Anti-infective AgentsCancidas (caspofungin acetate) Injection
Manufacturer: Merck Research Laboratories
Drug Approval Classification: Supplemental NDA (approval date: 1/7/03)
New Indication: Cancidas (caspofungin acetate) injection is now indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections.
Dosing: A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Caspofungin acetate should be administered by slow intravenous infusion over approximately 1 hour. Duration of treatment should be dictated by the patient's clinical and microbiological response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia.
Clinical Summary: There were 239 patients with invasive candidiasis enrolled in a phase 3 randomized, double-blind study. Amphotericin B was the active control. At the end of study and up to 8weeks post-study period, caspofungin was as effective as amphotericin B.
Cancidas (caspofungin acetate) Labeling
Cancidas (caspofungin acetate) InjectionZyvox (linezolid) Tablets and Injection
Manufacturer: Pharmacia & Upjohn
Drug Approval Classification: Supplemental NDA (approval date: 12/19/02)
New Indication: A new pediatric indication has been approved for Zyvox (linezolid).
Zyvox is indicated to treat gram-positive infections in pediatric patients ranging in age from birth through 11 years who have:
complicated and uncomplicated skin and skin structure infections,
community-acquired pneumonia (also supported by evidence from an uncontrolled study in patients ranging in age from 8 months through 12 years), and
vancomycin-resistant Enterococcus faecium infections.
Zyvox is indicated for the treatment of pediatric patients ranging in age from 5 through 17 years who have:
uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.
Recommended dosing for patients aged birth to 10 years is 10 mg/kg every 8 hours by intravenous injection or by oral administration for the following infections:
complicated skin and skin structure infections,
nosocomial pneumonia, and
vancomycin-resistant Enterococcus faecium infections
In the treatment of uncomplicated skin and skin structure infections caused by S aureus (methicillin-susceptible strains only) or S pyogenes, patients are dosed on the basis of their age:
Patients younger than 5 years of age: 10 mg/kg by oral administration every 8 hours Patients 5-11 years of age: 10 mg/kg by oral administration every 12 hours
Neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life.
Clinical Summary: The safety and efficacy of linezolid was assessed in 308 pediatric patients with gram-positive bacterial infections in a randomized, open-label, comparator-controlled trial. Patients were treated for a total of 10 to 28 days and could receive concomitant gram-negative antibiotics if clinically indicated. The cure rate was 81% in linezolid-treated patients compared with 83% in those patients randomized to vancomycin (comparator).
Adverse Effects: In clinical trials, linezolid was compared with cefadroxil and vancomycin. Diarrhea and nausea were the 2 most common adverse events. No differences in adverse event rates were seen between linezolid and its comparators.
Pharmacokinetics: Linezolid clearance in pediatric patients is most rapid in the youngest age groups (ranging from > 1 week old to 11 years), resulting in lower single-dose systemic exposure (area under the drug concentration curve [AUC]) and shorter half-life compared with adults.
Zyvox (linezolid) Tablets and Injection Letter
Medscape Pharmacists. 2003;4(1) © 2003 Medscape
Cite this: February 2003 - Medscape - Feb 20, 2003.