Aclidinium bromide with formoterol fumarate dihydrate inhalation
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Inhalation powder containing aclidinium bromide and formoterol fumarate.
Drugs List
Therapeutic Indications
Uses
Chronic obstructive pulmonary disease
Dosage
Adults
1 inhalation twice daily.
Additional Dosage Information
If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.
Contraindications
Children under 18 years
Galactosaemia
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Cardiac arrhythmias
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Hypertension
Hypoxia
Lactose intolerance
Narrow angle glaucoma
New York Heart Association class III failure
New York Heart Association class IV failure
Phaeochromocytoma
Pregnancy
Seizures
Severe cardiovascular disorder
Thyrotoxicosis
Unstable angina
Urinary retention
Within 6 months of a myocardial infarction
Correct electrolyte disorders before treatment
Not suitable for acute treatment of asthma
Advise ability to drive/operate machinery may be affected by side effects
Ensure patient has a fast acting bronchodilator available
Contains lactose
Check patient is using correct inhaler technique
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Risk of narrow angle glaucoma
May cause hypokalaemia
Prolonged treatment may lead to dental caries
Discontinue if paradoxical bronchospasm occurs
Advise patient not to exceed stated dose
Advise patient to seek medical advice if treatment is ineffective
Pregnancy and Lactation
Pregnancy
Use the combination of aclidinium bromide with formoterol fumarate with caution during pregnancy.
The manufacturer recommends aclidinium bromide with formoterol fumarate is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
There is little data available on the use of this medication in pregnant women.
Studies in animals have shown foetotoxicity at much higher dose levels than the maximum human exposure to aclidinium bromide and side effects at very high systemic exposure levels in reproduction studies with formoterol.
Lactation
Use the combination of aclidinium bromide with formoterol fumarate with caution during breastfeeding.
The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the breastfed infant.
It is unknown whether aclidinium bromide and/or its metabolites or formoterol are excreted in human milk. Animal studies have shown excretion of small amounts of aclidinium bromide and/or metabolites and formoterol into milk.
Side Effects
Agitation
Anaphylactic reaction
Angina pectoris
Angioedema
Anxiety
Blurred vision
Bronchospasm (paradoxical)
Cough
Creatine phosphokinase increased
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dysphonia
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Increased blood pressure
Insomnia
Muscle spasm
Myalgia
Nasopharyngitis
Nausea
Palpitations
Prolongation of QT interval
Pruritus
Rash
Sinusitis
Stomatitis
Tachycardia
Throat irritation
Tooth abscess
Tremor
Urinary retention
Urinary tract infections
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: January 2021
Reference Sources
Summary of Product Characteristics: Duaklir Genuair 340 micrograms/12 micrograms inhalation powder. AstraZeneca UK Limited. Revised August 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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