This product is not indicated in the management of status asthmaticus, which is a serous 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 this product with caution in patients with severe cardiac disease, hypertension, hypothyroidism, acute myocardial injury or peptic ulcer.
Drug Interactions: Synergism, between xanthine bronchodilators (e.g., theophylline), ephedrine and other sympathomimetic bronchodilators has been reported. This should be considered whenever these agents are prescribed concomitantly. Concurrent administration of dyphylline and probenecid, which competes for tubular secretion, has been shown to increase plasma half-life and dyphylline (See Clinical Pharmacology
Mutagenesis, Impairment of Fertility: No long-term animal studies have been performed with this product.
Pregnancy: Teratogenic effects - Pregnancy Category C, Animal reproduction studies have not been conducted with this formulation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This medication 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 this product is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children below the age of six have not been established. Use caution when administering to children six years of age or older.