Saltrol

Saltrol

salmeterol + fluticasone

Manufacturer:

Getz Pharma

Distributor:

Getz Pharma
Concise Prescribing Info
Contents
Per 25 mcg/125 mcg MDI actuation Salmeterol xinafoate 25 mcg, fluticasone propionate 125 mcg. Per 25 mcg/250 mcg MDI actuation Salmeterol xinafoate 25 mcg, fluticasone propionate 250 mcg
Indications/Uses
Regular treatment of asthma (reversible obstructive airways disease) including patients on effective maintenance doses of long-acting β agonists & inhaled corticosteroids; who are symptomatic on current inhaled corticosteroid therapy; on regular bronchodilator therapy who require inhaled corticosteroids. Regular treatment of COPD including bronchitis & emphysema.
Dosage/Direction for Use
Asthma (reversible obstructive airways disease) Adult & adolescent ≥12 yr 2 inhalation bid. COPD Adult 2 inhalation bid.
Contraindications
Hypersensitivity. Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Special Precautions
Immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm, hypotension) including anaphylaxis. Do not use for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. Do not use for the relief of acute symptoms, ie, as rescue therapy for the treatment of acute episodes of bronchospasm. Discontinue regular use of oral or inhaled, short-acting β2 agonists when beginning treatment. Clinically significant CV effects & fatalities w/ excessive use of inhaled sympathomimetic drugs. Do not use another medicine containing a LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. Candida albicans infection of the mouth & pharynx may occur; monitor patients periodically. Advise patient to rinse mouth w/ water w/o swallowing after inhalation. Monitor patients w/ signs & symptoms of pneumonia. Patients w/ active or quiescent TB infections of the resp tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex; more serious or fatal course of chickenpox or measles. Taper slowly if transferring from systemic corticosteroids to inhaler. Reduce slowly if hypercorticism & adrenal suppression (including adrenal crisis) occur. Discontinue & institute alternate therapy if paradoxical bronchospasm & upper airway symptoms occur. Patients w/ CV disorders especially coronary insufficiency, cardiac arrhythmias & HTN. Assess patients for decrease in bone mineral density initially & periodically thereafter. Monitor growth of ped patients receiving inhaler routinely; patients w/ change in vision or w/ history of increased IOP, glaucoma, &/or cataracts. May present systemic eosinophilic conditions & Churg-Strauss syndrome. Convulsive disorders or thyrotoxicosis, DM & ketoacidosis. May produce significant hypokalemia. Hyperglycemia in patients w/ history of DM. Pregnancy & lactation.
Adverse Reactions
Headache; nasopharyngitis. Candidiasis of the mouth & throat, bronchitis, pneumonia (in COPD patients); hypokalemia; hoarseness/dysphonia, sinusitis; muscle cramps, arthralgia, traumatic fractures, myalgia.
Drug Interactions
Increased systemic corticosteroid & increased CV adverse effects w/ strong CYP3A4 inhibitors. Potentiated action of salmeterol on vascular system w/ MAOIs & TCAs. May weaken or antagonize the effect of salmeterol w/ β adrenergic blockers. Potentially serious hypokalemia w/ β2 agonist therapy in acute severe asthma may be potentiated by xanthine derivatives, steroids & diuretics. β agonists eg, salmeterol can acutely worsen the ECG changes &/or hypokalemia that resulted from non-K-sparing diuretics (eg, loop or thiazide diuretics) administration.
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
Saltrol 25 mcg/125 mcg MDI
Packing/Price
120 actuation x 1's (P334.82/box)
Form
Saltrol 25 mcg/250 mcg MDI
Packing/Price
120 actuation x 1's (P477.68/box)
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