Terbutaline oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing terbutaline sulfate
Drugs List
Therapeutic Indications
Uses
Bronchial asthma
Reversible airways obstruction
Dosage
Not all formulations are licensed for all age groups.
The recommended minimum dosage interval is 7 hours.
MHRA safety update November 2013 issued a warning stating that oral SABAs should not be used in any obstetric indication.
Adults
Tablets
2.5 mg three times daily for the first one to two weeks, then the dose may be increased to 5 mg three times daily if required.
Oral solution
The starting dose should be 3 mg three times daily. The dose may be increased to 4.5 mg three times daily if required.
Elderly
Tablets
2.5 mg three times daily for the first one to two weeks, then the dose may be increased to 5 mg three times daily if required.
Oral solution
The starting dose should be 3 mg three times daily. The dose may be increased to 4.5 mg three times daily if required.
Children
Children 15 to 18 years
Tablets
2.5 mg three times daily for the first one to two weeks, then the dose may be increased to 5 mg three times daily if required.
Oral solution
The starting dose should be 3 mg three times daily. The dose may be increased to 4.5 mg three times daily if required.
Children 7 to 15 years
Starting dose should be 2.5 mg twice a day. However, in some patients, the dose may need to be increased to 2.5 mg three times a day or 75 micrograms/kg three times a day of the oral solution.
Children 1 month to 7 years
75 micrograms/kg (maximum 2.5 mg) three times a day.
Tablets are not licensed for use in children under 7 years.
Contraindications
Hypertrophic cardiomyopathy
Precautions and Warnings
Predisposition to hypokalaemia
Predisposition to long QT syndrome
Breastfeeding
Cardiac arrhythmias
Cardiac failure
Diabetes mellitus
First trimester of pregnancy
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Hypertension
Hyperthyroidism
Hypoxia
Ischaemic heart disease
Lactose intolerance
Thyrotoxicosis
May decrease glucose tolerance in patients with diabetes mellitus
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Monitor antidiabetic drug treatment
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Monitor serum potassium regularly in patients with severe asthma
Neonate exposed in utero: Risk of hypoglycaemia in preterm neonate
Advise patient to report any chest pain
Advise patient to seek medical advice if asthma seems to be worsening
May reduce serum potassium levels
MHRA safety update November 2013 issued a warning stating that oral SABAs should not be used in any obstetric indication.
Pregnancy and Lactation
Pregnancy
Administer terbutaline with caution in pregnant patients during the first trimester. No reports linking the use of terbutaline with congenital defects have been located. Reproductive studies in mice, rats and rabbits have revealed no evidence of impaired fertility or foetal harm.
Terbutaline rapidly crosses the placenta. Adverse effects in the foetus and newborn (tremors, tachycardia, hypoglycaemia, and hypokalaemia) have been reported, especially when high doses of beta 2-agonists are used.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
This medication should be used with caution during breastfeeding.
Terbutaline is secreted in breast milk but is unlikely to affect the infant at therapeutic levels. Although no toxic effects have been observed with the use of terbutaline, its use can lead to restlessness and tachycardia in the infant.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
Agitation
Angioedema
Atrial fibrillation
Behavioural disturbances
Bronchospasm (paradoxical)
Cardiac arrhythmias
Collapse
Extrasystoles
Fine tremor (usually hands)
Headache
Hypersensitivity reactions
Hypokalaemia
Hypotension
Mouth irritation
Muscular cramps
Myocardial ischaemia
Nausea
Palpitations
Peripheral vasodilatation
Rash
Restlessness
Sleep disturbances
Supraventricular tachycardia
Tachycardia
Throat irritation
Urticaria
Wheezing
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2014
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013.
Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013.
Summary of Product Characteristics: Bricanyl Tablets 5mg. Astrazeneca UK Ltd. Revised March 2009.
Summary of Product Characteristics: Bricanyl 0.3 mg/ml Syrup. Astrazeneca UK Ltd. Revised January 2010.
MHRA Drug Safety Update November 2013
Available at: https://www.mhra.gov.uk
Last accessed: December 13, 2013
UK Drugs in Lactation Advisory Service.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/guide.htm
Last accessed: January 22, 2013
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