Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Contraindications

Children under 18 years
Galactosaemia

Precautions and Warnings

Breastfeeding
Cardiac arrhythmias
Glucose-galactose malabsorption syndrome
History of long QT syndrome
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
Urinary retention

Not suitable for acute treatment of bronchospasm
Ensure patient has a fast acting bronchodilator available
Contains lactose
Check patient is using correct inhaler technique
Risk of narrow angle glaucoma
Advise patient to report any unexpected changes in eye symptoms immediately
Prolonged treatment may lead to dental caries
Discontinue if paradoxical bronchospasm occurs
Discontinue treatment if skin rash or other allergic reaction occurs
Advise patient not to exceed stated dose
Patient should seek medical advice if usual relief is diminished

Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.

Pregnancy and Lactation

Pregnancy

Use glycopyrronium with caution in pregnancy.

Glycopyrrolate is an anticholinergic agent. Data is very limited but animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

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.

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 glycopyrronium with caution in breastfeeding.

It is unknown whether glycopyrronium bromide passes into human milk but due to its short plasma half-life and its quaternary structure, it is unlikely that significant quantities would penetrate milk. Glycopyrronium bromide (including its metabolites) was excreted in the milk of lactating rats.

Glycopyrronium has poor oral bioavailability so it is unlikely that glycopyrronium bromide would pose a significant risk to a breastfeeding infant.

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.

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
Asthenia
Atrial fibrillation
Bronchospasm (paradoxical)
Cystitis
Dental decay
Dry mouth
Dyspepsia
Dysphonia
Dysuria
Epistaxis
Fatigue
Gastro-enteritis
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypoaesthesia
Insomnia
Musculoskeletal pain
Nasopharyngitis
Nausea
Non-cardiac chest pain
Painful extremities
Palpitations
Productive cough
Pruritus
Rash
Rhinitis
Sinusitis
Throat irritation
Urinary retention
Urinary tract infections
Vomiting

Presentation

Powder for inhalation capsules containing glycopyrronium bromide.

Drugs List

Therapeutic Indications

Uses

Chronic obstructive pulmonary disease

Dosage

Adults

Contraindications

Children under 18 years
Galactosaemia

Precautions and Warnings

Breastfeeding
Cardiac arrhythmias
Glucose-galactose malabsorption syndrome
History of long QT syndrome
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
Urinary retention

Not suitable for acute treatment of bronchospasm
Ensure patient has a fast acting bronchodilator available
Contains lactose
Check patient is using correct inhaler technique
Risk of narrow angle glaucoma
Advise patient to report any unexpected changes in eye symptoms immediately
Prolonged treatment may lead to dental caries
Discontinue if paradoxical bronchospasm occurs
Discontinue treatment if skin rash or other allergic reaction occurs
Advise patient not to exceed stated dose
Patient should seek medical advice if usual relief is diminished

Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.

Pregnancy and Lactation

Pregnancy

Use glycopyrronium with caution in pregnancy.

Glycopyrrolate is an anticholinergic agent. Data is very limited but animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

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.

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 glycopyrronium with caution in breastfeeding.

It is unknown whether glycopyrronium bromide passes into human milk but due to its short plasma half-life and its quaternary structure, it is unlikely that significant quantities would penetrate milk. Glycopyrronium bromide (including its metabolites) was excreted in the milk of lactating rats.

Glycopyrronium has poor oral bioavailability so it is unlikely that glycopyrronium bromide would pose a significant risk to a breastfeeding infant.

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.

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

Counselling

If a dose is missed, the next dose should be taken as soon as possible.
Ensure patient has a fast acting bronchodilator available. Patient should seek medical advice if usual relief is diminished. Discontinue if paradoxical bronchospasm occurs. Prolonged treatment may lead to dental caries. Advise patient not to exceed stated dose. Not suitable for acute treatment of bronchospasm. Discontinue treatment if skin rash or other allergic reaction occurs.
Advise patient to report any unexpected changes in eye symptoms immediately.

Side Effects

Angioedema
Asthenia
Atrial fibrillation
Bronchospasm (paradoxical)
Cystitis
Dental decay
Dry mouth
Dyspepsia
Dysphonia
Dysuria
Epistaxis
Fatigue
Gastro-enteritis
Headache
Hyperglycaemia
Hypersensitivity reactions
Hypoaesthesia
Insomnia
Musculoskeletal pain
Nasopharyngitis
Nausea
Non-cardiac chest pain
Painful extremities
Palpitations
Productive cough
Pruritus
Rash
Rhinitis
Sinusitis
Throat irritation
Urinary retention
Urinary tract infections
Vomiting

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 2018

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Seebri Breezhaler Inhalation Powder, Hard Capsules 44mcg. Novartis Pharmaceuticals UK Ltd. Revised July 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 April 2018