Flutiform

Regular treatment of asthma where use of combination product is appropriate in patients not adequately controlled w/ inhaled corticosteroids & as-required inhaled short-acting β₂ agonist or adequately controlled on both inhaled corticosteroid & a long-acting β₂ agonist. 50/5 mcg MDI: Adults, adolescents & childn ≥5 yr. 125/5 mcg MDI: Adults & adolescents ≥12 yr. 250/10 mcg MDI: Adults only.

50/5 mcg & 125/5 mcg MDI Adult 2 inhalations (puffs) bd in the morning & evening. May be increased to max 250/10 mcg MDI for 2 inhalations (puffs) bd. 50/5 mcg MDI Adolescent & childn ≥5 yr 2 inhalations (puffs) bd in the morning & evening. 125/5 mcg MDI Adolescent ≥12 yr 2 inhalations (puffs) bd in the morning & evening. Patient whose asthma is adequately controlled May be transferred to the lowest strength ie, 50/5 mcg MDI titrated to the lowest dose at which effective symptom control is maintained. 250/10 mcg MDI Adult 2 inhalations (puffs) bd in the morning & evening. May be transferred to a lower strength ie, 125/5 mcg MDI or ultimately to the lowest strength ie, 50/5 mcg MDI, titrated to the lowest dose at which effective symptom control is maintained.

Hypersensitivity.

Not to be used for acute asthma symptoms. Prophylactic use in exercise-induced asthma. Not to be initiated during exacerbation, or if patient has significantly worsening or acutely deteriorating asthma. Serious asthma-related AR & exacerbations. Not to be used as 1st treatment for asthma. Review patient if they experience required increasing use of short-acting bronchodilators is required, if short-acting bronchodilators become less effective or ineffective or if asthma symptoms persist. Potentially life-threatening sudden & progressive deterioration in asthma control; consider increasing corticosteroid therapy. Not to be stopped abruptly in patients w/ asthma due to risk of exacerbation. Patients w/ pulmonary or quiescent TB, fungal, viral or other airway infections; w/ thyrotoxicosis, phaeochromocytoma, DM, uncorrected hypokalaemia or predisposed to low levels of serum K, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe HTN, aneurysm or other severe CV disorders eg, ischaemic heart disease, cardiac arrhythmias or severe heart failure. Potentially serious hypokalaemia; monitor serum K levels in patients w/ unstable or acute severe asthma & in other conditions w/ increased likelihood for hypokalaemia AR. Patients w/ existing QTc interval prolongation. Additional blood sugar control in diabetics. Impaired adrenal function from previous systemic steroid therapy. Discontinue immediately if paradoxical bronchospasm occurs w/ an immediate increase in wheezing & shortness of breath after dosing. Possible visual disturbance; consider referring to ophthalmologist if patient presents w/ symptoms eg, blurred vision or other visual disturbances. Potential systemic effects on prolonged high-dose treatment including adrenal suppression & acute adrenal crisis, Cushing's syndrome, Cushingoid features, growth retardation in childn & adolescents, decreased bone mineral density, cataract, glaucoma & more rarely, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn). Regularly monitor hypothalamic pituitary adrenocortical axis function. Not to be used w/ an additional long-acting β₂-agonists. To be used even when asymptomatic. Concomitant use w/ potent CYP3A4 inhibitors. Possible increased pulmonary deposition & systemic absorption & AR when using a spacer device. Contains small amount of ethanol (approx 1 mg/actuation). Severe hepatic impairment. Not recommended during pregnancy. Lactation. Not recommended for childn <5 yr. Increased risk of adrenal suppression & acute adrenal crisis in childn & adolescent <16 yr taking high doses of inhaled corticosteroids; additional systemic corticosteroid treatment during periods of stress or elective surgery. Regularly monitor the height of childn receiving prolonged treatment.

Potentially, sleep disorders including insomnia; headache, tremor, dizziness; palpitations, ventricular extrasystoles; asthma exacerbation, dysphonia, throat irritation; dry mouth; rash.

Caution during long-term treatment & co-administration w/ strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole, telithromycin). ECG changes &/or hypokalaemia w/ non-K sparing diuretics (eg, loop or thiazide diuretics). Possible added hypokalaemic effect by xanthine derivatives & glucocorticosteroids. Cardiac tolerance may be impaired by L-dopa, L-thyroxine, oxytocin & alcohol. Concomitant use w/ MAOIs, furazolidone & procarbazine may precipitate hypertensive reactions. Elevated risk of arrhythmias during concomitant use w/ anaesth w/ halogenated hydrocarbons. Potential additive effects w/ other β-adrenergics. Risk of arrhythmias may be increased w/ digitalis glycosides. Increased risk of ventricular arrhythmias w/ QTc interval-prolonging drugs (eg, TCAs, MAOIs, phenothiazines, quinidine, disopyramide, procainamide & antihistamines. Sympathetic effects may be potentiated by additional adrenergic drugs. Effects may be inhibited mutually when concurrently used w/ β-blockers (including eye drops for glaucoma treatment).

Antiasthmatic & COPD Preparations

R03AK11 - formoterol 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.

POM