Jane S. Ricciuti, RPh, MS


October 21, 2003

In This Article

Anti-infective Agents

Cipro XR
(ciprofloxacin) Extended-Release Tablets

Manufacturer: Bayer Corporation

Drug Approval Classification: Original New Drug Application (Approval Date: 8/27/03)

New Indication: Cipro XR (ciprofloxacin extended-release tablets) is indicated for complicated urinary tract infections and acute uncomplicated pyelonephritis.

Cipro XR (ciprofloxacin) Extended-Release Tablets Labeling

Cleocin (clindamycin phosphate) Cream

Manufacturer: Pharmacia & Upjohn

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 8/20/03)

New Precautions: This supplemental approval provides for the addition of the following information on geriatric use:

  • Geriatric Use

    • Clinical studies for Cleocin (clindamycin phosphate) Vaginal Cream 2% did not include sufficient numbers of subjects 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

Cleocin (clindamycin phosphate) Cream Labeling

Cleocin (clindamycin phosphate) Cream

(daptomycin) for Injection

Manufacturer: Cubist Pharmaceutical Inc.

Drug Approval Classification: Original New Drug Application (Approval Date: 9/12/03)

Indication: Cubicin (daptomycin) is indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following gram-positive microorganisms:

  • Staphylococcus aureus

  • Streptococcus pyogenes

  • Streptococcus agalactiae

  • Streptococcus dysgalactiae

  • Enterococcus faecalis (vancomycin-susceptible strains only)

Dosing: Daptomycin, 4 mg/kg, is administered over a 30-minute infusion once every 24 hours for 7-14 days.

Clinical Summary: Daptomycin is the first FDA-approved agent in a new class of antibiotics called cyclic lipopeptide antibacterial agents. Daptomycin binds to bacterial membranes and causes a rapid depolarization of membrane potential. The loss of membrane potential leads to inhibition of protein, DNA, and RNA synthesis, which results in bacterial cell death.

Daptomycin was approved based on clinical studies involving more than 1400 adults. The clinical studies demonstrated that daptomycin was equivalent to standard treatments, such as vancomycin, oxacillin, or nafcillin, in the treatment of complicated skin and skin structure infections.

Adverse Effects: Most adverse events in the clinical studies were mild to moderate. The most common adverse events included gastrointestinal disorders, injection site reactions, fever, headache, insomnia, dizziness, and rash.

It is recommended that blood tests measuring creatine phosphokinase levels be performed weekly in patients who receive daptomycin. In clinical trials, muscle injury was found rarely in patients, but after therapy creatine phosphokinase levels returned to normal.

Pharmacokinetics: Daptomycin follows linear pharmacokinetics at doses up to 6 mg/kg once daily. Steady-state concentrations are reached by the third day of administration. At doses of 4-6 mg/kg, the Cmax is 57.8 mg to 133 mcg/mL, Tmax is 0.8-0.5 hours, and half-life is 8.1-9 hours.

Daptomycin does not inhibit or induce the following CYP450 isoforms: 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4. Caution is advised when daptomycin is administered with tobramycin. The Cmax of daptomycin is reduced by 10% when coadministered with tobramycin; the clinical significance of this interaction is unknown.

Cubicin (daptomycin) for Injection Labeling