NUELIN-SR 125 TABLET [SIN11399P]

Product Info

NUELIN-SR 125 TABLET

[SIN11399P]

INDICATIONS: For the relief and prophylaxis of reversible bronchospasm associated with bronchial asthma, bronchitis, emphysema and related conditions.

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.

ADULTS: 200 to 300 mg (one tablet) every twelve hours. This dose can be gradually increased or decreased by half a tablet if sufficient therapeutic effect is not achieved or if side effects occur.

CHILDREN: Nuelin SR is not recommended for administration to children under 2 years of age. For children over 2 years, administration as advised by the physician. The daily dose should be adjusted according to bodyweight, usually on the basis of up to 10 mg/kg bodyweight every twelve hours. As a guideline, a child from 12 kg to 25 kg bodyweight (2–7 years) usually requires 125 mg bid and a child over 25 kg, 250 mg bid. 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%.

NOTE: Nuelin SR tablets should be taken every twelve hours. On no account should the tablets be chewed or crushed.

CONTRAINDICATIONS: Nuelin SR should not be used where hypersensitivity to its constituents or to xanthines generally is known or has been demonstrated.