Depomed and Esprit Pharma's Proquin XR

APRIL 01, 2006
Monica Holmberg, PharmD

Depomed Inc and Esprit Pharma have entered a license agreement for Proquin XR, a prolonged-release formulation of ciprofloxacin hydrochloride. Proquin XR is indicated for the treatment of uncomplicated urinary tract infections.1

Ciprofloxacin and other fluoroquinolone drugs are noted to cause gastrointestinal (GI) side effects such as nausea and diarrhea. In some cases, these side effects are reported as so severe that patients choose to discontinue treatment with the medication. Nausea and diarrhea with Proquin XR, however, were described in clinical trials as uncommon. Depomed credits Proquin XR's lengthy dissolution time of 6 hours—compared with 30 minutes with regular-release ciprofloxacin and 2 hours with Cipro XR—as being responsible for the decreased GI side effects. According to the manufacturer, the extended release time results in a gentler effect on the patient's intestinal system.2

Treatment with Proquin XR consists of a 3-day regimen of a once-daily 500- mg tablet. Proquin XR is indicated only for uncomplicated urinary tract infections with cultures or epidemiology that suggests Escherichia coli or Klebsiella pneumoniae as the responsible organisms. Proquin XR should not be used to treat pyelonephritis, complicated urinary tract infections, or other infections.3

Mechanism of Action

Proquin XR inhibits the topoisomerase responsible for bacterial DNA replication, transcription, repair, and recombination. Its resulting activity is broad-spectrum against both gramnegative and gram-positive bacteria.3

Clinical Trials

Proquin XR was evaluated in a clinical trial of 1037 patients with uncomplicated urinary tract infections. The randomized, double-blind, phase 3 clinical trial compared once-a-day Proquin XR with immediate- release ciprofloxacin 250 mg twice a day for 3 days. Success rates and bacteriologic eradication were comparable in both groups.2,3

Contraindications,Warnings, and Precautions

Proquin XR is contraindicated in patients with a known hypersensitivity to ciprofloxacin or any of the fluoroquinolone agents.

Proquin XR should be avoided in patients <18 years old, pregnant women, and lactating women, because its safety in these populations has yet to be established. Ciprofloxacin and other fluoroquinolones have been associated with convulsions, increased intracranial pressure, and toxic psychosis. Cautious use is advised in patients with known or suspected central nervous system disorders. Some patients using fluoroquinolones have experienced tendon ruptures. Elderly patients and/or patients using corticosteroids may be at increased risk.

Concurrent use of theophylline with Proquin XR should be avoided, because the combination has resulted in fatal reactions. Proquin XR also may interact with antacids, caffeine, calcium products, probenecid, warfarin, glyburide, phenytoin, sucralfate, or didanosine.

The use of Proquin XR in patients with severe renal failure has not been studied. Dose adjustment, however, is not needed for patients with mild-to-moderate renal impairment. Similarly, Proquin XR has not been evaluated in patients with acute hepatic insufficiency, but patients with chronic stable cirrhosis do not need an adjusted dose of Proquin XR.3

Patient Counseling

Proquin XR should be taken once daily at about the same time for 3 days. Patients should take it with their evening meal or their largest meal of the day. Proquin XR tablets should be swallowed whole and never split, crushed, or chewed. Patients should avoid taking this drug at the same time as aluminum- or magnesium-containing antacids, sucralfate, didanosine (Videx) chewable buffered tablets or pediatric powder, iron or calcium supplements, or zinc preparations.

Additionally, Proquin XR may be associated with an increased effect from caffeine due to caffeine accumulation. Patients may want to avoid or limit caffeine products while using Proquin XR.3

The most frequently reported side effects with Proquin XR are headache and vaginal yeast infection. Other less common side effects include nausea, diarrhea, dizziness, and abdominal pain.2,3

Dr. Holmberg is a pharmacist with Phoenix Children's Hospital, Phoenix, Ariz.

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