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Deterioration of Disease and Acute Episodes: Seretide Evohaler DC should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Seretide Evohaler DC has not been studied in subjects with acutely deteriorating asthma or COPD. The initiation of Seretide Evohaler DC in this setting is not appropriate.
Seretide Evohaler DC 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.
When beginning treatment with Seretide Evohaler DC, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.
Excessive Use of Seretide Evohaler DC and Use with Other Long-Acting Beta2-Agonists: Seretide Evohaler DC should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using Seretide Evohaler DC should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason.
Local Effects of Inhaled Corticosteroids: In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in subjects treated with Seretide Evohaler DC. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with Seretide Evohaler DC continues, but at times therapy with Seretide Evohaler DC may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following inhalation to help reduce the risk of oropharyngeal candidiasis.
Pneumonia: There was an increased reporting of pneumonia in studies of patients with COPD receiving 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.
Transferring Patients from Systemic Corticosteroid Therapy: 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.
Hypercorticism and Adrenal Suppression: Fluticasone propionate, a component of Seretide Evohaler DC, will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since fluticasone propionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of Seretide Evohaler DC in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. A relationship between plasma levels of fluticasone propionate and inhibitory effects on stimulated cortisol production has been shown after 4 weeks of treatment with fluticasone propionate inhalation aerosol. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing Seretide Evohaler DC.
Because of the possibility of significant systemic absorption of inhaled corticosteroids in sensitive patients, patients treated with Seretide accuhaler should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response.
It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients who are sensitive to these effects. If such effects occur, Seretide Evohaler DC should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids, and other treatments for management of asthma symptoms should be considered.
Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: It was observed in a drug interaction study that concomitant use of systemic ketoconazole increases exposure to 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 SEREVENT (see Interactions, and Pharmacology: Pharmacokinetics under Actions).
Paradoxical Bronchospasm and Upper Airway Symptoms: 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). Upper airway symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported in patients receiving Seretide accuhaler.
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of Seretide Evohaler DC.
Cardiovascular and Central Nervous System Effects: Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia (see Overdosage). Therefore, Seretide Evohaler DC, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Salmeterol, a component of Seretide Evohaler DC, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of salmeterol at recommended doses, if they occur, the drug may need to be discontinued.
Reduction in Bone Mineral Density: Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care.
Effect on Growth: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving Seretide Evohaler DC routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including Seretide Evohaler DC, titrate each patient's dosage to the lowest dosage that effectively controls his/her symptoms (see Special patient groups under Dosage & Administration).
Glaucoma and Cataracts: Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including fluticasone propionate, a component of Seretide Evohaler DC. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Other: 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 SERETIDE has failed to give adequate control of asthma, the patient should be reviewed by a physician.
Treatment with SERETIDE should not be stopped abruptly in patients with asthma due to 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.
SERETIDE should be administered with caution in patients with thyrotoxicosis.
A transient decrease in serum potassium may occur with all sympathomimetic drugs at higher therapeutic doses. Therefore, SERETIDE should be used with caution in 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.
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 SERETIDE on the above activities, but the pharmacology of both drugs does not indicate any effect. Of note, the common adverse reactions of this drug include headache, muscle cramps, arthralgia, traumatic fractures and myalgia. In addition, it may also have the following adverse reactions such as tremor, anxiety, sleep disorders, dyspnoea, facial and oropharyngeal oedema, bronchospasm, palpitations, tachycardia, atrial fibrillation, angina pectoris.
