OXIS™ TURBUHALER™ inhalation powder, 4.5 micrograms/dose and 9 micrograms/dose (delivered doses, equivalent to 6 and 12 micrograms/metered dose)
Abbreviated Core Data Sheet (Abbreviated Prescribing Information)
See local Prescribing Information for full details, as Prescribing Information may vary from country to country.
Indications: OXIS TURBUHALER is indicated, as add on therapy to maintenance treatment with inhaled corticosteroids, for the relief of broncho-obstructive symptoms and prevention of exercise-induced symptoms in patients with asthma when adequate treatment with corticosteroids is not sufficient.
Oxis Turbuhaler is also indicated for the relief and prevention of broncho-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD).
Dosage:
Adults and elderly:
Asthma:
Relief medication: 4.5 or 9 micrograms for the relief of acute broncho-obstructive symptoms.
Normal maintenance dosage: 4.5-9 micrograms once or twice daily.
The daily dose for regular use should not exceed 36 micrograms, however occasional daily doses of up to 54 micrograms may be allowed within a 24-hour period.
COPD:
Normal maintenance dosage: 9 micrograms once or twice daily.
The daily dose for regular use should not exceed 18 micrograms. If required, additional inhalations above those prescribed for regular therapy may be used for relief of symptoms, up to a maximum total daily dose of 36 micrograms (regular plus as required).
Children 6 years and older:
Asthma:
Relief medication:4.5 or 9 micrograms for the relief of acute broncho-obstructive symptoms.
Normal maintenance dosage: 4.5-9 micrograms once or twice daily.
The daily dose for regular use should not exceed 18 micrograms, however occasional daily doses of up to 36 micrograms may be allowed within a 24-hour period.
Prevention of exercise-induced bronchoconstriction:
Adults and children 6 years and older: 4.5-9 micrograms in the morning or before exercise.
Contraindications: Hypersensitivity to formoterol or inhaled lactose.
Warnings and precautions: Asthmatic patients who require maintenance therapy with a β2-agonist, should also receive optimal anti-inflammatory therapy with corticosteroids. Patients must be advised to continue taking anti-inflammatory therapy after the introduction of Oxis Turbuhaler even when the symptoms improve. Should symptoms persist, or should the number of doses of bronchodilator required to control symptoms increase, a reassessment of the therapy should be done. Treatment with Oxis Turbuhaler should not be initiated to treat a severe exacerbation. Caution should be observed in patients with thyrotoxicosis, severe cardiovascular disorder and prolongation of the QTc-interval. Additional blood glucose controls are recommended initially in diabetics. The hypokalemic effect of β2-agonists may be potentiated by concomitant treatments (see Interactions). Particular caution is recommended in acute severe asthma. Serum potassium levels should be monitored in those situations. An increased exposure to formoterol can be expected in patients with severe liver cirrhosis.
Interactions: Beta-adrenergic blockers (including eye drops) can weaken or inhibit the effect of Oxis Turbuhaler. Hypokalemia may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics. There is a theoretical risk that concomitant treatment with other drugs known to prolong the QTc-interval may give rise to a pharmacodynamic interaction with formoterol and increase the possible risk of ventricular arrhythmias. Examples of such drugs include certain antihistamines (eg, terfenadine, astemizole, mizolastine), certain antiarrhythmics (eg, quinidine, disopyramide, procainamide), erythromycin and tricyclic antidepressants.
Pregnancy and lactation: Clinical experience in pregnant women is limited. Treatment with OXIS TURBUHALER may be considered at all stages of pregnancy if needed to obtain asthma control, and if the expected benefit to the mother is greater than any possible risk to the foetus. There is no information regarding the passage of formoterol into human milk.
Undesirable effects: Common: headache, palpitations, tremor. Uncommon: agitation, restlessness, sleep disturbances, muscle cramps, tachycardia. Rare: exanthema, urticaria, pruritus, hypokalemia, bronchospasm.
As for all β2-agonists, cardiac arrhythmias have been rarely reported.In isolated cases the following undesirable effects have been reported: nausea, taste disturbances, dizziness, angina pectoris, variations in the blood pressure, hyperglycaemia. Treatment with β2-sympathomimetics may result in increased blood levels of insulin, free fatty acids, glycerol and ketone bodies.
Legal category: On Medical Prescription.
Further information is available on request from AstraZeneca address or local AstraZeneca subsidiaries.
Oxis™ Turbuhaler™ is a registered trademark owned by the AstraZeneca group of companies. Other trademarks are Oxis™ Turbohaler™, Oxeze™ Turbuhaler™ and Oxez™ Turbuhaler™.
© AstraZeneca 2007
Date of preparation:October, 2007 |
