Jane S. Ricciuti, RPh, MS


January 23, 2004

In This Article

Anti-infective Agents

(levofloxacin) Tablets & Injection

Manufacturer: Johnson & Johnson Pharmaceutical

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 10/23/03)

New Indication: Levaquin (levofloxacin) tablets and injection are now indicated for use in treating community acquired pneumonia.

Dosing: Levofloxacin 750 mg once daily for 5 days

Levaquin (levofloxacin) Tablets & Injection Letter

Levaquin (levofloxacin) Tablets & Injection

Malarone (atovaquone and proguanil hydrochloride) Tablets

Manufacturer: GlaxoSmithKline

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 12/2/03)

New Indication: This supplemental new drug application provides for the use of Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets, 62.5 mg/25 mg for the treatment of Plasmodium falciparum malaria in pediatric patients weighing 5-11 kg.

Dosing: Pediatric dosing is based on body weight; see product labeling for detailed dosing information.

Clinical Summary: The efficacy of Malarone in treating acute uncomplicated P falciparum malaria was tested in pediatric patients weighing 5-11 kg in an open-label, randomized trial. Patients received either Malarone (2 or 3 Pediatric Tablets once daily depending upon body weight) for 3 days (n = 100) or amodiaquine (10 mg/kg/day) for 3 days (n = 100). A clinical response was obtained in 95% (87/92) of the pediatric patients who received Malarone and in 53% (41/78) of those who received amodiaquine.

A randomized, open-label study was conducted which included 221 healthy pediatric patients (weighing 5-11 kg and aged 2-17 years) who were at risk of contracting malaria by traveling to an endemic area. The mean duration of travel was 15 days (range, 1-30 days). Prophylaxis with Malarone (n = 110, dosage based on body weight) began 1 or 2 days before patients entered the endemic area and lasted until 7 days after leaving the area. A control group (n = 111) received prophylaxis with chloroquine/proguanil dosed according to World Health Organization guidelines. No cases of malaria occurred in either group of children. However, the study was not large enough to allow for statements of comparative efficacy.

Adverse Effects: The most common adverse events were abdominal pain (13%), headache (13%), and cough (10%). Abdominal pain (13% vs 8%) and vomiting (5% vs 3%) were reported more often with Malarone than with placebo, while fever (5% vs 12%) and diarrhea (1% vs 5%) were more common with placebo.

Pharmacokinetics: The elimination half-life of atovaquone is shorter in pediatric patients (1-2 days) than in adult patients (2-3 days). In clinical trials, plasma trough levels of atovaquone and proguanil in pediatric patients weighing 5-40 kg were within the range observed in adults after dosing by body weight.

Malarone (atovaquone and proguanil hydrochloride) Tablets Labeling

Malarone (atovaquone and proguanil hydrochloride) Tablets


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