Indications

Adult : Fluticasone Propionate Inhaler is indicated in the prophylaxis and maintenance of mild, moderate and severe asthma. Fluticasone Propionate has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator ... Read more Adult : Fluticasone Propionate Inhaler is indicated in the prophylaxis and maintenance of mild, moderate and severe asthma. Fluticasone Propionate has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilator alone or with other prophylactic therapy. Children : Any child who requires preventive asthma medication, including patients not controlled on currently available prophylactic medication.

Composition

Pharmacology

Fluticasone Propionate inhaler is a pressurized metered dose inhaler. It is intended for oral inhalation only. It contains Fluticasone Propionate BP as an active ingredient. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systemic effect of usual dose.

Dosage & Administration

Adults and children over 16 years of age : 100 to 1000 mcg twice daily. Patients should be given a starting dose of inhaled fluticasone propionate which is appropriate for the severity of their disease: Mild asthma : 100 to 250 mcg twice daily; Moderate asthma: 250 to 500 mcg twice daily, Severe asthma : 500 to 1000 mcg twice daily. Children over 4 years of age : 50 to 200 mcg twice daily. Children aged 1 to 4 years : 100 mcg twice daily administered via a paediatric spacer device with a face mask. Special patient groups : There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment.

Contraindications

Fluticasone Propionate is contraindicated in patient with a history of hypersensitivity to any ingredient of the preparation.

Side Effects

Infections and infestations : Very common: Candidiasis of mouth and throat. Rare: Oesophageal candidiasis. Immune system disorders : Uncommon: Cutaneous hypersensitivity reactions. Very rare: Angioedema (mainly facial and oropharyngeal oedema), respiratory symptoms (dyspnoea and/or bronchospasm) and anaphylactic reactions. Endocrine disorders : Very rare: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decreased bone mineral density, cataract and glaucoma. Metabolism and nutrition disorders : Very rare: Hyperglycaemia Psychiatric disorders : Very rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children). Respiratory, thoracic and mediastinal disorders : Common: Hoarseness. Very rare: Paradoxical bronchospasm. Skin and subcutaneous tissue disorders : Common: Contusions

Pregnancy & Lactation

Fertility : There are no data on human fertility. Animal studies indicate no effects of fluticasone propionate on male or female fertility. Pregnancy : There are limited data in pregnant women. Administration of Fluticasone Propionate inhaler during pregnancy should only be considered if the expected benefit on the mother is greater than any possible risk to the foetus. Results from the retrospective epidemiological study did not find any increased risk of major congenital malformations (MCMs) following exposure to fluticasone propionate when compared to other inhaled corticosteroids, during the first trimester of pregnancy. Lactation : The excretion of fluticasone propionate into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following subcutaneous administration there was evidence of fluticasone propionate in the breast milk. However, plasma levels in patients following inhaled application of fluticasone propionate at recommended doses are likely to be low. Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.

Precautions & Warnings

Increasing use of short-acting inhaled B2-agonists to control asthma symptoms indicates deterioration of asthma control. Under these conditions, the patient's therapy plan should be reassessed. Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to increasing corticosteroid dosage. In patients considered at risk, daily peak flow monitoring may be instituted. Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods; these effects are much less likely to occur than with oral corticosteroids. It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored. It is important, therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained. Treatment with Fluticasone Propionate Inhaler should not be stopped abruptly. As with all inhaled corticosteroids, special care is necessary in patients with active or quiescent pulmonary tuberculosis.

Therapeutic Class

Fluocinolone & Combined Preparations, Respiratory corticosteroids

Storage Conditions

Pressurized canister, do not puncture, break or incinerate even when apparently empty. Avoid storage of direct sunlight and heat. Store below 30°C. Keep away from eyes. Keep away from children.