Salflumix Easyhaler

Per 50/250 mcg/dose Salmeterol 50 mcg, fluticasone propionate 250 mcg. Per 50/500 mcg/dose Salmeterol 50 mcg, fluticasone propionate 500 mcg

Regular treatment of asthma where use of combination product (inhaled corticosteroid & long-acting β₂ agonist) is appropriate in patients not adequately controlled w/ inhaled corticosteroids & short-acting β₂ agonist (as needed) or patients already adequately controlled on both inhaled corticosteroid & long-acting β₂ agonist. Symptomatic treatment of patients w/ COPD, 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 of 50/250 mcg or 50/500 mcg bid. COPD Adult 1 inhalation of 50 mcg/500 mcg bid. Disease control Titrate to lowest dose at which effective control of symptoms is maintained. Alternatively, may be titrated to once daily in the morning (if patient has history of daytime symptoms) or at night (if patient has history of nocturnal symptoms).

Hypersensitivity to salmeterol, fluticasone propionate or lactose.

Allergic reactions due to small amounts of milk proteins from lactose. Discontinue treatment immediately if paradoxical bronchospasm occurs. Not to be used to treat acute asthma symptoms for which fast & short-acting bronchodilator is required. Not to be initiated during exacerbation or significantly worsening or acutely deteriorating asthma. Avoid abrupt discontinuation. Serious asthma-related adverse events & exacerbations; uncontrolled or worsened asthma symptoms. Sudden & progressive deterioration in asthma control. Cardiac arrhythmias eg, supraventricular tachycardia, extrasystoles & atrial fibrillation, & mild transient reduction in serum K at high therapeutic doses. Increased blood glucose levels. Tremor, palpitations & headache. Adrenal suppression & acute adrenal crisis in prolonged use. Visual disturbances eg, blurred vision. Pneumonia including pneumonia requiring hospitalisation. Patients w/ active or quiescent pulmonary TB & fungal, viral or other airway infections; severe CV disorders or heart rhythm abnormalities, DM, thyrotoxicosis, uncorrected hypokalaemia or those predisposed to low levels of serum K; past high dose emergency corticosteroid therapy requirement. History of DM. Smoking, old age, low BMI, severe COPD. Monitor adrenocortical function regularly. Refer to ophthalmologist for evaluation of possible cataract, glaucoma or rare diseases eg, central serous chorioretinopathy. Avoid concomitant use w/ ritonavir; ketoconazole. Hepatic impairment. Pregnancy & lactation. Not to be used in childn <12 yr. Cushing's syndrome, cushingoid features, adrenal suppression, decrease in bone mineral density, cataract & glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression in childn. Growth retardation in childn & adolescents. Regularly monitor height of childn receiving prolonged treatment. Childn & adolescent <16 yr taking high doses of fluticasone propionate.

Headache; nasopharyngitis. Mouth & throat candidiasis, pneumonia in COPD patients, bronchitis; hypokalaemia; throat irritation, hoarseness/dysphonia, sinusitis; contusions; muscle cramps, traumatic fractures, arthralgia, myalgia.

Increased plasma exposure w/ potent (ritonavir), slightly less potent (ketoconazole, itraconazole, telithromycin, cobicistat-containing products) & moderately potent (erythromycin) CYP3A inhibitors. Salmeterol: Weakened or antagonised effect w/ β-adrenergic blockers (non-selective & selective). Potentiated hypokalemia w/ xanthine derivatives, steroids & diuretics. Additive effect w/ other β-adrenergic-containing drugs.

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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