Fludalt Duo

Fludalt Duo

salmeterol + fluticasone

Manufacturer:

Favorex

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 250/50 mcg inhalation Fluticasone propionate 250 mcg, salmeterol xinafoate 50 mcg.
Indications/Uses
Regular treatment of reversible obstructive airways disease (ROAD) including asthma in childn & adults & COPD including chronic bronchitis & emphysema.
Dosage/Direction for Use
ROAD Adult & adolescent ≥12 yr 1 inhalation bd. COPD Adult 1 inhalation of 250/50-500/50 mcg bd.
Special Precautions
Not for acute symptomatic relief. Not to be initiated in unstable & acutely deteriorating asthma. Active or quiescent pulmonary TB, thyrotoxicosis, preexisting CV disease, patients predisposed to low serum K levels. Development of pneumonia in COPD patients. Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataract & glaucoma. Monitor adrenocortical function regularly when transferring from oral steroid therapy. Avoid abrupt w/drawal &/or discontinuation. High doses & prolonged use. May affect ability to drive & use machines. Pregnancy & lactation. Childn <4 yr. Growth retardation in childn & adolescents.
Adverse Reactions
Tremor, subjective palpitations & headache; muscle cramps. Hoarseneness, mouth & throat candidiasis.
Drug Interactions
Increased plasma conc w/ ritonavir. Increased systemic exposure by CYP450 inhibitors eg, erythromycin & ketoconazole. Prolonged QTc interval w/ ketoconazole. Avoid nonselective & selective β-blockers.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AK06 - salmeterol 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
Fludalt Duo inhalation powd 250/50 mcg
Packing/Price
60's
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