Fluticasone propionate and salmeterol inhalation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Inhalers containing fluticasone propionate and salmeterol.
Drugs List
Therapeutic Indications
Uses
Asthma: Maintenance
Chronic obstructive pulmonary disease (FEV1<60% predicted normal)
Dosage
Adults
Asthma
One inhalation of 100micrograms fluticasone propionate and 12.75micrograms salmeterol dry powder inhaler twice daily.
or
One inhalation of 100micrograms fluticasone propionate and 50micrograms salmeterol dry powder inhaler twice daily. Reduce to one inhalation once daily if control maintained.
or
One inhalation of 202micrograms fluticasone propionate and 12.75micrograms salmeterol dry powder inhaler twice daily.
or
One inhalation of 250micrograms fluticasone propionate and 50micrograms salmeterol dry powder inhaler twice daily. Reduce to one inhalation once daily if control maintained.
or
One inhalation of 500micrograms fluticasone propionate and 50micrograms salmeterol dry powder inhaler twice daily.
or
Two inhalations of 50micrograms fluticasone propionate and 25micrograms salmeterol cfc free inhaler twice daily.
(Reduce to two inhalations once daily if control maintained).
or
Two inhalations of 125micrograms fluticasone propionate and 25micrograms salmeterol cfc free inhaler twice daily.
or
Two inhalations of 250micrograms fluticasone propionate and 25micrograms salmeterol cfc free inhaler twice daily.
Chronic Obstructive Pulmonary Disease
One inhalation of 500micrograms fluticasone propionate and 50micrograms salmeterol dry powder inhaler twice daily.
This medication is indicated for the symptomatic treatment of patients with COPD, with a FEV1 less than 60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Children
Asthma
Children aged 12 to 18 years
(See Dosage; Adult)
Children aged 4 to 12 years
One inhalation of 100micrograms fluticasone propionate and 50micrograms salmeterol dry powder inhaler twice daily. Reduce to one inhalation once daily if control maintained.
or
Two inhalations of 50micrograms fluticasone propionate and 25micrograms salmeterol cfc free inhaler twice daily.
(Reduce to two inhalations once daily if control maintained).
The maximum licensed dose of fluticasone propionate for children is 100micrograms twice daily.
Contraindications
Children under 4 years
Breastfeeding
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children aged 4 to 18 years
Family history of long QT syndrome
Major risk factors for decreased bone mineral content
Predisposition to hypokalaemia
Adrenal insufficiency
Cardiac arrhythmias
Diabetes mellitus
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Hypertension
Hyperthyroidism
Hypokalaemia
Lactose intolerance
Pregnancy
Pulmonary tuberculosis
Severe cardiovascular disorder
Thyrotoxicosis
Correct electrolyte disorders before treatment
May decrease glucose tolerance in patients with diabetes mellitus
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 indicated for all uses
Not all available brands are licensed for all age groups
Not all strengths are suitable for use in children under 18 years
Some formulations contain lactose
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
COPD - symptomatic decompensation may follow cessation of therapy
High doses may cause adrenal suppression/bone metabolism changes
May reduce serum potassium levels
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 not to reduce steroid therapy without medical advice
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 propionate with salmeterol with caution during pregnancy.
Drug Combination
The manufacturer advises that the use of fluticasone propionate with salmeterol should only be considered if the expected benefit to the mother is greater than any risk to the foetus. Animal studies indicate reproductive toxicity after use of beta2 adrenoreceptor agonists and glucocorticosteroids. Available data following use in human pregnancy does not indicate malformation or foeto/neonatal toxicity.
Lactation
The combination of fluticasone propionate with salmeterol is contraindicated during breastfeeding.
Drug Combination
Use of fluticasone propionate with salmeterol is contraindicated by the manufacturer. The manufacturer recommends a decision must be made whether to cease breastfeeding or stop taking the medication. Studies show that fluticasone propionate and salmeterol are excreted into the milk of lactating rats. It is unknown whether fluticasone propionate, salmeterol and their metabolites are excreted in human milk. The effects on exposed infants are unknown.
Side Effects
Adrenal suppression
Aggression
Anaphylactic reaction
Anaphylactic shock
Angina pectoris
Angioedema
Anxiety
Arthralgia
Atrial fibrillation
Back pain
Behavioural disturbances (children)
Blurred vision
Bronchitis
Bronchospasm
Candidiasis (mouth or throat)
Cardiac arrhythmias
Cataracts
Central serous chorioretinopathy
Contact dermatitis
Contusion
Cough
Cushing's syndrome
Cushingoid facies
Cutaneous reactions
Decrease in bone mineral density
Depression
Dizziness
Dyspepsia
Dysphonia
Dyspnoea
Extrasystoles
Extremity pain
Facial oedema
Glaucoma
Growth retardation (children)
Headache
Hoarseness
Hyperactivity in children
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Influenza
Irritability
Laceration
Muscular cramps
Myalgia
Nasal congestion
Nasopharyngitis
Oesophageal candidiasis
Oropharyngeal oedema
Oropharyngeal pain
Palpitations
Paradoxical bronchospasm (on inhalation)
Pharyngitis
Pneumonia
Rhinitis
Sinusitis
Sleep disturbances
Supraventricular tachycardia
Systemic effects (large quantities and/or prolonged use)
Tachycardia
Throat irritation
Traumatic fractures
Tremor
Upper abdominal pain
Visual disturbances
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 2018
Reference Sources
Summary of Product Characteristics: Aerivio Spiromax 50micrograms/ 500micrograms inhalation powder. Teva B.V. Revised June 2017.
