Respontin_TM Nebules_TM

1ml or 2ml plastic ampoules containing 0.25mg/ml of Ipratropium Bromide Ph.Eur.

Oral inhalation solution via a nebuliser.

Respontin Nebules are indicated for the treatment of reversible airways obstruction.

The recommended dose is:

Adults : 0.4 to 2ml solution (100-500 micrograms) up to four times daily.

Children (3 to 14 years): 0.4 to 2ml solution (100-500 micrograms) up to three times daily.

The volume of ipratropium bromide solution may need to be diluted in order to obtain a final volume suitable for the particular nebuliser used. If dilution is necessary use only sterile sodium chloride 0.9% solution.

There is no specific information on the use of the isotonic nebuliser solution in the elderly. Clinical trials with the previously available hypotonic formulation included patients over 65 years and no adverse reactions specific to this age group were reported.

Known hypersensitivity to any components of the formulation or to atropine.

Use of the nebuliser solution should be subject to close medical supervision during initial dosing. There have been rare reports of paradoxical bronchospasm associated with the administration of ipratropium bromide nebuliser solution. The patient should be advised to seek medical advice should a reduced response become apparent.

Patients must be instructed in the correct administration of Respontin Nebules and warned not to allow the solution or mist to enter the eyes. Acute angle-closure glaucoma has been reported rarely when ipratropium bromide has been used in conjunction with nebulised β₂-agonist bronchodilators. Protection of the eyes appears to prevent any increase in intra-ocular pressure and patients who may be susceptible to glaucoma should be warned specifically of the need for ocular protection. Inhaled doses of ipratropium bromide up to 1mg have not been associated with elevation of intra-ocular pressure.

Use anticholinergic agents with caution in patients with prostatic hypertrophy.

There is evidence that the concurrent administration of ipratropium bromide and sympathomimetic drugs produces a greater relief of bronchospasm than either drug given alone. Ipratropium bromide has been shown to produce effective bronchodilatation in patients receiving β-adrenergic blocking agents.

Ipratropium bromide has been in general use for several years and there is no definite evidence of ill-consequence during pregnancy. Animal studies have shown no hazard. Nevertheless, medicines should not be used in pregnancy, especially during the first trimester, unless the expected benefit is thought to outweigh any possible risk to the fetus.

None stated.

Anticholinergic side-effects are unlikely at therapeutic doses, but some patients may experience a dry mouth. Urinary retention and constipation have only rarely been reported with ipratropium bromide. There is no evidence that in the therapeutic dose range, ipratropium bromide has any adverse effect on bronchial secretion.

Inhaled doses of 5mg produce an increase in heart rate and palpitation but single doses at 2mg have been given to adults and 1mg to children without causing side-effects. Single doses of ipratropium bromide 30mg by mouth cause anticholinergic side effects but these are not severe and do not require specific reversal.

Ipratropium bromide is an anticholinergic bronchodilater which affects airways function primarily through its neural effects on the parasympathetic nervous system. Ipratropium bromide blocks the acetylcholine receptors on smooth muscle in the lung. Stimulation of these receptors normally produces contraction and depending on the degree of activation, bronchoconstriction. Thus ipratropium bromide will cause bronchodilatation.

Ipratoprium 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. Following, inhalation, uptake into the plasma is minimal, a peak blood concentration is obtained 1½ to 3 hours after inhalation. Excretion is chiefly via the kidneys.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

None stated.

24 months.

Store below 25^OC. Protect from light.

This product contains no preservative. A new Nebule should be used for each dose. A Nebule should be opened immediately before administration and any remaining solution should be discarded. Any unused Nebules should be discarded four weeks after opening the foil pack.

1 or 2 ml low density polyethylene ampoules in boxes of 20 in strips of 5 or 10.

The nebulised solution may be inhaled through a face mask, T-piece or via an endotracheal tube. Intermittent positive pressure ventilation (IPPV) may be used but is rarely necessary. When there is a risk of anoxia through hypoventilation, oxygen should be added to the inspired air.

As many nebulisers operate on a continuous flow basis, it is likely that some nebulised drug will be released into the local environment. Ipratropium bromide should therefore be administered in a well-ventilated room, particularly in hospitals where several patients may be using nebulisers at the same time. Do not allow the solution or mist to enter the eyes.

Glaxo Wellcome UK Limited, trading as Allen & Hanburys,

Stockley Park West,

Uxbridge,

Middlesex,

UB11 1BT.

PL10949/0275

15^th April 2003

September 1997

POM.