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Advair Diskus - Advair Diskus Side Effects - Advair Diskus - Canada Pharmacy

Advair Diskus
Salmeterol Xinafoate--Fluticasone Propionate

Pharmacology: Advair Diskus contains salmeterol and fluticasone, which have differing modes of action for the treatment of reversible obstructive airways disease and asthma. Salmeterol is a long-acting bronchodilator that prevents breakthrough symptoms of wheezing and chest tightness; fluticasone is an inhaled anti-inflammatory agent that reduces airways irritability. Advair can offer a more convenient regime for patients requiring concurrent long-acting beta ₂-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below: rx canada pharmacy

Salmeterol is a selective, long-acting (12 hours), slow onset (10 to 20 minutes) beta ₂-adrenoceptor agonist with a long side-chain which binds to the exo-site of the receptor. rx canada pharmacy

Salmeterol offers more effective protection against histamine-induced bronchoconstriction and produces a longer duration of bronchodilation, lasting for at least 12 hours, than recommended doses of conventional short-acting beta ₂-agonists. rx canada pharmacy

In vitro tests on human lung have shown salmeterol is a potent and long-lasting inhibitor of the release of mast cell mediators, such as histamine, leukotrienes and prostaglandin D ₂. rx canada pharmacy

In man, salmeterol inhibits the early and late phase response to inhaled allergen. The late phase response is inhibited for over 30 hours after a single dose, when the bronchodilator effect is no longer evident. The full clinical significance of these findings is not yet clear. The mechanism is different from the anti-inflammatory effect of corticosteroids. rx canada pharmacy

Fluticasone is a highly potent glucocorticoid anti-inflammatory steroid. When administered by inhalation at therapeutic dosages, it has a direct potent anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, and less adverse effects than systemically administered corticosteroids. rx canada pharmacy

In comparisons with beclomethasone dipropionate, fluticasone propionate has demonstrated greater topical potency. rx canada pharmacy

Pharmacokinetics: There is no evidence in animal or human subjects that the administration of salmeterol and fluticasone together by the inhaled route affects the pharmacokinetics of either component. For pharmacokinetic purposes, therefore, each component can be considered separately. rx canada pharmacy

Salmeterol acts locally in the lung, therefore, plasma levels are not an indication of therapeutic effect. Because of the low therapeutic dose, systemic levels of salmeterol are low or undetectable after inhalation of recommended doses (50 µg twice daily). rx canada pharmacy

Salmeterol is predominantly cleared by hepatic metabolism; liver function impairment may lead to accumulation of salmeterol in plasma. Therefore, salmeterol should be used with caution in patients with hepatic disease. rx canada pharmacy

Following i.v. administration, the pharmacokinetics of fluticasone are proportional to the dose. Fluticasone is extensively distributed within the body. The volume of distribution at steady state is approximately 300 L and has a very high clearance which is estimated to be 1.1 L/m, indicating extensive hepatic extraction. Peak plasma fluticasone concentrations are reduced by approximately 98% within 3 to 4 hours and only low plasma concentrations are associated with the terminal half-life, which is approximately 8 hours. rx canada pharmacy

Following oral administration of fluticasone, 87 to 100% of the dose is excreted in the feces. Following doses of either 1 or 16 mg, up to 20% and 75%, respectively, is excreted in the feces as the parent compound. Absolute oral bioavailability is negligible (<1%), due to a combination of incomplete absorption from the gastrointestinal tract and extensive first-pass metabolism. rx canada pharmacy

Following inhaled dosing, systemic absolute bioavailability of fluticasone is estimated as 12 to 26%, dependent on presentation. Systemic absorption of fluticasone occurs mainly through the lungs, and is initially rapid, then prolonged. rx canada pharmacy

The plasma protein binding of fluticasone is 91%. Fluticasone is extensively metabolized by CYP3A4 enzyme to an inactive carboxylic acid derivative. rx canada pharmacy


Indications: Regular treatment of reversible obstructive airways disease, including asthma in patients 4 years of age and older, where the use of a combination product is appropriate. This may include: patients on effective maintenance doses of long-acting beta ₂-agonists and inhaled corticosteroids; and patients who are symptomatic on current inhaled corticosteroid therapy. rx canada pharmacy

