Tiotropium with olodaterol inhalation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for inhalation of tiotropium with olodaterol.
Drugs List
Therapeutic Indications
Uses
Chronic obstructive pulmonary disease
Dosage
Adults
2 inhalations once daily taken at the same time of the day. Dose should not be exceeded.
Contraindications
Children under 18 years
Breastfeeding
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Arterial aneurysm
Benign prostatic hyperplasia
Bladder outflow obstruction
Cardiac arrhythmias
Cardiovascular disorder
Diabetes mellitus
Electrolyte imbalance
History of cardiac failure
History of myocardial infarction
History of torsade de pointes
Hypertension
Hypertrophic obstructive cardiomyopathy
Hypocalcaemia
Hypokalaemia
Ischaemic heart disease
Narrow angle glaucoma
Pregnancy
Renal impairment - creatinine clearance below 50ml/minute
Seizures
Severe hepatic impairment
Severe renal impairment
Supraventricular tachycardia
Thyrotoxicosis
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
Avoid contact with eyes
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
If visual disturbances occur, perform ophthalmic evaluation
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely patient at risk of cardiovascular disorders
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Advise patient to report any blurred vision or any other eye symptoms
Advise patient to report new or worsening signs of cardiac failure
May reduce serum potassium levels
Prolonged treatment may lead to dental caries
Discontinue if paradoxical bronchospasm occurs
Advise patient not to exceed stated dose
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
Pregnancy and Lactation
Pregnancy
Use the combination of tiotropium with olodaterol with caution during pregnancy.
The effects of using tiotropium with olodaterol as a combined product during pregnancy are unknown. The manufacturer advises that it is preferable to avoid the use of tiotropium with olodaterol in pregnancy. Potential risks are unknown.
Known effects of tiotropium during pregnancy
At the time of writing there is limited amount of data from the use of tiotropium in pregnancy. Animal studies do not indicate direct/indirect harmful effects regarding reproductive toxicity at clinically relevant doses.
Known effects of olodaterol during pregnancy
As a component of this product, olodaterol may inhibit labour as beta2-adrenergic agonists have a relaxant effect on uterine smooth muscle.
Lactation
The combination of tiotropium with olodaterol is contraindicated during breastfeeding.
The manufacturer advises discontinuing breastfeeding or discontinuing tiotropium with olodaterol. It is unknown whether tiotropium with olodaterol is excreted in human milk. Effects on exposed infants are unknown. In animal studies both tiotropium and olodaterol and/or their metabolites have been detected in the milk of lactating rats; it is not known whether either of the substances pass into human breastmilk.
Side Effects
Anaphylactic reaction
Angioedema
Arthralgia
Atrial fibrillation
Back pain
Blurred vision
Bronchospasm
Constipation
Cough
Dehydration
Dizziness
Dry mouth
Dry skin
Dysphagia
Dysphonia
Dysuria
Epistaxis
Gastroesophageal reflux disease
Gingivitis
Glaucoma
Glossitis
Headache
Hypersensitivity reactions
Hypertension
Increase in dental caries
Increased intra-ocular pressure
Insomnia
Intestinal obstruction
Joint swelling
Laryngitis
Nasopharyngitis
Nausea
Oropharyngeal candidiasis
Palpitations
Paralytic ileus
Pharyngitis
Pruritus
Rash
Sinusitis
Skin infection
Skin ulcer
Stomatitis
Supraventricular tachycardia
Tachycardia
Urinary retention
Urinary tract infections
Urticaria
Overdosage
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 ).
Further Information
Last Full Review Date: September 2019
Reference Sources
Summary of Product Characteristics: Spiolto Respimat 2.5microgram/2.5microgram, inhalation solution. Boehringer Ingelheim International GmbH. Revised April 2019.
Summary of Product Characteristics: Yanimo Respimat 2.5microgram/2.5microgram, inhalation solution. Boehringer Ingelheim International GmbH. Revised April 2019.
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