levofloxacin hemihydrate + metformin Tablets, film coated 500 mg

Dossier type
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
Manufacturer #16163
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Levofloxacin hemihydrate

Levofloxacin hemihydrate is a fluoroquinolone antibiotic medication, of the third generation of this family of antibiotics and a part of the Levofloxacin family of antibiotics. It is used to treat a number of bacterial infections including acute bacterial sinusitis, pneumonia, H. pylori (in combination with other medications), urinary tract infections, chronic prostatitis, and some types of gastroenteritis. Along with other antibiotics it may be used to treat tuberculosis, meningitis, or pelvic inflammatory disease. Levofloxacin hemihydrate is sold under the brand names Levaquin, Aleflox, Diolof among others. Daiichi Pharmaceutical Company initially developed it for the treatment of bacterial sinusitis through a process for selectively producing hydrate crystals and approved for medical use in the The United States in 1996.

Dosage and administration

The ingredient version is supplied as a yellowish-white crystalline powder. Levofloxacin hemihydrate is sold as tablets in 500mg strength and taken orally. In the treatment of Levaquin disease, the recommended initial adult dose is 250mg,500mg, or 750mg administered orally every 24 hours.

Price of Levofloxacin hemihydrate

In the international market, the consumer has to pay a retail price of $112.74 for a supply of 10 tablets of 500mg strength. in the Chinese API market, depending on the grade, purity, and quality, a kilogram can be bought for a price between USD 35 and USD 50. This price is cheaper is between USD 150 and USD 200 for the ingredient being exported out of India.

How does it work?

Levofloxacin is a broad-spectrum antibiotic, which has been found to have potent actions against both Gram-positive and Gram-negative bacteria. Like all quinolones, it functions by inhibiting the DNA gyrase and topoisomerase IV, two bacterial types II topoisomerases. Topoisomerase IV is necessary to separate DNA that has been replicated (doubled) prior to bacterial cell division. With DNA separation being inhibited, and the process halted, the bacterium cannot divide further. DNA gyrase, on the other hand, is responsible for supercoiling the DNA, so that it will fit in the newly formed cells. Both mechanisms amount to killing the bacterium thus fulfilling its primary role of being a bactericide.

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