Flutiform

Flutiform

fluticasone + formoterol

Manufacturer:

Mundipharma

Distributor:

DKSH

Marketer:

Meiji
Concise Prescribing Info
Contents
Per 125 mcg/5 mcg MDI Fluticasone propionate 125 mcg, formoterol fumarate 5 mcg. Per 250 mcg/10 mcg MDI Fluticasone propionate 250 mcg, formoterol fumarate 10 mcg
Indications/Uses
Asthmatic patients ≥12 yr. Patients not adequately controlled w/ inhaled corticosteroids & inhaled short-acting β2 agonists or already controlled on both & inhaled corticosteroid, & a long-acting β2 agonists.
Dosage/Direction for Use
Adult Max: 2 inhalations (puffs) of Flutiform 250 mcg/10 mcg bid. Patients ≥12 yr 2 inhalations bid of 50 mcg/5 mcg inhaler in the morning & evening. Total daily dose may be increased to 2 inhalations of 125 mcg/5 mcg inhaler bid if patient's asthma remains poorly controlled.
Contraindications
Special Precautions
Serious asthma-related adverse events & exacerbations may occur during treatment. Patients w/ thyrotoxicosis, phaeochromocytoma, DM, uncorrected hypokalemia 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 prolongation of QTc interval. Concomitant use w/ hypokalaemic drugs or potentiate hypokalaemia eg, xanthine-derivatives, steroids & diuretics. Unstable asthma w/ variable use of rescue bronchodilators in acute severe asthma; monitor serum K levels. Consider blood sugar control in diabetic patients. Pregnancy & lactation. Childn <12 yr.
Adverse Reactions
Hyperglycemia, worsening of asthma, headache, tremor, dizziness, palpitation, changes in taste or alteration in voice, dry mouth, sore throat, peripheral edema.
Drug Interactions
Increased risk of systemic side effects w/ potent CYP 3A4 inhibitors eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole, telithromycin. May result to ECG changes &/or hypokalemia w/ non-K sparing diuretics eg, loop or thiazide diuretics; xanthine derivatives & glucocorticosteroids. Cardiac tolerance to β2-sympathomimetics may be impaired w/ levodopa, levothyroxine, oxytocin & alcohol. May precipitate hypertensive reactions w/ MAOIs including w/ similar properties eg, furazolidone & procarbazine. Elevated risk of arrhythmias w/ anaesth w/ halogenated hydrocarbons. Potentially additive effect w/ β-adrenergics. Hypokalemia may increase the risk of arrhythmias w/ digitalis glycosides. May increase the risk of ventricular arrhythmias w/ drugs that prolong QTc interval eg, TCAs, MAOIs, antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide & antihistamines.
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 dose x 1's
Form
Flutiform 250 mcg/10 mcg MDI
Packing/Price
120 dose x 1's
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