Flutiform

Per actuation 50/5 mcg MDI Fluticasone propionate 50 mcg, formoterol fumarate dihydrate 5 mcg. 125/5 mcg MDI Fluticasone propionate 125 mcg, formoterol fumarate dihydrate 5 mcg. 250/10 mcg MDI Fluticasone propionate 250 mcg, formoterol fumarate dihydrate 10 mcg

Treatment of asthma in patients not adequately controlled w/ inhaled corticosteroids & 'as required' inhaled short-acting β₂ agonist; or patients already adequately controlled on both inhaled corticosteroid & a long-acting β₂ agonist.

50/5 mcg MDI Adult 2 inhalations (puffs) bd in the morning & evening. Dose can be increased by administering a higher strength of Flutiform (125/5 mcg MDI or 250/10 mcg MDI). Adolescent 2 inhalations (puffs) bd in the morning & evening. Dose can be increased by administering a higher strength of Flutiform (125/5 mcg MDI). Childn ≥5 yr 2 inhalations (puffs) bd in the morning and evening. 125/5 mcg MDI Adult 2 inhalations (puffs) bd in the morning & evening. Dose can be increased by administering a higher strength of Flutiform (250/10 mcg MDI), or decreased to the lowest strength (50/5 mcg MDI) if asthma is adequately controlled. Adolescent ≥12 yr 2 inhalations (puffs) bd in the morning & evening. Dose can be decreased to the lowest strength of Flutiform (50/5 mcg MDI) if asthma is adequately controlled. 250/10 mcg MDI Adult 2 inhalations (puffs) bd in the morning & evening. Dose can be decreased to a lower strength of Flutiform (125/5 mcg MDI or 50/5 mcg MDI) if asthma is adequately controlled.

Hypersensitivity.

Not for the treatment of acute asthma symptoms for which a fast & short-acting bronchodilator is required. Not to be used as 1st treatment for asthma. Not to be initiated during an exacerbation, or if patients have significantly worsening or acutely deteriorating asthma. Do not stop treatment abruptly due to risk of exacerbation. Caution in patients w/ pulmonary or quiescent TB, fungal or viral or other infections of the airway; thyrotoxicosis, phaeochromocytoma, DM, uncorrected hypokalaemia or patients 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.; existing QTc interval prolongation; patients transferring to Flutiform therapy, particularly if there is any reason to suppose adrenal function impairment from previous systemic steroid therapy; patients transferring from oral steroids or who have required high dose emergency of corticosteroid therapy. Potentially serious hypokalaemia may result from high doses of β₂ agonists. Consider additional blood sugar controls in DM patients. Paradoxical bronchospasm. Visual disturbance. Increased risk of systemic effects on prolonged & high-dose treatment including adrenal suppression & acute adrenal crisis, Cushing's syndrome, Cushingoid features, growth retardation in childn & adolescents, decrease in bone mineral density, cataract, glaucoma & more rarely, psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (particularly in childn). Concomitant use w/ potent CYP3A4 inhibitors. Patients w/ severe hepatic impairment. Pregnancy & lactation. Not recommended for use in childn <5 yr. 125/5 mcg MDI Should not be used in childn <12 yr. 250/10 mcg MDI Should not be used in adolescents & childn.

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

Increased risk of systemic side effects w/ CYP3A4 inhibitors eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole, telithromycin, cobicistat. ECG changes &/or hypokalaemia that may result from non-K sparing diuretics can be acutely worsened by β-agonists. Xanthine derivates & glucocorticosteroids may add to a possible hypokalaemic effect of the β-agonists. L-Dopa, L-thyroxine, oxytocin & alcohol can impair cardiac tolerance towards β₂-sympathomimetics. Potential hypertensive reactions w/ MAOIs including agents w/ similar properties (eg, furazolidone & procarbazine). Elevated risk of arrhythmias w/ halogenated hydrocarbon anaesth. Potentially additive effect w/ β-adrenergic drugs. Hypokalaemia may increase the risk of arrhythmias in patients treated w/ digitalis glycosides. Caution when co-administered w/ TCAs or MAOIs, & during the immediate 2-wk period following their discontinuation, or other drugs known to prolong the QTc interval eg, antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide, & antihistamines. Antagonistic effect w/ β-blockers; may also produce severe bronchospasm in asthmatic patients.

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.

P₁S₁S₃