Ipratropium Other names: Ipratropium bromide

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

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

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

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

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

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

The safety of ipratropium during human pregnancy has not been established. The benefits of using ipratropium during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. Nonclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.

It is not known whether ipratropium bromide is excreted into breast milk. It is unlikely that ipratropium bromide would reach the infant to an important extent, however caution should be exercised when ipratropium is administered to nursing mothers.

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 ipratropium. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.

Many of the listed undesirable effects can be assigned to the anticholinergic properties of ipratropium. As with all inhalation therapy ipratropium 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: 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

Immune system disorder

Uncommon: Hypersensitivity, Anaphylactic reaction, Angioedema of tongue, lips & face

Nervous system disorders

Common: Headache, Dizziness

Eye disorders

Uncommon: Blurred vision, Mydriasis¹, Intraocular pressure increased¹, Glaucoma¹, Eye pain¹, Halo vision, Conjunctival hyperaemia, Corneal oedema

Rare: Accommodation disorder

Cardiac Disorders

Uncommon: Palpitations, Supraventricular tachycardia

Rare: Atrial fibrillation, Heart rate increased

Respiratory, Thoracic and Mediastinal Disorders

Common: Throat irritation, Cough

Uncommon: Bronchospasm, Paradoxical bronchospasm², Laryngospasm, Pharyngeal oedema, Dry throat

Gastro-intestinal Disorders

Common: Dry mouth, Nausea, Gastro-intestinal motility disorder

Uncommon: e.g. Diarrhoea, Constipation, Vomiting, Stomatitis

Skin and subcutaneous tissue disorders

Uncommon: Rash, Pruritus

Rare: Urticaria

Renal and Urinary Disorders

Uncommon: Urinary retention³

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. Ipratropium 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.