Theophylline should not be administered concomitantly with other xanthines. Use with caution in patients with hypoxemia, hypertension, cardiac disease, congestive heart failure, alcoholism, elderly patients and patients with a history of peptic ulcer.
Theophylline may occasionally act as a local irritant to the gastrointestinal tract. Symptoms are more commonly centrally mediated and associated with serum drug concentrations >20 mcg/mL.
Salbutamol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension; in patients with convulsive disorders, hyperthyroidism or diabetes mellitus.
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 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 Durasalyn-CR.