ABRIDGED PRODUCT INFORMATION
fluticasone propionate / formoterol fumarate fumarate (flutiform^®)

INDICATIONS: Indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate: For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2 agonist or For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.

DOSAGE AND ADMINISTRATION: Adults and adolescents aged 12 years and above Two inhalations (puffs) of fluticasone propionate/formoterol fumarate (flutiform®) 50mcg/5mcg or 125mcg/5mcg inhaler twice daily. For adults only: Two inhalations (puffs) of fluticasone propionate/formoterol fumarate (flutiform®) 250mcg/10mcg inhaler twice daily.
CONTRAINDICATIONS: Hypersensitivity to any of the active substances or to any of the excipients.
WARNING AND PRECAUTIONS: Keep out of reach of children. Should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required, prophylactic treatment in exercise-induced asthma and first treatment for asthma. Patients should not be initiated on fluticasone propionate/ formoterol fumarate fumarate (flutiform^®) during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on fluticasone propionate/ formoterol fumarate fumarate (flutiform^®). Treatment should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under the supervision of a prescriber. It should be used with caution in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncorrected hypokalemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, or other severe cardiovascular disorders, such as ischemic heart disease, cardiac arrhythmias or severe heart failure. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. NOT recommended for use in children under 12 years of age until further data become available.
DRUG INTERACTIONS: No formal drug interaction studies have been performed with fluticasone propionate/ formoterol fumarate fumarate (flutiform^®). Caution needs to be taken in long-term treatment and co-administration with strong CYP3A4 inhibitors should be avoided if possible.  Concomitant treatment with MAOIs, including agents with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions. Hypokalemia may increase the risk of arrhythmias in patients who are treated with digitalis glycoside. Should be administered with caution to patients being treated with TCAs or MAOIs and during the immediate two-week period following their discontinuation or other drugs known to prolong the QTc interval such as antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide, and antihistamines.
ADVERSE REACTIONS: As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.  Since fluticasone propionate/ formoterol fumarate fumarate (flutiform^®) contains both fluticasone propionate and formoterol fumarate fumarate, the same pattern of undesirable effects as reported for these substances may occur.

PHARMACODYNAMICS: fluticasone propionate/ formoterol fumarate fumarate (flutiform^®) contains both fluticasone propionate and formoterol fumarate fumarate.  These drugs represent two classes of medications (a synthetic corticosteroid and a selective, long-acting β₂-adrenergic receptor agonist).Fluticasone propionate is a synthetic, trifluorinated glucocorticoid with potent anti-inflammatory activity in the lungs when given by inhalation. Fluticasone propionate reduces symptoms and exacerbations of asthma with less adverse effects than when corticosteroids are administered systemically. formoterol fumarate fumarate is a long-acting selective β₂-adrenergic receptor agonist. Inhaled formoterol fumarate fumarate acts locally in the lung as a bronchodilator. The onset of bronchodilating effect is rapid, within 1-3 min and the duration of effect is at least 12 hrs after a single dose.
PHARMACOKINETICS: A number of studies have examined the pharmacokinetic characteristics of fluticasone propionate and formoterol fumarate fumarate from fluticasone propionate/ formoterol fumarate fumarate (flutiform^®) compared with the individual components, given both together and separately.
There is a high variability both within and between the pharmacokinetic studies however, in general, there is a trend for the systemic exposure of fluticasone and formoterol fumarate to be less from this fixed combination of of fluticasone propionate and formoterol fumarate fumarate than from the individual components given together. Pharmacokinetic equivalence between fluticasone propionate/ formoterol fumarate fumarate (flutiform^®) and the constituent monoproducts has not been demonstrated. Long-term comparative data of fluticasone propionate/ formoterol fumarate fumarate (flutiform^®) versus fluticasone propionate and formoterol fumarate fumarate are not available.
PRESENTATION: 50mcg/5mcg, 125mcg/5mcg, 250mcg/10mcg metered dose inhaler (suspension) - 120 actuations per inhaler
REGISTRATION NUMBER: DR-XY43961 (50mcg/5mcg), DR-XY43964 (125mcg/5mcg), and DR-XY43965 (250mcg/10mcg)
CAUTION: Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription.
If you experience any side effect/s or adverse drug reaction/s with the use of this product, immediately seek medical attention and report via FDA at www.fda.gov.ph and Mundipharma Drug Safety Unit at pharmacovigilancenatrapharm@gmail.com +639209116177.
For detailed information, please refer to the full prescribing information.

Based on PI with revision date 22 Nov 19 (CCDS v3 dated 2 June 2015)