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Formoterol fumarate inhalation

Updated 2 Feb 2023 | Long acting beta agonists


Inhalation formulations of formoterol fumarate

Drugs List

  • ATIMOS MODULITE 12microgram inhaler cfc-free
  • EASYHALER FORMOTEROL 12microgram dry powder inhaler
  • FORADIL 12microgram capsules (for inhalation)
  • formoterol 12microgram capsules (for inhalation)
  • formoterol 12microgram dry powder inhaler
  • formoterol 12microgram inhaler cfc-free
  • formoterol 6microgram dry powder inhaler
  • OXIS 12 TURBOHALER dry powder inhaler
  • OXIS 6 TURBOHALER dry powder inhaler
  • Therapeutic Indications


    Chronic obstructive pulmonary disease
    Prevention of exercise-induced bronchospasm
    Prophylaxis of bronchial asthma where inhaled corticosteroid is indicated
    Symptom relief of broncho-obstruction in asthma when steroids insufficient
    Symptom relief of bronchospasm in chronic obstructive pulmonary disease



    Relief Medication for acute bronchospasm
    6 to 12 micrograms for relief of symptoms.

    Regular Dosage for maintenance therapy
    6 to 12 micrograms once to twice daily. Up to 24 micrograms twice daily. Regular use dose should not exceed 48 micrograms daily, however up to a maximum of 72 micrograms may be used within a 24 hour period. 36 micrograms should not be exceeded on any single occasion.

    Prevention of exercise induced bronchoconstriction
    12 micrograms before exercise.

    Chronic obstructive pulmonary disease (COPD)
    12 micrograms once to twice daily. The maximum daily dose for regular use is 24 micrograms.
    Additional inhalations above those prescribed for the regular maintenance therapy may be used for relief of symptoms up to a maximum total daily dose of 48 micrograms (plus maintenance therapy as required). 24 micrograms should not be exceeded on any single occasion.


    Not all available brands are licensed for use in children under 12 years.
    Not all available brands are licensed for all uses.

    6 to 18 years:
    Relief Medication for acute bronchospasm
    6 to 12 micrograms for relief of symptoms.

    Regular Dosage for maintenance therapy
    12 micrograms once to twice daily. Regular use dose should not exceed 24 micrograms daily, however up to a maximum of 48 micrograms may be used within a 24 hour period. 12 micrograms should not be exceeded on any single occasion.

    Prevention of exercise induced bronchoconstriction
    6 to 12 micrograms before exercise.


    Children under 6 years

    Precautions and Warnings

    Children 6 to 12 years
    Arterial aneurysm
    Cardiac arrhythmias
    Cardiac disorder
    Diabetes mellitus
    Glucose-galactose malabsorption syndrome
    Hepatic cirrhosis
    Hypertrophic obstructive cardiomyopathy
    Idiopathic subvalvular aortic stenosis
    Ischaemic heart disease
    Lactose intolerance
    Long QT syndrome
    Occlusive peripheral vascular disorder
    Severe decompensated cardiac failure
    Severe hypertension
    Third degree atrioventricular block

    Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
    Therapy should not be initiated during exacerbation of asthma
    Advise patient dizziness may affect ability to drive or operate machinery
    Do not substitute for steroid therapy
    Not all available brands are licensed for all indications
    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
    Check patient is using correct inhaler technique
    If frequent need for prophylaxis of exercise induced asthma,review therapy
    Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
    Monitor serum potassium regularly in patients with severe asthma
    CSM (CHM) requests reporting of adverse reactions to cfc-free inhalers
    Discontinue at least 12 hours before the start of anaesthesia
    Do not withdraw this drug suddenly
    Discontinue if paradoxical bronchospasm occurs
    Maintain treatment at the lowest effective dose
    Advise patient not to exceed stated dose
    Advise patient that CFC-free inhalers may have different taste or sensation
    Advise patient to continue taking corticosteroid therapy
    Patient should seek medical advice if usual relief is diminished

