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Terbutaline oral

Updated 2 Feb 2023 | Selective beta-2-agonists

Presentation

Oral formulations containing terbutaline sulfate

Drugs List

  • BRICANYL 5mg tablets
  • terbutaline 5mg tablets
  • 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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