Fenoterol Hydrobromide

Registered South African indications:

• Symptomatic treatment of acute asthma attacks
• Prophylaxis of exercise induced asthma
• Symptomatic treatment of bronchial asthma and other conditions with reversible airway narrowing e.g. chronic obstructive bronchitis

Contraindications 

• Hypersensitivity to the active ingredient and any of its excipients
• Hypertrophic subvalvular aortic stenosis
• Hypertrophic obstructive cardiomyopathy
• Tachyarrhythmias

Cautions

• Pregnancy 
• Breastfeeding 
• Uncontrolled diabetes mellitus
• Myocardial insufficiency
• Cardiac failure
• Angina pectoris
• Cardiac dysrrhythmias
• Hypertension
• Severe organic heart and vascular disorders
• Closed angle glaucoma
• Hyperthyroidism
• Pheochromocytoma

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

Acute asthma episodes

• Inhaled (neb): 1.25mg, is sufficient for prompt symptom relief in most cases; In very severe cases: 2.5mg, is required for symptomatic relief, admin. under medical supervision
• Inhaled (inh): 100μg, is sufficient for prompt symptom relief in many cases; In more severe cases: Repeat after 5min if breathing has not noticeably improved

Inhaler
If an attack has not been relieved by 2 puffs, further puffs may be required; In these cases, patients should consult the doctor or the nearest hospital immediately

Prophylaxis of exercise-induced asthma

• Inhaled (neb): 1.25mg, up to 4 times dly
• Inhaled (inh): 100-200μg, for each admin.; Max: 800μg/24hrs

Bronchospasm associated with chronic obstructive airway disease
- Including bronchitis and pulmonary emphysema

• Inhaled (neb): 1.25mg, up to 4 times dly

Bronchial asthma and other conditions with reversible airways narrowing

• Inhaled (inh): If repeated dosing is required: 100-200μg, for each admin.; Max: 800μg/24hrs

Ampoules for nebulising
Lower dosages might be beneficial in some patients. Another suitable dosage form must be used in such cases. Deliver nebulised dose over 10 to 20 minutes
Fenoterol hydrobromide can be administered using a range of commercially available nebulising devices
For prolonged use, treatment on demand (symptom-oriented) may be preferable to regular use
Particularly in the case of regular use, patients should be re-evaluated for the addition or the increase of anti-inflammatory therapy to control airway inflammation and to prevent long-term damage
It is inappropriate and possibly hazardous to simply increase the use of beta-agonists such as fenoterol beyond the recommended dose over extended periods
The use of high amounts of beta-agonists on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. In this case, therapy plan should be reviewed, particularly the adequacy of anti-inflammatory therapy, to prevent potentially life-threatening deterioration of disease control

Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid responsive chronic obstructive pulmonary disease (COPD)

Do not exceed the recommended dosage

Paed. forms avail. in SA and covered in this monograph: neb

Acute asthma episodes

Younger than 6 years

• No information available

Between 6-14 years

• Inhaled (neb): 0.5mg, is sufficient for prompt symptom relief in most cases 

Children over 14 years

• See adult dosages

Prophylaxis of exercise-induced asthma
Bronchospasm associated with chronic obstructive airway disease
- Including bronchitis and pulmonary emphysema

Younger than 6 years

• No information available

Between 6-14 years

• Inhaled (neb): 0.5mg, up to 4 times dly

Children over 14 years

• See adult dosages

Ampoules for nebulising
Lower dosages might be beneficial in some patients. Another suitable dosage form must be used in such cases. Deliver nebulised dose over 10 to 20 minutes
Fenoterol hydrobromide can be administered using a range of commercially available nebulising devices
For prolonged use, treatment on demand (symptom-oriented) may be preferable to regular use
Particularly in the case of regular use, patients should be re-evaluated for the addition or the increase of anti-inflammatory therapy to control airway inflammation and to prevent long-term damage
It is inappropriate and possibly hazardous to simply increase the use of beta-agonists such as fenoterol beyond the recommended dose over extended periods
The use of high amounts of beta-agonists on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. In this case, therapy plan should be reviewed, particularly the adequacy of anti-inflammatory therapy, to prevent potentially life-threatening deterioration of disease control

Concomitant anti-inflammatory therapy should be considered

Do not exceed the recommended dosage

Pregnancy

• Caution
• Safety has not been established. Fenoterol may inhibit uterine contrations

Breastfeeding

• Caution
• Safety in breastfeeding has not been established. Pre-clinical studies have shown that fenoterol is excreted into breast milk

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

• Prohibited - At all times

Central Nervous System Disorders

• Fear
• Anxiety
• Restlessness
• Tremor
• Insomnia
• Confusion
• Irritability
• Psychotic states
• Headache
• Dizziness 

Cardiovascular Disorders

• Palpitations
• Tachycardia
• Cardiac arrhythmia
• Angina pectoris
• Cardiac arrest
• Flushing

Respiratory Disorders

• Cough
• Paradoxical bronchospasm
• Dyspnoea

Gastrointestinal Disorders

• Nausea and vomiting
• Increased salivation

Genitourinary Disorders

• Dysuria 
• Urinary retention

Endocrine and Metabolic Disorders

• Altered metabolism
• Changes in blood sugar concentrations
• Decreased appetite
• Hypokalaemia

Musculoskeletal Disorders

• Weakness
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Sweating
• Skin reactions

• Beta-2 agonists
• Sympathomimetics
• Anticholinergics
• Xanthine derivatives
• Cardiac glycosides
• Quinidine
• Monoamine oxidase inhibitors
• Tricyclic antidepressants
• Corticosteroids
• Diuretics
• Beta blocker
• Halogenated hydrocarbon anaesthetics

None routine. Specific cases may require

• Potassium levels

Fenoterol hydrobromide is a selective beta-2 agonist which acts in the lungs to cause relaxation of bronchial smooth muscle thus relieving bronchospasm.

Nebuliser solution (per 2ml) 0.5mg

• Adco Fenoterol Hbr (Adcock) originator 

Nebuliser solution (per 2ml) 1.25mg

• Adco Fenoterol Hbr (Adcock) originator

Nebuliser solution (per ml) 1mg

• Berotec 0.1%  (Ingelheim) originator

Inhaler 100μg

• Berotec 100 HFA (Ingelheim)

Also available in the following form: Syrup

COMBINATION PREPARATIONS

Nebuliser solution udv (per 4ml) 1.25mg/0.5mg

• Atrovent Beta u.d.v (Ingelheim) originator