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Terbutaline parenteral

Presentation

Solution for injection or infusion containing terbutaline sulfate.

Drugs List

  • BRICANYL 2.5mg/5ml injection
  • BRICANYL 500microgram/1ml injection
  • terbutaline 2.5mg/5ml injection
  • terbutaline 500microgram/1ml injection
  • Therapeutic Indications

    Uses

    Bronchial asthma
    Premature labour : prevention
    Reversible airways obstruction

    Dosage

    Dosages should be individualised.

    Adults

    Treatment of severe forms of bronchospasm

    Subcutaneous, intramuscular or slow intravenous injection
    250 micrograms to 500 micrograms up to four times a day.
    The subcutaneous and intramuscular routes are usually preferred.

    Continuous intravenous infusion
    Terbutaline sulfate may also be given as a solution containing 3 to 5 micrograms/ml by continuous intravenous infusion at a rate of 1.5 to 5 micrograms/minute for 8 to 10 hours.

    Premature labour

    The use of SABAs for tocolysis in premature labour is restricted to 48 hours maximum parenteral use under specialist supervision.

    Administer as early as possible after the onset of premature labour, and after evaluation of the patient to exclude any contraindications to the use of terbutaline.

    Initial dosage
    5 micrograms/minute infused during the first 20 minutes. Increase by 2.5 micrograms/minute at 20 minute intervals until contractions cease. It is unlikely that more than 10 micrograms/minute will be required. 20 micrograms/minute must not be exceeded.

    Discontinue treatment if labour progresses despite maximum dose of terbutaline sulfate.

    If successful in halting labour continue infusion for 1 hour at the chosen rate then decrease by 2.5 micrograms/minute every 20 minutes until the lowest dose capable of suppressing contractions has been reached.

    The infusion dose must be carefully titrated with reference to suppression of contractions, increase in pulse rate and changes in blood pressure. Avoid maternal heart rate of over 120 beats/minute.

    Ensure maternal hydration level is carefully monitored to avoid pulmonary oedema. Keep volume of infusion fluid to a minimum. A controlled infusion device, preferably a syringe pump should be used.

    Children

    Treatment of severe forms of bronchospasm

    Subcutaneous, intramuscular or slow intravenous injection

    Children aged 15 to 18 years: 250 micrograms to 500 micrograms up to four times a day.

    Children aged 2 to 15 years: 10 micrograms/kg body weight (maximum dose 300 micrograms total)

    The subcutaneous and intramuscular routes are usually preferred.

    The following alternative dosing schedule for continuous intravenous infusion may be suitable:

    Children aged 2 to 18 years: Initially 2 to 4 micrograms/kg as a loading dose, then 1 to 10 micrograms/kg/hour according to response and heart rate (doses above 10 micrograms/kg/hour with close monitoring).

    Children aged under 2 years (unlicensed): Initially 2 to 4 micrograms/kg as a loading dose, then 1 to 10 micrograms/kg/hour according to response and heart rate (doses above 10 micrograms/kg/hour with close monitoring).

    Contraindications

    Antepartum haemorrhage - if treating premature labour
    Hypertrophic cardiomyopathy
    Intra-uterine infection - if treating premature labour
    Ischaemic heart disease - if treating premature labour
    Placenta abruptio - if treating premature labour
    Placenta praevia - if treating premature labour
    Pre-eclampsia or eclampsia - if treating premature labour
    Threatened abortion in first trimester
    Threatened abortion in second trimester
    Umbilical cord compression - if treating premature labour

    Precautions and Warnings

    Children under 2 years
    Predisposition to hypokalaemia
    Predisposition to long QT syndrome
    Breastfeeding
    Cardiac arrhythmias
    Cardiac failure
    Diabetes mellitus
    First trimester of pregnancy
    Hypertension
    Hyperthyroidism
    Hypoxia
    Ischaemic heart disease
    Lactic acidosis
    Thyrotoxicosis

    May decrease glucose tolerance in patients with diabetes mellitus
    Premature labour: Treatment to be supervised by an obstetrics specialist
    Premature labour: during infusion keep patient in lateral position
    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
    Premature labour - monitor cardiorespiratory function
    Advise patient to report any chest pain
    Increased bleeding after Caesarean section may occur
    May reduce serum potassium levels
    Premature labour - maximum duration of treatment is 48 hours

    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 to the foetus.

    With intravenous application there are some serious potential maternal side effects with terbutaline, however incidence is low. They include pulmonary oedema, myocardial ischaemia, cardiac arrhythmias, cerebral vasospasm, hypotension and miscellaneous metabolic alterations (hypokalaemia, increased serum lactate, and a decrease in measured haemoglobin concentration).
    Transient maternal hyperglycaemia has been reported with terbutaline followed by an increase in serum insulin levels.
    Transient hypoglycaemia has been reported in newborn preterm infants after maternal beta2- agonist treatment.

    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
    Hyperactivity
    Hyperglycaemia
    Hypersensitivity reactions
    Hypokalaemia
    Hypotension
    Lactic acidosis
    Maternal pulmonary oedema
    Mouth irritation
    Muscular cramps
    Myocardial ischaemia
    Nausea
    Pain on intramuscular injection
    Palpitations
    Peripheral vasodilatation
    Rash
    Restlessness
    Sleep disturbances
    Supraventricular tachycardia
    Tachycardia
    Tendency to uterine bleeding
    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.

    Summary of Product Characteristics: Bricanyl Injection, 0.5 mg/ml, solution for injection or infusion. Astrazeneca UK Ltd. Revised April 2017.

    MHRA Drug Safety Update November 2013
    Available at: https://www.mhra.gov.uk
    Last accessed: December 13, 2013

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 31 August 2017

    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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