Alinia tablets, Prevacid.
(nitazoxanide, Romark Laboratories)
The Food and Drug Administration approved nitazoxanide tablets for treatment of diarrhea caused by Giardia lamblia in patients aged 12 years and older and extended the age range for nitazoxanide oral suspension to patients aged 12 years and older. The oral suspension was approved in November 2002 for children aged 1-11 years who have diarrhea caused by Giardia lamblia and Cryptosporidium parvum.
* Recommended Dosage: One 500-mg tablet b.i.d. for 3 days.
* Special Considerations: Abdominal pain, diarrhea, headache, and nausea were the most common adverse events in clinical trials with nitazoxanide. These effects did not occur significantly more in patients taking nitazoxanide vs. placebo.
* Comment: The efficacy of nitazoxanide tablets and oral suspension was 83%-100% in terms of resolving diarrhea and related symptoms, according to adult clinical trials.
Nitazoxanide is the first antiprotozoal agent approved in its class. It received priority review from the FDA for treating Giardia, the most prevalent intestinal protozoal infection in the United States.
The medication will be supplied in 3-day packs, each containing six 500-mg tablets. It will also be packaged in bottles of 60 tablets. It should be available in pharmacies now, the company said.
"Nitazoxanide is a new drug offering promise against relatively common causes of diarrhea. As with any new drug, postmarketing monitoring of side effects and efficacy will be very important before its wide-scale use can be unequivocally advocated," said Dr. Richard H. Sandier of the department of pediatrics at Rush Children's Hospital, Chicago. Dr. Sandler has no conflict of interest regarding Romark Laboratories.
(lansoprazole, TAP Pharmaceutical Products Inc.)
The FDA approved lansoprazole for short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 12-17 years. Lansoprazole is now approved for use in pediatric patients aged 1-17 years.
* Recommended Dosage: 15 mg once daily for up to 8 weeks for short-term treatment of symptomatic, nonerosive GERD in patients aged 12-17 years. Recommended dosage is 30 mg once daily up to 8 weeks for patients aged 12-17 years with erosive esophagitis.
For short-term treatment of symptomatic GERD and short-term treatment of erosive esophagitis in children aged 1-11years: 15 mg once daily for up to 12 weeks if 30 kg or less or 30 mg once daily for up to 12 weeks if over 30 kg.
* Special Considerations: The most frequently reported treatment-related adverse events in a study of 87 adolescent patients taking delayed-release lansoprazole capsules were headache, abdominal pain, nausea, and dizziness.
* Comment: In the open-label, multi-center study of adolescent patients with symptomatic GERD, 89% had mild to moderate symptoms at baseline.
A total of 64 patients (74%) had nonerosive GERD, and 23 patients (26%) had erosive esophagitis.
During 8 weeks of treatment, participants reported a 63% reduction in frequency and a 69% reduction in severity of GERD symptoms. Erosive esophagitis healed in all but 1 of the 22 adolescents after 8 weeks of treatment; the other patient remained symptomatic after 12 weeks of treatment.
"We use a lot of proton pump inhibitors in adolescents, and this is a medicine we have been using in teenagers for quite a while," said Dr. Wallace Crandall of the department of pediatrics at Ohio State University, Columbus.
He added that the expanded indication for adolescents is "important because drug companies often do not take the time to approve drugs in children." Dr. Crandall is on the speakers' bureau for TAP Pharmaceuticals.
"The efficacy of the various proton pump inhibitors is similar. One of the things they've done is to make Prevacid more user friendly for children," Dr. Crandall said. The agent is available as delayed-release capsules, delayed-release orally disintegrating tablets, and delayed-release oral suspension.
"If there are children and teenagers who need long-term use of proton pump inhibitors, it may be worthwhile to evaluate those patients to make sure they don't have Barrett's esophagus, eosinophilic esophagitis, Helicobacter, or some other disorder."
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|Title Annotation:||New & Approved|
|Publication:||Family Practice News|
|Date:||Oct 1, 2004|
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