Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: Inhalation Asthma prophylaxis As fluticasone propionate dry powder or metered dose inhaler: Mild asthma: Initial: 100 mcg bid. Moderate and severe asthma: Initial: 250-500 mcg bid, may be increased up to 1,000 mcg bid based on individual response. As fluticasone propionate nebule: 500-2,000 mcg bid. As fluticasone furoate dry powder inhaler: Initial: 100 mcg once daily, may be increased to 200 mcg once daily if necessary. The dosage may be increased until control is achieved or reduced to the minimum effective dose according to the individual response. Nasal Allergic rhinitis As fluticasone propionate 0.05% spray: 100 mcg into each nostril once daily preferably in the morning, may be increased to bid as required. Maintenance dose: 50 mcg once daily. As fluticasone furoate spray: Initial: 55 mcg into each nostril once daily, may be reduced to 27.5 mcg into each nostril once daily when maximum benefit and symptom control has been achieved. Nasal polyps As fluticasone propionate drops: Instill 200 mcg into each nostril 1 or 2 times daily for at least 4-6 weeks. Topical Corticosteroid-responsive dermatoses As 0.05% cream or 0.005% ointment: Apply thinly and rub gently to the affected area 1 or 2 times/day for up to 4 weeks until improvement occurs, then reduce frequency of application or change treatment to a less potent preparation.
Oral inhalation: Primary treatment of status asthmaticus or other acute asthma episodes requiring intensive measures. Nasal: Treatment of asthma, current or recent nasal septal ulcers, surgery, injury or trauma that is not fully healed. Topical: Untreated cutaneous infections, rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation; dermatoses including dermatitis and nappy rash in infants <3 months.
Special Precautions
Patients with COPD, diabetes mellitus, ocular disease (e.g. cataracts, glaucoma), major risk factors for decreased bone mineral count (e.g. prolonged immobilisation, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition); infections (e.g. ocular herpes simplex, active or quiescent respiratory tract TB; viral, fungal, bacterial, or parasitic systemic infections); psoriasis, history of local hypersensitivity to other corticosteroids (topical). Avoid abrupt withdrawal. Hepatic impairment. Children. Pregnancy and lactation. Patient Counselling Topical: Do not apply on thin or broken skin, large surface area, or on occluded areas of the skin (e.g. intertriginous areas or under occlusive dressings). Monitoring Parameters Monitor peak flow, FEV1, and other pulmonary function tests, LFTs; growth in children and adolescent via stadiometry. Assess for signs and symptoms of adrenal suppression, ocular changes, nasal ulceration or septal perforation, oral candidiasis (long-term use), skin infections, and possible eosinophilic conditions.
Adverse Reactions
Significant: Adrenal suppression (e.g. suppression of hypothalamic-pituitary-adrenal axis, hypercortisolism, Cushing's syndrome), immunosuppression (prolonged use), pneumonia, local oropharyngeal candidiasis, local nasal effects (e.g. epistaxis, nasal septal perforation, ulceration, or erosion), visual disturbances (e.g. blurred vision, increased intraocular pressure, glaucoma, cataract, central serous chorioretinopathy), decreased bone mineral density, growth retardation in children, hyperglycaemia or glycosuria, delayed wound healing, localised reactions (e.g. skin atrophy), rebound of pre-existing dermatoses, withdrawal symptoms (e.g. joint/muscle pain, lassitude, depression). Rarely, vasculitis or other systemic eosinophilic conditions, psychological or behavioural effects in children (e.g. psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression), hypersensitivity reactions (e.g. anaphylaxis, angioedema, bronchospasm, hypotension, contact dermatitis, rash, urticaria). Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea, toothache, dyspepsia. General disorders and administration site conditions: Fatigue, malaise. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Headache, dizziness, unpleasant taste or smell. Respiratory, thoracic and mediastinal disorders: Hoarseness, dysphonia, cough, sinusitis, nasopharyngitis, rhinalgia, nasal or throat dryness, irritation, burning and soreness. Skin and subcutaneous tissue disorders: Pruritus, local skin burning, contusions, skin thinning, erythema, striae, pigmentation changes, hypertrichosis. Vascular disorders: Hypertension.
Potentially Fatal: Paradoxical bronchospasm, adrenal insufficiency.
Drug Interactions
May increase risk of systemic exposure and side effects with CYP3A4 inhibitors (e.g. ritonavir, cobicistat, ketoconazole, itraconazole).
ATC Classification
R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
D07AC17 - fluticasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
R03BA05 - fluticasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
Disclaimer: This information is independently developed by CIMS based on fluticasone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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