Xalflu

Regular treatment of asthma where use of combination product (long-acting β₂-agonist & inhaled corticosteroid) is appropriate eg, in patients not adequately controlled w/ inhaled corticosteroids & as needed inhaled short-acting β₂-agonist, or those already adequately controlled on both inhaled corticosteroid & long-acting β₂-agonist. Symptomatic treatment of patients w/ COPD w/ FEV₁ <60% predicted normal (pre-bronchodilator) & history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Asthma Adult & adolescent ≥12 yr 1 inhalation bid. Titrate dose to lowest dose at which effective control of symptoms is maintained. Alternatively, may be given once daily at night if patient has history of nocturnal symptoms, or in the morning if patient has history of mainly daytime symptoms. Childn ≥4 yr 1 inhalation of 50 mcg salmeterol & 100 mcg fluticasone propionate bid. Max dose of fluticasone propionate: 100 mcg bid. COPD Adult including elderly 1 inhalation of 50 mcg salmeterol & 250 mcg fluticasone propionate bid.

Hypersensitivity.

Immediately discontinue treatment if paradoxical bronchospasm occurs. Not to be used to treat acute asthma symptoms; during exacerbation, or if w/ significantly worsening or acutely deteriorating asthma. Not to be stopped abruptly. Uncontrolled & worsened asthma symptoms; sudden & progressive deterioration in asthma control. Tremor, palpitations & headache. Possible systemic effects including Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract & glaucoma; adrenal suppression & acute adrenal crisis in prolonged treatment w/ high doses of inhaled corticosteroids. Pneumonia, including pneumonia requiring hospitalisation in patients w/ COPD; current smoking, older age, low BMI & severe COPD. Visual disturbance; consider referral to ophthalmologist for evaluation of possible causes of visual disturbance which may include cataract, glaucoma or rare diseases eg, central serous chorioretinopathy. Patients w/ active or quiescent pulmonary TB & fungal, viral or other airway infections; severe CV disorders or heart rhythm abnormalities, existing or history of DM, thyrotoxicosis, uncorrected hypokalaemia or those predisposed to low levels of serum K. Regularly monitor adrenocortical function in patients transferring from oral steroids. Avoid concomitant use w/ ritonavir; ketoconazole or other potent CYP3A4 inhibitors. Hepatic impairment. Pregnancy & lactation. Growth retardation in childn & adolescents <16 yr taking high doses of fluticasone propionate (≥1,000 mcg/day) for long periods. Regularly monitor height of childn receiving prolonged treatment w/ inhaled corticosteroids. Childn <4 yr.

Nasopharyngitis; headache. Mouth & throat candidiasis, pneumonia (in COPD patients), bronchitis; hypokalemia; throat irritation, hoarseness/dysphonia, sinusitis; contusions; muscle cramps, traumatic fractures, arthralgia, myalgia.

Increased exposure w/ less potent CYP3A inhibitor ketoconazole. Salmeterol: Weakened or antagonised effect w/ β-adrenergic blockers. Potentiated serious hypokalaemia w/ xanthine derivatives, steroids & diuretics. Additive effect w/ other β-adrenergic containing medicinal products. Increased risk of systemic side effects w/ other potent CYP3A4 inhibitors eg, itraconazole, telithromycin, ritonavir. Fluticasone propionate: Increased plasma conc w/ highly potent CYP3A4 inhibitor ritonavir. Increased exposure & risk of systemic side effects w/ other potent CYP3A inhibitors (eg, itraconazole & cobicistat-containing products), & moderate CYP3A inhibitors (eg, erythromycin).

Antiasthmatic & COPD Preparations

R03BA05 - fluticasone ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
R03AK06 - salmeterol and fluticasone ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.

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