29 Jun 2009

DUOVENT (Fenoterol, ipratropium) - United Kingdom

Updated: 29 Jun 2009

DUOVENT

The management of acute severe asthma or acute exacerbation of chronic asthma presenting as an emergency requiring treatment by nebuliser.

DUOVENT Description, Presentation and Dosage

DUOVENT Description

DUOVENT Drug Class Description

Selective b2 -agonists (beta- agonists, beta-adrenoceptor stimulants). / anticholinergic bronchodilators (antimuscarinics, anticholinergics).

DUOVENT Drug Description

Each single dose unit contains Fenoterol Hydrobromide 1.25 mg and Ipratropium Bromide 0.5 mg.

DUOVENT Generic Name

Fenoterol, ipratropium

DUOVENT Presentation

DUOVENT Presentation

Nebuliser solution. A clear, colourless or almost colourless solution.

DUOVENT Manufacturer

Boehringer Ingelheim

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DUOVENT Dosage

DUOVENT Adult Dosage

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.

Administration

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 Child Dosage

Duovent and Duovent Autohaler: Under 6 years, not recommended; over 6 years, 1 puff three times daily. Duovent UDV: Not recommended.

DUOVENT Precautions, Reactions and Contraindications

DUOVENT Special Precautions

DUOVENT Special Precautions

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.

DUOVENT Adverse Reactions

DUOVENT Adverse Reactions

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.

Frequencies

Very common - GREATER-THAN OR EQUAL TO (8805) 1/10

Common - GREATER-THAN OR EQUAL TO (8805) 1/100 < 1/10

Uncommon - GREATER-THAN OR EQUAL TO (8805) 1/1,000 < 1/100

Rare - GREATER-THAN OR EQUAL TO (8805) 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

Urticaria -Rare

Metabolism and nutrition disorders

Hypokalaemia - Not known

Psychiatric disorders

Psychological alterations - Rare

Nervousness - Rare

Nervous system disorders

Headache - Rare

Dizziness - Rare

Fine Tremor - Rare

Hyperactivity in children - Not known

Eye disorders

Narrow Angle Glaucoma - Rare

Ocular accommodation disturbances - Not known

Increased Intraocular pressure - Not known

Eye pain - Not known

Mydriasi - Not known

Cardiac Disorders

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)

Local irritation

- Pharyngitis - Common(3 )

- Throat irritation - Rare(3)

Laryngospasm(1) - Rare(1)

Inhalation induced bronchospasm - Not known

Gastro-intestinal Disorders

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

DUOVENT Contraindications

DUOVENT Contraindications

Hypertrophic obstructive cardiomyopathy, tachyarrhythmia. Hypersensitivity to fenoterol hydrobromide or atropine-like substances or to any of the excipients of the product.

Related Drugs - Respiratory

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