Advair should not be used in patients whose asthma can be managed by occasional use of short-acting, inhaled beta ₂-agonists. Advair contains a long-acting beta ₂-agonist and should not be used as a rescue medication. To relieve acute asthmatic symptoms, a short-acting inhaled bronchodilator (e.g., salbutamol) should be used. rx canada pharmacy

Contraindications: In patients with cardiac tachyarrhythmias, in patients with untreated fungal, bacterial or tuberculous infections of the respiratory tract, and in patients with a known or suspected hypersensitivity to any ingredient of the preparation. rx canada pharmacy

Advair Diskus contains lactose (see Supplied) and is contraindicated in patients with IgE-mediated allergic reactions to lactose or milk. rx canada pharmacy

Advair is not to be used in the primary treatment of status asthmaticus or other acute episodes of asthma, or in patients with moderate to severe bronchiectasis. rx canada pharmacy


Warnings: Advair should not be used to treat acute symptoms-- It is crucial to inform patients of this and prescribe a fast- and short-acting, inhaled beta ₂-agonist (e.g., salbutamol) to relieve acute asthmatic symptoms. rx canada pharmacy

Monitoring Asthma Control: Increasing use of short-acting inhaled bronchodilators to control symptoms indicates deterioration of asthma control. Sudden and progressive deterioration in asthma control is potentially life-threatening and the treatment plan should be re-evaluated. Also, where current dosage of Advair has failed to give adequate control of reversible obstructive airways disease, the patient should be reviewed by a physician. Consideration should be given to additional corticosteroid therapy, and to antibiotics if an infection is present. rx canada pharmacy

Before introducing Advair, adequate education should be provided to the patient on how to use the drug and what to do if asthma flares up. rx canada pharmacy

Use With Short-acting Beta ₂-agonists: Patients should be clearly instructed to use short-acting, inhaled beta ₂-agonists only for symptomatic relief if they develop asthma symptoms while taking Advair (see Precautions, Drug Interactions). rx canada pharmacy

Systemic Steroid Replacement by Inhaled Steroid: Particular care is needed in asthmatic patients who are transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred during and after transfer. For the transfer of patients being treated with oral corticosteroids, inhaled corticosteroids should first be added to the existing oral steroid therapy, which is then gradually withdrawn. rx canada pharmacy

Patients with adrenocortical suppression should be monitored regularly and the oral steroid reduced cautiously. Some patients transferred from other inhaled steroids or oral steroids remain at risk of impaired adrenal reserve for a considerable time after transferring to inhaled fluticasone. rx canada pharmacy

After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery or infections, particularly gastroenteritis. Although inhaled fluticasone may provide control of asthmatic symptoms during these episodes, it does not provide the systemic steroid which is necessary for coping with these emergencies. The physician may consider supplying oral steroids for use in times of stress (e.g., worsening asthma attacks, chest infections, surgery). rx canada pharmacy

During periods of stress or a severe asthmatic attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume systemic steroids immediately and to contact their physician for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic steroids during periods of stress or a severe asthma attack. To assess the risk of adrenal insufficiency in emergency situations, routine tests of adrenal cortical function, including measurement of early morning and evening cortisol levels, should be performed periodically in all patients. An early morning resting cortisol level may be accepted as normal only if it falls at or near the normal mean level. rx canada pharmacy

Cardiovascular Effects: Although clinically not significant, a small increase in QTc interval has been reported with therapeutic doses of salmeterol. It is not known if this becomes clinically significant when concomitant medications causing similar effects are prescribed and/or in the presence of heart diseases, hypokalemia, or hypoxia. rx canada pharmacy

Fatalities have been reported following excessive use of aerosol preparations containing sympathomimetic amines, the exact cause of which is unknown. Cardiac arrest was reported in several instances. rx canada pharmacy

In individual patients, any beta ₂-adrenergic agonist may have a clinically significant cardiac effect. rx canada pharmacy

Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of salmeterol, as demonstrated by rare cases of urticaria, angioedema, rash and bronchospasm. rx canada pharmacy

Upper Airway Symptoms: Symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported rarely in patients receiving salmeterol. rx canada pharmacy

Metabolic Changes: In common with other beta-adrenergic agents, salmeterol can induce reversible metabolic changes (hyperglycemia, hypokalemia) (see Precautions). rx canada pharmacy

