Formoterol Fumarate

Registered South African indications:

• Asthma
• Chronic obstructive pulmonary disease
• Exercise-induced bronchospasm

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Tachycardia, third degree atrioventricular block, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, prolonged Q-T interval (Q-Tc >0.44 sec) e.g. congenital or drug-induced, and thyrotoxicosis (inh)
• Safety in children under the age of 6 years has not been established (inh)

Cautions 

• Pregnancy
• Breastfeeding
• Thyrotoxicosis
• Phaeochromocytoma
• Hypertrophic obstructive cardiomyopathy
• Idiopathic subvalvular aortic stenosis
• Severe hypertension
• Aneurysm
• Ischaemic heart disease
• Cardiac arrhythmias
• Tachyarrhythmias
• Third degree atrioventricular block
• Severe heart failure
• Occlusive vascular disease
• QT prolongation or risk factors thereof
• Diabetes mellitus
• Hypokalaemia
• Hypoxia
• Paradoxical bronchospasm
• Seizures
• Galactose intolerance (turbo)
• Glucose-galactose malasorption
• Lapp lactase deficiency

Forms avail. in SA and covered in this monograph:  inc, inh, turbo

Acute asthma exacerbation

• Inhaled (turbo): 9μg, as needed; Max: 54μg/24hrs
• Inhaled (inh): 12-24μg, as needed; Max: 48μg/24hrs

Prevention of exercise-induced bronchospasm

• Inhaled (turbo): 9μg, 15min prior to exercise
• Inhaled (inh): 12μg, 15min prior to exercise

Maintenance of asthma

• Inhaled (turbo): 9-18μg, 12-24hrly; Max dose: 27μg; Max: 54μg/24hrs
• Inhaled (inc): 12-24μg, 12hrly; Max: 48μg/24hrs
• Inhaled (inh): 12μg, 12hrly; Max 48μg/24hrs

Chronic obstructive pulmonary disease

• Inhaled (turbo): 9μg, 12-24hrly Max dose: 18μg; Max: 36μg/24hrs
• Inhaled (inc): 12μg, 12hrly; Max: 48μg/24hrs
• Inhaled (inh): 12μg, 12-24hrly; Max 48μg/24hrs

Paed. forms avail. in SA and covered in this monograph: inc, inh, turbo

Acute asthma attack

Younger than 6 years

• Not established for use

Older than 6 years

• Inhaled (turbo): 9μg, as needed; Max: 36μg/24hrs
• Inhaled (inh): 12-24μg, as needed; Max: 48μg/24hrs

Maintenance of asthma

Younger than 6 years

• Not established for use

Older than 6years

• Inhaled (turbo): 9μg, 12-24hrly; Max dose: 9μg; Max: 36μg/24hrs
• Inhaled (inc): 12μg, 12hrly; Max: 24μg/24hrs
• Inhaled (inh): 12μg, 12 hrly; Max: 24μg/24hrs

Prevention of exercise-induced bronchospasm
Prevention of allergen-exposure bronchospasm

Younger than 6 years

• Not established for use

Older than 6 years

• Inhaled (turbo): 9μg, 15min prior to exposure
• Inhaled (inh): 12μg, 15min prior to exercise

Pregnancy

• Caution
• There are no or limited amount of data from the use of formoterol in pregnant women. In animal studies formoterol has caused implantation losses as well as decreased early postnatal survival and birth weight. The effects appeared at considerably higher systemic exposures than those reached during clinical use of formoterol. Treatment with formoterol may be considered at all stages of pregnancy if needed to obtain asthma control and if the expected benefit to the mother is greater than any possible risk to the fetus. The potential risk for human is unknown

Breastfeeding 

• Caution
• It is unknown whether formoterol is excreted in human milk. In rats, small amounts of formoterol have been detected in maternal milk. Administration of formoterol to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child

Fertility

• There is no available data on the effect of formoterol on human fertility. No impairment of fertility was observed in studies performed in male and female rats

Renal Impairment 

• No dose adjustment recommended

Hepatic Impairment 

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Agitation
• Anxiety
• Nervousness
• Restlessness
• Insomnia
• Headache
• Tremor
• Dizziness
• Dysgeusia
• Abnormal behaviour
• Hallucination
• Central nervous system stimulation 

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Cardiac arrhythmias
• Peripheral oedema
• Angina pectoris
• QT prolongation
• Hypertension  

Respiratory Disorders

• Bronchospasm
• Throat irritation
• Acute asthma exacerbation
• Cough
• Dyspnoea

Gastrointestinal Disorders

• Dry mouth
• Nausea

Genitourinary Disorders

• Nephritis

Endocrine and Metabolic Disorders

• Hypokalaemia
• Hyperglycaemia

Musculoskeletal Disorders

• Muscle cramps
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Hyperhidrosis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reaction
• Thrombocytopenia

• Sympathomimetics  
• Xanthine derivatives
• Steroids
• QT prolonging agents  
• Halogenated hydrocarbons
• Anticholinergics
• Beta blockers
• Monoamine oxidase inhibitors
• Macrolides
• Diuretics

None routine. Specific cases may require

• Serum potassium
• Blood glucose

Incorrect route of administration

• There have been reports of patients who have mistakenly swallowed formoterol capsules instead of placing the capsules in the inhalation device. The majority of these ingestions were not associated with side effects. Healthcare providers should discuss with the patient how to correctly use the medicine. Healthcare provider should ask how the patient is using formoterol capsules

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Inhaler - EML (Hospital)

All other forms - Non-EML

Formoterol fumarate is a selective beta-2 adrenoceptor agonist that relaxes bronchial smooth muscle, resulting in bronchodilating effects in patients with reversible airways obstruction.

Inhaler 12μg

• Foratec HFA (Cipla Medpro)

Inhaler 9μg

• Oxis Turbuhaler (AstraZeneca) originator

Inhalation capsule 12μg

• Foradil (Novartis) originator
• Foratec DP-Caps (Cipla Medpro)

COMBINATION PREPARATIONS

Formoterol fumarate/ Budesonide

Inhaler 4.5μg/80μg

• Vannair 80:4.5μg (AstraZeneca)  originator
• Symbicord Turbuhaler 80:4.5μg (AstraZeneca) originator

Inhaler 4.5μg/160μg

• Vannair 160:4.5μg (AstraZeneca) originator
• Symbicord Turbuhaler 160:4.5μg (AstraZeneca) originator

Inhaler 9μg/320μg

• Symbicord Turbuhaler 320:4.5μg (AstraZeneca) originator