Drugs List

Therapeutic Indications

Uses

Allergic rhinitis - perennial and seasonal
Rhinitis - vasomotor
Treatment of nasal polyps

Contraindications

Children under 6 years

Precautions and Warnings

Children aged 6 to 18 years
Recurrent epistaxis
Uncontrolled nasal infection
Breastfeeding
Pregnancy
Pulmonary tuberculosis
Recent nasal surgery
Recent nasal trauma

Corticosteroid cover required in adrenal insufficiency
May mask symptoms or signs of infections
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Concomitant treatment may be necessary for allergy eye symptoms
Not all available brands/formulations are licensed for use in children
Not all available products are licensed for all uses
Consider adrenal suppression when transferring from systemic steroid
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Inspect nasal mucosa regularly in patients on long term treatment
Monitor regularly the height of children receiving prolonged treatment
Prolonged or high dose may lead to adrenal suppression
Corticosteroids may cause growth retardation in children under 18 years
During transfer from oral steroids allergic conditions may be unmasked
Systemic effects possible with any inhaled corticosteroid
Discontinue if localised infection occurs
Maintain treatment at the lowest effective dose
Duration of use should not exceed 3 months
Several days treatment needed to obtain full effect
Advise patient to seek medical advice if treatment is ineffective
Refer to doctor if symptoms persist after 2 weeks treatment
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use budesonide with caution in pregnancy.

The use of budesonide has not been associated with appreciable human teratogenicity and inhaled budesonide does not appear to represent a significant risk for congenital defects or malformations during early pregnancy.

In animal studies glucocorticosteroids have been shown to induce malformations. This is not thought to be relevant for humans given recommended doses.

Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.

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 budesonide with caution in breastfeeding.

Budesonide has a relatively low molecular weight and high lipid solubility and can be anticipated to be excreted into breast milk. The amount inhaled budesonide secreted into breast milk are minimal and infant exposure is negligible, and it is considered to be acceptable to use during breastfeeding.

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

Adrenal suppression
Aggression in children
Anaphylactic reaction
Angioedema
Anxiety
Blurred vision
Cataracts
Cushing's syndrome
Cushingoid facies
Depression
Dermatitis
Dysphonia
Epistaxis
Glaucoma
Growth retardation (children)
Haemorrhagic secretions (slight)
Hypersensitivity reactions
Increased intra-ocular pressure
Itching
Muscle spasm
Nasal dryness and stinging
Nasal ulceration
Osteoporosis
Perforation of nasal septum
Pruritus
Psychomotor hyperactivity
Rash
Sleep disorders
Sneezing
Urticaria

Presentation

Nasal spray containing budesonide.

Drugs List

Therapeutic Indications

Uses

Allergic rhinitis - perennial and seasonal
Rhinitis - vasomotor
Treatment of nasal polyps

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 6 years

Precautions and Warnings

Children aged 6 to 18 years
Recurrent epistaxis
Uncontrolled nasal infection
Breastfeeding
Pregnancy
Pulmonary tuberculosis
Recent nasal surgery
Recent nasal trauma

Corticosteroid cover required in adrenal insufficiency
May mask symptoms or signs of infections
Systemic corticosteroids may be needed during elective surgery
Systemic corticosteroids may be needed during periods of stress
Concomitant treatment may be necessary for allergy eye symptoms
Not all available brands/formulations are licensed for use in children
Not all available products are licensed for all uses
Consider adrenal suppression when transferring from systemic steroid
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Inspect nasal mucosa regularly in patients on long term treatment
Monitor regularly the height of children receiving prolonged treatment
Prolonged or high dose may lead to adrenal suppression
Corticosteroids may cause growth retardation in children under 18 years
During transfer from oral steroids allergic conditions may be unmasked
Systemic effects possible with any inhaled corticosteroid
Discontinue if localised infection occurs
Maintain treatment at the lowest effective dose
Duration of use should not exceed 3 months
Several days treatment needed to obtain full effect
Advise patient to seek medical advice if treatment is ineffective
Refer to doctor if symptoms persist after 2 weeks treatment
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use budesonide with caution in pregnancy.

The use of budesonide has not been associated with appreciable human teratogenicity and inhaled budesonide does not appear to represent a significant risk for congenital defects or malformations during early pregnancy.

In animal studies glucocorticosteroids have been shown to induce malformations. This is not thought to be relevant for humans given recommended doses.

Animal studies have also identified an involvement of excess prenatal glucocorticoids in increased risks for intrauterine growth retardation, adult cardiovascular disease and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour at exposures below the teratogenic dose range.

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 budesonide with caution in breastfeeding.

Budesonide has a relatively low molecular weight and high lipid solubility and can be anticipated to be excreted into breast milk. The amount inhaled budesonide secreted into breast milk are minimal and infant exposure is negligible, and it is considered to be acceptable to use during breastfeeding.

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

Adrenal suppression
Aggression in children
Anaphylactic reaction
Angioedema
Anxiety
Blurred vision
Cataracts
Cushing's syndrome
Cushingoid facies
Depression
Dermatitis
Dysphonia
Epistaxis
Glaucoma
Growth retardation (children)
Haemorrhagic secretions (slight)
Hypersensitivity reactions
Increased intra-ocular pressure
Itching
Muscle spasm
Nasal dryness and stinging
Nasal ulceration
Osteoporosis
Perforation of nasal septum
Pruritus
Psychomotor hyperactivity
Rash
Sleep disorders
Sneezing
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: September 2018

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

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.

Summary of Product Characteristics: Benacort 64micrograms Nasal Spray. McNeil Products Ltd. Revised July 2018.

Summary of Product Characteristics: Budesonide 64micrograms/actuation, Aqueous Nasal Spray. Sandoz Limited. Revised June 2017.

Summary of Product Characteristics: Rhinocort Aqua 64micrograms, nasal spray. McNeil Products Ltd. Revised July 2018.

NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 9 September 2018

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: 06 November 2015
Last accessed: 09 September 2018