Candidiasis: Therapeutic dosages of fluticasone propionate frequently cause the appearance of C. albicans (thrush) in the mouth and throat. The development of pharyngeal and laryngeal candidiasis is a cause for concern because the extent of its penetration into the respiratory tract is unknown. Patients may find it helpful to rinse out their mouth with water after using the Diskus. Symptomatic candidiasis can be treated with topical anti-fungal therapy while continuing to use Advair (see Precautions, Drug Interactions). rx canada pharmacy

Effect on Infection: Patients who are on drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled i.m. immunoglobulin (IG) may be indicated. If chickenpox develops, treatment with antiviral agents may be considered. rx canada pharmacy

Paradoxical Bronchospasm: As with other inhalation therapy, paradoxical bronchospasm may occur, characterized by an immediate increase in wheezing after dosing. This should be treated immediately with a fast-acting inhaled bronchodilator (e.g., salbutamol) to relieve acute asthmatic symptoms. Advair should be discontinued immediately, the patient assessed, and if necessary, alternative therapy instituted. rx canada pharmacy

Precautions: General: Do not introduce Advair as a treatment for acutely deteriorating asthma. Advair is intended for the maintenance treatment of asthma (see Indications) and should not be introduced in acutely deteriorating asthma, which is a potentially life-threatening condition. rx canada pharmacy

Do not use Advair to treat acute symptoms. A short-acting, inhaled beta ₂-agonist, not Advair, should be used to relieve acute asthma symptoms. When prescribing Advair, the physician should also provide the patient with a short-acting, inhaled beta ₂-agonist (e.g., salbutamol) to treat symptoms that occur acutely, despite regular twice daily (morning and evening) use of Advair. rx canada pharmacy

When beginning treatment with Advair, patients who have been taking short-acting, inhaled beta ₂-agonists on a regular basis (e.g., q.i.d.) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief if they develop acute asthma symptoms while taking Advair. rx canada pharmacy

Watch for increasing use of short-acting, inhaled beta ₂agonists, which is a marker of deteriorating asthma. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient's short-acting inhaled beta ₂-agonist becomes less effective or the patient needs more inhalations than usual, this may be a marker of destabilization of asthma. In this setting, the patient requires immediate re-evaluation with reassessment of the treatment regimen. rx canada pharmacy

Do not exceed recommended dosage. Advair should not be used more frequently than twice daily (morning and evening) at the recommended dose of one inhalation. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias. rx canada pharmacy

Adolescent and Pediatric Patients and Asthma Severity Reassessment: In adolescents and children, the severity of asthma may vary with age and periodic reassessment should be considered to determine if continued maintenance therapy with Advair is still indicated. rx canada pharmacy

Cardiovascular and Other Effects: No clinically significant effect on the cardiovascular system is usually seen after the administration of inhaled salmeterol in recommended doses, but the cardiovascular and CNS effects seen with all sympathomimetic drugs (e.g., increased blood pressure, heart rate, excitement) can occur after use of salmeterol and may require discontinuation of the drug. Salmeterol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines (see also Precautions, Do Not Exceed Recommended Dosage). rx canada pharmacy

As has been described with other beta-adrenergic agonist bronchodilators, clinically significant changes in systolic and/or diastolic blood pressure, pulse rate, and ECG have been seen infrequently in individual patients in controlled clinical studies with salmeterol. rx canada pharmacy

Metabolic Effects: Doses of the related beta ₂-adrenoceptor agonist salbutamol, when administered i.v., have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. No effects on glucose have been seen with salmeterol at recommended doses. Administration of beta ₂-adrenoceptor agonists may cause a decrease in serum potassium, possibly through intracellular shunting, which has the potential to increase the likelihood of arrythmias. The decrease is usually transient, not requiring supplementation. rx canada pharmacy

Clinically significant changes in blood glucose and/or serum potassium were seen rarely during clinical studies with long-term administration of salmeterol at recommended doses. rx canada pharmacy

Systemic Effects: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods; these effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important therefore, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained (see Adverse Effects). rx canada pharmacy

Certain individuals can show greater susceptibility to the effects of inhaled corticosteroid than do most patients. rx canada pharmacy

Long-Term Effects: The long-term effects of fluticasone in human subjects are still unknown. In particular, the local effects of the drug on developmental or immunologic processes in the mouth, pharynx, trachea, and lungs are unknown. There is also no information about the possible long-term systemic effects of the agent. During long-term therapy, HPA axis function and hematological status should be assessed periodically. rx canada pharmacy

