Adeflo MDI

Adeflo MDI

salmeterol + fluticasone

Manufacturer:

Glenmark

Distributor:

Cathay Drug
Concise Prescribing Info
Contents
Per 25 mcg/50 mcg/actuation MDI Salmeterol xinafoate 25 mcg, fluticasone propionate 50 mcg. Per 25 mcg/125 mcg/actuation MDI Salmeterol xinafoate 25 mcg, fluticasone propionate 125 mcg. Per 25 mcg/250 mcg/actuation MDI Salmeterol xinafoate 25 mcg, fluticasone propionate 250 mcg
Indications/Uses
Regular treatment of asthma where use of a combination product (long-acting β2-agonist & inhaled corticosteroid) is appropriate: Patients not adequately controlled w/ inhaled corticosteroids & as needed inhaled short acting β2-agonist; already adequately controlled on both inhaled corticosteroids & long-acting β2-agonist.
Dosage/Direction for Use
Adult & adolescent ≥12 yr 2 inhalations bid. 25 mcg/50 mcg MDI Childn ≥4 yr 2 inhalations bid. Max: 100 mcg bid.
Contraindications
Special Precautions
Pulmonary TB. Do not use to treat acute asthma symptoms for which fast & short-acting bronchodilator is required. Do not initiate during exacerbation or significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events & exacerbation; systemic effects (particularly childn & adolescents <16 yr at high doses) may occur. Deterioration of asthma control (may be sudden & progressive). Rarely, cardiac arrhythmias eg, supraventricular tachycardia, extrasystoles & atrial fibrillation & mild transient reduction in serum K (high doses) may occur. Possible development of pneumonia & other lower resp tract infections in patients w/ COPD. Reduce dose gradually once symptoms are controlled. Transferring intake from oral to inhalation. Prolonged treatment. Concomitant use w/ ritonavir; systemic ketoconazole or other potent CYP34 inhibitors. Black African patients or Afro-Caribbean ancestry. Pregnancy & lactation. Childn <4 yr.
Adverse Reactions
Headache; nasopharyngitis. Candidiasis, pneumonia, bronchitis; hypokalemia; hoarseness/dysphonia, sinusitis; traumatic fractures, arthralgia, myalgia. Childn: Cushing's syndrome, Cushingoid features, adrenal suppression & growth retardation in childn & adolescents; anxiety, sleep disorders/behavioral changes including hyperactivity & irritability.
Drug Interactions
Avoid nonselective & selective β-blockers in patients w/ asthma. Additive effects w/ other β-adrenergic containing drugs. Fluticasone propionate: Markedly reduced serum cortisol conc w/ ritonavir. Increased exposure w/ CYP3A inhibitors eg, ketoconazole; itraconazole. Salmeterol: May prolong QTc interval & palpitations w/ CYP3A4 inhibitors eg, ketoconazole; itraconazole, telithromycin, ritonavir.
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
Adeflo MDI 25 mcg/125 mcg
Packing/Price
(120 actuations) 1's
Form
Adeflo MDI 25 mcg/250 mcg
Packing/Price
(120 actuations) 1's
Form
Adeflo MDI 25 mcg/50 mcg
Packing/Price
(120 actuations) 1's
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