Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease
Preventive treatment of bronchial asthma due to exercise
Symptom relief of broncho-obstruction in asthma when steroids insufficient

Contraindications

Children under 4 years
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children aged 4 to 12 years
Family history of long QT syndrome
Predisposition to hypokalaemia
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Diabetes mellitus
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Hypertension
Hyperthyroidism
Lactose intolerance
Pregnancy
Thyrotoxicosis

Correct electrolyte disorders before treatment
May decrease glucose tolerance in patients with diabetes mellitus
Advise patient dizziness may affect ability to drive or operate machinery
Do not substitute for steroid therapy
Ensure patient has a fast acting bronchodilator available
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
Some formulations contain lactose
Some formulations may contain alcohol
Some products may contain soya or soya derivative
Consider use of a spacer device for suitable patients and formulations
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium regularly in patients with severe asthma
Advise patient to seek medical advice if asthma seems to be worsening
CSM (CHM) requests reporting of adverse reactions to cfc-free inhalers
May reduce serum potassium levels
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Advise patient not to reduce steroid therapy without medical advice
Advise patient not to use for relief of acute attacks
Advise patient to continue taking corticosteroid therapy
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use salmeterol with caution in pregnancy.

There are no adequate data available on the use of salmeterol in human pregnancy to assess the possible harmful effects. The limited data that has been published identified no congenital malformations. However the study lacked the sensitivity to identify minor anomalies.

Animal studies in selected species of rabbits using doses well in excess of normal human doses have shown foetal toxicity secondary to beta adrenoreceptor stimulation. Extensive experience with other beta-2 agonists has provided no evidence that such effects are relevant for women receiving clinical doses of salmeterol.

It is not known if salmeterol crosses the placenta to the foetus. However, plasma levels of salmeterol after inhaled therapeutic doses are negligible which would suggest that the risk to the foetus is probably minimal.

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 salmeterol with caution in breastfeeding.

It is not known whether salmeterol passes into human breast milk. In rats, small amounts of salmeterol have been detected in maternal milk following oral dosing.

Plasma levels of salmeterol after inhaled therapeutic doses are negligible which would suggest that it is unlikely that clinically significant amounts would be found in human breast milk.

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

Anaphylactic reaction
Anaphylactic shock
Angioedema
Arthralgia
Atrial fibrillation
Bronchospasm (paradoxical)
Cardiac arrhythmias
Chest pain
Dizziness
Extrasystoles
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Increased blood pressure
Insomnia
Muscular cramps
Nausea
Nervousness
Oedema
Oropharyngeal irritation
Palpitations
Rash
Supraventricular tachycardia
Tachycardia
Tremor

Presentation

Inhalation formulations of salmeterol

Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease
Preventive treatment of bronchial asthma due to exercise
Symptom relief of broncho-obstruction in asthma when steroids insufficient

Dosage

The full benefits of treatment will be apparent after several doses of the drug.

The dosage or frequency of administration should only be increased on medical advice.

Adults

Elderly

Children

Contraindications

Children under 4 years
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children aged 4 to 12 years
Family history of long QT syndrome
Predisposition to hypokalaemia
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Diabetes mellitus
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Hypertension
Hyperthyroidism
Lactose intolerance
Pregnancy
Thyrotoxicosis

Correct electrolyte disorders before treatment
May decrease glucose tolerance in patients with diabetes mellitus
Advise patient dizziness may affect ability to drive or operate machinery
Do not substitute for steroid therapy
Ensure patient has a fast acting bronchodilator available
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
Some formulations contain lactose
Some formulations may contain alcohol
Some products may contain soya or soya derivative
Consider use of a spacer device for suitable patients and formulations
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium regularly in patients with severe asthma
Advise patient to seek medical advice if asthma seems to be worsening
CSM (CHM) requests reporting of adverse reactions to cfc-free inhalers
May reduce serum potassium levels
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Advise patient not to reduce steroid therapy without medical advice
Advise patient not to use for relief of acute attacks
Advise patient to continue taking corticosteroid therapy
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use salmeterol with caution in pregnancy.

There are no adequate data available on the use of salmeterol in human pregnancy to assess the possible harmful effects. The limited data that has been published identified no congenital malformations. However the study lacked the sensitivity to identify minor anomalies.

Animal studies in selected species of rabbits using doses well in excess of normal human doses have shown foetal toxicity secondary to beta adrenoreceptor stimulation. Extensive experience with other beta-2 agonists has provided no evidence that such effects are relevant for women receiving clinical doses of salmeterol.

It is not known if salmeterol crosses the placenta to the foetus. However, plasma levels of salmeterol after inhaled therapeutic doses are negligible which would suggest that the risk to the foetus is probably minimal.

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 salmeterol with caution in breastfeeding.

It is not known whether salmeterol passes into human breast milk. In rats, small amounts of salmeterol have been detected in maternal milk following oral dosing.

Plasma levels of salmeterol after inhaled therapeutic doses are negligible which would suggest that it is unlikely that clinically significant amounts would be found in human breast milk.

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

Anaphylactic reaction
Anaphylactic shock
Angioedema
Arthralgia
Atrial fibrillation
Bronchospasm (paradoxical)
Cardiac arrhythmias
Chest pain
Dizziness
Extrasystoles
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Increased blood pressure
Insomnia
Muscular cramps
Nausea
Nervousness
Oedema
Oropharyngeal irritation
Palpitations
Rash
Supraventricular tachycardia
Tachycardia
Tremor

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: February 2017

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 8 February 2017.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 8 February 2017.

Summary of Product Characteristics: NeoventTM CFC-free Inhaler 25 micrograms/actuation. Fannin (UK) Ltd. Revised March 2016.

Summary of Product Characteristics: Serevent Accuhaler. Glaxo Wellcome UK Ltd. Revised March 2014.

Summary of Product Characteristics: Serevent Evohaler. Glaxo Wellcome UK Ltd. Revised July 2014.

Summary of Product Characteristics: Soltel CFC-free Inhaler 25 micrograms/actuation. Cipla (EU) Limited. Revised July 2014.

Summary of Product Characteristics: Vertine CFC-free Inhaler 25 micrograms/actuation. Teva UK Limited. Revised March 2012.