Jane S. Ricciuti, RPh, MS


February 07, 2005

In This Article

Anti-infective Agents

Manufacturer: Bayer Pharmaceuticals Corporation

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 1/07/05)

New Indication: These supplemental new drug applications provide for changes to the Indications and Usage, Adverse Reactions, and Inhalational Anthrax-Additional Information sections of the package labeling.

Ciprofloxacin serum concentrations served as a surrogate endpoint and were deemed to be reasonably likely to predict clinical benefit; they provided the initial basis for approval for inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Clinical Summary: The following new information has been added to the labeling section of ciprofloxacin titled "INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION":

  • More than 9300 persons were recommended to complete a minimum of 60 days of antibiotic prophylaxis against possible inhalational exposure to B anthracis during 2001. Ciprofloxacin was recommended to most of those individuals for all or part of the prophylaxis regimen. Some persons were also given anthrax vaccine or were switched to alternative antibiotics. No one who received ciprofloxacin or other therapies as prophylactic treatment subsequently developed inhalational anthrax. The number of persons who received ciprofloxacin as all or part of their post-exposure prophylaxis regimen is unknown.

  • Among the persons surveyed by the Centers for Disease Control and Prevention, over 1000 reported receiving ciprofloxacin as sole post-exposure prophylaxis for inhalational anthrax. Gastrointestinal adverse events (nausea, vomiting, diarrhea, or stomach pain), neurological adverse events (problems sleeping, nightmares, headache, dizziness or lightheadedness) and musculoskeletal adverse events (muscle or tendon pain and joint swelling or pain) were more frequent than had been previously reported in controlled clinical trials. This higher incidence, in the absence of a control group, could be explained by a reporting bias, concurrent medical conditions, other concomitant medications, emotional stress or other confounding factors, and/or a longer treatment period with ciprofloxacin. Because of these factors and limitations in the data collection, it is difficult to evaluate whether the reported symptoms were drug-related.


Cipro (ciprofloxacin) Injection, Tablets, and Oral Suspension Labeling

Medscape DrugInfo

Cipro (ciprofloxacin) Injection, Tablets, and Oral Suspension

Manufacturer: Pfizer, Inc.

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 12/21/04)

New Indication: This supplemental new drug application provides for the use of Vfend (voriconazole) tablets, injection, and oral suspension for candidemia in non-neutropenic patients and the following Candida infections:

  • disseminated infections in skin, and

  • infections in abdomen, kidney, bladder wall, and wounds.

Dosing: Non-neutropenic patients with candidemia and other deep tissue Candida infections should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.

The recommended dose of intravenous injection of voriconazole is 6 mg/kg every 12 hours for the first 24 hours followed by 3-4 mg/kg every 12 hours. The oral dose is 200 mg every 12 hours.

Clinical Summary: To support the labeled indication for candidemia in non-neutropenic patients, voriconazole was compared to the regimen of amphotericin B followed by fluconazole, an open-label, comparative study in non-neutropenic patients with candidemia associated with clinical signs of infection. Patients were randomized in a 2:1 ratio to receive either voriconazole (n = 283) or the regimen of amphotericin B followed by fluconazole (n = 139). Patients were treated with randomized study drug for a median of 15 days. Most of the candidemia in patients evaluated for efficacy was caused by C albicans (46%), followed by C tropicalis (19%), C parapsilosis (17%), C glabrata (15%), and C krusei (1%). A successful response required all of the following: resolution or improvement in all clinical signs and symptoms of infection, blood cultures negative for Candida , infected deep tissue sites negative for Candida or resolution of all local signs of infection, and no systemic antifungal therapy other than study drug. The primary analysis demonstrated that voriconazole was comparable to the regimen of amphotericin B followed by fluconazole (41% response rate for both) in the treatment of candidemia. Patients who did not have a 12-week assessment for any reason were considered a treatment failure.


Vfend (voriconazole) Tablets, Injection, and Oral Suspension Labeling

Medscape DrugInfo

Vfend (voriconazole) Tablets, Injection, and Oral Suspension