MedPath logo

NUELIN SYRUP 80 mg/15 ml

Prescription Only
Drug type: Therapeutic
ATC code: R03DA04
Dosage form: SYRUP
Route of administration: ORAL
Active ingredient: THEOPHYLLINE; THEOPHYLLINE

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.

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%.

Registrant
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Approval Date
1989-05-09
Approval Number
SIN02770P
Manufacturer
Ensign Laboratories Pty Ltd
Licence Holder
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED