Drugs List

Therapeutic Indications

Uses

Prevention of allergen-induced bronchospasm
Prevention of exercise-induced bronchospasm
Reversible airways obstruction
Treatment of acute severe asthma

Contraindications

None known

Precautions and Warnings

Children under 12 years
Predisposition to hypokalaemia
Predisposition to long QT syndrome
Arterial aneurysm
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Diabetes mellitus
Hypertension
Hyperthyroidism
Hypoxia
Ischaemic heart disease
Phaeochromocytoma
Pregnancy
Thyrotoxicosis

May decrease glucose tolerance in patients with diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Do not use as a substitute for inhaled or oral corticosteroids
Not all available brands are licensed for use in children under 12 years
Not to be used as the sole or main treatment for severe or unstable asthma
Check patient is using correct inhaler technique
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Advise patient to report any chest pain
Advise patient to seek medical advice if asthma seems to be worsening
May reduce serum potassium levels
Discontinue if paradoxical bronchospasm occurs
Advise patient that CFC-free inhalers may have different taste or sensation
Advise patient to seek medical advice if treatment is ineffective
If relief lasts for less than 3 hours patient should seek medical advice

Inhaled salbutamol preparations are not appropriate for managing premature labour and should not be used for threatened abortion.

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

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.

In a surveillance study including 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. There have also been rare reports of various congenital anomalies following intrauterine exposure to salbutamol (including cleft plate, limb defects and cardiac disorders).

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 14-17 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 breast feeding

Salbutamol is probably excreted in breast milk and it is not known whether salbutamol has a harmful effect on the neonate.

No reports are available for its use although other drugs in its class (terbutaline) are considered compatible.

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
Dizziness
Dry mouth
Extrasystoles
Fine tremor (usually hands)
Hallucinations
Headache
Hyperactivity in children
Hyperexcitability (children)
Hypersensitivity reactions
Hypokalaemia
Hypotension
Increased blood lactate levels
Insomnia
Lactic acidosis
Mouth irritation
Muscular cramps
Myalgia
Myocardial ischaemia
Nausea
Nervous tension
Palpitations
Peripheral vasodilatation
Pruritus
Sleep disturbances
Supraventricular tachycardia
Tachycardia
Taste disturbances
Throat irritation
Urticaria
Vomiting
Wheezing

Presentation

Breath actuated and cfc-free inhalation formulations of salbutamol.

Drugs List

Therapeutic Indications

Uses

Prevention of allergen-induced bronchospasm
Prevention of exercise-induced bronchospasm
Reversible airways obstruction
Treatment of acute severe asthma

Dosage

Adults

Children

Additional Dosage Information

Contraindications

None known

Precautions and Warnings

Children under 12 years
Predisposition to hypokalaemia
Predisposition to long QT syndrome
Arterial aneurysm
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Diabetes mellitus
Hypertension
Hyperthyroidism
Hypoxia
Ischaemic heart disease
Phaeochromocytoma
Pregnancy
Thyrotoxicosis

May decrease glucose tolerance in patients with diabetes mellitus
Advise ability to drive/operate machinery may be affected by side effects
Do not use as a substitute for inhaled or oral corticosteroids
Not all available brands are licensed for use in children under 12 years
Not to be used as the sole or main treatment for severe or unstable asthma
Check patient is using correct inhaler technique
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Advise patient to report any chest pain
Advise patient to seek medical advice if asthma seems to be worsening
May reduce serum potassium levels
Discontinue if paradoxical bronchospasm occurs
Advise patient that CFC-free inhalers may have different taste or sensation
Advise patient to seek medical advice if treatment is ineffective
If relief lasts for less than 3 hours patient should seek medical advice

Inhaled salbutamol preparations are not appropriate for managing premature labour and should not be used for threatened abortion.

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

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.

In a surveillance study including 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. There have also been rare reports of various congenital anomalies following intrauterine exposure to salbutamol (including cleft plate, limb defects and cardiac disorders).

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 14-17 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 breast feeding

Salbutamol is probably excreted in breast milk and it is not known whether salbutamol has a harmful effect on the neonate.

No reports are available for its use although other drugs in its class (terbutaline) are considered compatible.

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
Dizziness
Dry mouth
Extrasystoles
Fine tremor (usually hands)
Hallucinations
Headache
Hyperactivity in children
Hyperexcitability (children)
Hypersensitivity reactions
Hypokalaemia
Hypotension
Increased blood lactate levels
Insomnia
Lactic acidosis
Mouth irritation
Muscular cramps
Myalgia
Myocardial ischaemia
Nausea
Nervous tension
Palpitations
Peripheral vasodilatation
Pruritus
Sleep disturbances
Supraventricular tachycardia
Tachycardia
Taste disturbances
Throat irritation
Urticaria
Vomiting
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: May 2013

Reference Sources

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: Airomir Autohaler. Teva UK Limited. Revised May 2015.

Summary of Product Characteristics: AirSalb CFC-free inhaler 100 microgram/dose. Sandoz Limited. November 2015.

Summary of Product Characteristics: Salamol Easi-Breathe CFC-Free Inhaler, IVAX Pharmaceutials UK. Revised November 2015.

Summary of Product Characteristics: Ventolin Evohaler. GlaxoSmithKline UK. Revised July 2015.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 August 2017