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Indications/Uses
Asthma (Reversible Obstructive Airway Disease): Salmeterol + Fluticasone propionate (Seretide) is indicated in the regular treatment of asthma (Reversible Obstructive Airways Disease).
This may include: Patients on effective maintenance doses of long-acting beta-agonists and inhaled corticosteroids.
Patients who are symptomatic on current inhaled corticosteroid therapy.
Patients on regular bronchodilator therapy who require inhaled corticosteroids.
Chronic Obstructive Pulmonary Disease (COPD): Salmeterol + Fluticasone propionate (Seretide) is indicated for the regular treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.
This may include: Patients on effective maintenance doses of long-acting beta-agonists and inhaled corticosteroids.
Patients who are symptomatic on current inhaled corticosteroid therapy.
Patients on regular bronchodilator therapy who require inhaled corticosteroids.
Chronic Obstructive Pulmonary Disease (COPD): Salmeterol + Fluticasone propionate (Seretide) is indicated for the regular treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.
Dosage/Direction for Use
Salmeterol + Fluticasone propionate (Seretide) is for inhalation only.
Patients should be made aware that Salmeterol + Fluticasone propionate (Seretide) must be used regularly for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of Salmeterol + Fluticasone propionate (Seretide) they are receiving remains optimal and is only changed on medical advice.
Asthma (Reversible Obstructive Airways Disease): The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with twice daily Salmeterol + Fluticasone propionate (Seretide), titration to the lowest effective dose could include Salmeterol + Fluticasone propionate (Seretide) given once daily.
Patients should be given the strength of Salmeterol + Fluticasone propionate (Seretide) containing the appropriate fluticasone propionate dosage for the severity of their disease.
If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Seretide) at a therapeutically equivalent corticosteroid dose may result in an improvement in asthma control. For patients whose asthma control is acceptable on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Seretide) may permit a reduction in corticosteroid dose while maintaining asthma control.
Recommended Doses: There are no data available for use of Salmeterol + Fluticasone propionate (Seretide) in children aged under 4 years.
Diskus: Adults and adolescents 12 years and older: One inhalation (50 micrograms salmeterol and 100 micrograms fluticasone propionate) twice daily or One inhalation (50 micrograms salmeterol and 250 micrograms fluticasone propionate) twice daily or One inhalation (50 micrograms salmeterol and 500 micrograms fluticasone propionate) twice daily.
Children 4 years and older: One inhalation (50 micrograms salmeterol and 100 micrograms fluticasone propionate) twice daily.
MDI: Adults and adolescents 12 years and older: Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily or Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily or Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
Children 4 years and older: Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.
Chronic Obstructive Pulmonary Disease (COPD): Diskus: For adult patients the recommended dose is one inhalation 50/250 micrograms to 50/500 micrograms salmeterol/fluticasone propionate twice daily.
MDI: For adult patients the recommended dose is two inhalations 25/125 micrograms to 25/250 micrograms salmeterol/fluticasone propionate twice daily.
Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.
Patients should be made aware that Salmeterol + Fluticasone propionate (Seretide) must be used regularly for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of Salmeterol + Fluticasone propionate (Seretide) they are receiving remains optimal and is only changed on medical advice.
Asthma (Reversible Obstructive Airways Disease): The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with twice daily Salmeterol + Fluticasone propionate (Seretide), titration to the lowest effective dose could include Salmeterol + Fluticasone propionate (Seretide) given once daily.
Patients should be given the strength of Salmeterol + Fluticasone propionate (Seretide) containing the appropriate fluticasone propionate dosage for the severity of their disease.
If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Seretide) at a therapeutically equivalent corticosteroid dose may result in an improvement in asthma control. For patients whose asthma control is acceptable on inhaled corticosteroid therapy alone, substitution with Salmeterol + Fluticasone propionate (Seretide) may permit a reduction in corticosteroid dose while maintaining asthma control.
Recommended Doses: There are no data available for use of Salmeterol + Fluticasone propionate (Seretide) in children aged under 4 years.
Diskus: Adults and adolescents 12 years and older: One inhalation (50 micrograms salmeterol and 100 micrograms fluticasone propionate) twice daily or One inhalation (50 micrograms salmeterol and 250 micrograms fluticasone propionate) twice daily or One inhalation (50 micrograms salmeterol and 500 micrograms fluticasone propionate) twice daily.
Children 4 years and older: One inhalation (50 micrograms salmeterol and 100 micrograms fluticasone propionate) twice daily.
MDI: Adults and adolescents 12 years and older: Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily or Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily or Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
Children 4 years and older: Two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily.
