Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Contraindications

Children under 18 years
Galactosaemia
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Coronary arteriosclerosis
Diabetes mellitus
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of myocardial infarction
History of torsade de pointes
Hypertension
Hypoxia
Ischaemic heart disease
Lactose intolerance
Left ventricular dysfunction
Myocardial infarction
Narrow angle glaucoma
Pregnancy
Renal impairment - glomerular filtration rate below 30ml/minute/1.73m sq
Seizures
Severe hepatic impairment
Thyrotoxicosis
Urinary retention

Correct electrolyte disorders before treatment
May decrease glucose tolerance in patients with diabetes mellitus
Not suitable for acute treatment of asthma
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 blood glucose closely in patients with diabetes mellitus
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Risk of narrow angle glaucoma
May reduce serum potassium levels
Prolonged treatment may lead to dental caries
Discontinue if allergic reaction occurs
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

Pregnancy and Lactation

Pregnancy

Use the combination of indacaterol with glycopyrronium with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus. There is little data on the use of this medication in pregnant women but animal studies do not indicate any direct/indirect harmful effects to reproductive toxicity at clinically relevant exposure.

Indacaterol may inhibit labour due to the relaxant effect on the uterine smooth muscle.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use the combination of indacaterol with glycopyrronium with caution in 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 not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk but data has shown excretion in the milk of lactating rats.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Angioedema
Atrial fibrillation
Bladder outflow obstruction
Bronchospasm (paradoxical)
Chest pain
Cough
Dental decay
Diabetes mellitus
Dizziness
Dry mouth
Dyspepsia
Dysphonia
Epistaxis
Fatigue
Gastro-enteritis
Glaucoma
Headache
Hyperglycaemia
Hypersensitivity reactions
Insomnia
Muscle spasm
Musculoskeletal pain
Myalgia
Myocardial ischaemia
Nasopharyngitis
Oropharyngeal pain
Painful extremities
Palpitations
Paraesthesia
Peripheral oedema
Pruritus
Pyrexia
Rash
Rhinitis
Sinusitis
Tachycardia
Throat irritation
Upper respiratory tract infection
Urinary retention
Urinary tract infections

Presentation

Inhalation powder hard capsules containing indacaterol maleate and glycopyrronium bromide.

Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Galactosaemia
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Coronary arteriosclerosis
Diabetes mellitus
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of myocardial infarction
History of torsade de pointes
Hypertension
Hypoxia
Ischaemic heart disease
Lactose intolerance
Left ventricular dysfunction
Myocardial infarction
Narrow angle glaucoma
Pregnancy
Renal impairment - glomerular filtration rate below 30ml/minute/1.73m sq
Seizures
Severe hepatic impairment
Thyrotoxicosis
Urinary retention

Correct electrolyte disorders before treatment
May decrease glucose tolerance in patients with diabetes mellitus
Not suitable for acute treatment of asthma
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 blood glucose closely in patients with diabetes mellitus
Monitor serum electrolytes
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Risk of narrow angle glaucoma
May reduce serum potassium levels
Prolonged treatment may lead to dental caries
Discontinue if allergic reaction occurs
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

Pregnancy and Lactation

Pregnancy

Use the combination of indacaterol with glycopyrronium with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus. There is little data on the use of this medication in pregnant women but animal studies do not indicate any direct/indirect harmful effects to reproductive toxicity at clinically relevant exposure.

Indacaterol may inhibit labour due to the relaxant effect on the uterine smooth muscle.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use the combination of indacaterol with glycopyrronium with caution in 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 not known whether indacaterol, glycopyrronium and their metabolites are excreted in human milk but data has shown excretion in the milk of lactating rats.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Angioedema
Atrial fibrillation
Bladder outflow obstruction
Bronchospasm (paradoxical)
Chest pain
Cough
Dental decay
Diabetes mellitus
Dizziness
Dry mouth
Dyspepsia
Dysphonia
Epistaxis
Fatigue
Gastro-enteritis
Glaucoma
Headache
Hyperglycaemia
Hypersensitivity reactions
Insomnia
Muscle spasm
Musculoskeletal pain
Myalgia
Myocardial ischaemia
Nasopharyngitis
Oropharyngeal pain
Painful extremities
Palpitations
Paraesthesia
Peripheral oedema
Pruritus
Pyrexia
Rash
Rhinitis
Sinusitis
Tachycardia
Throat irritation
Upper respiratory tract infection
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: November 2018

Reference Sources

Summary of Product Characteristics: Ultibro Breezhaler 85micrograms/43micrograms inhalation powder hard capsules. Novartis Pharmaceuticals Ltd. Revised July 2018.