Fluticasone Propionate

Registered South African indications:

• Prophylactic management of atopic asthma

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 

Cautions

• Pregnancy
• Breastfeeding
• Acute asthma 
• Adrenal suppression
• Diabetes mellitus
• Cushing's syndrome
• Decrease in bone mineral density
• Cataracts
• Glaucoma
• Psychiatric history
• Active or latent pulmonary tuberculosis
• Abrupt withdrawal
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malasorption

Forms avail. in SA and covered in this monograph: acc

Prophylactic management of atopic asthma

• Inhaled (acc): 100-1000μg, twice daily; Starting dose of inhaled fluticasone propionate should be appropriate for the severity of disease; Adjust until control is achieved or reduce to the minimum effective dose, according to the individual response

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Fluticasone propionate is for inhalation use only

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Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic. The onset of therapeutic effect is 4-7 days

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Fluticasone propionate is not for relief in acute attacks but for routine long-term management. Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms

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The dosage of fluticasone propionate should be adjusted according to the individual response. If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought

Paed. forms avail. in SA and covered in this monograph: acc

Prophylactic management of atopic asthma

Younger than 6 years

• Not established for use 

Older than 6 years old

• Inhaled (acc): 50-100μg, twice daily

Older than 16 years

• See adult dosage

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Fluticasone propionate is for inhalation use only

---

Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic. The onset of therapeutic effect is 4-7 days

---

Fluticasone propionate is not for relief in acute attacks but for routine long-term management. Patients will require a fast- and short-acting inhaled bronchodilator to relieve acute asthmatic symptoms

---

The dosage of fluticasone propionate should be adjusted according to the individual response. If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought

Pregnancy

• Caution
• There is inadequate evidence of safety of fluticasone propionate in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development, including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human fetus
• It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Because fluticasone propionate is delivered directly to the lungs by the inhalation route it avoids the high level of exposure that occurs when corticosteroids are given by systemic routes. Administration of fluticasone propionate during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus

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, plasma levels in humans after inhalation at recommended doses are likely to be low. 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

• No dose adjustment recommended 

Elderly

• No dose adjustment recommended 

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders 

• Anxiety
• Sleep disorders
• Somnolence
• Behavioural changes (predominantly in children)
• Depression
• Aggression (predominantly in children)
• Headache
• Dizziness
• Fatigue

Respiratory Disorders

• Hoarseness
• Dysphonia
• Paradoxical bronchospasm
• Epistaxis

Gastrointestinal Disorders

• Dyspepsia
• Dry mouth
• Nausea

Endocrine Disorders

• Cushing's syndrome
• Cushingoid features
• Adrenal suppression
• Growth retardation in children and adolescents
• Decreased bone mineral density
• Hyperglycaemia

Musculoskeletal disorders

• Arthralgia
• Weakness

Skin and Subcutaneous Tissue Disorders

• Contusions
• Rash
• Pruritus
• Urticaria

Immune, Blood and Lymphatic Disorders

• Cutaneous hypersensitivity reactions
• Angioedema
• Anaphylactic reactions
• Candidiasis 

Sensory Disorders 

• Glaucoma
• Increased intraocular pressure
• Cataract
• Unpleasant taste

• CYP3A4 inhibitors

None routine. Specific cases may require

• Height monitoring

Fluticasone proprionate binds to glucocorticoid receptors. The glucocorticoid receptor complexes down-regulate pro-inflammatory mediators and up-regulate anti-inflammatory mediators. The anti-inflammatory actions of corticosteroids are also thought to involve inhibition of cytosolic phospholipase A2, which controls the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Inhaler 50μg

• Flixotide 50 Inhaler CFC-Free (GSK) originator

Inhaler 125μg

• Flixotide 125 Inhaler CFC-Free (GSK) originator

Inhaler 250μg

• Flixotide 250 Inhaler CFC-Free (GSK) originator

Accuhaler 50μg

• Flixotide 50 Accuhaler (GSK) originator

Accuhaler 100μg

• Flixotide 100 Accuhaler (GSK) originator

Accuhaler 250μg

• Flixotide 250 Accuhaler (GSK) originator

Accuhaler 500μg

• Flixotide 500 Accuhaler (GSK) originator

Also available in the following forms: Cream, ointment, nasules and nasal spray.

COMBINATION PREPARATIONS

Salmeterol/ Fluticasone propionate

Inhaler 25μg/50μg

• Foxair 25/50 Inhaler (GSK) originator
• Sereflo 25/50 HFA (Cipla Medpro)

Inhaler 25μg/125μg

• Foxair 25/125 Inhaler (GSK) originator
• Sereflo 25/125 HFA (Cipla Medpro)

Inhaler 25μg/250μg

• Foxair 25/250 Inhaler (GSK) originator
• Sereflo 25/250 HFA (Cipla Medpro)

Accuhaler 50μg/100μg

• Foxair 50/100 Accuhaler (GSK) originator
• Seretide 50/100 Accuhaler (GSK) originator

Accuhaler 50μg/250μg

• Foxair 50/250 Accuhaler (GSK) originator
• Seretide 50/250 Accuhaler (GSK) originator

Accuhaler 50μg/500μg

• Foxair 50/500 Accuhaler (GSK) originator
• Seretide 50/500 Accuhaler (GSK) originator