Updated: 29 Jun 2009
Selective b2 -agonists (beta- agonists, beta-adrenoceptor stimulants). / anticholinergic bronchodilators (antimuscarinics, anticholinergics).
Each single dose unit contains Fenoterol Hydrobromide 1.25 mg and Ipratropium Bromide 0.5 mg.
Nebuliser solution. A clear, colourless or almost colourless solution.
DUOVENT UDVs may be administered from an intermittent positive pressure ventilator or from a properly maintained and functioning nebuliser.
The recommended dose for adults and children over 14 years is one vial (4 ml) to be nebulised immediately upon presentation. Each dose should be inhaled to dryness from the nebuliser. Repeat dosing may be given at the discretion of the treating physician, up to a maximum of 4 vials in 24 hours.
In acute severe asthma additional doses may be necessary depending on clinical response. Nebuliser treatment of acute severe asthma should be replaced by standard inhaler devices 24 - 48 hours before discharge unless the patient requires a nebuliser at home.
Clinical trials have included patients over 65 years. No adverse reactions specific to this age group have been reported.
DUOVENT UDVs should only be used in a nebuliser approved by your doctor.
1. The nebuliser or ventilator unit should be prepared by following the manufacturer's instructions and /or the advice of the physician.
2. A new single dose unit should be carefully separated from the strip. NEVER use one which has been previously opened.
3. Open the single dose unit by simply twisting off the top, always taking care to hold it in an upright position.
4. Unless otherwise instructed, all the contents of the single dose unit should be squeezed into the nebuliser chamber. If dilution of the single dose unit contents is necessary this should be done using ONLY sterile sodium chloride 0.9% solution as directed by the physician.
5. Use your nebuliser as directed by your doctor.
6. After nebulisation has finished, throw away any remaining solution from the single dose unit or nebuliser chamber.
7. Follow the manufacturer's instructions for cleaning the nebuliser. It is important that the nebuliser is kept clean.
Duovent and Duovent Autohaler: Under 6 years, not recommended; over 6 years, 1 puff three times daily. Duovent UDV: Not recommended.
Patients must be instructed in the correct use of a nebuliser and warned not to exceed the prescribed dose. The patient must be instructed to seek medical advice in the event of DUOVENT failing to provide relief of bronchospasm. In the case of acute, rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.
For prolonged use, on demand (symptom-oriented) treatment may be preferable to regular use. Patients should be evaluated for the addition or the increase of anti-inflammatory therapy (e.g. inhaled corticosteroids) to control airway inflammation and to prevent deterioration of disease control.
The use of increasing amounts of beta2-agonist containing products such as DUOVENT on a regular basis to control symptoms of bronchial obstruction may suggest declining disease control. If bronchial obstruction deteriorates it is inappropriate and possibly hazardous to simply increase the use of beta2-agonist containing products such as DUOVENT, beyond the recommended dose over extended periods of time. In this situation, the patient's therapy plan, and in particular the adequacy of anti-inflammatory therapy with inhaled corticosteroids should be reviewed to prevent potentially life threatening deterioration of disease control.
Other sympathomimetic bronchodilators should only be used with DUOVENT under medical supervision.
In the following conditions DUOVENT should only be used after careful risk/benefit assessment, especially when doses higher than recommended are used:
Insufficiently controlled diabetes mellitus, myocardial insufficiency, angina, cardiac dysrhythmias, hypertension, recent myocardial infarction, hypertrophic subvalvular aortic stenosis, severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma.
The administration of nebuliser solutions has occasionally been associated with cases of paradoxical bronchoconstriction.
Potentially serious hypokalemia may result from beta2-agonist therapy. Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma or with bladder neck obstruction or with prostatic hyperplasia.
Patients must be instructed in the correct administration of DUOVENT UDVs. Care should be taken to prevent the solution or mist from entering the eyes. It is recommended that the nebulised solution be administered via a mouth piece. If this is not available and a nebuliser mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
There have been isolated reports of ocular complications (i.e. mydriasis, increased intra-ocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide either alone or in combination with an adrenergic beta2-agonist was sprayed into the eyes.
Inhaled doses of ipratropium bromide nebuliser solution up to 1 mg have not been associated with elevation of intra-ocular pressure.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma.
Should any combination of these symptoms develop, treatment with miotic eye drops should be initiated and specialist advice sought immediately.
As patients with cystic fibrosis may be more prone to gastro-intestinal motility disturbances, DUOVENT as with other anticholinergics should be used with caution in these patients.
Immediate hypersensitivity reactions may occur after administration of DUOVENT, as demonstrated by rare cases of urticaria, angio-oedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
The following side effects have been reported. The frequencies given below are based on clinical trials involving 2009 patients who have been treated with fenoterol and ipratropium combinations.
Very common - 1/10
Common - 1/100 < 1/10
Uncommon - 1/1,000 < 1/100
Rare - 1/10,000 < 1/1,000
Very rare - < 1/10,000
Not known - Cannot be estimated from the available data
Immune system disorders
Anaphylactic reaction (1) - Rare (1)
Allergic type reactions - Rare
Angio-oedema of tongue, lips and face - Not known
Skin rash - Rare
Metabolism and nutrition disorders
Hypokalaemia - Not known
Psychological alterations - Rare
Nervousness - Rare
Nervous system disorders
Headache - Rare
Dizziness - Rare
Fine Tremor - Rare
Hyperactivity in children - Not known
Narrow Angle Glaucoma - Rare
Ocular accommodation disturbances - Not known
Increased Intraocular pressure - Not known
Eye pain - Not known
Mydriasi - Not known
Tachycardia, increased heart rate - Uncommon
Arrhythmias - Uncommon
Atrial fibrillation - Rare
Palpitations - Rare
Supraventricular tachycardia - Rare
Decrease in diastolic blood pressure - Not known
Increase in systolic blood pressure - Not known
Respiratory, Thoracic and Mediastinal Disorders
Cough - Common(3)
- Pharyngitis - Common(3 )
- Throat irritation - Rare(3)
Laryngospasm(1) - Rare(1)
Inhalation induced bronchospasm - Not known
Dryness of mouth - Uncommon
Nausea (with or without vomiting) - Uncommon
Gastro-intestinal motility disturbances(4) - Uncommon
Skin and Subcutaneous Disorders
Skin reactions - Uncommon
Sweating - Not known
Musculosceletal and Connective Tissue Disorders
Myalgia - Rare
Muscle cramps - Rare
Weakness (muscle) - Not known
Renal and Urinary Disorders
Urinary retention - Rare
(1) observed in trials with the mono-compound ipratropium bromide
(3) verum frequency only for local side effects
(4) e.g. constipation, diarrhoea
Hypertrophic obstructive cardiomyopathy, tachyarrhythmia. Hypersensitivity to fenoterol hydrobromide or atropine-like substances or to any of the excipients of the product.
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