Atrovent

Atrovent^® 250 UDVs^®, 1 ml

Atrovent^® UDVs^®, 2 ml

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

For excipients, see 6.1.

Nebuliser solution.

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• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

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

Hypersensitivity

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

Paradoxical bronchospasm

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.

Ocular complications

Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma.

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.

Renal and urinary effects

ATROVENT UDVs should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-outflow obstruction).

Gastro-intestinal motility disturbances

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.

The chronic co-administration of ATROVENT inhalation with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of ATROVENT with other anticholinergic drugs is not recommended.

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 section Special warnings and precautions for use) may be increased when nebulised ipratropium bromide and beta₂-agonists are administered simultaneously.

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, accommodation disorder, mydriasis and blurred vision during treatment with ATROVENT. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

The toxicity of ipratropium bromide has been investigated extensively in the following types of studies: acute, subchronic and chronic toxicity, carcinogenicity, reproductive toxicity and mutagenicity via oral, intravenous, subcutaneous, intranasal and/or inhalation routes. Based on these toxicity studies, the probability of systemic anticholinergic side effects decreases in the following order:

intravenous > subcutaneous > oral > inhalation > intranasal.

Pre-clinically, ipratropium bromide was found to be well-tolerated. Two-year carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to approximately 1,200 times the maximum recommended human daily dose for intranasal ipratropium. Results of various mutagenicity tests were negative.

Studies to investigate the possible influence of ipratropium bromide on fertility, embryo-fetotoxicity, and peri-/postnatal development have been performed on mice, rats and rabbits. High oral levels, i.e. 1000 mg/kg/day in the rat and 125 mg/kg/day in the rabbit were maternotoxic for both species and embryo-/fetotoxic in the rat, where the fetal weight was reduced. Treatment-related malformations were not observed. The highest, technically feasible doses for inhalation of the pressurised inhalation, solution, 1.5 mg/kg/day (human equivalent dose of 0.24 mg/kg/day) in rats and 1.8 mg/kg/day (human equivalent dose of 0.576 mg/kg/day) in rabbits, showed no adverse effects on reproduction.

These doses are 6- and 14-fold the maximum recommended human daily dose (MRHDD) of 2 mg or 0.04 mg/kg (based on a body weight of 50 kg).

Sodium Chloride

1N Hydrochloric Acid

Purified Water

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• J44 Other chronic obstructive pulmonary disease
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24 months (unopened).

As the product contains no preservative, a fresh vial should be used for each dose and the vial should be opened immediately before administration. Any solution left in the vial should be discarded.

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

None.

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

PL 0015/0108

27 August 1986 / 23 December 2005

February 2018

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system

• J42 Chronic bronchitis, unspecified
• J44 Other chronic obstructive pulmonary disease
• J45 Asthma
• J999* Diagnosis of diseases of the respiratory system