anticholinergic

ipratropium bromide

Each single dose unit contains 0.025 % w/v ipratropium bromide i.e. 250 micrograms in 1 ml and 500 micrograms in 2 ml.

Nebuliser solution.

ATROVENT UDVs are indicated for treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD).

ATROVENT UDVs are indicated, when used concomitantly with inhaled beta₂-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma.

The dosage should be adapted to the individual needs of the patient. In children aged 12 years and under, only ATROVENT 250 UDVs, 1 ml should be used. The following doses are recommended:

Adults (including the elderly) and children over 12 years of age:

250 - 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or 1 vial of 500 micrograms in 2 ml) 3 to 4 times daily.

For treatment of acute bronchospasm, 500 micrograms.

Repeated doses can be administered until the patient is stable. The time interval between the doses may be determined by the physician.

It is advisable not to exceed the recommended daily dose during either acute or maintenance treatment. Daily doses exceeding 2 mg in adults and children over 12 years of age should only be given under medical supervision.

ATROVENT UDVs may be combined with a short-acting beta₂-agonist in the same nebuliser chamber, for simultaneous administration where co-administration is required. The solution should be used as soon as possible after mixing and any unused solution should be discarded.

ATROVENT UDVs can be administered using a range of commercially available nebulising devices. The dose of nebuliser solution may need to be diluted in order to obtain a final volume suitable for the particular nebuliser being used (usually 2 – 4 ml); if dilution is necessary use only sterile sodium chloride 0.9% solution.

ATROVENT UDVs and disodium cromoglycate inhalation solutions that contain the preservative benzalkonium chloride should not be administered simultaneously in the same nebuliser as precipitation may occur.

The unit dose vials are intended only for inhalation with suitable nebulising devices and should not be taken orally or administered parenterally.

Please refer to the patient information leaflet for instructions on use with a nebuliser.

Children 6 - 12 years of age:

250 micrograms (i.e. one vial of 250 micrograms in 1ml) up to a total daily dose of 1mg (4 vials).

The time interval between doses may be determined by the physician.

Children 0 – 5 years of age (for treatment of acute asthma only):

125 – 250 micrograms (i.e. half to one vial of 250 micrograms in 1 ml) up to a total daily dose of 1 mg (4 vials).

Ipratropium bromide should be administered no more frequently than 6 hourly in children under 5 years of age.

For acute bronchospasm, repeated doses may be administered until the patient is stable.

If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be sought. In the case of acute or rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.

Known hypersensitivity to atropine or its derivatives, or to any other component of the product.

Use of the nebuliser solution should be subject to close medical supervision during initial dosing.

Immediate hypersensitivity reactions following the use of ATROVENT have been demonstrated by cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.

Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma, or with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-outflow obstruction).

As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, ATROVENT, as with other anticholinergics, should be used with caution in these patients.

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, has come into contact with the eyes during nebuliser therapy.

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 drops should be initiated and specialist advice sought immediately.

Patients must be instructed in the correct administration of ATROVENT UDVs. Care must be taken not to allow the solution or mist to enter the eyes. It is recommended that the nebulised solution is administered via a mouthpiece. 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.

As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. ATROVENT UDVs should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted.

There is evidence that the administration of ATROVENT with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.

The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see Special Warnings and Precautions for Use) may be increased when nebulised ipratropium bromide and beta₂-agonists are administered simultaneously.

Many of the listed undesirable effects can be assigned to the anticholinergic properties of ATROVENT. As with all inhalation therapy ATROVENT may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the drug.

The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.

Frequencies

⁽¹⁾ ocular complications have been reported when aerolised ipratropium bromide, either alone or in combination with an adrenergic beta₂-agonist, has come into contact with the eyes.

⁽²⁾ As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. ATROVENT UDVs should be discontinued immediately, the patient assessed and, if necessary, alterative treatment instituted.

⁽³⁾ the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction.

Boehringer Ingelheim Limited

(POM)

16 March 2012