Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Contraindications

Children under 18 years
Asthma
Galactosaemia

Precautions and Warnings

Predisposition to hypokalaemia
Predisposition to long QT syndrome
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Coronary arteriosclerosis
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hypertension
Hyperthyroidism
Hypoxia
Lactose intolerance
Myocardial infarction
Pregnancy
Seizures
Severe hepatic impairment
Thyrotoxicosis

May decrease glucose tolerance in patients with diabetes mellitus
Contains lactose
Check patient is using correct inhaler technique
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Advise patient to seek medical advice if COPD seems to be worsening
Advise pt to seek medical attention if diff. swallowing or breathing occurs
May reduce serum potassium levels
Discontinue if allergic reaction occurs
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 with caution during pregnancy.

There are no data from the use of indacaterol in pregnant women available.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposure. Like other beta 2-adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Indacaterol should only be used during pregnancy if the expected benefits outweigh the potential risks.

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 14-17 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 with caution during breastfeeding

It is not known whether indacaterol/metabolites are excreted in human milk.

Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from indacaterol therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

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
Bronchospasm (paradoxical)
Cardiac arrhythmias
Chest pain
Cough
Diabetes mellitus
Dizziness
Fine tremor (usually hands)
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Muscle spasm
Musculoskeletal pain
Myalgia
Myocardial ischaemia
Nasopharyngitis
Palpitations
Paraesthesia
Peripheral oedema
Pharyngolaryngeal pain
Pruritus
Rash
Rhinorrhoea
Sinusitis
Tachycardia
Throat irritation
Upper respiratory tract infection
Urticaria

Presentation

Inhalation powder, hard capsules containing indacaterol maleate.

Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Asthma
Galactosaemia

Precautions and Warnings

Predisposition to hypokalaemia
Predisposition to long QT syndrome
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Coronary arteriosclerosis
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Hypertension
Hyperthyroidism
Hypoxia
Lactose intolerance
Myocardial infarction
Pregnancy
Seizures
Severe hepatic impairment
Thyrotoxicosis

May decrease glucose tolerance in patients with diabetes mellitus
Contains lactose
Check patient is using correct inhaler technique
Monitor serum K+ in patients on high dose steroids/xanthines/diuretics
Monitor serum potassium in hypoxic patients
Advise patient to seek medical advice if COPD seems to be worsening
Advise pt to seek medical attention if diff. swallowing or breathing occurs
May reduce serum potassium levels
Discontinue if allergic reaction occurs
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 with caution during pregnancy.

There are no data from the use of indacaterol in pregnant women available.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposure. Like other beta 2-adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Indacaterol should only be used during pregnancy if the expected benefits outweigh the potential risks.

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 14-17 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 with caution during breastfeeding

It is not known whether indacaterol/metabolites are excreted in human milk.

Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from indacaterol therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

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
Bronchospasm (paradoxical)
Cardiac arrhythmias
Chest pain
Cough
Diabetes mellitus
Dizziness
Fine tremor (usually hands)
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypokalaemia
Muscle spasm
Musculoskeletal pain
Myalgia
Myocardial ischaemia
Nasopharyngitis
Palpitations
Paraesthesia
Peripheral oedema
Pharyngolaryngeal pain
Pruritus
Rash
Rhinorrhoea
Sinusitis
Tachycardia
Throat irritation
Upper respiratory tract infection
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: April 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

Summary of Product Characteristics: Onbrez Breezhaler 150 and 300 microgram inhalation powder, hard capsules. Novartis Pharmaceuticals UK Ltd. Revised July 2012.