Generic Medicine Info
Should be taken on an empty stomach (i.e. At least one hour before food or two hours after food).
Acute porphyria. IV: Concomitant use with other xanthine drugs. Oral: Concomitant use with ephedrine (in children <6 years or <22 kg).
Special Precautions
Patient with history of seizure, active influenza infection or undergoing influenza immunisation, acute febrile illness, cardiac arrhythmias or other CV disease, chronic alcoholism, active or history of peptic ulcer, thyroid disorder, glaucoma, diabetes mellitus, severe hypoxaemia, sepsis with multiorgan failure, shock, hypertension, cystic fibrosis, acute pulmonary oedema, cor pulmonale, compromised circulatory function. Simultaneous administration by >1 route/preparation. Not recommended for infants <6 months. Avoid extravasation (IV). Smokers. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation. Monitoring Parameters Monitor serum theophylline levels following initiation of treatment and before increasing the dose, in the presence of signs or symptoms of toxicity, when new or worsening of illness occurs, during changes in treatment regimen; changes in fluid balance, electrolyte concentrations, or acid-balance (during prolonged use). For oral maintenance, measure theophylline serum concentrations 3 days after dosage adjustment. Observe the infusion site (IV). Monitor heart and respiratory rate, serum K levels; arterial or capillary blood gases (if applicable); CNS effects (e.g. insomnia, irritability).
Adverse Reactions
Significant: May exacerbate seizure, arrhythmias, and peptic ulcer; urinary retention (particularly in elderly males). Cardiac disorders: Palpitations, tachycardia. Ear and labyrinth disorders: Vertigo. Eye disorders: Visual disturbances. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, gastrointestinal haemorrhage, GERD; gastric irritation (oral). General disorders and administration site conditions: Hyperthermia and extreme thirst (at higher dose). Immune system disorders: Hypersensitivity. Metabolism and nutrition disorders: Hypokalaemia, hyponatraemia, hypophosphataemia. Nervous system disorders: Headache, confusional state, dizziness, tremor. Psychiatric disorders: Anxiety, insomnia, restlessness; delirium and maniacal behaviour (high dose). Respiratory, thoracic and mediastinal disorders: Hyperventilation. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, exfoliative dermatitis, rash maculo-papular, erythema. Vascular disorders: Hypotension.
Potentially Fatal: Severe theophylline toxicity.
Drug Interactions
May increase plasma theophylline concentration with fluvoxamine, cimetidine, fluconazole, macrolides (e.g. clarithromycin, erythromycin), quinolones (e.g. norfloxacin, ciprofloxacin), propranolol, isoniazid, allopurinol (at high doses e.g. 600 mg daily), estrogen-containing oral contraceptives, disulfiram, Ca channel blockers (e.g. verapamil), mexiletine, propafenone, interferon-alfa, influenza vaccine, tacrine, thiabendazole, methotrexate, thyroid hormones, or zafirlukast. May decrease plasma theophylline concentration with rifampicin, ritonavir, antiepileptic drugs (e.g. carbamazepine, phenytoin, phenobarbital, primidone), sulfinpyrazone, and aminoglutethimide. Increased risk of convulsions with ketamine. May diminish the effects of benzodiazepines and lithium. Increased risk of arrhythmias with halothane. May antagonise the neuromuscular blocking effects of pancuronium. Diminished bronchodilatory effects with β- blockers. May inhibit the effects of adenosine receptor agonists (e.g. adenosine, dipyridamole, regadenoson). May enhance the sensitivity and toxic potential of cardiac glycosides. Increased CNS stimulation with doxapram. Increased risk of hypokalaemia with β2-adrenergic agonists, corticosteroids, and diuretics.
CIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03DA05 - aminophylline ; Belongs to the class of xanthines. Used in the systemic treatment of obstructive airway diseases.
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