Ofloxacin Granules

(Product under development)
Ofloxacin GranulesOfloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class considered to be a second-generation fluoroquinolone.

The original brand, Floxin, has been discontinued by the manufacturer in the United States on 18 June 2009, though generic equivalents continue to be available.

Ofloxacin was first patented in 1982 (European Patent Daiichi) and received approval from the U.S. Food and Drug Administration (FDA) on December 28, 1990.

Ofloxacin is sold under a wide variety of brand names as well as generic drug equivalents, for oral and intravenous administration. Ofloxacin is also available for topical use, as eye drops and ear drops (marketed as Ocuflox and Floxin Otic respectively in the United States).

Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50% of its “mirror image” or enantiomer dextrofloxacin. When levofloxacin disks were not available in early clinical trials, a 5-pg ofloxacin disk was substituted.

The U.S. Food and Drug Administration (FDA) medical reviewers considered the two drugs to be one and the same and hence interchangeable.

Like other quinolones, ofloxacin has been associated with a significant number of serious adverse drug reactions, such as tendon damage (including spontaneous tendon ruptures) and peripheral neuropathy (which may be irreversible); such reactions may manifest long after therapy had been completed, and, in severe cases, may result in life-long disabilities. Ofloxacin has also been associated with severe psychiatric adverse reactions.

Hepatotoxicity has also been reported with the use of ofloxacin. Case reports of hepatitis have been published for the older fluoroquinolones including ciprofloxacin, ofloxacin, and norfloxacin.

Available Form:
Ofloxacin Granules
Ofloxacin Pellets

Umang Pharmatech equipments used for production of Ofloxacin Granules:
Drug Layering, Fluid Bed Dryer, Fluid Bed Coater, Sifter & Blender, Extruder and Twin spheronizer.


Ofloxacin Granules
Systematic (IUPAC) Name
Ofloxacin Granules
Identifiers
Ofloxacin Granules
Chemical data
(RS)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.05,13]trideca-5(13),6,8,11-tetraene-11-carboxylic acid
CAS number : 82419-36-1
ATC code : J01MA01 ,S01AX11, S02AA16
PubChem : CID 4583
DrugBank : APRD00502
ChemSpider : 4422
UNII : A4P49JAZ9H
KEGG : D00453
ChEBI : CHEBI:7731
ChEMBL : CHEMBL4
Formula : C18H20FN3O4
Mol. mass : 361.368 g/mol


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