Drugs List

Therapeutic Indications

Uses

Prevention of allergen-induced bronchospasm
Prevention of exercise-induced bronchospasm
Reversible airways obstruction

Contraindications

Children under 4 years

Precautions and Warnings

Children 4 to 6 years
Impaired glucose tolerance
Arterial aneurysm
Breastfeeding
Cardiac arrhythmias
Cardiac failure
Cardiovascular disorder
Diabetes mellitus
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Hypertension
Hyperthyroidism
Hypertrophic obstructive cardiomyopathy
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypoxia
Ischaemic heart disease
Lactose intolerance
Phaeochromocytoma
Pregnancy
Thyrotoxicosis

May decrease glucose tolerance in patients with diabetes mellitus
Do not use as a substitute for inhaled or oral corticosteroids
Not all available brands are licensed for use in children under 6 years
Not to be used as the sole or main treatment for severe or unstable asthma
Some formulations contain lactose
Check patient is using correct inhaler technique
Monitor blood glucose closely in patients with diabetes mellitus
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
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
If relief lasts for less than 3 hours patient should seek medical advice

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

Angina pectoris
Angioedema
Atrial fibrillation
Behavioural disturbances
Bronchospasm (paradoxical)
Burning tongue
Cardiac arrhythmias
Collapse
Cough
Dizziness
Erythema
Extrasystoles
Fine tremor (usually hands)
Hallucinations
Headache
Hyperactivity
Hyperexcitability (children)
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypokalaemia
Hypotension
Hypoxia
Ketoacidosis
Mouth irritation
Muscular cramps
Myocardial ischaemia
Nausea
Nephritis
Nervous tension
Palpitations
Peripheral vasodilatation
Pruritus
Rash
Restlessness
Sleep disturbances
Supraventricular tachycardia
Sweating
Tachycardia
Taste disturbances
Throat irritation
Thrombocytopenia
Urticaria
Wheezing

Presentation

Dry powder for inhalation containing salbutamol.

Drugs List

Therapeutic Indications

Uses

Prevention of allergen-induced bronchospasm
Prevention of exercise-induced bronchospasm
Reversible airways obstruction

Dosage

Adults

Children

Adolescents

Contraindications

Children under 4 years

Precautions and Warnings

Children 4 to 6 years
Impaired glucose tolerance
Arterial aneurysm
Breastfeeding
Cardiac arrhythmias
Cardiac failure
Cardiovascular disorder
Diabetes mellitus
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Hypertension
Hyperthyroidism
Hypertrophic obstructive cardiomyopathy
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hypoxia
Ischaemic heart disease
Lactose intolerance
Phaeochromocytoma
Pregnancy
Thyrotoxicosis

May decrease glucose tolerance in patients with diabetes mellitus
Do not use as a substitute for inhaled or oral corticosteroids
Not all available brands are licensed for use in children under 6 years
Not to be used as the sole or main treatment for severe or unstable asthma
Some formulations contain lactose
Check patient is using correct inhaler technique
Monitor blood glucose closely in patients with diabetes mellitus
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
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
If relief lasts for less than 3 hours patient should seek medical advice

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

Angina pectoris
Angioedema
Atrial fibrillation
Behavioural disturbances
Bronchospasm (paradoxical)
Burning tongue
Cardiac arrhythmias
Collapse
Cough
Dizziness
Erythema
Extrasystoles
Fine tremor (usually hands)
Hallucinations
Headache
Hyperactivity
Hyperexcitability (children)
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypokalaemia
Hypotension
Hypoxia
Ketoacidosis
Mouth irritation
Muscular cramps
Myocardial ischaemia
Nausea
Nephritis
Nervous tension
Palpitations
Peripheral vasodilatation
Pruritus
Rash
Restlessness
Sleep disturbances
Supraventricular tachycardia
Sweating
Tachycardia
Taste disturbances
Throat irritation
Thrombocytopenia
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: July 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: Easyhaler Salbutamol 100 micrograms. Orion Corporation. Revised August 2016.

Summary of Product Characteristics: Easyhaler Salbutamol 200 micrograms. Orion Corporation. Revised May 2016.

Summary of Product Characteristics: Salbulin MDPI Novolizer. Meda Pharmaceuticals Ltd. Revised February 2017.

Summary of Product Characteristics: Ventolin Accuhaler. Glaxo Wellckome UK Ltd. Revised July 2015.

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