Theophylline (Oral Modified Release)
Brand names: Uniphyllin, Slo-Phyllin, Nuelin SA
Theophylline is an oral xanthine bronchodilator used as add-on therapy in asthma and COPD when other treatments are insufficient.
Adult dose
Paediatric dose
Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.
Usual paediatric maintenance dose for children aged 6 years and above. Some children with chronic asthma require and tolerate much higher doses (10-16 mg/kg twice daily). Clearance is increased in children compared with adults and decreases towards adult values in late teens, so lower (adult-based) dosages may be required for adolescents. Theophylline distributes poorly into body fat, so mg/kg doses should be calculated on lean (ideal) bodyweight. Other dosage forms are available that are more suitable for children under 6 years; theophylline is contraindicated in children under 6 months. Plasma theophylline monitoring applies as for adults. Verify against a children's formulary before prescribing.
US labelling (FDA)
Reference — US labelling, may differ from UKDOSAGE AND ADMINISTRATION Theophylline (Anhydrous) Extended-Release Tablets 400 or 600 mg can be taken once a day in the morning or evening. It is recommended that Theophylline (Anhydrous) Extended-Release Tablets be taken with meals. Patients should be advised that if they choose to take Theophylline (Anhydrous) Extended-Release Tablets with food it should be taken consistently with food and if they take it in a fasted condition it should routinely be taken fasted. It is important that the product whenever dosed be dosed consistently with or without food. Theophylline (Anhydrous) Extended-Release Tablets are not to be chewed or crushed because it may lead to a rapid release of theophylline …
Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-12-04. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.
Contraindications
- Hypersensitivity to theophylline and other xanthines or to any of the excipients
- Patients with porphyria
- Concomitant administration with ephedrine in children less than 6 years of age (or less than 22 kg)
- Children under 6 months of age
Side effects
- Seizures or convulsions
- Cardiac arrhythmias, sinus tachycardia, atrial tachycardia and palpitations
- Nausea, vomiting, abdominal pain and gastric irritation / gastro-oesophageal reflux
- Headache, tremor, dizziness, agitation, anxiety and insomnia
- Hypokalaemia and hyperuricaemia
- Urinary retention (elderly males with pre-existing partial urinary tract obstruction) and diuresis
Interactions
- May increase theophylline plasma concentrations: cimetidine, ciprofloxacin, macrolide antibiotics such as erythromycin, propranolol, isoniazid, oral contraceptives, mexiletine, ranitidine, fluvoxamine
- Increase theophylline clearance (dose increase may be needed): aminoglutethimide, carbamazepine, isoprenaline, phenytoin, rifampicin, ritonavir, sulphinpyrazone, barbiturates and St John's wort; smoking and alcohol consumption also increase clearance
- Reduce theophylline clearance (dose reduction may be needed): aciclovir, allopurinol, carbimazole, cimetidine, clarithromycin, diltiazem, disulfiram, erythromycin, fluconazole, interferon, isoniazid, methotrexate, mexiletine, nizatidine, pentoxifylline, propafenone, propranolol (SPC list truncated at the source-fetch limit)
Clinical monograph
How it works
It causes bronchodilation and has some anti-inflammatory effect (via phosphodiesterase inhibition and adenosine antagonism); the mechanism is not fully defined.
Prescribing in practice
- It has a narrow therapeutic index — toxicity (nausea, palpitations, arrhythmia, seizures) can occur near therapeutic levels, so monitor plasma levels.
- Many factors alter its level — smoking and enzyme inducers lower it; macrolides, ciprofloxacin, heart failure and liver disease raise it.
- Modified-release brands differ and are not interchangeable — prescribe by brand.
Monitoring
Monitor plasma theophylline levels (and at dose or interacting-drug changes) and watch for toxicity.
Counselling the patient
- Stay on the same brand.
- Report palpitations, persistent vomiting, or feeling shaky or agitated.
- Tell your clinician if you start or stop smoking, as it changes how the drug works.
Evidence & guidelines
An add-on bronchodilator in asthma/COPD (NICE NG80/NG115), used with level monitoring because of its narrow margin.
Reference: BTS/SIGN Asthma Guidelines 2019; GOLD COPD 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).
Related
Curated clinical cross-links plus same-class fallbacks.
- Modified Mallampati Classification · Airway Assessment
- Modified Early Warning Score (MEWS) · Early Warning
- Modified Shock Index (MSI) · Haemodynamic Assessment
- Modified Sgarbossa's Criteria (Smith Modification) for MI in LBBB · ECG Interpretation
- DOAC Score for Selecting Direct Oral Anticoagulant in Non-Valvular AF · Anticoagulation
- Modified Early Warning Score · Early Warning
- Acute Asthma in Adults · BTS/SIGN British Guideline on Asthma 2019; NICE NG80
- Pulmonary Embolism Assessment · NICE NG158; ESC 2019 PE Guidelines
- Acute Exacerbation of COPD (AECOPD) · NICE NG115; GOLD 2024
- Spontaneous Pneumothorax (Adult) · BTS Pleural Disease 2023
- Atypical Pneumonia (Legionella / Mycoplasma / Chlamydophila) · BTS 2023; IDSA
- COPD Exacerbation Management · NICE NG115 / GOLD 2024