Finished product reference
Theophylline / Guaifenesin
Solution · Oral · 50 mg/30 mg/5mL · 120 mL
- List code
- 1211
- Pharmacologic class
- Bronchodilator–expectorant combination; methylxanthine plus expectorant
What it is and how it works
Theophylline relaxes bronchial smooth muscle, probably through phosphodiesterase inhibition and adenosine receptor antagonism, and has respiratory stimulant and anti-inflammatory effects. Guaifenesin is an expectorant thought to increase the volume and reduce the viscosity of bronchial secretions, aiding their clearance.
Indications
Symptomatic treatment of bronchospasm associated with asthma, chronic bronchitis and COPD when accompanied by tenacious mucus.
Contraindications
Hypersensitivity to xanthines, acute porphyria, and concomitant use with other xanthine preparations.
Warnings and precautions
Theophylline has a narrow therapeutic index; toxicity (nausea, vomiting, tachycardia, arrhythmias, seizures) can occur, and plasma levels are altered by smoking, heart failure, liver disease, fever, viral infections and many interacting drugs (e.g. ciprofloxacin, erythromycin, cimetidine, fluvoxamine increase levels; rifampicin, carbamazepine, phenytoin reduce levels). Caution in cardiac arrhythmias, hypertension, hyperthyroidism, peptic ulcer, epilepsy and the elderly; hypokalaemia may be potentiated by beta2-agonists and corticosteroids.
Pregnancy
Use only if clearly needed, with monitoring of theophylline levels; neonatal irritability or apnoea may occur after exposure near term.
Storage and supply
Store below 25 °C, protected from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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