Salbutamol parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection and infusion containing salbutamol as salbutamol sulfate.
Drugs List
Therapeutic Indications
Uses
Parenteral beta2 agonist for treatment of bronchospasm in asthma & OAD
Uncomplicated premature labour : inhibition
Unlicensed Uses
Hyperkalaemia
Dosage
Adults
Relief of severe bronchospasm
Salbutamol may be administered by the subcutaneous, intramuscular or intravenous route.
Subcutaneous route
500 micrograms (8 micrograms/kg body weight), repeated every four hours as required.
Intramuscular route
500 micrograms (8 micrograms/kg body weight), repeated every four hours as required.
Slow intravenous injection
250 micrograms (4 micrograms/kg bodyweight) injected slowly. Repeat if necessary.
Intravenous infusion
3 to 20 micrograms salbutamol/minute, adjusted according to response. Higher doses have been used with success in patients with respiratory failure.
In the management of premature labour (salbutamol solution for infusion only)
Infusion rates providing 10 to 45 micrograms salbutamol/minute are usually sufficient to control uterine contractions. The recommended starting rate is 10 micrograms/minute, increasing the rate at 10 minute intervals until contractions lessen in strength, frequency or duration. The infusion rate may then be increased slowly until contractions stop. Once uterine contractions have stopped, the infusion rate should be maintained at the same level for one hour and then reduced by 50% decrements at six hourly intervals. If labour progresses despite treatment, the infusion should be stopped.
Administer infusion as soon as possible after diagnosis of premature labour and patient evaluation to exclude any contra-indications in the use of salbutamol.
During infusion the maternal pulse rate should be monitored and the infusion rate adjusted to avoid excessive maternal heart rate (above 120 beats/minute).
The volume of infusion fluid must be kept to a minimum to control the level of hydration and avoid the risk of maternal pulmonary oedema. A controlled infusion device, preferably a syringe pump, should be used.
Children
Relief of severe bronchospasm
Children aged over 12 years: See Dosage; Adults.
The following alternative dosing schedule may be suitable:
Acute Asthma by intravenous injection over 5 minutes
Children aged 12 to 18 years: 15 micrograms/kg (maximum 250 micrograms) as a single dose.
Children aged 2 to 12 years (unlicensed):15 micrograms/kg (maximum 250 micrograms) as a single dose.
Children aged 1 month to 2 years (unlicensed):5 micrograms/kg as a single dose.
Acute Asthma by continuous intravenous infusion
Children aged 12 to 18 years:1 to 2 micrograms/kg/minute, adjusted according to response and heart rate up to 5 micrograms/kg/minute; doses above 2 micrograms/kg/minute should be given in an intensive care setting.
Children aged 1 month to 12 years (unlicensed):1 to 2 micrograms/kg/minute, adjusted according to response and heart rate up to 5 micrograms/kg/minute; doses above 2 micrograms/kg/minute should be given in an intensive care setting.
Severe hyperkalaemia by intravenous injection over 5 minutes (unlicensed):
Children aged 1 month to 18 years:4 micrograms/kg as a single dose; repeat if necessary.
Neonates: 4 micrograms/kg as a single dose; repeat if necessary.
Administration
Salbutamol solution for infusion must be diluted before use.
Salbutamol solution for infusion should not be administered in the same syringe or infusion as any other medication.
Contraindications
Antepartum haemorrhage - if treating premature labour
Cardiac disorder - if treating premature labour
Intra-uterine foetal death
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
Umbilical cord compression - if treating premature labour
Precautions and Warnings
Children under 12 years
Impaired glucose tolerance
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Diabetes mellitus
History of torsade de pointes
Hypertension
Hyperthyroidism
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypoxia
Ischaemic heart disease
Multiple pregnancy
Pregnancy
Severe cardiac failure
Thyrotoxicosis
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Evaluate patients for cardiovascular disease prior to treatment
Not all available brands are licensed for all indications
Not all available brands are licensed for all routes of administration
Not to be used as the sole or main treatment for severe or unstable asthma
Premature labour: Treatment to be supervised by an obstetrics specialist
Monitor fluid balance + cardio-respiratory function if treating prem. lab
Monitor for development of lactic acidosis
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium regularly in severe asthmatic or hypoxic patients
Advise patient to report any chest pain
Advise patient to seek medical advice if asthma seems to be worsening
Discontinue if pulmonary oedema occurs
Premature labour - maximum duration of treatment is 48 hours
The use of SABAs for tocolysis in premature labour is restricted to 48 hours maximum parenteral use under specialist supervision.
Pregnancy and Lactation
Pregnancy
Use salbutamol with caution in pregnancy.
Inhaled salbutamol is considered a drug of choice for pregnant women (Schaefer 2007).
Salbutamol has been in widespread use for many years in human beings without apparent ill consequences; this includes its well established use in the management of premature labour. However, as with the majority of drugs, there is little published evidence of its safety in the early stages of human pregnancy, but in animal studies there is evidence of some harmful effects on the foetus at very high doses.
There are no published reports linking salbutamol to congenital anomalies in humans although few reports involve use in the 1st trimester. Of 1090 newborns exposed to salbutamol during the 1st trimester 48 major birth defects were observed with 43 of these expected. Only in the case of polydactyly 6/3 (observed/expected) was there any suggestion of an association with salbutamol although other factors may have been involved.
Adverse effects seen in both mother and foetus are largely secondary to the drugs cardiovascular and metabolic profile, including: tachycardia, hypotension which may lead to foetal distress, cardiac failure, pulmonary oedema and death; hyperglycaemia followed by an increase in serum insulin which is more pronounced in diabetic patients.
Other effects reported are: increased growth hormone levels, retinopathy of prematurity and a decreased incidence of neonatal respiratory distress syndrome.
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
Use with caution in breastfeeding.
Inhaled salbutamol is likely to be present in human breast milk. Briggs and Schaefer state that inhaled salbutamol is generally considered compatible with breastfeeding, although very large maternal doses of inhaled beta 2 agonists may cause restlessness and tachycardia in the infant (Schaefer 2007).
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
Angioedema
Atrial fibrillation
Bronchospasm (paradoxical)
Cardiac arrhythmias
Collapse
Dyspnoea
Extrasystoles
Fine tremor (usually hands)
Headache
Hyperactivity
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Hypotension
Ketoacidosis
Lactic acidosis
Local pain (injection site)
Muscular cramps
Myocardial ischaemia
Nausea
Nervous tension
Palpitations
Peripheral vasodilatation
Pulmonary oedema
Stinging
Supraventricular tachycardia
Tachycardia
Urticaria
Vomiting
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: March 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: Ventolin Injection 500 mcg. Glaxo Wellcome UK. Revised February 2015.
Summary of Product Characteristics: Ventolin Solution for IV Infusion. Glaxo Wellcome UK. Revised February 2015.
MHRA Drug Safety Update November 2013
Available at: https://www.mhra.gov.uk
Last accessed: 26.03.14
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 August 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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