NUELIN SR Tablet / NUELIN Syrup Ref.[50311] Active ingredients: Theophylline

Desirable therapeutic levels are considered to be between 10-20 µg/mL (55-110 µmol/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.

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 section 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS).

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 %.

Nuelin-SR Tablets

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 Tablets are 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 (twice a day) and a child over 25 kg, 250 mg bid (twice a day).

Note: For children taking Nuelin-SR tablets, Nuelin Syrup may be considered as an alternative.

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

Nuelin Syrup

Not recommended for children under 2 years except on the advice of a doctor.

Nuelin Syrup is best taken an hour before meals with a glass of water, or if necessary with or immediately after meals to lessen gastro-intestinal irritation.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

See also section 4.8 ADVERSE EFFECT (UNDESIRABLE EFFECTS) for possible drug effects that may be seen in overdosage.

Symptoms

Early symptoms of toxicity such as anorexia, nausea, vomiting, headache, irritability, agitation, anxiety, insomnia, hypotension, palpitations and tachycardia, may progress to sensory disturbances, confusion, hyperthermia, ventricular arrhythmias, extreme thirst, delirium and convulsions.

Every theophylline overdose should be regarded as potentially fatal and all patients should be closely monitored.

Treatment

There is no specific antidote to theophylline. Symptomatic support is indicated. Gastric lavage and general supportive measures (eg to maintain circulation, respiration and fluid and electrolyte balance) are recommended. Oral activated charcoal may reduce serum theophylline levels, whilst in severe cases charcoal haemoperfusion may be required.

The important features of overdose management are:

Gastric Decontamination

Gastric lavage is recommended especially when slow release preparations have been ingested. Note that the conscious state, gag reflex or occurrence of seizures may require the patient to be intubated before lavage is carried out. (Ipecac-induced emesis is not appropriate because it reduces the likelihood that patients will be able to tolerate oral charcoal.)

Use of Activated Charcoal and Cathartic (either sorbitol or polyethylene glycol)

This has been shown in several studies to reduce the half-life of theophylline substantially, even when absorption has been completed. The recommended dose is 1 g/kg every 4-6 hours (or 10 g/hour) until the theophylline level has plateaued or commenced falling or is below 55 µmol/L. (This depends on the experience of the physician in managing theophylline overdose.)

Control of Emesis (otherwise patients will not tolerate charcoal)

Metoclopramide, ranitidine, droperidol and possibly ondansetron can be used but there is no controlled trial evidence for any of these.

Theophylline Monitoring (See also section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE)

If side effects appear or if unusually high doses are required, serum theophylline should be monitored. Blood samples for monitoring should be drawn immediately before administration of the morning dose when the serum theophylline level is lowest. Another sample should be drawn 5-10 hours after administration of Nuelin SR when the theophylline level is at a maximum

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Store below 30°C.

Nuelin SR Tablets: HDPE bottle, 100’s

Nuelin Syrup: Amber PET bottle; 500 mL, 100 mL*, 5 L*

^* Not Marketed

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.