Discontinuance: Treatment with inhaled corticosteroids should not be stopped abruptly, but tapered gradually. rx canada pharmacy

Eosinophilic Conditions: In rare cases, patients on inhaled fluticasone may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone and these underlying conditions has not been established. rx canada pharmacy

Effect on Infection: Corticosteroids may mask some signs of infection and new infections may appear. A decreased resistance to localized infection has been observed during corticosteroid therapy. This may require treatment with appropriate therapy or stopping the administration of fluticasone until the infection is eradicated (see Warnings, Effect on Infection). rx canada pharmacy

Hypothyroidism and Cirrhosis: There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. rx canada pharmacy

Proper Use of the Diskus: To ensure the proper dosage and administration of the drug, the patient must be instructed by a physician or other health professional in the use of the Diskus (see Blue Section, Information for the Patient). rx canada pharmacy

Drug Interactions : Short-acting Beta-agonists: Aerosol bronchodilators of the short-acting adrenergic stimulant type may be used for relief of breakthrough symptoms while using salmeterol. Increasing use of such preparations to control symptoms indicates deterioration of asthma control and the patient's therapy plan should be reassessed. rx canada pharmacy

The regular, concomitant use of salmeterol and other sympathomimetic agents is not recommended, since such combined use may lead to deleterious cardiovascular effects. rx canada pharmacy

MAOIs and Tricyclic Antidepressants: Salmeterol should be administered with extreme caution to patients being treated with MAOIs or tricyclic antidepressants or within 2 weeks of discontinuation of such agents, because the action of salmeterol on the vascular system may be potentiated by these agents. rx canada pharmacy

Methylxanthines: The concurrent use of i.v. or orally administered methylxanthines (e.g., aminophylline, theophylline) by patients receiving salmeterol has not been completely evaluated. rx canada pharmacy

Beta-blocking Drugs: Nonselective beta-blocking drugs should never be prescribed in asthma since they may antagonize the bronchodilating action of salmeterol. Cardioselective beta-blocking drugs should be used with caution in asthmatics. rx canada pharmacy

ASA: Use with caution in conjunction with corticosteroids in hypoprothrombinemia. rx canada pharmacy

Other Drugs: Use Advair with caution in patients receiving other medications causing hypokalemia and/or increased QTc interval (diuretics, high dose steroids, antiarrhythmics, astemizole, terfenadine) since cardiac and vascular effects may be potentiated. rx canada pharmacy

Clinically significant drug interactions with fluticasone are unlikely due to the very low plasma concentration achieved after inhaled dosing. However, care should be taken when coadministering strong hepatic inhibitors of the CYP3A4 enzyme system (e.g., ketoconazole and ritonavir) since there is potential for increased systemic exposure to fluticasone. rx canada pharmacy

Pregnancy: There are no adequate and well-controlled studies with Advair in pregnant women. Advair should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. rx canada pharmacy

In animal studies, some effects on the fetus, typical for a beta-agonist, occurred at exposure levels substantially higher than those that occur with therapeutic use. Extensive use of other beta-agonists has provided no evidence that effects in animals are relevant to human use. rx canada pharmacy

Like other glucocorticoids, fluticasone is teratogenic to rodent species. Adverse effects typical of potent corticosteroids are only seen at high systemic exposure levels; administration by inhalation ensures minimal systemic exposure. The relevance of these findings to humans has not yet been established, since well-controlled trials relating to fetal risk in humans are not available. Infants born of mothers who have received substantial doses of glucocorticoids during pregnancy should be carefully observed for hypoadrenalism. rx canada pharmacy

Labor and Delivery: There are no well-controlled human studies that have investigated effects of salmeterol on preterm labor or labor at term. Because of the potential for beta-agonist interference with uterine contractility, use of Advair during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. rx canada pharmacy

Lactation: Plasma levels of salmeterol after inhaled therapeutic doses are very low (85 to 200 pg/mL) in humans and therefore levels in milk should be correspondingly low. Studies in lactating animals indicate that salmeterol is likely to be secreted in only very small amounts in breast milk.

