Fluticasone propionate nasal spray
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Nasal spray containing fluticasone propionate
Drugs List
Therapeutic Indications
Uses
Perennial allergic rhinitis - prevention and treatment
Seasonal allergic rhinitis - prophylaxis and treatment
Dosage
Adults
Prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis
POM products
Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice a day may be required. Once symptoms are under control a maintenance dose of one spray per nostril once a day may be used. If symptoms recur the dosage may be increased accordingly. The minimum dose at which effective control of symptoms is maintained should be used.
The maximum daily dose should not exceed four sprays into each nostril.
Prophylaxis and treatment of allergic rhinitis
P products
Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice a day may be required. Once symptoms are under control a maintenance dose of one spray per nostril once a day may be used. If symptoms recur the dosage may be increased accordingly. The minimum dose at which effective control of symptoms is maintained should be used.
The maximum daily dose should not exceed four sprays into each nostril.
GSL products
Two sprays into each nostril once a day, preferably in the morning. Once symptoms are under control a maintenance dose of one spray per nostril once a day may be used. If symptoms recur the dosage may be increased accordingly. The minimum dose at which effective control of symptoms is maintained should be used.
The maximum daily dose should not exceed two sprays into each nostril.
Elderly
(See Dosage; Adult)
Children
Prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis
POM products
Children over 12 years
Two sprays into each nostril once a day, preferably in the morning. In some cases two sprays into each nostril twice a day may be required. Once symptoms are under control a maintenance dose of one spray per nostril once a day may be used. If symptoms recur the dosage may be increased accordingly. The minimum dose at which effective control of symptoms is maintained should be used.
The maximum daily dose should not exceed four sprays into each nostril.
Children 4 to 12 years
One spray into each nostril once a day, preferably in the morning. In some cases one spray into each nostril twice a day may be required. The minimum dose at which effective control of symptoms is maintained should be used.
The maximum daily dose should not exceed two sprays into each nostril.
Additional Dosage Information
For full therapeutic benefit regular usage is essential. The absence of an immediate effect should be explained to the patient, as maximum relief may not be obtained until after 3 to 4 days of treatment.
Contraindications
Children under 4 years
Precautions and Warnings
Children aged 4 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
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
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
Systemic side effects may occur
Maintain treatment at the lowest effective dose
Advise patient to seek medical advice if treatment is ineffective
Use regularly to maintain freedom from symptoms
Pregnancy and Lactation
Pregnancy
Use fluticasone propionate with caution 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 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 fluticasone propionate with caution in breastfeeding.
The secretion of fluticasone propionate in human breast milk has not been investigated. Subcutaneous administration of fluticasone propionate to lactating laboratory rats produced measurable plasma levels and evidence of fluticasone propionate in milk. However, following intranasal administration to primates, no drug was detected in the plasma, and it is therefore unlikely that the drug would be detectable in milk. When fluticasone aqueous nasal spray is used in breast feeding mothers, the therapeutic benefits must be weighed against the potential hazards to mother and baby.
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
Anaphylaxis
Anxiety
Behavioural disturbances
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)
Headache
Hypersensitivity reactions
Increased intra-ocular pressure
Nasal ulceration
Perforation of nasal septum
Psychological changes
Psychomotor hyperactivity
Rash
Sleep disturbances
Systemic steroid effects
Tongue swelling
Unpleasant smell
Unpleasant taste
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: February 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, 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.
Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.
Paediatric Formulary Committee. BNF for Children 2015-2016. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2015.BNF for Children (2011-2012) Pharmaceutical Press, London.
Summary of Product Characteristics: Flixonase Aqueous Nasal Spray. GlaxoSmithkine UK. Revised April 2014.
Summary of Product Characteristics: Nasofan Allergy 50 microgram Nasal Spray. Teva UK Limited. Revised July 2015.
Summary of Product Characteristics: Nasofan Aqueous 50 microgram Nasal Spray. Teva UK Limited. Revised May 2015.
Summary of Product Characteristics: Pirinase Hayfever Relief for Adults 0.05% nasal spray. GlaxoSmithKline Consumer Healthcare. Revised December 2015.
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