Flutiform

Flutiform

fluticasone + formoterol

Manufacturer:

Mundipharma
Concise Prescribing Info
Contents
Per actuation 50 mcg/5 mcg MDI Fluticasone propionate 50 mcg, formoterol fumarate dihydrate 5 mcg. 125 mcg/5 mcg MDI Fluticasone propionate 125 mcg, formoterol fumarate dihydrate 5 mcg. 250 mcg/10 mcg MDI Fluticasone propionate 250 mcg, formoterol fumarate dihydrate 10 mcg
Indications/Uses
Regular treatment of asthma 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 mcg/5 mcg MDI Adults, adolescents & childn ≥5 yr. 125 mcg/5 mcg MDI Adults & adolescents ≥12 yr. 250 mcg/10 mcg MDI Adults only.
Dosage/Direction for Use
50 mcg/5 mcg MDI Adult, adolescent & childn ≥5 yr 2 inhalations (puffs) bd in the morning & evening. 125 mcg/5 mcg MDI Adult & adolescent ≥12 yr 2 inhalations (puffs) bd in the morning & evening. 250 mcg/10 mcg MDI Adult 2 inhalations (puffs) bd in the morning & evening.
Contraindications
Special Precautions
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. Potentially life-threatening sudden & progressive deterioration in asthma control. 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. Visual disturbance. 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. Concomitant use w/ potent CYP3A4 inhibitors. Severe hepatic impairment. Not recommended during pregnancy. Lactation. Not recommended for childn <5 yr.
Adverse Reactions
Potentially, sleep disorders including insomnia; headache, tremor, dizziness; palpitations, ventricular extrasystoles; asthma exacerbation, dysphonia, throat irritation; dry mouth; rash.
Drug Interactions
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), 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. Sympathetic effects may be potentiated by adrenergic drugs. Effects may be inhibited mutually when concurrently used w/ β-adrenergic antagonists (including eye drops for glaucoma treatment). Concomitant use w/ β-blockers including those used as eye drops or for glaucoma treatment.
ATC Classification
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.
Presentation/Packing
Form
Flutiform 125 mcg/5 mcg MDI
Packing/Price
120 actuation x 1's
Form
Flutiform 250 mcg/10 mcg MDI
Packing/Price
120 actuation x 1's
Form
Flutiform 50 mcg/5 mcg MDI
Packing/Price
120 actuation x 1's
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