Glucocorticoids are excreted in human milk. The excretion of fluticasone into human breast milk has not been investigated. When measurable plasma levels were obtained in lactating laboratory rats following s.c. administration, there was evidence of fluticasone in the breast milk. However, plasma levels in patients following inhaled fluticasone at recommended doses are likely to be low. rx canada pharmacy

Since there is no experience with use of Advair by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. rx canada pharmacy

Children: The safety and effectiveness of Advair in children younger than 4 years of age have not been established. rx canada pharmacy

It is recommended that the height of children and adolescents receiving prolonged treatment with inhaled corticosteroids is regularly monitored (see Adverse Effects). rx canada pharmacy

Geriatrics: As with other beta ₂-agonists, special caution should be observed when using salmeterol in elderly patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug. Based on available data, no adjustment of salmeterol dosage in geriatric patients is warranted.

Adverse Effects: As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a fast- and short-acting inhaled bronchodilator. Advair Diskus should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. rx canada pharmacy

The type and severity of adverse reactions associated with salmeterol and fluticasone may be expected with Advair. There is no incidence of additional adverse events following combined administration of the two compounds. rx canada pharmacy

Salmeterol: The pharmacological side effects of beta ₂-agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. rx canada pharmacy

Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) may occur in some patients. rx canada pharmacy

There have been reports of arthralgia and hypersensitivity reactions, including rash, edema and angioedema. rx canada pharmacy

There have been reports of oropharyngeal irritations as well as rare reports of muscle cramps. rx canada pharmacy

Fluticasone: In general, inhaled corticosteroid therapy may be associated with dose-dependent increases in the incidence of ocular complications, reduced bone density, suppression of HPA axis responsiveness to stress, and inhibition of growth velocity in children. Such events have been reported rarely in clinical trials with fluticasone. rx canada pharmacy

Glaucoma may be exacerbated by inhaled corticosteroid treatment for asthma or rhinitis. In patients with established glaucoma who require long-term inhaled corticosteroid treatment, it is prudent to measure intraocular pressure before commencing the inhaled corticosteroid and to monitor it subsequently. In patients without established glaucoma, but with a potential for developing intraocular hypertension (e.g., the elderly), intraocular pressure should be monitored at appropriate intervals. rx canada pharmacy

In elderly patients treated with inhaled corticosteroids, the prevalence of posterior subcapsular and nuclear cataracts is probably low but increases in relation to the daily and cumulative lifetime dose. Cofactors such as smoking, ultraviolet B exposure, or diabetes may increase the risk. Children may be less susceptible. rx canada pharmacy

A reduction of growth velocity in children or teenagers may occur as a result of inadequate control of chronic diseases such as asthma or from use of corticosteroids for treatment. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route and weigh the benefits of corticosteroid therapy and asthma control against the possibility of growth suppression if any child's or adolescent's growth appears slowed. rx canada pharmacy

Osteoporosis and fracture are the major complications of long-term asthma treatment with parenteral or oral steroids. Inhaled corticosteroid therapy is also associated with dose-dependent bone loss, although the degree of risk is very much less than with oral steroid. This risk may be offset by estrogen replacement in post-menopausal women, and by titrating the daily dose of inhaled steroid to the minimum required to maintain optimal asthma control. It is not yet known whether the peak bone density achieved during youth is adversely affected if substantial amounts of inhaled corticosteroid are administered prior to 30 years of age. Failure to achieve maximal bone density during youth could increase the risk of osteoporotic fracture when those individuals reach 60 years of age and older. rx canada pharmacy

Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients receiving inhaled fluticasone. These may be relieved by gargling with water after use of Advair. Symptomatic candidiasis can be treated with topical antifungal therapy while still continuing with Advair (see Precautions, Drug Interactions). rx canada pharmacy

Cutaneous hypersensitivity reactions have been reported as well as rare cases of facial and oropharyngeal edema. rx canada pharmacy

Eosinophilic Conditions: In rare cases, patients on inhaled fluticasone may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone and these underlying conditions has not been established. rx canada pharmacy

In the Advair group, there was no apparent relationship to fluticasone dose for drug-related adverse events (15% with 50/100 µg, 19% with 50/250 µg and 17% with 50/500 µg). rx canada pharmacy

Children: A total of 257 pediatric patients participated in the clinical development programme and received either the combination 50 µg salmeterol/100 µg fluticasone Diskus or concurrent therapy (with salmeterol and fluticasone propionate administered via separate inhalers). Only one drug-related adverse event, candidiasis, was reported with an incidence of 2% or more in the Advair group. The combination product was generally well tolerated and the safety profile was comparable to that observed in the concurrent therapy group. rx canada pharmacy

