Drugs List

Therapeutic Indications

Uses

Perennial allergic rhinitis - prevention and treatment
Seasonal allergic rhinitis - prophylaxis and treatment
Vasomotor rhinitis - prophylaxis and treatment

Contraindications

Children under 6 years

Precautions and Warnings

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

Caution in transfer from oral steroids in adrenal insufficiency
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 are licensed for all age groups
Contains benzalkonium chloride
Advise patient to avoid spraying this preparation into or near the eyes
If growth in children is slowed, consider referral to a paediatrician
Monitor regularly the height of children receiving prolonged treatment
Perform eye tests in any patient with vision change/ophthalmologic symptoms
Systemic side effects may occur
Maintain treatment at the lowest effective dose
Several days treatment needed to obtain full effect
Advise patient to seek medical advice if treatment is ineffective
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use beclometasone nasal spray with caution in pregnancy.

The manufacturers note that the use of this medication should be avoided during pregnancy unless thought essential by the doctor.

A position statement from a joint committee of the American College of Obstetricians and Gynecologists (ACOG) and the American College of Allergy, Asthma and Immunology (ACAAI) published in 2000 notes that beclometasone is considered one of the inhaled steroids of choice for use during pregnancy.

In animal studies corticosteroids have been shown to induce malformations including cleft palate and intra-uterine growth retardation. With subcutaneous doses 0.1 and 0.5 times the maximum human daily inhalation dose revealed embryonic growth retardation, omphalocele, cleft palate and retarded cranial ossification. This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure. Clinically significant exposure of the embryo or foetus is unlikely.

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 beclometasone nasal spray with caution in breastfeeding.

The manufacturers note that the use of this medication should be avoided during pregnancy unless thought essential by the doctor.

It is not known whether beclometasone is excreted into breast milk. Other corticosteroids are excreted into milk in low concentrations, and the passage of beclometasone into milk should be expected.

Due to the potency of beclometasone, only very small doses are generally used and, therefore, minimal plasma levels are attained. Intranasal absorption is generally minimal. Due to small doses administered, absorption into maternal plasma is extremely small. Therefore, it is unlikely that these doses would produce clinical significance in a breastfeeding 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

Adrenal suppression
Aggression
Anaphylactic reaction
Anaphylactoid reaction
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Central serous chorioretinopathy
Cushing's syndrome
Cushingoid facies
Depression
Dryness and irritation of nose
Dryness and irritation of throat
Dyspnoea
Epistaxis
Erythema
Facial oedema
Glaucoma
Growth retardation (children)
Hypersensitivity reactions
Increased intra-ocular pressure
Ocular oedema
Oedema of the lips
Oedema of the throat
Perforation of nasal septum
Pruritus
Psychological changes
Psychomotor hyperactivity
Rash
Sleep disturbances
Systemic effects (large quantities and/or prolonged use)
Unpleasant smell
Unpleasant taste
Urticaria
Visual disturbances

Presentation

Aqueous nasal spray containing beclometasone dipropionate.

Drugs List

Therapeutic Indications

Uses

Perennial allergic rhinitis - prevention and treatment
Seasonal allergic rhinitis - prophylaxis and treatment
Vasomotor rhinitis - prophylaxis and treatment

Dosage

Adults

Children

Contraindications

Children under 6 years

Precautions and Warnings

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

Caution in transfer from oral steroids in adrenal insufficiency
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 are licensed for all age groups
Contains benzalkonium chloride
Advise patient to avoid spraying this preparation into or near the eyes
If growth in children is slowed, consider referral to a paediatrician
Monitor regularly the height of children receiving prolonged treatment
Perform eye tests in any patient with vision change/ophthalmologic symptoms
Systemic side effects may occur
Maintain treatment at the lowest effective dose
Several days treatment needed to obtain full effect
Advise patient to seek medical advice if treatment is ineffective
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Use beclometasone nasal spray with caution in pregnancy.

The manufacturers note that the use of this medication should be avoided during pregnancy unless thought essential by the doctor.

A position statement from a joint committee of the American College of Obstetricians and Gynecologists (ACOG) and the American College of Allergy, Asthma and Immunology (ACAAI) published in 2000 notes that beclometasone is considered one of the inhaled steroids of choice for use during pregnancy.

In animal studies corticosteroids have been shown to induce malformations including cleft palate and intra-uterine growth retardation. With subcutaneous doses 0.1 and 0.5 times the maximum human daily inhalation dose revealed embryonic growth retardation, omphalocele, cleft palate and retarded cranial ossification. This is not likely to be relevant for humans given recommended nasal doses which results in minimal systemic exposure. Clinically significant exposure of the embryo or foetus is unlikely.

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 beclometasone nasal spray with caution in breastfeeding.

The manufacturers note that the use of this medication should be avoided during pregnancy unless thought essential by the doctor.

It is not known whether beclometasone is excreted into breast milk. Other corticosteroids are excreted into milk in low concentrations, and the passage of beclometasone into milk should be expected.

Due to the potency of beclometasone, only very small doses are generally used and, therefore, minimal plasma levels are attained. Intranasal absorption is generally minimal. Due to small doses administered, absorption into maternal plasma is extremely small. Therefore, it is unlikely that these doses would produce clinical significance in a breastfeeding 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

Adrenal suppression
Aggression
Anaphylactic reaction
Anaphylactoid reaction
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Central serous chorioretinopathy
Cushing's syndrome
Cushingoid facies
Depression
Dryness and irritation of nose
Dryness and irritation of throat
Dyspnoea
Epistaxis
Erythema
Facial oedema
Glaucoma
Growth retardation (children)
Hypersensitivity reactions
Increased intra-ocular pressure
Ocular oedema
Oedema of the lips
Oedema of the throat
Perforation of nasal septum
Pruritus
Psychological changes
Psychomotor hyperactivity
Rash
Sleep disturbances
Systemic effects (large quantities and/or prolonged use)
Unpleasant smell
Unpleasant taste
Urticaria
Visual disturbances

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: June 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.

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

Summary of Product Characteristics: Beconase Aqueous Nasal Spray. GlaxoSmithKline UK. Revised January 2018.

Summary of Product Characteristics: Beconase Hayfever. Omega Pharma Ltd. Revised March 2017.

Summary of Product Characteristics: Beconase Hayfever Relief for Adults 0.05% Nasal Spray. Omega Pharma Ltd. April 2018.

Summary of Product Characteristics: Nasobec Aqueous. Teva UK Limited. Revised November 2017.

Summary of Product Characteristics: Nasobec Hayfever. Teva UK Limited. Revised November 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 June 2018