Theophylline/ Etofylline

Registered South African indications:

• Acute and chronic bronchial asthma 
• Bronchospasm
• Bronchitis 
• Emphysema

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Contraindications

• Hypersensitivity to the active ingredient and any of the excipients in this combination product
• Diabetes
• Breastfeeding

Cautions

Caution in the following patient groups

• Pregnancy
• Renal impairment
• Hepatic impairment
• Elderly

Children

• Children are particularly susceptible to the effects of theophylline and therefore theophylline/etofylline syrup should not be administered more frequently than every eight hours

Overdosage in children

• Overdosage in children can be dangerous, as absorption is unpredictable. It may be characterised by haematemesis, stimulation of the central nervous system and diuresis

Use in elderly and cardiac/liver disease

• Theophylline/ etofylline syrup should be administered with caution to elderly patients and those suffering from cardiac disease and liver disease

Peptic ulceration

• Care should be taken in patients with a history of peptic ulceration

Smokers and haemodialysis

• Smokers may require increased dosage as may patients undergoing routine haemodialysis

Sucrose content

• Contains sucrose. Patients with rare hereditary conditions such as fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take theophylline/etofylline

Diabetes mellitus

• Sucrose may have an effect on the glycaemic control of patients with diabetes mellitus

Forms avail. in SA and covered in this monograph: syr

Acute and chronic bronchial asthma 
Bronchospasm
Bronchitis 
Emphysema

Theophylline/ Etofylline
80/10 (mg/15ml) 

• Oral (syr): 60-75ml, at the onset of an acute attack; Maintenance: 15-30ml, 8hrly after meals 

Paed. forms avail. in SA and covered in this monograph: syr

Acute and chronic bronchial asthma 
Bronchospasm
Bronchitis 
Emphysema

Theophylline/ Etofylline
80/10 (mg/15ml) 

• Oral (syr): 30ml, at the onset of an acute attack; Maintenance: 15ml, 8hrly after meals 

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Caution
• Safety in pregnancy has not been established

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; dose adjustment recommended (Theophylline)

Hepatic Impairment

• Caution; dose adjustment recommended (Theophylline)

Elderly

• Caution; dose adjustment recommended (Theophylline)

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Theophylline
Central Nervous System Disorders

• Headache
• Confusion
• Restlessness
• Vertigo
• Tremor
• Seizures
• Anxiety
• Insomnia
• Mania
• Delirium

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Cardiac arrhythmias
• Hypotension

Respiratory Disorders

• Hyperventilation

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain
• Diarrhoea
• Gastro-oesophageal reflux
• Gastrointestinal bleeding

Endocrine and Metabolic Disorders

• Hypokalaemia
• Hypophosphataemia
• Hyponatraemia 
• Hyperthermia
• Extreme thirst

Skin and Subcutaneous Tissue Disorders

• Rash
• Maculopapular rash
• Erythema
• Pruritus
• Urticaria
• Exfoliative dermatitis

Sensory Disorders

• Visual disturbances

Etofylline
Central Nervous System Disorders

• Insomnia
• Irritability

Cardiovascular Disorders

• Tachycardia
• Palpitations

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Nausea and vomiting

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Theophylline

• Xanthine derivatives 
• Beta-2 agonists 
• Steroids 
• Diuretics 
• Allopurinol 
• Cimetidine 
• Influenza vaccine 
• Propranolol 
• Macrolide antibiotics 
• Lithium 
• St John's wort 
• Ketamine 
• Beta blockers 
• Doxapram
• CYP450 inducers 

Etofylline

• Central nervous system depressants 
• Warfarin
• Sulphonylureas

None routine. Specific cases may require

• Theophylline levels (see additional prescribing points)  

Check theophylline levels if patient has any symptoms suggestive of theophylline toxicity e.g. tachycardia and gastrointestinal disturbances

Levels should also be checked if medications known to reduce clearance of theophylline are commenced

Theophylline 
Theophylline is a phosphodiesterase inhibitor which results in smooth muscle relaxation, diuresis, cardiac stimulation, cerebral stimulation and skeletal muscle stimulation. Through its ability to bring about smooth muscle relaxation, theophylline acts predominently as a bronchodilator and vasodilator.

Etofylline 
Etofylline is N-7 substituted theophylline derivative which acts similar to other xanthines. The bronchodilating action of xanthines is thought to result from the competitive inhibition of phosphodiesterase, which is the enzyme responsible for the breakdown cyclic AMP in smooth muscle cells.

COMBINATION PREPARATIONS

Theophylline/ Etofylline nicotinate

Syrup (per 15ml) 80mg/10mg

• Theophen (Pharmacare)
• Solphyllin (Adcock) originator