Overdose: Symptoms and Treatment: There are no data available from clinical trials on overdose with Advair (salmeterol/fluticasone); however, data on overdose with individual drugs are given below. rx canada pharmacy

The signs and symptoms of salmeterol overdose are: tremor, headache, tachycardia, cardiac arrhythmias, hypokalemia, hypertension and, in extreme cases, sudden death. Treatment should be symptomatic; cardiac and respiratory function should be monitored and support provided if necessary. The preferred antidote is the judicious use of a cardioselective beta-blocking agent. Cardioselective beta-blocking drugs should be used with caution, bearing in mind the danger of inducing an asthmatic attack. Serum potassium level should be monitored. If Advair therapy has to be withdrawn due to overdose of the beta-agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. rx canada pharmacy

Inhalation of fluticasone doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function recovers in a few days and can be verified by measuring plasma cortisol. However, if higher than recommended dosage is continued over prolonged periods, some degree of adrenal suppression may result. Monitoring of adrenal reserve may be necessary. In cases of fluticasone overdose, Advair therapy may still be continued at a suitable dosage for symptom control. rx canada pharmacy


Dosage: Should not be used to treat acute symptoms. It is crucial to inform patients of this and prescribe a short-acting beta ₂-agonist for this purpose. Medical attention should be sought if patients find that short-acting relief bronchodilator treatment becomes less effective or if they need more inhalations than usual. Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under medical supervision. rx canada pharmacy

As twice-daily regular treatment, Advair provides 24-hour bronchodilation and can replace regular use of a fast-acting, short duration (4-hour) inhaled or oral bronchodilator (e.g., salbutamol). Short-acting beta ₂-agonists should be used only to relieve acute asthma symptoms (see Precautions). rx canada pharmacy

Patients should be regularly reassessed so that the strength of Advair they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose of fluticasone at which effective control of symptoms is maintained. rx canada pharmacy

The patient should be made aware that for optimum benefit, Advair should be taken regularly, even when asymptomatic. rx canada pharmacy

As a general rule, rinsing the mouth and gargling with water after each inhalation can help in preventing the occurrence of candidiasis. Cleansing dentures has the same effect. rx canada pharmacy

Advair Diskus is to be administered by oral inhalation only. rx canada pharmacy

Adults and adolescents over 12 years of age: 1 inhalation Advair 100 Diskus (50 µg salmeterol and 100 µg fluticasone propionate) twice daily; or 1 inhalation Advair 250 Diskus (50 µg salmeterol and 250 µg fluticasone propionate) twice daily; or 1 inhalation Advair 500 Diskus (50 µg salmeterol and 500 µg fluticasone propionate) twice daily. rx canada pharmacy

Children (4 to 11 years of age): 1 inhalation Advair 100 Diskus (50 µg salmeterol and 100 µg fluticasone propionate) twice daily. rx canada pharmacy

General Considerations: At present, there are insufficient clinical data to recommend the use of Advair in children younger than 4 years of age. rx canada pharmacy

Geriatrics and Patients with Impaired Renal Function: There is no need to adjust the dose in the otherwise healthy elderly or in patients with impaired renal function (see Precautions, Drug Interactions). Because salmeterol is predominantly cleared by hepatic metabolism, it should be used with caution in patients with hepatic disease. rx canada pharmacy

Information for the Patient: See Blue Section--Information for the Patient Advair Diskus. rx canada pharmacy


Supplied: Advair 100 Diskus: A plastic inhaler device containing a foil strip with 60 blisters. Each blister contains 50 µg of salmeterol (as the xinafoate salt) and 100 µg of fluticasone propionate. Nonmedicinal ingredients: lactose (which acts as a carrier). rx canada pharmacy

Advair 250 Diskus: A plastic inhaler device containing a foil strip with 60 blisters. Each blister contains 50 µg of salmeterol (as the xinafoate salt) and 250 µg of fluticasone propionate. Nonmedicinal ingredients: lactose (which acts as a carrier). rx canada pharmacy

Advair 500 Diskus: A plastic inhaler device containing a foil strip with 60 blisters. Each blister contains 50 µg of salmeterol (as the xinafoate salt) and 500 µg of fluticasone propionate. Nonmedicinal ingredients: lactose (which acts as a carrier). rx canada pharmacy

Do not store Advair Diskus above 30°C. Keep in a dry place.

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