Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SYRUP
**DOSAGE AND ADMINISTRATION** Desirable therapeutic levels are considered to be between 10–20 mcg/mL (55–110 micromole/L). Higher levels may produce toxic effects. Toxic effects may also occur at therapeutic levels. When maximum response is required, dose levels should be individually titrated. Serum theophylline may be monitored to confirm that levels are within the therapeutic range. Monitoring is particularly recommended when dose levels exceed 1 g daily in adults or 24 mg/kg daily in children. **NUELIN SYRUP** Adults – 25 mL every six hours. Children under 2 years – Not to be given except on the advice of a physician. Children over 2 years – 1 mL/kg bodyweight (up to a maximum of 25 mL) every six hours. Appropriate dosage adjustments should be made for smoking, heart failure, acute pulmonary oedema, chronic alcohol ingestion, established hepatic cirrhosis, severe airways obstruction, severe pneumonia, severe hypoxia, thyroid function adolescence (12–18 years), children (8–12 years) and concomitant use of interacting drugs. (See Drug Interactions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children have rapid clearance of theophylline and may require a dosage increase that should be controlled by measurement of serum theophylline. **ELDERLY** In patients aged over 65 years theophylline clearance is decreased by approximately 25%.
ORAL
Medical Information
**INDICATIONS** For the relief and prophylaxis of reversible bronchospasm associated with bronchial asthma, bronchitis, emphysema and related conditions.
**CONTRAINDICATIONS** Nuelin Syrup should not be used where hypersensitivity to its constituents or to xanthines generally is known or has been demonstrated.
R03DA04
theophylline
Manufacturer Information
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Ensign Laboratories Pty Ltd
Active Ingredients
Documents
Package Inserts
Nuelin Syrup PI.pdf
Approved: October 8, 2018