Chronic Obstructive Pulmonary Disease (COPD): Diskus: For adult patients the recommended dose is one inhalation 50/250 micrograms to 50/500 micrograms salmeterol/fluticasone propionate twice daily.
MDI: For adult patients the recommended dose is two inhalations 25/125 micrograms to 25/250 micrograms salmeterol/fluticasone propionate twice daily.
Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal or hepatic impairment.
Overdosage
The available information on overdose with Salmeterol + Fluticasone propionate (Seretide), salmeterol and/or fluticasone propionate is given as follows: The expected symptoms and signs of salmeterol overdosage are those typical of excessive beta2-adrenergic stimulation, including tremor, headache, tachycardia, increases in systolic blood pressure and hypokalaemia. There is no specific treatment for an overdose of salmeterol and fluticasone propionate. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Acute inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action as normal adrenal function typically recovers within a few days.
If higher than approved doses of Salmeterol + Fluticasone propionate (Seretide) are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis, mainly occurring in children exposed to higher than approved doses over prolonged periods (several months or years); observed features have included hypoglycaemia associated with decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in the dosage of the inhaled fluticasone propionate component.
It is not recommended that patients receive higher than approved doses of Salmeterol + Fluticasone propionate (Seretide). It is important to review therapy regularly and titrate down to the lowest approved dose at which effective control of disease is maintained (see Dosage & Administration).
Acute inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary-adrenal axis. This does not usually require emergency action as normal adrenal function typically recovers within a few days.
If higher than approved doses of Salmeterol + Fluticasone propionate (Seretide) are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis, mainly occurring in children exposed to higher than approved doses over prolonged periods (several months or years); observed features have included hypoglycaemia associated with decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in the dosage of the inhaled fluticasone propionate component.
It is not recommended that patients receive higher than approved doses of Salmeterol + Fluticasone propionate (Seretide). It is important to review therapy regularly and titrate down to the lowest approved dose at which effective control of disease is maintained (see Dosage & Administration).
Contraindications
Salmeterol + Fluticasone propionate (Seretide) is contraindicated in patients with a history of hypersensitivity to any of the ingredients (see Description).
Special Precautions
Salmeterol + Fluticasone propionate (Seretide) is not for relief of acute symptoms for which a fast and short-acting bronchodilator (e.g. salbutamol) is required. Patients should be advised to have their relief medication available at all times.
Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should be reviewed by a physician. Consideration should be given to increasing corticosteroid therapy. Also, where the current dosage of Salmeterol + Fluticasone propionate (Seretide) has failed to give adequate control of asthma, the patient should be reviewed by a physician.
Treatment with Salmeterol + Fluticasone propionate (Seretide) should not be stopped abruptly in patients with asthma due to the risk of exacerbation, therapy should be titrated-down under physician supervision. For patients with COPD, cessation of therapy may be associated with symptomatic decompensation and should be supervised by a physician.
There was an increased reporting of pneumonia in studies of patients with COPD receiving Salmeterol + Fluticasone propionate (Seretide) (see Adverse Reactions). Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap.
As with all inhaled medication containing corticosteroids, Salmeterol + Fluticasone propionate (Seretide) should be administered with caution in patients with active or quiescent pulmonary tuberculosis.
Salmeterol + Fluticasone propionate (Seretide) should be administered with caution in patients with thyrotoxicosis.
Cardiovascular effects such as increases in systolic blood pressure and heart rate, may occasionally be seen with all sympathomimetic drugs, especially at higher than therapeutic doses. For this reason, Salmeterol + Fluticasone propionate (Seretide) should be used with caution in patients with pre-existing cardiovascular disease.
A transient decrease in serum potassium may occur with all sympathomimetic drugs at higher therapeutic doses. Therefore, Salmeterol + Fluticasone propionate (Seretide) should be used with caution in patients predisposed to low levels of serum potassium.
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 (see Overdosage). Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and central serous chorioretinopathy. It is important, therefore for asthma patients, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained.
The possibility of impaired adrenal response should always be borne in mind in emergency and elective situations likely to produce stress and appropriate corticosteroid treatment considered (see Overdosage).
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
Because of the possibility of impaired adrenal response, patients transferring from oral steroid therapy to inhaled fluticasone propionate therapy should be treated with special care, and adrenocortical function regularly monitored.
Following introduction of inhaled fluticasone propionate, withdrawal of systemic therapy should be gradual and patients encouraged to carry a steroid warning card indicating the possible need for additional therapy in times of stress.
There have been very rare reports of increases in blood glucose levels (see Adverse Reactions) and this should be considered when prescribing to patients with a history of diabetes mellitus.
During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects.
