Flutiform

Flutiform

fluticasone + formoterol

Manufacturer:

Mundipharma

Distributor:

Mundipharma
Concise Prescribing Info
Contents
Per 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
Asthma in patients not adequately controlled w/ inhaled corticosteroids & as required inhaled short-acting β2-agonist OR adequately controlled on both an inhaled corticosteroid & long-acting β2-agonist.
Dosage/Direction for Use
50 mcg/5 mcg & 125 mcg/5 mcg MDI Adult & adolescent ≥12 yr 2 inhalations (puffs) bid. 250 mcg/10 mcg MDI Adult 2 inhalations (puffs) bid.
Contraindications
Special Precautions
Not for the treatment of acute asthma symptoms w/ required fast- & short-acting bronchodilator & as 1st-treatment for asthma. Avoid use w/ exercise-induced asthma, during exacerbation/significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events & exacerbations may occur. Do not use as 1st-treatment for asthma. Avoid abrupt discontinuation. Patients w/ thyrotoxicosis, pheochromocytoma, DM, uncorrected hypokalemia or patients predisposed to low serum K levels, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe HTN, aneurysm or other severe CV disorders eg, ischemic heart disease, cardiac arrhythmias or severe heart failure; existing QTc interval prolongation; switching patients from previous systemic steroid therapy. Pulmonary or quiescent TB, fungal or viral or other infections of the airway; unstable asthma w/ variable rescue bronchodilator use; paradoxical bronchospasm. Consider blood sugar control in diabetic patients. Concomitant use w/ drugs that induce or potentiate hypokalemic effect eg, xanthine derivatives & steroids. Prolonged & high-dose treatment. Regularly monitor hypothalamic pituitary adrenocortical (HPA) axis function. Severe hepatic impairment. Pregnancy & lactation. Childn <12 yr.
Adverse Reactions
Sleep disorders including insomnia; headache, tremor, dizziness; palpitations, ventricular extrasystoles; exacerbation of asthma, dysphonia, throat irritation; dry mouth; rash; peripheral edema.
Drug Interactions
Marked increase in plasma levels w/ co-administration of strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole, telithromycin). TCAs or MAOIs (during the immediate 2-wk period following discontinuation) or other drugs known to prolong QTc interval eg, antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide & antihistamines. ECG changes &/or hypokalemia may occur w/ non-K-sparing diuretics. Possible hypokalemic effect w/ xanthine derivatives, glucocorticosteroids & digitalis glycosides. L-Dopa, L-thyroxine, oxytocin & alcohol may impair cardiac tolerance towards β2-sympathomimetics. Elevated risk of arrhythmias w/ anesth w/ halogenated hydrocarbons. Additive effect w/ other β-adrenergic drugs. Concurrent administration w/ β-adrenergic receptor antagonists may inhibit effects.
MIMS Class
Antiasthmatic & COPD Preparations
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 (P1,214/container)
Form
Flutiform 250 mcg/10 mcg MDI
Packing/Price
120 actuation x 1's (P2,060/container)
Form
Flutiform 50 mcg/5 mcg MDI
Packing/Price
120 actuation x 1's (P1,214/container)
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