"The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis
Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United "...
Single-dose inhalation studies in rats and monkeys at doses up to 180-times higher than doses routinely used in clinical studies are well tolerated. Single dose oral administration of Pulmozyme (dornase alfa) in doses up to 200 mg/kg are also well tolerated by rats.
Cystic fibrosis patients have received up to 20 mg BID for up to 6 days and 10 mg BID intermittently (2 weeks on/2 weeks off drug) for 168 days. These doses were well tolerated.
Pulmozyme (dornase alfa) is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.
Last reviewed on RxList: 12/16/2008
This monograph has been modified to include the generic and brand name in many instances.
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