Aerotide

Aerotide

salmeterol + fluticasone

Manufacturer:

Inpac Pharma

Distributor:

DKLL

Marketer:

Aerocare
Concise Prescribing Info
Contents
Per 25/125 mcg susp for inhalation Salmeterol 25 mcg, fluticasone propionate 125 mcg. Per 25/250 mcg susp for inhalation Salmeterol 25 mcg, fluticasone propionate 250 mcg
Indications/Uses
Regular treatment of asthma (reversible obstructive airways disease) in patients on effective maintenance dose of long-acting β-agonists & inhaled corticosteroids; who are symptomatic on current inhaled corticosteroid therapy; on regular bronchodilator therapy requiring inhaled corticosteroids. Regular treatment of COPD including chronic bronchitis & emphysema.
Dosage/Direction for Use
Oral inhalation Asthma (reversible obstructive airways disease) Adult & adolescent ≥12 yr 2 inhalations bid. Childn ≥4 yr Max: 100 mcg of fluticasone propionate bid. COPD Adult Recommended starting dose: 2 inhalations bid.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue immediately if paradoxical bronchospasm w/ immediate increase in wheezing after dosing occurs. Not to be used in patients w/ hypersensitivity; invasive fungal infections except in necessary cases. Not for relief of acute symptoms requiring fast- & short-acting bronchodilator (eg, salbutamol). Not to be stopped abruptly in patients w/ asthma due to risk of exacerbation. Sudden & progressive deterioration in asthma control. Symptomatic decompensation in patient w/ COPD cessation of therapy. Possible development of pneumonia in patients w/ COPD; systemic effects eg, Cushing's syndrome, cushingoid features, adrenal suppression, growth retardation in adolescents & childn, decreased bone mineral density, cataract, glaucoma; impaired adrenal response. CV effects eg, increased systolic BP & heart rate; transient decrease in serum K at higher dose; tremor, subjective palpitations, headache. Patients w/ gastroenteritis, current or history of DM, active or quiescent pulmonary TB, viral infections; thyrotoxicosis; pre-existing CV disease; predisposition to low serum K levels. Gradually w/draw systemic therapy following initiation of inhaled fluticasone propionate. Regularly monitor height of childn receiving prolonged treatment; adrenocortical function. Avoid concomitant use w/ ritonavir. Concomitant use w/ CYP3A4 inhibitors eg, ketoconazole. Pregnancy & lactation. Childn <4 yr w/ asthma (reversible obstructive airways disease).
Adverse Reactions
Headache. Mouth & throat candidiasis, pneumonia (in COPD patients); hoarseness/dysphonia; muscle cramps, arthralgia.
Drug Interactions
Avoid use w/ non-selective & selective β-blockers. Salmeterol: Prolonged QTc interval w/ ketoconazole. Fluticasone propionate: Increased plasma conc resulting to reduced serum cortisol conc & systemic corticosteroid effects w/ ritonavir. Increased systemic exposure of ketoconazole.
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
Aerotide 125 susp for inhalation
Packing/Price
120 actuation x 1's
Form
Aerotide 250 susp for inhalation
Packing/Price
120 actuation x 1's
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