Fluticasone Propionate

Registered South African indications:

• Allergic rhinitis (hay fever) (nas, aqs)
• Small to medium-sized nasal polyps and associated symptoms of nasal obstruction (nod)

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Coadministration with antiretrovirals (nas)

Cautions

• Pregnancy
• Breastfeeding
• Moderate to severe hepatic impairment
• Unilateral polyposis (sol)
• Local infections in nasal passages or sinuses
• Injury or surgery to the nose
• Problems with ulceration in the nose
• High dosages
• Withdrawal of systemic corticosteroids (sol)
• Prolonged use
• Benzalkonium chloride intolerance (nas)

Forms avail. in SA and covered in this monograph: nas, aqs, nod

South African registered indications and dosages

Short term prophylaxis and treatment of symptoms of allergic rhinitis (hay fever)

• Nasal (nas): 100μg (2 actuations) per nostril, once daily preferably in the morning; Treatment duration: <6 months

Prophylaxis and treatment of seasonal and perennial allergic rhinitis (including hay fever)

• Nasal (aqs): 100μg (2 actuations) per nostril, once daily preferably in the morning; If necessary, the dosage may be increased: Up to max. dose of 100μg (2 actuations) per nostril, twice daily

Small to medium-sized nasal polyps and associated symptoms of nasal obstruction
- As regular treatment

• Nasal (nod): 400μg (one container's contents) into the nose, once or twice daily, divided between the affected nostrils

For all indications, regular usage is essential for full therapeutic benefit

Maximum relief may not be obtained until after 3 to 4 days of treatment (nas, aqs)
Maximum relief may not be obtained until after several weeks of treatment (nod)

For the indication of nasal polyps, if no improvement in symptoms is seen after four to six weeks, alternative therapies should be considered. The diagnosis should be confirmed by a specialist. Nasal polyps require regular medical assessment to monitor the severity of the condition

Forms avail. in SA and covered in this monograph: nas, aqs, nod

South African registered indications and dosages

Short term prophylaxis and treatment of symptoms of allergic rhinitis (hay fever)

Nasal (nas)

• Younger than 12 years: No specific recommendation provided
• Older than 12 years: See adult dosage

Prophylaxis and treatment of allergic rhinitis
- Seasonal

Nasal (aqs)

• Younger than 4 years: No specific recommendation provided
• Between 4-11 years: 50μg (1 actuations) per nostril, once daily preferably in the morning; Max: 100μg (2 actuations) per nostril/24hrs
• 12 years and older: See adult dosage

Safety and efficacy has not been studied for periods longer than 4 weeks

- Perennial

Nasal (aqs)

• Younger than 4 years: No specific recommendation provided
• Between 4-11 years: Not established for use
• 12 years and older: See adult dosage

There are insufficient clinical data at present to recommend the use of fluticasone propionate nasal spray for the indication of prophylaxis and treatment of perennial allergic rhinitis in children between 4 - 11 years

Small to medium-sized nasal polyps and associated symptoms of nasal obstruction
- As regular treatment

Nasal (nod)

• Younger than 16 years: Not established for use
• Older than 16 years: See adult dosage

There are insufficient data at present to recommend the use of fluticasone propionate for the treatment of nasal polyps in children. Unilateral polyposis rarely occurs, and could be indicative of other conditions

Pregnancy

• Caution
• There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus. It should be noted, however, that the foetal changes in animals occur after relatively high systemic exposure; direct intranasal application ensures minimal systemic exposure
  As with other drugs, the use of fluticasone propionate during human pregnancy requires that the possible benefits of the drug be weighed against the possible hazards

Breastfeeding

• Caution
• 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 the 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 propionate is used in breastfeeding mothers the therapeutic benefits must be weighed against the potential hazards to mother and baby

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Mild: No dose adjustment recommended
• Moderate to severe: Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Anxiety
• Sleep disorders
• Psychomotor hyperactivity
• Behavioural changes
• Depression
• Aggression (particularly in children)

Respiratory Disorders

• Epistaxis
• Nasal dryness
• Nasal irritation
• Throat dryness
• Throat irritation
• Nasal septal perforation
• Nasal ulcers
• Bronchospasm

Gastrointestinal Disorders

• Pharyngeal candidiasis
• Nasal candidiasis

Endocrine and Metabolic Disorders

• Hyperglycaemia
• Cushing's syndrome
• Cushingoid features
• Adrenal suppression
• Growth retardation in children

Skin and Subcutaneous Tissue Disorders

• Skin rash

Immune, Blood and Lymphatic System Disorders

• Angioedema (oedema of the face or tongue)
• Hypersensitivity reactions
• Anaphylaxis/anaphylactic reactions

Sensory Disorders

• Unpleasant taste
• Unpleasant smell
• Glaucoma
• Raised intraocular pressure
• Cataract
• Blurred vision

• Potent P450 CYP3A4 inhibitors
• Antiretrovirals
• Ritonavir
• Cobicistat
• Corticosteroid agents

None routine. Specific cases may require

• Height (children)
• Ophthalmic examination
• Hepatic function

Fluticasone propionate is a glucocorticosteroid which has potent anti-inflammatory activity by acting via the glucocorticoid receptor. Fluticasone propionate causes little or no HPA axis suppression following intranasal administration. Fluticasone propionate has been shown to reduce inflammatory mediators in both the early and late phase reactions of allergic rhinitis.

Nasal spray (per spray) 50μg

• Flixonase  Aqueous Nasal Spray (GSK)
• Flixonase (GSK) originator
• Flomist (Cipla Medpro)
• Flonase (GSK) originator
• Fluticasone OTC Teva (Teva Pharmaceuticals)

Nasules (per nasule) 400μg

• Flixonase (GSK) originator

Also available in the following forms: Inhaler, accuhaler, cream and ointment.