creams. The company actively invests in research and development to bring innovative products to market.

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SPARFLOXACIN

Sparfloxacin is a fluoroquinolone antibiotic. It is used in the treatment of bacterial infections, specifically community-acquired lower respiratory tract infections like acute sinusitis, exacerbations of chronic bronchitis caused by susceptible bacteria, and community-acquired pneumonia. it is active against Chlamydia pneumonia, Haemophilus parainfluenzae, Haemophilus influenza, Moraxella catarrhalis, Streptococcus pneumonia, Mycoplasma pneumonia, Enterobacter cloacae, Klebsiella pneumonia, and Staphylococcus aureus. However, it has been withdrawn from sales in the USA. Sparfloxacin is sold under the brand names Zagam, Zagam Respipac among others. Rhone DPC Europe patented Sparfloxacin in 1985 and approved it for medical use in 1993. However, it is no longer available in the United States due to a controversial safety profile.

Dosage and Administration

Sparfloxacin is sold as 200mg tablets in a blister pack of 11 or a bottle of 55 tablets. It is taken orally with or without food, however, the patient has to take antacids containing magnesium and aluminum or sucralfate or Videx, or the pediatric powder for oral solution, 4 hours after taking Sparfloxacin. For patients with normal renal function, the recommended daily dose is, two 200- mg tablets, as the loading dose on day one, followed by one 200-mg tablet, every 24 hours, for a total of 10 days of therapy. For patients with renal impairment whose creatinine clearance is lower than 50 mL per minute, the loading dose is two 200-mg tablets on day 1, followed by one 200-mg tablet, every 48 hours, for a total of 9 days of therapy.

The PRICE of Sparfloxacin

In India, the price of the generic version of the 200 mg tablets cost USD 13.06. however, there are several drug manufacturers of Sparfloxacin, and is available at much lower prices too. It is not approved for sale in the USA anymore.

How does it work?

Sparfloxacin is quinolones and fluoroquinolones. Its main action is bactericidal, which is actively killing bacteria. It works by inhibiting the bacterial DNA gyrase or the topoisomerase IV enzyme. This in turn inhibits DNA replication and transcription. It easily enters the cells, thus is often used to treat intracellular pathogens such as Legionella pneumophila and Mycoplasma pneumonia. DNA gyrase is the main target for many gram-negative bacteria, whereas topoisomerase IV is the target for many gram-positive bacteria.

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