Ciprofloxacin Hydrochloride, known as the brand name antibiotic Proquin XR, is an effectual fluoroquinolone. Marketed by Depomed, the patent for Proquin XR is set to expire on September 19, 2016. Ciprofloxacin hydrochloride is projected to flourish as a generic antibiotic, due in part to its ease of use as a once daily 500 milligram dose. Another benefit of ciprofloxacin hydrochloride is the specific indication it has, as it is only for the treatment of uncomplicated urinary tract infections or acute cystitis, caused by susceptible strains of Escherichia coli and Klebsiella pneumoniae. This powerful medication is not interchangeable with other ciprofloxacin products like Cipro. Due to the particular indication of ciprofloxacin hydrochloride, this potent drug remains efficacious, and has not yet been shown to have a resistance from patients. Side effects are minimal, and may include a yeast infection, inflamed nose and throat, headache, or an urgent need to urinate.
The American Foundation for Urological Disease reports that as many as ten million visits are made to physicians each year to seek treatment for urinary tract infections. This staggering number of cases highlights the great need for additional and affordable treatments to combat these infections. Many urinary tract infections are caused by the bacterium E. coli, and require antibiotic treatment to treat the infection.
A Phase II clinical study compared Proquin XR, or ciprofloxacin hydrochloride once daily with the currently marketed immediate release twice-daily ciprofloxacin formulation, known as Cipro. This double blind, randomized and parallel-group study compared the efficacy, safety and tolerability of both the extended release and immediate release ciprofloxacin formulations. While both medications were successful at eradicating the infection, as well as the clinical signs and symptoms of the infection, patients who received ciprofloxacin hydrochloride experienced less adverse effects compared to Cipro. The patients were evaluated at the one week mark after treatment, and approximately five weeks post-treatment. Patients who were dosed with ciprofloxacin hydrochloride reported that they experienced less gastrointestinal disturbances than their counterparts who were dosed with Cipro. Depomed, Inc. gained approval from the United States Food and Drug Administration (FDA) for Proquin XR for the treatment of uncomplicated UTIs, with the distinction of being the first version of ciprofloxacin with nausea and diarrhea listed as “uncommon” adverse events in its label, rather than “common” adverse events. Considering the data that indicates nausea and diarrhea are types of side effects that cause patients discontinue ciprofloxacin treatment, this label statement is a boon to ciprofloxacin hydrochloride. Additionally, Depomed indicated that Proquin XR (ciprofloxacin hydrochloride) is designed to gradually release in a six hour period, which helps to avoid large quantities being dumped into the patient’s intestinal system, where it can lead to adverse effects. The innovative nature of ciprofloxacin hydrochloride is leading research teams to examine future opportunities for this powerful product.
LGM Pharma provides API Ciprofloxacin hydrochloride, CAS# 86483-48-9 for research and development purposes.
Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.