Guaifenesin/ Terbutaline

Registered South African indications:

• Cough 

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

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Patients with acute porphyria
• Patients already on any other asthma preparation
• Patients receiving monoamine oxidase inhibitors or within fourteen days of stopping such treatment
• Pregnancy
• Lactation

Cautions

Caution should be exercised in the following patients

• Renal impairment
• Hepatic impairment
• Patients who have recently suffered heart attacks
• Patients with uncontrolled diabetes mellitus
• Patients receiving antihypertensive therapy
• Patients receiving other sympathomimetics

Effect of treatment

• If there is no improvement within 12-24 hours, a doctor must be consulted immediately

Susceptibility to beta2-adrenergic stimulation

• Guaifenesin/ terbutaline should be used with caution when an increased susceptibility to beta2-adrenergic stimulation can be expected, for instance, in patients with:
  • Hyperthyroidism
  • Ischaemic heart disease
  • Arrhythmia and tachycardia
  • Occlusive vascular disorders including arteriosclerosis, hypertension, aneurysms, or closed-angle glaucoma

Angina pectoris

• Anginal pain may be precipitated in patients with angina pectoris

Not indicated for use in adults

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

Symptomatic relief of cough associated with bronchospasm

Guaifenesin/ Terbutaline sulphate
66.5/1.5 (mg/5ml)

• Younger than 3 years: Not established for use
• Between 3-7 years: Oral (syr): 2.5-5ml, 8hrly
• Older than 7 years: Oral (syr): 5-10ml, 8hrly

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

Pregnancy

• Contraindicated
• Safety in pregnancy has not been established

Breastfeeding

• Contraindicated
• Safety in lactation has not been established

Renal Impairment

• Severe: Caution; no dose adjustment recommended (Guaifenesin)

Hepatic Impairment

• Severe: Caution; no dose adjustment recommended (Guaifenesin)

Elderly

• No dose adjustment recommended (Guaifenesin, Terbutaline)

Porphyria

• Contraindicated
  Contraindicated in patients with acute porphyria

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

Guaifenesin

Central Nervous System Disorders 

• Dizziness
• Drowsiness 
• Headache

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Nausea and vomiting

Genitourinary Disorders

• Nephrolithiasis

Endocrine and Metabolic Disorders

• Hypouricemia

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Urticaria 
• Rash

Terbutaline
Central Nervous System Disorders

• Tremor
• Headache
• Sleep disorder
• Agitation
• Restlessness

Cardiovascular Disorders 

• Tachycardia
• Palpitations
• Arrhythmias
• Tachycardia and extrasystoles
• Myocardial ischaemia 

Respiratory Disorders

• Paradoxical bronchospasm

Gastrointestinal Disorders

• Nausea
• Mouth and throat irritation

Endocrine and Metabolic Disorders

• Hypokalaemia
• Hyperglycaemia 

Musculoskeletal Disorders

• Muscle spasms

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Exanthema

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions 
• Anaphylaxis
• Peripheral vasodilation

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

Guaifenesin

• Cough suppressants

Terbutaline

• Non-selective beta blocking agents (including eye drops) 
• Sympathomimetic agents 
• Halogenated anaesthetics  
• Potassium-depleting diuretics 
• Methylxanthines 
• Corticosteroids 

Additional interactions for this combination product

• Monoamine oxidase inhibitors
• Cardiac glycosides
• Quinidine
• Tricyclic antidepressants
• Antidiabetic agents

None routine 

Guaifenesin
The exact mechanism of action of guaifenesin is unknown. It may act by irritating gastric vagal receptors resulting in the activation of efferent parasympathetic reflexes, which cause glands to secrete less viscous mucous. This may help to clear small airways obstructed by congealed mucous.

Terbutaline
Terbutaline sulfate is a selective beta-2 adrenoceptor agonist. It relaxes bronchial smooth muscle, inhibits the release of endogenous spasmogens, inhibits oedema caused by endogenous mediators, and increases mucociliary clearance. 

COMBINATION PREPARATIONS

Guaifenesin/ Terbutaline

Solution (per 5ml) 66.5mg/1.5mg

• Benylin Bronchospect (Johnson & Johnson) originator