DUOVENT UDV Nebulizer solution Ref.[50624] Active ingredients: Ipratropium

Dosing Considerations

Treatment should be initiated and administered under medical supervision, e.g. in the hospital setting. Home based treatment can be recommended in exceptional cases (severe symptoms or experienced patients requiring higher doses) when a low dose rapid acting beta-agonist bronchodilator has been insufficient in providing relief after consultation with an experienced physician. Administration should be stopped when sufficient symptom relief is achieved.

COPD: CHRONIC BRONCHITIS AND EMPHYSEMA

DUOVENT UDV (ipratropium bromide/fenoterol hydrobromide) nebulizer solution dosage should be individualized and patient response should be monitored to determine the requirement for more than a single bronchodilator by the prescribing physician on an ongoing basis. Concomitant anti-inflammatory therapy should be considered for patients with steroid-responsive chronic obstructive pulmonary disease (COPD).

Counselling on smoking cessation should be the first step in treating patients with chronic obstructive pulmonary disease (COPD) who smoke, independent of the clinical presentation i.e. chronic bronchitis (with or without airflow limitation) or emphysema.

Smoking cessation produces symptomatic benefits and has been shown to confer a survival advantage by slowing or stopping the progression of chronic bronchitis and emphysema.

ASTHMA: DUOVENT UDV (ipratropium bromide/fenoterol hydrobromide) nebulizer solution should be used only under medical supervision in patients with severe acute exacerbations of asthma who require more than a single bronchodilator.

In accordance with the present practice for asthma treatment, concomitant antiinflammatory therapy should be part of the regimen if DUOVENT UDV is needed on a regular daily basis.

If a previously effective dosage regimen fails to provide the usual relief, or if the effects of a dose last for less than 3 hours, medical advice should be sought immediately; this is a sign of seriously worsening asthma that requires reassessment of therapy.

Recommended Dose and Dosage Adjustment

Adults and adolescents 12 years of age or over: The usual dose is 4 mL of DUOVENT UDV nebulizer solution (each plastic unit dose vial contains a total of 0.5 mg of ipratropium bromide and 1.25 mg fenoterol hydrobromide in 4 mL of isotonic saline).

Not recommended for children under 12 years of age.

Missed Dose

If a dose is missed, the next scheduled dose should be taken. An extra dose must not be taken.

Administration

This solution is ready for use and requires no dilution.

DUOVENT UDV nebulizing solution must be administered by means of nebulizer using gas flow (oxygen or compressed air).

DUOVENT UDV nebulizing solution can be administered using a range of commercially available nebulizing devices. The lung and systemic drug exposure is dependent on the nebulizer used.

Where wall oxygen is available the solution is best administered at a flow rate of 6-8 litres per minute.

Patients should follow the instructions provided by the manufacturer of the nebulizing device for proper care, maintenance and cleaning of the equipment.

DILUTION INSTRUCTIONS

If the full content of DUOVENT UDV is to be nebulized, squeeze the plastic vial to empty its contents into the nebulizer chamber. If instructions were given to use a dose less than one complete vial, use a syringe to transfer the necessary amount to the nebulizer chamber. Where wall oxygen is available, the solution is best administered at a flow rate of 6-8 L/min. Any solution left in the plastic vial must be discarded because DUOVENT UDV does not contain preservatives. In most cases, dilution of the dose with sterile preservative-free saline is not necessary. However, volumes of DUOVENT solution less than 2 mL are not appropriate for nebulization and must be diluted with sterile preservative-free saline or another suitable nebulizer solution to make-up a total fill volume of 2-5 mL.

The effects of overdosage are expected to be primarily related to fenoterol. Overdosage resulting in excessive β adrenergic stimulation may cause tachycardia, palpitations, tremor, hypotension, widening of the pulse pressure, anginal pain, flushing, arrhythmia, hypertension and in extreme cases, sudden death. Expected symptoms of overdosage with ipratropium bromide (such as dry mouth, visual accommodation disturbances) are mild because the systemic availability of inhaled ipratropium is very low. Metabolic acidosis and hypokalaemia have also been observed with fenoterol when applied in doses higher than recommended for the approved indications of DUOVENT UDV. If DUOVENT UDV (ipratropium bromide/fenoterol hydrobromide) overdosage occurs, cardiac and respiratory support should be provided as required.

Treatment with DUOVENT UDV should be discontinued. Acid base and electrolyte monitoring should be considered.

Administration of sedatives, tranquilizers, or in severe cases, intensive therapy may be appropriate for the treatment of overdosage. Beta receptor blockers, preferably β1 selective, are suitable as specific antidotes; however, a possible increase in bronchial obstruction must be taken into account and the dose should be adjusted carefully in patients suffering from bronchial asthma or COPD because of the risk of precipitating severe bronchospasm, which may be fatal.

Furthermore, an increase in mucociliary clearance has been demonstrated after administration of higher doses of fenoterol.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Unopened unit dose vials of DUOVENT UDV should be stored at room temperature (15-25°C) and protected from heat and light. If necessary, the solution may be diluted with preservative-free sterile sodium chloride solution 0.9% and used immediately. Any solution remaining in the vial must be discarded.