ADEFLO Salmeterol Xinafoate / Fluticasone Propionate 50mcg / 500mcg Dry Powder Inhalation Capsule 40's + Inhaler 1's
RXDRUG-DR-XY379847-40
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Salmeterol + Fluticasone is indicated in the regular treatment of reversible obstructive airways disease (ROAD), including asthma where use of combination therapy (bronchodilator and inhaled corticosteroid) is appropriate. Maintenance treatment of chronic obstructive pulmonary disease including chronic bronchitis and emphysema.
Dosage/Direction for Use
Adults and adolescents 12 years and over: 1 inhalation of Salmeterol Xinafoate 50 mcg + Fluticasone Propionate 250 mcg or 50 mcg/500 mcg a day (morning and evening), approximately 12 hours apart or as prescribed by the physician.
The recommended initial dosage for patients aged 12 years and older based on asthma severity.
Improvement in asthma control following inhaled administration of ADEFLO (salmeterol + fluticasone propionate) can occur 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of ADEFLO (salmeterol + fluticasone propionate) with a higher strength may provide additional improvement in asthma control.
If a previously effective dosage regimen of ADEFLO (salmeterol + fluticasone propionate) falls to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (eg, replacing the current strength of ADEFLO (salmeterol + fluticasone propionate) with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.
Chronic Obstructive Pulmonary Disease: The recommended dosage for patients with COPD is 1 inhalation of ADEFLO (salmeterol + fluticasone propionate) 50 mcg/250 mcg or 50 mcg/500 mcg twice daily (morning and evening, approximately 12 hours apart).
If shortness or breath occurs in the period between doses, an inhaled, short-acting beta-2 agonist should be taken for immediate relief.
The recommended initial dosage for patients aged 12 years and older based on asthma severity.
Improvement in asthma control following inhaled administration of ADEFLO (salmeterol + fluticasone propionate) can occur 30 minutes of beginning treatment, although maximum benefit may not be achieved for 1 week or longer after starting treatment. Individual patients will experience a variable time to onset and degree of symptom relief.
For patients who do not respond adequately to the starting dosage after 2 weeks of therapy, replacing the current strength of ADEFLO (salmeterol + fluticasone propionate) with a higher strength may provide additional improvement in asthma control.
If a previously effective dosage regimen of ADEFLO (salmeterol + fluticasone propionate) falls to provide adequate improvement in asthma control, the therapeutic regimen should be reevaluated and additional therapeutic options (eg, replacing the current strength of ADEFLO (salmeterol + fluticasone propionate) with a higher strength, adding additional inhaled corticosteroid, initiating oral corticosteroids) should be considered.
Chronic Obstructive Pulmonary Disease: The recommended dosage for patients with COPD is 1 inhalation of ADEFLO (salmeterol + fluticasone propionate) 50 mcg/250 mcg or 50 mcg/500 mcg twice daily (morning and evening, approximately 12 hours apart).
If shortness or breath occurs in the period between doses, an inhaled, short-acting beta-2 agonist should be taken for immediate relief.
Contraindications
Fluticasone Propionate: Known hypersensitivity or allergy to any ingredients.
Salmeterol Xinafoate: Hypersensitivity to salmeterol or any component.
Previous history of paradoximal bronchospasm.
Salmeterol Xinafoate: Hypersensitivity to salmeterol or any component.
Previous history of paradoximal bronchospasm.
Warnings
In case of powder residues, blow through the nozzle or use a brush and periodically wash with water.
Special Precautions
Fluticasone Propionate: Infection of nasal passages and sinuses.
Recent nasal surgery or injury.
Pregnant and lactating women.
Caution is advised in children as this drug may affect growth patterns.
Not recommended for children younger than 4 years old.
Salmeterol Xinafoate: Avoid using salmeterol as sole agent for asthma control.
Patients should be instructed to stop salmeterol when they have breakthrough asthma symptoms or acute asthma exacerbation and to shift to short acting selective β-agonist.
Avoid use during pregnancy.
Recent nasal surgery or injury.
Pregnant and lactating women.
Caution is advised in children as this drug may affect growth patterns.
Not recommended for children younger than 4 years old.
Salmeterol Xinafoate: Avoid using salmeterol as sole agent for asthma control.
Patients should be instructed to stop salmeterol when they have breakthrough asthma symptoms or acute asthma exacerbation and to shift to short acting selective β-agonist.
Avoid use during pregnancy.
Use In Pregnancy & Lactation
Avoid use during pregnancy.
Adverse Reactions
Salmeterol may cause fine tremor of skeletal muscle (particularly the hands), palpitations, tachycardia, nervous tensions, headaches, peripheral vasodilatation, and rarely muscle cramps. Inhalation causes fewer side-effects than systemic administration, and the more selective beta-2 agonist cause fewer side-effect than less selective beta agonists. Potentially serious hypokalemia has been reported after large doses. Hypersensitivity reactions have occurred, including paradoximal bronchospasm, angioedema, urticaria, hypotension, and collapse.
Fluticasone hypersensitivity reactions may occur. Eosinophilic conditions, including Churg-Strauss syndrome, have been reported rarely, in most cases following a transfer from oral corticosteroid therapy. Inhalation administration of large amounts of fluticasone propionate may produce systemic effects also. The adverse effects of corticosteroid may result from unwanted mineralocorticoid or glucocorticoid actions, or from inhibition of the hypothalamic-pituitary-adrenal axis. Despite the fact that inhaled fluticasone is generally thought to lack systemic effects at therapeutic doses, a study in 25 healthy subjects indicated that fluticasone propionate as single inhaled doses of 250, 500 and 1000 μg did produce a reduction in plasma cortisol, indicating suppression with fluticasone particularly at high doses, and the effect may be more marked with repeated than with single doses.
