"The US Food and Drug Administration has approved AstraZeneca's Symbicort inhalation aerosol (80/4.5 mcg) for children aged 6 to 12 years with asthma that is not well controlled with an inhaled corticosteroid, the company has announced.
LUFYLLIN (dyphylline) is not indicated in the management of status asthmaticus, which is a serious medical emergency.
Pregnancy: Teratogenic effects Pregnancy Category C. Animal reproduction studies have not been conducted with LUFYLLIN (dyphylline) . It is also not known if LUFYLLIN (dyphylline) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. LUFYLLIN (dyphylline) should be given to a pregnant woman only if clearly needed.
Nursing mothers: Dyphylline is present in human milk at approximately twice the maternal plasma concentration. Caution should be exercised when LUFYLLIN (dyphylline) is administered to a nursing woman.
Pediatric use: Safety and effectiveness in children have not been established.
Geriatric Use: Clinical studies of LUFYLLIN (dyphylline) did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapyThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/20/2005
Additional Lufyllin Information
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