Drugs List

Therapeutic Indications

Uses

Treatment of nasal polyps

Contraindications

Children under 16 years

Precautions and Warnings

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
Avoid application to broken skin
Avoid contact with eyes
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Monitor regularly the height of children receiving prolonged treatment
Patients on prolonged therapy should be regularly reviewed
Unilateral polyps unusual/irregular/ulcerating/bleeding to be investigated
Prolonged/excessive use may lead to adrenal suppression
Systemic side effects may occur
Maintain treatment at the lowest effective dose
Advise patients that maximal therapeutic benefit will take several weeks
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Caution is advised in 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 of 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 14-17 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

Caution is advised in breastfeeding.

Due to low systemic concentrations obtained with fluticasone inhalation and the drug's poor oral bioavailability, it is doubtful if clinically significant amounts would be ingested by a nursing infant.

The excretion of fluticasone propionate into human breast milk has not been investigated. Following subcutaneous administration in lactating laboratory rats, there was evidence of fluticasone propionate in the breast milk, however plasma levels in patients following intranasal application of fluticasone propionate at recommended doses are low.

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
Anaphylaxis
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Cushing's syndrome
Cushingoid facies
Depression
Dryness and irritation of nose
Dryness and irritation of throat
Epistaxis
Facial oedema
Glaucoma
Growth retardation (children)
Hypersensitivity reactions
Increased intra-ocular pressure
Mouth swelling
Nasal ulceration
Perforation of nasal septum
Psychological changes
Psychomotor hyperactivity
Rash
Sleep disturbances
Systemic steroid effects
Visual disturbances

Presentation

Nasal drops containing fluticasone propionate

Drugs List

Therapeutic Indications

Uses

Treatment of nasal polyps

Dosage

Adults

Elderly

Children

Contraindications

Children under 16 years

Precautions and Warnings

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
Avoid application to broken skin
Avoid contact with eyes
If growth in children is slowed, consider referral to a paediatrician
If visual disturbances occur, perform ophthalmic evaluation
Monitor regularly the height of children receiving prolonged treatment
Patients on prolonged therapy should be regularly reviewed
Unilateral polyps unusual/irregular/ulcerating/bleeding to be investigated
Prolonged/excessive use may lead to adrenal suppression
Systemic side effects may occur
Maintain treatment at the lowest effective dose
Advise patients that maximal therapeutic benefit will take several weeks
Use regularly to maintain freedom from symptoms

Pregnancy and Lactation

Pregnancy

Caution is advised in 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 of 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 14-17 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

Caution is advised in breastfeeding.

Due to low systemic concentrations obtained with fluticasone inhalation and the drug's poor oral bioavailability, it is doubtful if clinically significant amounts would be ingested by a nursing infant.

The excretion of fluticasone propionate into human breast milk has not been investigated. Following subcutaneous administration in lactating laboratory rats, there was evidence of fluticasone propionate in the breast milk, however plasma levels in patients following intranasal application of fluticasone propionate at recommended doses are low.

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
Anaphylaxis
Anxiety
Behavioural disturbances
Blurred vision
Bronchospasm
Cataracts
Cushing's syndrome
Cushingoid facies
Depression
Dryness and irritation of nose
Dryness and irritation of throat
Epistaxis
Facial oedema
Glaucoma
Growth retardation (children)
Hypersensitivity reactions
Increased intra-ocular pressure
Mouth swelling
Nasal ulceration
Perforation of nasal septum
Psychological changes
Psychomotor hyperactivity
Rash
Sleep disturbances
Systemic steroid effects
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: July 2013

Reference Sources

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

BNF for Children (2012-2013) Pharmaceutical Press, London.

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.

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

Summary of Product Characteristics: Flixonase Nasule Drops. Allen & Hanburys Ltd. Revised March 2018.