Fluticasone hypersensitivity reactions may occur. Eosinophilic conditions, including Churg-Strauss syndrome, have been reported rarely, in most cases following a transfer from oral corticosteroid therapy. Inhalation administration of large amounts of fluticasone propionate may produce systemic effects also. The adverse effects of corticosteroid may result from unwanted mineralocorticoid or glucocorticoid actions, or from inhibition of the hypothalamic-pituitary-adrenal axis. Despite the fact that inhaled fluticasone is generally thought to lack systemic effects at therapeutic doses, a study in 25 healthy subjects indicated that fluticasone propionate as single inhaled doses of 250, 500 and 1000 μg did produce a reduction in plasma cortisol, indicating suppression with fluticasone particularly at high doses, and the effect may be more marked with repeated than with single doses.
Drug Interactions
Salmeterol and other beta-2 agonist with corticosteroids, diuretics, or xanthines increases the risk of hypokalaemia, and monitoring of potassium concentrations is recommended in severe asthma, where such combination therapy is the rule. For an outline of interactions associated with sympathomimetics in general.
Concurrent use of fluticasone with barbiturates, carbamazepine, phenytoin, primidone, or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids. Conversely oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids. Use of corticosteroids with potassium depleting diuretics, such as thiazides or furosemide may cause excessive potassium loss.
Concurrent use of fluticasone with barbiturates, carbamazepine, phenytoin, primidone, or rifampicin may enhance the metabolism and reduce the effects of systemic corticosteroids. Conversely oral contraceptives or ritonavir may increase plasma concentrations of corticosteroids. Use of corticosteroids with potassium depleting diuretics, such as thiazides or furosemide may cause excessive potassium loss.
Caution For Usage
Instruction for Use/Handling: Remove the cap.
Steadily hold the base and open the inhaler turning the nozzle counterclockwise.
Introduce the capsule into the loading chamber.
Close the nozzle turning it counterclockwise.
Thoroughly press the two buttons, keeping the inhaler in vertical position.
Deeply breathe out.
Introduce the whole nozzle into the mouth and breathe in, closing the lips (avoid air passing around the nozzle). Try it again (three to four times) until the capsule is completely empty.
After use, extract the empty capsule and close the inhaler.
Steadily hold the base and open the inhaler turning the nozzle counterclockwise.
Introduce the capsule into the loading chamber.
Close the nozzle turning it counterclockwise.
Thoroughly press the two buttons, keeping the inhaler in vertical position.
Deeply breathe out.
Introduce the whole nozzle into the mouth and breathe in, closing the lips (avoid air passing around the nozzle). Try it again (three to four times) until the capsule is completely empty.
After use, extract the empty capsule and close the inhaler.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: The combination previously-mentioned represents 2 classes of medications (a synthetic corticosteroid and a selective, long-acting beta-adrenergic receptor agonist) that have different effects on clinical and physiological indices.
Fluticasone Propionate: It is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. In vitro assays using human lung cytosol preparations have established fluticasone propionate as a human glucocorticosteriod receptor agonist with an affinity 18 times greater than dexamethasone, almost twice that of beclomethasone - 17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate and over 3 times that of budesonide. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to inhibit multiple cell types (eg, mast cells, eosinophils, basophils, lymphocytes, macrophages and neutrophils) and mediator production or secretion (eg, histamine, eicosanoids, leukotrienes and cytokines) involved in the asthmatic response. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma. Inflammation is also a component in the pathogenesis of chronic obstructive pulmonary disease (COPD).
Salmeterol Xinafoate: It is a long-acting beta-2 adrenergic agonist. The pharmacologic effect of Salmeterol Xinafoate is part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels caused relaxation of bronchial smooth muscle and inhibition of release mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediator, such as histamine, leukotrienes and prostaglandin D2, from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor-induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route.
Fluticasone Propionate: It is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. In vitro assays using human lung cytosol preparations have established fluticasone propionate as a human glucocorticosteriod receptor agonist with an affinity 18 times greater than dexamethasone, almost twice that of beclomethasone - 17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate and over 3 times that of budesonide. Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to inhibit multiple cell types (eg, mast cells, eosinophils, basophils, lymphocytes, macrophages and neutrophils) and mediator production or secretion (eg, histamine, eicosanoids, leukotrienes and cytokines) involved in the asthmatic response. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma. Inflammation is also a component in the pathogenesis of chronic obstructive pulmonary disease (COPD).
Salmeterol Xinafoate: It is a long-acting beta-2 adrenergic agonist. The pharmacologic effect of Salmeterol Xinafoate is part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels caused relaxation of bronchial smooth muscle and inhibition of release mediators of immediate hypersensitivity from cells, especially from mast cells. In vitro tests show that salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediator, such as histamine, leukotrienes and prostaglandin D2, from human lung. Salmeterol inhibits histamine-induced plasma protein extravasation and inhibits platelet-activating factor-induced eosinophil accumulation in the lungs of guinea pigs when administered by the inhaled route.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Adeflo
Full Details
Dosage Strength
50 mcg / 500 mcg
Drug Ingredients
- Fluticasone
- Salmeterol
Drug Packaging
Dry-Powder Inhalation In Capsule 40's
Generic Name
Salmeterol Xinafoate / Fluticasone Propionate
Dosage Form
Dry-Powder Inhalation In Capsule
Registration Number
DR-XY379847
Drug Classification
Prescription Drug (RX)
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