• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
  • Striverdi Respimat
    / Boehringer Ingelheim


    Active Ingredient
    Olodaterol (as HCl) 2.5 mcg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Inhalation

    30 Doses

    not in the basket chart 28765 9869

    Dosage

    The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler. Two puffs from the Respimat inhaler comprise one medicinal dose.
    Adults: The recommended dose is 5 microgram olodaterol given as two puffs from the Respimat inhaler once daily, at the same time of the day. The recommended dose should not be exceeded.
    Elderly population: Elderly patients can use this drug  at the recommended dose.
    Hepatic impairment: Patients with mild to moderate hepatic impairment can use this formulation at the recommended dose. There are no data available for the use of this formulation in patients with severe hepatic impairment.
    Renal impairment: Renally impaired patients can use this drug at the recommended dose. There is limited experience with the use of this formulation in patients with severe renal impairment.
    Paediatric population: There is no relevant use of this agent  in the paediatric population (under 18 years). 


    Indications

    Indicated as a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD).

     


    Contra-Indications

    Hypersensitivity to olodaterol or to any of the excipients.


    Special Precautions

    Asthma: This formulation should not be used in asthma. The long-term efficacy and safety of olodaterol in asthma have not been studied.
    Acute bronchospasm: This formulation, as a once-daily maintenance bronchodilator, should not be used for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
    Hypersensitivity: As with all medications, immediate hypersensitivity reactions may occur after administration of this formulation.
    Paradoxical bronchospasm: As with other inhaled medicines this formulation  may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs this drug  should be discontinued immediately and alternative therapy substituted.
    Systemic effects: Long-acting beta2-adrenergic agonists should be administered with caution in patients with cardiovascular disorders, especially ischaemic heart disease, severe cardiac decompensation, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, hypertension and aneurysm, in patients with convulsive disorders or thyrotoxicosis, in patients with known or susp­ected prolongation of the QT interval (i.e. QT > 0.44 s) and in patients who are unusually responsive to sympathomimetic amines. Patients with a history of myocardial infarction during the previous year, patients with unstable or life-threatening cardiac arrhythmias, hospitalised for heart failure during the previous year or with a diagnosis of paroxysmal tachycardia (> 100 beats per minute) were excluded from the clinical trials. Therefore, experience in these patient groups is limited. This formulation should be used with caution in these patient groups.
    Cardiovascular effects: Like other β2-adrenergic agonists, olodaterol may produce clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure and/ or other symptoms. In case such effects occur, treatment may need to be discontinued. In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes such as flattening of the T wave and ST segment depression, although the clinical significance of these observations is unknown.
    Hypokalaemia: β2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. In patients with severe COPD, hypokalaemia may be potentiated by hypoxia and concomitant treatment; this may increase susceptibility to cardiac arrhythmias.
    Hyperglycaemia: Inhalation of high doses of β2-adrenergic agonists may produce increases in plasma glucose.
    Anaesthesia: Caution needs to be taken in case of a planned operation with halogenated hydrocarbon anaesthetics due to an increased susceptibility to the adverse cardiac effects of β-agonist bronchodilators. This drug should not be used in conjunction with any other medications containing long-acting β2-adrenergic agonists. Patients who have been taking inhaled short-acting β2-adrenergic agonists on a regular basis (e.g. four times a day) should be instructed to use them only for symptomatic relief of acute respiratory symptoms.
    See prescribing information for full details


    Side Effects

    Nasopharyngitis, dizziness, hypertension, rash and arthralgia. These were usually mild or moderate in intensity.
    See prescribing information for full details.


    Drug interactions

    Adrenergic agents: Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of this drug. Xanthine derivatives, steroids and diuretics Concomitant treatment with xanthine derivatives, steroids or non-potassium-sparing diuretics may potentiate any hypokalaemic effect of adrenergic agonists.
    Beta-blockers: Beta-adrenergic receptor blockers may weaken or antagonise the effect of this formulation. Therefore, this drug should only be given together with beta-adrenergic blockers (including eye drops) if there are compelling reasons for their use. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution. MAO inhibitors and tricyclic antidepressants, QTc-prolonging drugs. Monoamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval may potentiate the action of this agent on the cardiovascular system.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no data from the use of this drug  in pregnant women available.
    Lactation: Clinical data from nursing women exposed to olodaterol are not available.
    See prescribing information for full details.


    Overdose

    Symptoms: An overdose of olodaterol is likely to lead to exaggerated effects typical of beta2-adrenergic agonists, e.g. myocardial ischaemia, hypertension or hypotension, tachycardia, arrhythmia, palpitation, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalaemia, hyperglycaemia, and metabolic acidosis.
    Treatment of overdose: Treatment with this formulation should be discontinued. Supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective beta-blockers may be considered, but only subject to extreme caution since the use of beta-adrenergic blocker medication may provoke bronchospasm.


    Important notes

    Storage: Store below 30°C, do not freeze.
    Shelf life: 3 years. In-use shelf life: 3 months.


    Manufacturer
    Boehringer Ingelheim Pharma KG, Germany
    CLOSE