Contraindications
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.
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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.
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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).
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ATC Classification
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. R01AD08 - fluticasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis. |