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LUFYLLIN (dyphylline) is not indicated in the management of status asthmaticus, which is a serious medical emergency.

Although the relationship between plasma levels of dyphylline and appearance of toxicity is unknown, excessive doses may be expected to be associated with an increased risk of adverse effects.


General:   Use LUFYLLIN (dyphylline) with caution in patients with severe cardiac disease, hypertension, hyperthyroidism, acute myocardial injury, or peptic ulcer.

Carcinogenesis, mutagenesis, impairment of fertility:   No long-term animal studies have been performed with LUFYLLIN (dyphylline) .

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 therapy

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/20/2005


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