Nuelin SR Special Precautions

As there is a correlation between plasma levels of theophylline and therapeutic effect and as patient response can vary considerably due to variable rates of elimination, monitoring plasma levels in individual patients is strongly recommended. Dosage should be individualised if optimal therapeutic effect is to be achieved. However, individual patients also have a widely variable tolerance to adverse effects and so symptomatology should be considered as well as monitored levels.
Acute symptoms of asthma requiring rapid treatment: Sustained release products are therapeutically inappropriate for acute asthma requiring prompt treatment.
Theophylline should not be administered concurrently with other xanthine medications and caution should be exercised when sympathomimetic agents are also part of the regimen.
Theophylline clearance decreases in patients with reduced thyroid function, congestive heart failure, acute pulmonary oedema, chronic obstructive pulmonary disease, severe hypoxia, pneumonia, acute febrile episodes and during acute viral infection.
Because of its cardiac side effects, use theophylline with caution in patients with cardiac arrhythmias, coronary artery disease, unstable angina, cardiomyopathy and severe hypertension. Theophylline increases gastric acid secretion and should be used with caution in patients with peptic ulcer or gastro-oesophageal reflux.
Smoking may increase theophylline clearance and increased doses of theophylline may be required.
Xanthine containing beverages (e.g: tea, coffee, cola, cocoa) may interfere with some serum theophylline assays.
There is some evidence that Theophylline exhibit dose-dependent kinetics, at least in sick and elderly patients.
Use in Pregnancy: Theophylline does across the placental barrier. The effect on foetal development is not known. Theophylline clearance is significantly decreased in premature infants. Therefore, if this drug is administered to the mother near the time of delivery, the neonate should be monitored closely for the pharmacological effects of theophylline. Hence the use of theophylline in pregnant women should be balanced against the risk of uncontrolled asthma.
Use in Lactation: Theophylline is excreted in breast milk and irritability has been reported in infants of nursing mothers taking theophylline. It is advisable to keep serum theophylline concentrations as low as possible in nursing mothers while maintaining adequate asthma control.
Use in Children: Nuelin-SR are not recommended for administration to children under 2 years of age. For children over 2 years, administration as advised by the physician.