Duralyn-CR Special Precautions

Theophylline should not be administered concomitantly with other xanthines. Use with caution in patients with hyperemia, hypertension, cardiac disease, congestive heart failure, alcoholism, elderly patients and patients with history of peptic ulcer. Theophylline may occasionally acts as a local irritant to the gastrointestinal tract when administered orally, although gastrointestinal symptoms are more commonly centrally mediated and associated with serum drug concentrations >20 mcg/mL.
Use in pregnancy: It is not known whether theophylline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well-controlled studies in pregnant women. Theophylline should only be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Theophylline is distributed into breast milk and may cause irritability or other signs of toxicity in nursing infants. Because of the potential for serious adverse reactions in nursing infants from theophylline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in children <12 years have not been established with Duralyn-CR.