Drugs List

Therapeutic Indications

Uses

Asthma - prophylaxis

Contraindications

Children under 5 years
Breastfeeding
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children aged 5 to 18 years
Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Adrenal insufficiency
Arterial aneurysm
Cardiac arrhythmias
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
History of torsade de pointes
Hypertrophic obstructive cardiomyopathy
Idiopathic subvalvular aortic stenosis
Ischaemic heart disease
Phaeochromocytoma
Pregnancy
Pulmonary tuberculosis
Severe cardiac failure
Severe hepatic impairment
Severe hypertension
Thyrotoxicosis

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Correct electrolyte disorders before treatment
Re-evaluate therapy in active or quiescent pulmonary tuberculosis
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Therapy should not be initiated during exacerbation of asthma
Ensure patient has a fast acting bronchodilator available
Not all available brands are licensed for all age groups
Not all formulations are suitable for use in children under 18 years
Stabilise patient prior to transfer from systemic steroids
Consider use of a spacer device for suitable patients and formulations
Check patient is using correct inhaler technique
Consider adrenal suppression when transferring from systemic steroid
Consider monitoring ECG in patients at risk of QT prolongation
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Monitor adrenal function in stressed patients e.g.surgery/intensive care
Monitor for signs/symptoms of pneumonia in patients at risk
Monitor regularly the height of children receiving prolonged treatment
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium regularly in patients with severe asthma
During transfer from oral steroids allergic conditions may be unmasked
High doses may cause adrenal suppression/bone metabolism changes
Patient should seek medical advice if signs of pulmonary infection develop
Systemic effects possible with any inhaled corticosteroid
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Advise patient medication contains small amount of alcohol
Advise patient not to use for relief of acute attacks
Advise patient to rinse mouth with water after each dose
Advise patient to seek medical advice if treatment is ineffective
Consider issuing Steroid Treatment/Steroid Emergency Card
High dose:Advise patient to avoid chickenpox,measles etc; see Dr if exposed
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use the combination of fluticasone with formoterol with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus and that during labour there is the potential for beta agonist interference with uterine contractility.

There is little data on the combined use in pregnant women. Studies in animals have shown reproductive toxicity.

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

The combination of fluticasone with formoterol is contraindicated in breastfeeding.

The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication.

It is not known whether fluticasone propionate or formoterol fumarate are excreted in human breast milk, hence a risk to the breastfed infant cannot be excluded.

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

Adrenal suppression
Aggression
Agitation
Angina pectoris
Angioedema
Angioneurotic oedema
Anxiety
Asthenia
Behavioural disturbances
Blurred vision
Bronchospasm (paradoxical)
Candidiasis (mouth or throat)
Cataracts
Contusion
Cough
Cushing's syndrome
Cushingoid facies
Decrease in bone mineral density
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dysgeusia
Dyspepsia
Dysphonia
Dyspnoea
Exacerbation of pre-existing asthma
Exanthema
Glaucoma
Headache
Hyperactivity
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypokalaemia
Increased blood lactate levels
Increased susceptibility to infection
Insomnia
Muscle spasm
Myalgia
Nausea
Palpitations
Peripheral oedema
Prolongation of QT interval
Pruritus
Psychomotor impairment
Rash
Sinusitis
Skin atrophy
Sleep disturbances
Suppression of growth in children and adolescents
Tachycardia
Throat irritation
Tremor
Urticaria
Ventricular extrasystoles
Vertigo

Presentation

Inhalation formulations of fluticasone with formoterol.

Drugs List

Therapeutic Indications

Uses

Asthma - prophylaxis

Dosage

Titrate dose to the lowest dose at which effective control of symptoms is maintained.

The breath actuated inhaler is not licensed for children under 12 years.

Adults

Children

Contraindications

Children under 5 years
Breastfeeding
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children aged 5 to 18 years
Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Adrenal insufficiency
Arterial aneurysm
Cardiac arrhythmias
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
History of torsade de pointes
Hypertrophic obstructive cardiomyopathy
Idiopathic subvalvular aortic stenosis
Ischaemic heart disease
Phaeochromocytoma
Pregnancy
Pulmonary tuberculosis
Severe cardiac failure
Severe hepatic impairment
Severe hypertension
Thyrotoxicosis

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Correct electrolyte disorders before treatment
Re-evaluate therapy in active or quiescent pulmonary tuberculosis
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Therapy should not be initiated during exacerbation of asthma
Ensure patient has a fast acting bronchodilator available
Not all available brands are licensed for all age groups
Not all formulations are suitable for use in children under 18 years
Stabilise patient prior to transfer from systemic steroids
Consider use of a spacer device for suitable patients and formulations
Check patient is using correct inhaler technique
Consider adrenal suppression when transferring from systemic steroid
Consider monitoring ECG in patients at risk of QT prolongation
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Monitor adrenal function in stressed patients e.g.surgery/intensive care
Monitor for signs/symptoms of pneumonia in patients at risk
Monitor regularly the height of children receiving prolonged treatment
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium regularly in patients with severe asthma
During transfer from oral steroids allergic conditions may be unmasked
High doses may cause adrenal suppression/bone metabolism changes
Patient should seek medical advice if signs of pulmonary infection develop
Systemic effects possible with any inhaled corticosteroid
Do not withdraw this drug suddenly
Discontinue if paradoxical bronchospasm occurs
Maintain treatment at the lowest effective dose
Advise patient medication contains small amount of alcohol
Advise patient not to use for relief of acute attacks
Advise patient to rinse mouth with water after each dose
Advise patient to seek medical advice if treatment is ineffective
Consider issuing Steroid Treatment/Steroid Emergency Card
High dose:Advise patient to avoid chickenpox,measles etc; see Dr if exposed
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use the combination of fluticasone with formoterol with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus and that during labour there is the potential for beta agonist interference with uterine contractility.

There is little data on the combined use in pregnant women. Studies in animals have shown reproductive toxicity.

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

The combination of fluticasone with formoterol is contraindicated in breastfeeding.

The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication.

It is not known whether fluticasone propionate or formoterol fumarate are excreted in human breast milk, hence a risk to the breastfed infant cannot be excluded.

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

Adrenal suppression
Aggression
Agitation
Angina pectoris
Angioedema
Angioneurotic oedema
Anxiety
Asthenia
Behavioural disturbances
Blurred vision
Bronchospasm (paradoxical)
Candidiasis (mouth or throat)
Cataracts
Contusion
Cough
Cushing's syndrome
Cushingoid facies
Decrease in bone mineral density
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dry mouth
Dysgeusia
Dyspepsia
Dysphonia
Dyspnoea
Exacerbation of pre-existing asthma
Exanthema
Glaucoma
Headache
Hyperactivity
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Hypokalaemia
Increased blood lactate levels
Increased susceptibility to infection
Insomnia
Muscle spasm
Myalgia
Nausea
Palpitations
Peripheral oedema
Prolongation of QT interval
Pruritus
Psychomotor impairment
Rash
Sinusitis
Skin atrophy
Sleep disturbances
Suppression of growth in children and adolescents
Tachycardia
Throat irritation
Tremor
Urticaria
Ventricular extrasystoles
Vertigo

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: September 2018

Reference Sources

Summary of Product Characteristics: Flutiform 50micrograms/5micrograms; 125micrograms/5micrograms; 250micrograms/10micrograms, Napp Pharmaceuticals Ltd. Revised October 2018.

Summary of Product Characteristics: Flutiform K-haler 50micrograms/5micrograms; 125micrograms/5micrograms; 250micrograms/10micrograms, Napp Pharmaceuticals Ltd. Revised November 2017.