It was observed in a drug interaction study that concomitant use of systemic ketoconazole increases exposure to Salmeterol (Serevent). This may lead to prolongation in the QTc interval. Caution should be exercised when strong CYP3A4 inhibitors (e.g. ketoconazole) are co-administered with Salmeterol (Serevent).
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. Salmeterol-FP Accuhaler/Diskus or Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary (see Adverse Reactions).
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 to reduce with regular therapy (see Adverse Reactions).
Effects on Ability to Drive and Use Machines: There have been no specific studies of the effect of Salmeterol + Fluticasone propionate (Seretide) on the previously mentioned activities, but the pharmacology of both drugs does not indicate any effect.
Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should be reviewed by a physician. Consideration should be given to increasing corticosteroid therapy. Also, where the current dosage of Salmeterol + Fluticasone propionate (Seretide) has failed to give adequate control of asthma, the patient should be reviewed by a physician.
Treatment with Salmeterol + Fluticasone propionate (Seretide) should not be stopped abruptly in patients with asthma due to the risk of exacerbation, therapy should be titrated-down under physician supervision. For patients with COPD, cessation of therapy may be associated with symptomatic decompensation and should be supervised by a physician.
There was an increased reporting of pneumonia in studies of patients with COPD receiving Salmeterol + Fluticasone propionate (Seretide) (see Adverse Reactions). Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbation frequently overlap.
As with all inhaled medication containing corticosteroids, Salmeterol + Fluticasone propionate (Seretide) should be administered with caution in patients with active or quiescent pulmonary tuberculosis.
Salmeterol + Fluticasone propionate (Seretide) should be administered with caution in patients with thyrotoxicosis.
Cardiovascular effects such as increases in systolic blood pressure and heart rate, may occasionally be seen with all sympathomimetic drugs, especially at higher than therapeutic doses. For this reason, Salmeterol + Fluticasone propionate (Seretide) should be used with caution in patients with pre-existing cardiovascular disease.
A transient decrease in serum potassium may occur with all sympathomimetic drugs at higher therapeutic doses. Therefore, Salmeterol + Fluticasone propionate (Seretide) should be used with caution in patients predisposed to low levels of serum potassium.
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 (see Overdosage). Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and central serous chorioretinopathy. It is important, therefore for asthma patients, that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control is maintained.
The possibility of impaired adrenal response should always be borne in mind in emergency and elective situations likely to produce stress and appropriate corticosteroid treatment considered (see Overdosage).
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
Because of the possibility of impaired adrenal response, patients transferring from oral steroid therapy to inhaled fluticasone propionate therapy should be treated with special care, and adrenocortical function regularly monitored.
Following introduction of inhaled fluticasone propionate, withdrawal of systemic therapy should be gradual and patients encouraged to carry a steroid warning card indicating the possible need for additional therapy in times of stress.
There have been very rare reports of increases in blood glucose levels (see Adverse Reactions) and this should be considered when prescribing to patients with a history of diabetes mellitus.
During post-marketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects.
It was observed in a drug interaction study that concomitant use of systemic ketoconazole increases exposure to Salmeterol (Serevent). This may lead to prolongation in the QTc interval. Caution should be exercised when strong CYP3A4 inhibitors (e.g. ketoconazole) are co-administered with Salmeterol (Serevent).
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. Salmeterol-FP Accuhaler/Diskus or Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary (see Adverse Reactions).
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 to reduce with regular therapy (see Adverse Reactions).
Effects on Ability to Drive and Use Machines: There have been no specific studies of the effect of Salmeterol + Fluticasone propionate (Seretide) on the previously mentioned activities, but the pharmacology of both drugs does not indicate any effect.
Use In Pregnancy & Lactation
There are no data on human fertility.
Animal studies indicate no effects of fluticasone propionate or salmeterol xinafoate on male or female fertility. There are limited data in pregnant women. Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
Results from a retrospective epidemiological study did not find an increased risk of major congenital malformations (MCMs) following exposure to fluticasone propionate when compared to other inhaled corticosteroids, during the first trimester of pregnancy.
Reproductive toxicity studies in animals, either with single drug or in combination, revealed the foetal effects expected at excessive systemic exposure levels of a potent beta2-adrenoreceptor agonist and glucocorticosteroid. Extensive clinical experience with drugs in these classes has revealed no evidence that the effects are relevant at therapeutic doses. Salmeterol and fluticasone propionate concentrations in plasma after inhaled therapeutic doses are very low and therefore concentrations in human breast milk are likely to be correspondingly low. This is supported by studies in lactating animals, in which low drug concentrations were measured in milk. There are no data available for human breast milk.
Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Animal studies indicate no effects of fluticasone propionate or salmeterol xinafoate on male or female fertility. There are limited data in pregnant women. Administration of drugs during pregnancy should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
Results from a retrospective epidemiological study did not find an increased risk of major congenital malformations (MCMs) following exposure to fluticasone propionate when compared to other inhaled corticosteroids, during the first trimester of pregnancy.
Reproductive toxicity studies in animals, either with single drug or in combination, revealed the foetal effects expected at excessive systemic exposure levels of a potent beta2-adrenoreceptor agonist and glucocorticosteroid. Extensive clinical experience with drugs in these classes has revealed no evidence that the effects are relevant at therapeutic doses. Salmeterol and fluticasone propionate concentrations in plasma after inhaled therapeutic doses are very low and therefore concentrations in human breast milk are likely to be correspondingly low. This is supported by studies in lactating animals, in which low drug concentrations were measured in milk. There are no data available for human breast milk.
Administration during lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Adverse Reactions
MDI: All of the adverse reactions associated with the individual components, salmeterol xinafoate and fluticasone propionate, are listed as follows. There are no additional adverse reactions attributed to the combination product when compared to the adverse event profiles of the individual components.
Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000). The majority of frequencies were determined from pooled clinical trial data from 23 asthma and 7 COPD studies. Not all events were reported in clinical trials. For these events, the frequency was calculated based on spontaneous data.
Clinical Trial Data: Very common: Headache (see Precautions). Common: Candidiasis of mouth and throat, pneumonia (in COPD patients), hoarseness/dysphonia, muscle cramps, arthralgia; Uncommon: cutaneous hypersensitivity reactions, dyspnoea, cataract, hyperglycemia, anxiety, sleep disorders, tremor (see Precautions), palpitations (see Precautions), tachycardia, atrial fibrillation, throat irritation, contusions; Rare: Anaphylactic reactions, glaucoma, behavioural changes, including hyperactivity and irritability (predominantly in children), cardiac arrhythmias including supraventricular tachycardia and extrasystoles, angioedema (mainly facial and oropharyngeal oedema) and bronchospasm, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, paradoxical bronchospasm (see Precautions), oesophageal candidiasis.
Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000) and very rare (<1/10,000). The majority of frequencies were determined from pooled clinical trial data from 23 asthma and 7 COPD studies. Not all events were reported in clinical trials. For these events, the frequency was calculated based on spontaneous data.
Clinical Trial Data: Very common: Headache (see Precautions). Common: Candidiasis of mouth and throat, pneumonia (in COPD patients), hoarseness/dysphonia, muscle cramps, arthralgia; Uncommon: cutaneous hypersensitivity reactions, dyspnoea, cataract, hyperglycemia, anxiety, sleep disorders, tremor (see Precautions), palpitations (see Precautions), tachycardia, atrial fibrillation, throat irritation, contusions; Rare: Anaphylactic reactions, glaucoma, behavioural changes, including hyperactivity and irritability (predominantly in children), cardiac arrhythmias including supraventricular tachycardia and extrasystoles, angioedema (mainly facial and oropharyngeal oedema) and bronchospasm, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, paradoxical bronchospasm (see Precautions), oesophageal candidiasis.
Drug Interactions
Avoid use w/ non-selective & selective β-blockers. Increased plasma conc w/ ritonavir. Increased systemic exposure w/ ketoconazole.
Storage
Diskus: Store at temperatures not exceeding 30°C. Store in a dry place.
The Diskus is sealed in a foil overwrap which should only be opened when it is to be used for the first time. Once opened, the foil overwrap should be discarded.
MDI: Replace the mouthpiece cover firmly and snap it into position.
Salmeterol + Fluticasone propionate (Seretide) should be stored at temperatures not exceeding 30°C.
Protect from frost and direct sunlight.
As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold
The Diskus is sealed in a foil overwrap which should only be opened when it is to be used for the first time. Once opened, the foil overwrap should be discarded.
MDI: Replace the mouthpiece cover firmly and snap it into position.
Salmeterol + Fluticasone propionate (Seretide) should be stored at temperatures not exceeding 30°C.
Protect from frost and direct sunlight.
As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold
Action
Beta2-adrenoreceptor agonist/Corticosteroid.
MedsGo Class
Antiasthmatic & COPD Preparations
Features
Brand
Seretide 500 Diskus
Full Details
Dosage Strength
50mcg / 250mcg / dose
Drug Ingredients
- Fluticasone
- Salmeterol
Drug Packaging
Dry Powder for Inhalation 60 doses
Generic Name
Salmeterol (Xinafoate) / Fluticasone Propionate
Dosage Form
Dry Powder For Inhalation
Registration Number
DR-XY25841
Drug Classification
Prescription Drug (RX)