    To ensure safe use in the management of chronic asthma, long-acting beta-2 agonists should:

    Be added only if regular use of standard-dose inhaled corticosteroids has failed to control asthma adequately;
    Not be initiated in patients with rapidly deteriorating asthma;
    Be introduced at a low dose and the effect properly monitored before considering dose increase;
    Be discontinued in the absence of benefit;
    Not to be used for the relief of exercise-induced asthma symptoms unless regular inhaled corticosteroids are also used;
    Be reviewed as clinically appropriate: stepping down therapy should be considered when good long-term asthma control has been achieved.

    Patients should be advised to report any deterioration in symptoms following initiation of treatment with a long-acting beta-2 agonist.

    Pregnancy and Lactation


    Use with caution during pregnancy.

    It is not know if formoterol crosses the human placenta. The molecular weight of the dihydrate fumarate salt (about 841), low protein binding, and prolonged elimination half-life suggest that the drug will pass to the embryo and/or foetus. However, the mean steady state plasma concentrations of the drug after twice daily dosing ranged from 4.0 to 8.8 picograms/ml. Thus, very low drug concentrations will be available for placental transfer at the maternal-foetal interface.

    The animal data suggests low risk, but the limited human pregnancy experience prevents a more complete assessment of the embryo/foetal risk. However, there is no published evidence that drugs in this class cause developmental toxicity (growth retardation, structural defects, functional/behaviour defects, or death).

    Although formoterol has potent tocolytic activity in rodents, this effect has not been studied in humans. Moreover, the systemic bioavailability of the drug after inhalation is probably too low to inhibit uterine activity.

    Potential toxic effects of formoterol are maternal hyperglycaemia (especially in diabetics) resulting in newborn hypoglycaemia and maternal pulmonary oedema (especially when used with corticosteroids).

    Although published studies of these potential adverse effects from inhaled formoterol have not been located, the reported plasma drug concentrations appear to be too low to cause these toxicities. Because of the availability of extensive human pregnancy experience, either salbutamol or salmeterol would be a better choice if a pregnant woman required an inhaled beta-adrenergic bronchodilator. However, if a non-pregnant woman had a good response to inhaled formoterol, it would be reasonable to continue her on this drug during pregnancy.

    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 ( ) or if this is unavailable at the backup site ( ).


    Use with caution during breastfeeding

    No data is available on formoterol's transfer into human milk, but its extremely low plasma levels (4.0 to 8.8 picograms/ml) would suggest that milk levels would be incredibly low, if even measurable.

    It is not likely the amount present in human milk would be clinically relevant to a breastfed infant.

    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

    Side Effects

    Angina pectoris
    Atrial fibrillation
    Behavioural disturbances
    Blood pressure changes
    Bronchospasm (paradoxical)
    CNS stimulation
    Dry mouth
    Exacerbation of pre-existing asthma
    Hypersensitivity reactions
    Muscular cramps
    Oropharyngeal irritation
    Peripheral oedema
    Prolongation of QT interval
    Sleep disturbances
    Supraventricular tachycardia
    Taste disturbances
    Ventricular extrasystoles


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 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.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Atimos Modulite 12 micrograms. Trinity-Chiesi Pharmaceuticals Ltd. Revised November 2012.

    Summary of Product Characteristics: Foradil. Novartis Pharmaceuticals UK Ltd. December 2012.

    Summary of Product Characteristics: Formoterol Easyhaler 12 micrograms. Oriorn Pharma (UK) Ltd. Revised September 2011.

    Summary of Product Characteristics: Oxis Turbohaler 6. Astra Pharmaceuticals Ltd. Revised August 2010.

    Summary of Product Characteristics: Oxis Turbohaler 12. Astra Pharmaceuticals Ltd. Revised August 2010.

    NICE - Evidence Services
    Available at:
    Last accessed: 30 June 2017

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