Olodaterol inhalation solution
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Inhalation solution containing olodaterol (as hydrochloride).
Chronic obstructive pulmonary disease
Two inhalations once daily, at the same time of the day. The recommended dose should not be exceeded.
Children under 18 years
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Predisposition to hypokalaemia
History of cardiac failure
History of myocardial infarction
History of torsade de pointes
Hypertrophic obstructive cardiomyopathy
Ischaemic heart disease
Severe hepatic impairment
Severe renal impairment
Anaesthetist should be made aware patient is taking this medication
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Ensure patient has a fast acting bronchodilator available
Contains benzalkonium chloride: may cause wheezing & breathing difficulties
Check patient is using correct inhaler technique
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely patient at risk of cardiovascular disorders
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Advise patient to report new or worsening signs of cardiac failure
May reduce serum potassium levels
Discontinue if paradoxical bronchospasm occurs
Advise patient not to use for relief of acute attacks
Advise patient to seek medical advice if treatment is ineffective
Use regularly to maintain freedom from symptoms
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.
Pregnancy and Lactation
Use olodaterol with caution during pregnancy.
The manufacturer advises that it is preferable to avoid the use of olodaterol in pregnancy. Animal studies do not indicate direct or indirect harmful effects regarding reproductive toxicity at clinically relevant exposures. There is little data on the use of olodaterol in pregnant women. Risks are unknown.
Olodaterol may inhibit labour as beta2-adrenergic agonists have a relaxant effect on uterine smooth muscle.
Olodaterol is contraindicated during breastfeeding.
The manufacturer advises discontinuing breastfeeding or discontinuing olodaterol. It is unknown whether olodaterol or its metabolites are excreted in human milk. In animal studies excretion of olodaterol and its metabolites have been detected in milk. It is not known whether either of the substances pass into human breast milk. Since there is negligible systemic exposure of the breastfeeding woman to olodaterol and/or its metabolites at a human dose of 5microgram per day, effects on the breastfed newborn/infant are not expected.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: March 2021
Summary of Product Characteristics: Striverdi Respimat 2.5 microgram, solution for inhalation. Boehringer Ingelheim International GmbH. Revised December 2020.
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