Summary of Product Characteristics: AirFluSal Forspiro 50microgram/500microgram inhalation powder. Sandoz Limited. Revised June 2017.
Summary of Product Characteristics: AirFluSal 25microgram/125microgram per actuation pressurised inhalation, suspension. Sandoz Limited. Revised March 2017.
Summary of Product Characteristics: AirFluSal 25microgram/250microgram per actuation pressurised inhalation, suspension. Sandoz Limited. Revised March 2017.
Summary of Product Characteristics: Aloflute 25microgram/125microgram per metered dose pressurised inhalation, suspension. Mylan (3M Healthcare Limited). Revised June 2017.
Summary of Product Characteristics: Avenor 25microgram/50microgram per metered dose pressurised inhalation, suspension. Zentiva Pharma UK Limited. Revised June 2021.
Summary of Product Characteristics: Avenor 25microgram/125microgram per metered dose pressurised inhalation, suspension. Zentiva Pharma UK Limited. Revised June 2021.
Summary of Product Characteristics: Avenor 25microgram/250microgram per metered dose pressurised inhalation, suspension. Zentiva Pharma UK Limited. Revised June 2021.
Summary of Product Characteristics: Campona Airmaster 50micrograms/100microgram/dose inhalation powder, predispensed. Activase Pharmaceuticals Limited. Revised November 2021.
Summary of Product Characteristics: Campona Airmaster 50micrograms/250microgram/dose inhalation powder, predispensed. Activase Pharmaceuticals Limited. Revised November 2021.
Summary of Product Characteristics: Campona Airmaster 50micrograms/500microgram/dose inhalation powder, predispensed. Activase Pharmaceuticals Limited. Revised November 2021.
Summary of Product Characteristics: Combisal 25microgram/50microgram per metered dose pressurised inhalation, suspension. Aspire Pharma Ltd. Revised April 2018.
Summary of Product Characteristics: Combisal 25microgram/50microgram per metered dose pressurised inhalation, suspension. Aspire Pharma Ltd. Revised April 2018.
Summary of Product Characteristics: Combisal 25microgram/150microgram per metered dose pressurised inhalation, suspension. Aspire Pharma Ltd. Revised April 2018.
Summary of Product Characteristics: Combisal 25microgram/250microgram per metered dose pressurised inhalation, suspension. Aspire Pharma Ltd. Revised April 2018.
Summary of Product Characteristics: Fixkoh Airmaster 50microgram/100microgram/dose, inhalation powder. Thornton & Ross Ltd. Revised August 2020.
Summary of Product Characteristics: Fixkoh Airmaster 50microgram/250microgram/dose, inhalation powder. Thornton & Ross Ltd. Revised August 2020.
Summary of Product Characteristics: Fixkoh Airmaster 50microgram/500microgram/dose, inhalation powder. Thornton & Ross Ltd. Revised August 2020.
Summary of Product Characteristics: Fusacomb Easyhaler 50microgram/250microgram/dose, inhalation powder. Orion Corporations. Revised April 2018.
Summary of Product Characteristics: Fusacomb Easyhaler 50microgram/500microgram/dose, inhalation powder. Orion Corporations. Revised April 2018.
Summary of Product Characteristics: Seffalair Spiromax 12.75microgram/100microgram inhalation powder. Teva UK Limited. Revised August 2021.
Summary of Product Characteristics: Seffalair Spiromax 12.75microgram/202microgram inhalation powder. Teva UK Limited. Revised August 2021.
Summary of Product Characteristics: Sereflo 25 microgram/125 microgram per actuation pressurised inhalation, suspension. Fannin (UK) Limited. Revised December 2016.
Summary of Product Characteristics: Sereflo 25microgram/250microgram per actuation pressurised inhalation, suspension. Fannin (UK) Limited. Revised December 2016.
Summary of Product Characteristics: Sereflo Ciphaler 50microgram/250microgram per dose inhalation powder, predispensed. Cipla (EU) Limited. Revised September 2021.
Summary of Product Characteristics: Seretide 100, 250, 500 Accuhaler. Glaxo Wellcome Ltd. Revised December 2016.
Summary of Product Characteristics: Seretide 50, 125, 250 Evohaler. Allen & Hanburys. Revised April 2015.
Summary of Product Characteristics: Sirdupla 25microgram/125 microgram per metered dose pressurised inhalation, suspension. Mylan. Revised June 2017.
Summary of Product Characteristics: Sirdupla 25microgram/250 microgram per metered dose pressurised inhalation, suspension. Mylan. Revised June 2017.
Summary of Product Characteristics: Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed. Glenmark Pharmaceuticals Europe Ltd. Revised October 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 February 2022
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