Drugs List

Therapeutic Indications

Uses

Symptomatic relief of rhinorrhoea in allergic and non-allergic rhinitis

Contraindications

Children under 12 years

Precautions and Warnings

Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Cystic fibrosis
Narrow angle glaucoma
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Contains benzalkonium chloride
Avoid spray in or near eyes

As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, the ipratropium bromide nasal pump spray should be used with caution in these patients.

Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advise sought immediately.

Pregnancy and Lactation

Pregnancy

Use ipratropium bromide with caution in pregnancy.

The manufacturer has noted that safety has not been established and that the benefits of using ipratropium bromide during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.

Ipratropium was not teratogenic in mice, rats, and rabbits when administered either orally or by inhalation.

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 ipratropium bromide with caution in breastfeeding.

It is not known whether ipratropium bromide is excreted into breast milk.

Definitive data on the appearance of atropine in milk has not been published. Ipratropium is lipid insoluble and, similar to other quaternary ammonium bases, may appear in milk.
It is unlikely that the infant would absorb any ipratropium bromide, due to its poor tissue distribution and oral absorption of this drug. However, caution should be exercised when administered to nursing mothers.

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

Allergic reaction
Anaphylactic shock
Anaphylaxis
Angioedema
Angioedema of tongue, lips and face
Blurred vision
Bronchospasm
Conjunctival hyperaemia
Corneal oedema
Disturbances in accommodation
Dizziness
Dry mouth
Dry throat
Dryness and irritation of nose
Epistaxis
Eye pain
Gastro-intestinal motility disturbances
Glaucoma
Headache
Hypersensitivity reactions
Increased heart rate
Increased intra-ocular pressure
Laryngospasm
Mydriasis
Nausea
Ocular discomfort
Oropharyngeal oedema
Palpitations
Pharyngitis
Pruritus
Rash
Stomatitis
Supraventricular tachycardia
Throat irritation
Urinary retention
Urticaria
Visual haloes

Presentation

Nasal spray containing ipratropium bromide

Drugs List

Therapeutic Indications

Uses

Symptomatic relief of rhinorrhoea in allergic and non-allergic rhinitis

Dosage

Adults

Elderly

Children

Contraindications

Children under 12 years

Precautions and Warnings

Benign prostatic hyperplasia
Bladder outflow obstruction
Breastfeeding
Cystic fibrosis
Narrow angle glaucoma
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Contains benzalkonium chloride
Avoid spray in or near eyes

As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, the ipratropium bromide nasal pump spray should be used with caution in these patients.

Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advise sought immediately.

Pregnancy and Lactation

Pregnancy

Use ipratropium bromide with caution in pregnancy.

The manufacturer has noted that safety has not been established and that the benefits of using ipratropium bromide during a confirmed or suspected pregnancy must be weighed against the possible hazards to the unborn child. Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.

Ipratropium was not teratogenic in mice, rats, and rabbits when administered either orally or by inhalation.

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 ipratropium bromide with caution in breastfeeding.

It is not known whether ipratropium bromide is excreted into breast milk.

Definitive data on the appearance of atropine in milk has not been published. Ipratropium is lipid insoluble and, similar to other quaternary ammonium bases, may appear in milk.
It is unlikely that the infant would absorb any ipratropium bromide, due to its poor tissue distribution and oral absorption of this drug. However, caution should be exercised when administered to nursing mothers.

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

Allergic reaction
Anaphylactic shock
Anaphylaxis
Angioedema
Angioedema of tongue, lips and face
Blurred vision
Bronchospasm
Conjunctival hyperaemia
Corneal oedema
Disturbances in accommodation
Dizziness
Dry mouth
Dry throat
Dryness and irritation of nose
Epistaxis
Eye pain
Gastro-intestinal motility disturbances
Glaucoma
Headache
Hypersensitivity reactions
Increased heart rate
Increased intra-ocular pressure
Laryngospasm
Mydriasis
Nausea
Ocular discomfort
Oropharyngeal oedema
Palpitations
Pharyngitis
Pruritus
Rash
Stomatitis
Supraventricular tachycardia
Throat irritation
Urinary retention
Urticaria
Visual haloes

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: May 2014

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on May 07, 2014.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com Accessed on May 7, 2014.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Rinaspray 21 micrograms per metered dose, Nasal Spray solution. Sanofi. Revised December 2021.