UNIPHYLLIN

Posology Adults and the elderly The usual maintenance dose is 200 mg 12 hourly. This may be titrated to either 300 mg or 400 mg dependent on the therapeutic response. Paediatric population aged 6 years and above The usual paediatric maintenance dose is 9 mg/kg twice daily.

Some children with chronic asthma require and tolerate much higher doses (10- 16 mg/kg twice daily). Clearance is increased in children compared to values observed in adult subjects. The rapid clearance observed in children decreases towards adult values in late teens.

Therefore, lower dosages (based on usual adult dose) may be required for adolescents. UNIPHYLLIN tablets should not be used in children below 6 years of age. Other dosage forms are available that are more suitable for children aged less than 6 years.

Theophylline distributes poorly into body fat, therefore mg/kg doses should be calculated on the basis of lean (ideal) bodyweight. Plasma theophylline concentrations should ideally be maintained between 5 and 12 micrograms/ml. A plasma level of 5 micrograms/ml probably represents the lower level of clinical effectiveness.

Significant adverse reactions are usually seen at plasma theophylline levels greater than 20 micrograms/ml. Monitoring of plasma theophylline concentrations may be required when: • higher dosages are prescribed; • patients have co-morbidities resulting in impaired clearance; • theophylline is co-administered with medication that reduces theophylline clearance.

Patients vary in their response to xanthines and it may be necessary to titrate the dose on an individual basis. g. at the time of the ‘morning dip’ in lung function. In patients whose night time or day time symptoms persist despite other therapy and who are not currently receiving theophylline, then the total daily requirement of UNIPHYLLIN tablets (as specified above) may be added to their treatment regimen as either a single evening or morning dose.

Dose adjustment may be necessary if smoking started or stopped during treatment. Method of administration Oral These tablets must be swallowed whole and not broken, crushed or chewed as doing so may lead to a rapid release of theophylline with the potential for toxicity.

Missed dose If a patient forgets to take a dose but remembers within 4 hours of the time the dose was due to be taken, the tablets can be taken straight away. The next dose should be taken at the normal time. Beyond 4 hours the prescriber may need to consider alternative treatment until the next dose is due.

The following adverse drug reactions have been reported in the post-marketing setting for theophylline. Frequencies of “not known” have been assigned as accurate frequencies cannot be estimated from the available clinical trial data.

4 as theophylline may induce urinary retention in elderly males with pre-existing partial urinary tract obstruction. Reporting of adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The patient’s response to therapy should be carefully monitored – worsening of asthma symptoms requires medical attention. Due to potential decreased theophylline clearance, dose reduction and monitoring of serum theophylline concentrations may be required in elderly patients and patients with: • Cardiac arrhythmias or other cardiac disease • hepatic disease • exacerbations of lung disease • hypothyroidism • fever • viral infections.

Due to potential increased theophylline clearance, dose increase and monitoring of serum theophylline concentrations may be required in patients with hyperthyroidism (and when starting acute hyperthyroidism treatment) and cystic fibrosis.

Theophylline may: • act as a gastrointestinal tract irritant and increase gastric secretion, therefore caution should be exercised in patients with peptic ulcers; • exacerbate cardiac arrhythmias and therefore caution should be exercised in patients with cardiac disorders; • exacerbate frequency and duration of seizures and therefore caution should be exercised in patients with history of seizures and alternative treatment considered.

Use with caution in patients with severe hypertension or chronic alcoholism. Caution should be exercised in elderly males with pre-existing partial urinary tract obstruction, such as prostatic enlargement, due to risk of urinary retention.

Particular care is advised in patients suffering from severe asthma who require acute theophylline administration. It is recommended that serum theophylline concentrations are monitored in such situations. In case of insufficient effect of the recommended dose and in case of adverse events, theophylline plasma concentration should be monitored.

1. Patients with porphyria. Concomitant administration with ephedrine in children less than 6 years of age (or less than 22 kg). Theophylline is contraindicated in children under 6 months of age.