Spiolto Respimat

/ Boehringer Ingelheim

Posology: 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. The drug is not indicated to treat asthma and for the treatment of acute deteriorations of COPD.
Adults: The recommended dose is 5 microgram tiotropium and 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 and renal impairment: The formulation contains tiotropium which is a predominantly renally excreted drug and olodaterol, which is predominantly metabolized in the liver.
Hepatic impairment: Patients with mild and moderate hepatic impairment can use The drug at the recommended dose. There are no data available for use of olodaterol in patients with severe hepatic impairment.
Renal impairment: Renally impaired patients can use the drug at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min). This formulation  contains olodaterol. There is limited experience with the use of olodaterol in patients with severe renal impairment.
Paediatric population: There is no relevant use of the drug in the paediatric population (under 18 years). Method of administration to ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health care professionals.
For method of administration: See prescribing information for full details.

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Hypersensitivity to the active substances or to any of the excipients. History of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium.  

Asthma: This drug should not be used in asthma. The efficacy and safety of the drug  in asthma have not been studied. Not for acute use.  Not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Paradoxical bronchospasm: As with other inhaled medicines this drug  may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs this drug should be discontinued immediately and alternative therapy substituted.
Anticholinergic effects related to tiotropium: Narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction Consistent with the anticholinergic activity of tiotropium, the drug should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
Eye symptoms: Patients should be cautioned to avoid getting the spray into their eyes. They should be advised that this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema. Should any combination of these eye symptoms develop, patients should stop using  the Respimat and consult a specialist immediately.
Dental caries: Dry mouth, which has been observed with anti-cholinergic treatment, may in the long term be associated with dental caries.
Patients with renal impairment: As plasma concentration of tiotropium increases with decreased renal function in patients with moderate to severe renal impairment The drug should be used only if the expected benefit outweighs the potential risk. There is no long term experience in patients with severe renal impairment.
Cardiovascular effects: The experience with the drug  is limited in patients with a history of myocardial infarction during the previous year, unstable or life-threatening cardiac arrhythmia, hospitalized for heart failure during the previous year or with a diagnosis of paroxysmal tachycardia (>100 beats per minute).
Hypokalaemia: Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects.
Hyperglycaemia: Inhalation of high doses of beta2-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 beta agonist bronchodilators. The drug should not be used in conjunction with any other medications containing long-acting beta2-adrenergic agonists. Patients who have been taking inhaled, short-acting beta2-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. The drug should not be used more frequently than once daily.
Hypersensitivity: As with all medications, immediate hypersensitivity reactions may occur after administration of the drug.
Excipients: Benzalkonium chloride may cause wheezing and breathing difficulties. Patients with asthma are at an increased risk for these adverse events.
See prescribing information for full details.

Dry mouth, insomnia, headache, cough, hypertension.
See prescribing information for full details.

Although no formal in vivo drug interaction studies have been performed between this formulation  and other drugs, inhaled drug  has been used concomitantly with other COPD medicinal products, including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
Anticholinergic agents: The co-administration of tiotropium bromide, one component of the drug , with other anticholinergic containing drugs has not been studied and therefore is not recommended.
Adrenergic agents: Concomitant administration of other adrenergic agents (alone or as part of combination therapy) may potentiate the undesirable effects of the formulation.
Xanthine derivatives, steroids or diuretics: Concomitant treatment with xanthine derivatives, steroids, or non-potassium sparing diuretics may potentiate any hypokalemic effect of adrenergic agonists.
Beta-blockers: Beta-adrenergic blockers may weaken or antagonise the effect of olodaterol. Cardioselective beta-blockers could be considered, although they should be administered with caution.
MAO inhibitors and tricyclic antidepressants, QTc Prolonging drugs: Monamine oxidase inhibitors or tricyclic antidepressants or other drugs known to prolong the QTc interval may potentiate the action of this formulation on the cardiovascular system.
Pharmacokinetic Drug Drug interactions: No relevant effect on systemic exposure to olodaterol has been observed in drug-drug interaction studies with co-administration of fluconazole, used as model inhibitor of CYP2C9. Co-administration of ketoconazole as potent P-gp and CYP3A4 inhibitor increased systemic exposure to olodaterol by approximately 70%. No dose adjustment of this formulation  is necessary. In vitro investigations have shown that olodaterol does not inhibit CYP enzymes or drug transporters at the plasma concentrations achieved in clinical practice.

Pregnancy: There is a very limited amount of data from the use of this drug in pregnant women. As a precautionary measure, it is preferable to avoid the use of Spiolto Respimat during pregnancy.
Like other beta2-adrenergic agonists, olodaterol a component of Spiolto Respimat may inhibit labour due to a relaxant effect on uterine smooth muscle.
Lactation: Clinical data from nursing women exposed to tiotropium and/or olodaterol are not available. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Spiolto Respimat should be made taking into account the benefit of breast-feeding to the child and the benefit of Spiolto Respimat therapy to the woman.
See prescribing information for full details.                       

There is limited information on overdosing with this formulation. This drug has been studied up to 5 microgram / 10 microgram (tiotropium/olodaterol) in COPD patients and up to 10 microgram / 40 microgram (tiotropium/olodaterol) in healthy subjects; no clinically relevant effects were observed. An overdose could lead to exaggerated anti-muscarinic effects of tiotropium and/or exaggerated β2 agonists effects of olodaterol.
Symptoms: Overdose of anticholinergic tiotropium: High doses of tiotropium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 340 microgram tiotropium bromide in healthy volunteers. Additionally, no relevant adverse events, beyond dry mouth/throat and dry nasal mucosa were observed following 14-day dosing of up to 40 microgram tiotropium inhalation solution in healthy volunteers with the exception of pronounced reduction in salivary flow from day 7 onwards.
Overdose of ß2-agonist olodaterol: An overdose of olodaterol is likely to lead to exaggerated effects typical of beta2-adrenergic agonists, e.g. myocardial ischaemia, hypertension or hypotension, tachycardia, arrhythmias, palpitation, dizziness, nervousness, insomnia, anxiety, headache, tremor, dry mouth, muscle spasms, nausea, fatigue, malaise, hypokalemia, hyperglycemia, and metabolic acidosis.
Treatment of overdose: Treatment with Spiolto Respimat 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.

Storage: Store below 25°C. Do not freeze.
Shelf Life: In-use shelf life: 3 months. The expiry date of the product is indicated on the packaging materials.