- ipratropium bromide
POM: Prescription only medicine
This information is intended for use by health professionals
Children 6-12 years of ageThe recommended dose is 250 micrograms (i.e. one vial of 250 micrograms in 1 ml) up to a total daily dose of 1mg (4 vials).The time interval between doses may be determined by the physician.
Children 05 years of age (for treatment of acute asthma only)The recommended dose is 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. Respontin 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. Respontin 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.Respontin and disodium cromoglycate inhalation solutions that contain the preservative benzalkonium chloride should not be administered simultaneously in the same nebuliser as precipitation may occur.Please refer to the patient information leaflet for instructions on use with a nebuliser.
Initial dosingUse of the nebuliser solution should be subject to close medical supervision during initial dosing.
Immediate hypersensitivity reactionsImmediate hypersensitivity reactions following the use of ipratropium bromide have been demonstrated by cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
Use of anticholinergic agentsCaution 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).
Patients with cystic fibrosisAs patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, ipratropium bromide, as with other anticholinergics, should be used with caution in these patients.
Ocular complicationsThere 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.
Correct administrationPatients must be instructed in the correct administration of Respontin Nebules and warned 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.
BronchoconstrictionAs 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 bromide should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted (see section 4.8 paradoxical bronchospasm).
Lack of efficacyIf 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.
Beta-adrenergic drugs and xanthine preparationsThere is evidence that the administration of ipratropium bromide with beta-adrenergic drugs and xanthine preparations may produce an additive bronchodilatory effect.
Beta 2-agonistsThe risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see section 4.4) may be increased when nebulised ipratropium bromide and beta 2-agonists are administered simultaneously.
FertilityClinical data on fertility are not available for ipratropium bromide. Preclinical studies performed with ipratropium bromide showed no adverse effect on fertility.
PregnancyThe safety of ipratropium bromide during human pregnancy has not been established. The benefits of using ipratropium bromide during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.
Breast-feedingIt 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 ipratopium bromide is administered to nursing mothers.
|System Organ Class||Adverse Reaction||Frequency|
|Immune system disorders||hypersensitivity, anaphylactic reaction, angioedema of tongue, lips and face||uncommon|
|Nervous system disorders||headache, dizziness||common|
|Eye disorders (see section 4.4)||blurred vision, mydriasis, intraocular pressure increased, glaucoma, eye pain, halo vision, conjunctival hyperaemia, corneal oedema||uncommon|
|Cardiac disorders||palpitations, supraventricular tachycardia||uncommon|
|atrial fibrillation, heart rate increased||rare|
|Respiratory, thoracic and mediastinal disorders||throat irritation, cough||common|
|bronchospasm, paradoxical bronchospasm (see section 4.4), laryngospasm, pharyngeal oedema, dry throat||uncommon|
|Gastrointestinal disorders||dry mouth, nausea, gastro-intestinal motility disorder||common|
|diarrhoea, constipation, vomiting, stomatitis||uncommon|
|Skin and subcutaneous tissue disorders||rash, pruritus||uncommon|
|Renal and urinary disorders||urinary retention (the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction)||uncommon|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
SymptomsAs with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.
AbsorptionIpratoprium bromide is a quaternary ammonium compound which is poorly absorbed from the gastro-intestinal tract, and is slow to cross mucous membranes and the blood/brain barrier.
DistributionFollowing, inhalation, uptake into the plasma is minimal, a peak blood concentration is obtained 1½ to 3 hours after inhalation.
EliminationExcretion is chiefly via the kidneys.