Fenoterol Hydrobromide/ Ipratropium Bromide

Registered South African indications:

• Reversible airways obstruction as in bronchial asthma, chronic bronchitis and emphysema

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

Contraindications

Inhaler

• Hypersensitivity to the active ingredients and any of its excipients in this combination product
• Hypersensitivity to atropine-like substances
• Hypertrophic obstructive cardiomyopathy and tachyarrhythmias 
• Not to be used in children under 6 years of age

Solution for inhalation

• Hypersensitivity to the active ingredients and any of its excipients in this combination product
• Hypersensitivity to atropine-like substances
• Hypertrophic obstructive cardiomyopathy and tachyarrhythmias
• Not to be used in children under 18 years of age
• Pregnancy
• Breastfeeding

Cautions

• Pregnancy (inh) 
• Breastfeeding (inh)
• Cardiovascular disease
• Acute episodes of bronchospasm
• Cystic fibrosis
• Diabetes
• Glaucoma
• Hyperthyroidism
• Pheochromocytoma
• Prostatic hyperplasia/bladder neck obstruction
• Seizure disorder

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

Acute asthma episodes

Fenoterol Hydrobromide/ Ipratropium Bromide
50/20 (μg/inh)

• Inhaled (inh): 2 puffs are sufficient for prompt symptom relief in many cases; In more severe cases, if breathing has not noticeably improved after 5 mins: 2 further puffs may be admin.

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If an attack has not been relieved by 4 puffs, further puffs may be required. In these cases, patients should consult the doctor or the nearest hospital immediately

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1.25/0.5 (mg/4ml)

• Inhaled (neb): 1 unit dose vial is sufficient for prompt symptom relief in most cases; In very severe cases: 2 unit dose vials are required for relief, admin. under medical supervision

Intermittent and long-term treatment

Fenoterol Hydrobromide/ Ipratropium Bromide
50/20 (μg/inh)

• Inhaled (inh): 2-4 puffs, for each admin. (average 2-4 puffs 3 times dly); Max: 16 puffs/24hrs

1.25/0.5 (mg/4ml)

• Inhaled (neb): 1 unit dose vial, up to 4 times dly

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Solution for inhalation
The solution is ready for use and requires no dilution
Fenoterol hydrobromide/ ipratropium bromide can be administered using a range of commercially available nebulising devices. Where wall oxygen is available, the solution is best administered at a flow rate of 6-8 litres per minute

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The dosage should be adapted to the individual's requirements. Concomitant anti-inflammatory therapy should be considered for patients with bronchial asthma and steroid responsive chronic obstructive pulmonary disease (COPD)

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Do not exceed the recommended dose

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

Acute asthma episodes
Intermittent and long-term treatment

Fenoterol Hydrobromide/ Ipratropium Bromide
50/20 (μg/inh)

• Younger than 6 years: Contraindicated
• Older than 6 years: See adult dosage

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In children fenoterol hydrobromide/ ipratropium bromide metered dose inhaler should only be used on medical advice and under the supervision of an adult

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1.25/0.5 (mg/4ml)

• Contraindicated

Pregnancy

Inhaler

• Caution 
• Safety of use in pregnancy has not been established. Fenoterol hydrobromide/ ipratropium bromide metered dose inhaler may inhibit uterine contractions in pregnancy

Solution for inhalation

• Contraindicated

Breastfeeding

Inhaler

• Caution
• Safety of use in lactation has not been established. Preclinical studies have shown that fenoterol hydrobromide is excreted into breast milk

Solution for inhalation

• Contraindicated

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended 

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Prohibited - At all times

Central Nervous System Disorders

• Dizziness
• Headache
• Nervousness
• Psychological disorder

Cardiovascular Disorders

• Atrial fibrillation
• Cardiac arrhythmia
• Hypertension
• Hypotension
• Ischemic heart disease
• Palpitations
• Prolonged QT interval
• Supraventricular tachycardia
• Tachycardia

Respiratory Disorders

• Bronchospasm (inhalation-induced)
• Cough
• Pharyngitis
• Throat irritation
• Laryngospasm
• Oropharyngeal oedema

Gastrointestinal Disorders

• Constipation
• Diarrhoea
• Nausea and vomiting
• Xerostomia

Genitourinary Disorders

• Urinary retention

Endocrine and Metabolic Disorders

• Hyperglycemia
• Hypokalemia

Musculoskeletal Disorders

• Muscle cramps
• Myalgia
• Tremor
• Weakness

Skin and Subcutaneous Tissue Disorders

• Diaphoresis
• Skin rash
• Urticaria
• Angioedema

Immune, Blood and Lympregphatic System Disorders

• Hypersensitivity reactions
• Anaphylaxis

Sensory Disorders

• Accommodation disturbance
• Acute angle-closure glaucoma
• Eye pain
• Increased intraocular pressure
• Mydriasis

• Anticholinergic agents
• Potassium citrate
• Linezolid
• Glycopyrronium
• Xanthine derivatives
• Beta-blockers
• Potassium chloride
• Sympathomimetics
• Thiazide and thiazide-like diuretics
• Loop diuretics
• Topiramate
• Opioid analgesics
• Nitroglycerine
• Monoamine oxidase inhibitors
• Mianserin
• Inhalational anaesthetics
• Betahistine
• Glucagon
• Atomoxetine
• Atosiban
• Amantadine
• Acetylcholinesterase Inhibitors
• Beta-2 agonists

None routine. Specific cases may require

• Respiratory function
• Potassium levels

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

Ipratropium 
Ipratropium bromide is a quaternary ammonium compound with anticholinergic properties. It inhibits vagally-mediated reflexes by antagonising the action of acetylcholine in bronchial smooth muscle cells, facilitating bonchodilation.

COMBINATION PREPARATIONS

Fenoterol Hydrobromide/Ipratropium bromide

Inhaler 50μg/20μg

• Duovent HFA (Ingelheim) originator

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

• Atrovent Beta UDV (Ingelheim) originator
• Sabax Nebrafen (Adcock)