Seretide - Information, specialists, frequent questions.

Usage of Seretide

Indications: Seretide Evohaler is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: -patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist or -patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist
Contra Indications: Seretide is contraindicated in patients with hypersensitivity to any of the active substances or to the excipient

Adverse and side effects

As Seretide contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds. Adverse events which have been associated with salmeterol/fluticasone propionate are given below, listed by system organ class and frequency. Frequencies are defined as: very common (= 1/10), common (= 1/100 and < 1/10), uncommon (= 1/1000 and < 1/100), and very rare (< 1/10,000) including isolated reports. Very common, common and uncommon events were derived from clinical trial data. The incidence in placebo was not taken into account. Very rare events were derived from post-marketing spontaneous data. Infections and Infestations:- Candidiasis of the mouth and throat - Common, Pneumonia - *#Common, Bronchitis - *#Common Immune System Disorders:- Hypersensitivity reactions with the following manifestations: Cutaneous hypersensitivity reactions - Uncommon, Angioedema (mainly facial and oropharyngeal oedema), Respiratory symptoms (dyspnoea and/or bronchospasm), Anaphylactic reactions including anaphylactic shock - Very Rare Endocrine Disorders:- Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density, Cataract, Glaucoma - Very Rare Metabolism and Nutrition Disorders:- Hypokalaemia - #Common, Hyperglycaemia - Very Rare. Psychiatric Disorders:- Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children) - Very Rare Nervous System Disorders:- Headache - *Very Common, Tremor - Common. Cardiac Disorders:- Palpitations - Common, Tachycardia - Uncommon. Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) - Very Rare. Respiratory, Thoracic and Mediastinal Disorders:- Nasopharyngitis - **#Very Common. Throat irritation - Common, Hoarseness/dysphonia - Common, Sinusitis - *#Common, Paradoxical bronchospasm - Very Rare. Skin and subcutaneous tissue disorder:- Contusions - *#Common. Musculoskeletal and Connective Tissue Disorders:- Muscle cramps - Common. Traumatic fractures - *#Common, Arthralgia - Very Rare, Myalgia - Very Rare. *Reported commonly in placebo ** Reported very commonyly in placebo # Reported over 3 years in a COPD study The pharmacological side effects of beta-2-agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients.Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Seretide Evohaler. Pneumonia was reported in studies of patients with Chronic Obstructive Pulmonary Disease (COPD). Possible systemic effects include Cushing's syndrome, Cushingoid features,adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (See Special Precautions). There have been very rare reports of hyperglycaemia (See Special Precautions). As with other inhalation therapy, paradoxical bronchospasm may occur (See Special Precautions)

Special precautions

The management of asthmashould normally follow a stepwise programmeand patient response should be monitored clinically and by lung function tests. Seretide Evohaler should not be used to treatacute asthmasymptoms for which a fast and short acting bronchodilator is required. Patients should be advised to have their medicinal product to be used for relief in an acute asthma attack available at all times. Patients should not be initiated on Seretide during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with Seretide. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Seretide. Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma 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 undergo urgent medical assessment.Consideration should be given to increasing corticosteroid therapy. The patient should also be medically reviewed where the current dosage of Seretide has failed to give adequate control of asthma. Consideration should be given to additional corticosteroid therapies. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Seretide. Regular review of patients as treatment is stepped down is important. The lowest effective dose of Seretide should be used (See Adult Dosage). Treatment with Seretide should not be stopped abruptly. As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis. Rarely, Seretidemay cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Therefore Seretide should beusedwith caution in patients with severe cardiovascular disorders, heart rhythm abnormalities, diabetes mellitus,thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium. 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. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. Seretide Evohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Care should be taken when transferring patients to Seretide therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy. 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 Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained. It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Children and adolescents <16years taking high doses of fluticasone (typically 1000mcg/day) may be at particular risk. Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000mcg. Situations, which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage. Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Systemic absorption of salmeterol and fluticasone propionate is largely through the lungs. As the use of a spacer device with a metered dose inhaler may increase drug delivery to the lungs it should be noted that this could potentially lead to an increase in the risk of systemic adverse effects. Single dose pharmacokinetic data have demonstrated that the systemic exposure to salmeterol and fluticasone propionate may be increased as much as two-fold when the AeroChamber Plus spacer device is used with Seretide inhaleras compared with the Volumatic spacer device. The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk. This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered. The extent of the adrenal impairment may require specialist advice before elective procedures. Ritonavir can greatly increase the concentration of fluticasone propionate in plasma. Therefore, concomitant use should be avoided, unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side-effects. There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors (See Interactions). There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in a 3 year study in patients with Chronic Obstructive Pulmonary Disease (COPD) receiving Seretide compared with placebo (See Adverse Reactions). In a 3 year COPD study, older patients, patients with a lower body mass index (<25kg/m2) and patients with very severe disease (FEV1<30% predicted) were at greatest risk of developing pneumonia regardless of treatment.Physicians should remain vigilant for the possible development of pneumonia and other lower respiratory tract infections in patients with COPD as the clinical features of such infections and exacerbation frequently overlap. If a patient with severe COPD has experienced pneumonia the treatment with Seretide should be re-evaluated. Data from a large clinical trial (the Salmeterol Multi-Center Asthma Research Trial, SMART) suggested African-American patients were at increased risk of serious respiratory-related events or deaths when using salmeterol compared with placebo. It is not known if this was due to pharmacogenetic or other factors. Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remained uncontrolled or worsen whilst using Seretide

Questions about Seretide

Our experts have answered 1 questions about Seretide

Dr. Bushra Ibrahim Al-Rubeyi
Dr. Bushra Ibrahim Al-Rubeyi
Paediatrician
London
Aggression with inhaled steriods for asthma treatment have been reported together with hyperactivity and irritability. You did not mention your son's age and if he is teenager then this…
1 answers

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