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Hence, it should be used with extreme caution in patients susceptible to bone injuries. You can also report side effects directly via the national pharmacovigilance program of India by calling on 1800 180 3024.By reporting side-effects, you can help provide more information on the safety of this product.An overdose of formoterol would likely lead to effects that are typical for betaAcute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem. It is advisable to consult your doctor before consumption.Interaction with alcohol is unknown. However, an initial small but transient reduction in growth (approximately 1 cm) has been observed. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include formoterol/budesonide combination given once daily, when in the opinion of the prescriber, a long-acting bronchodilator would be required to maintain control.It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.Use of long-acting beta -adrenergic agonist (LABA) as monotherapy (without inhaled corticosteroids ) for asthma is associated with an increased risk of asthma related death. If paradoxical bronchospasm occurs following dosing with formoterol/ budesonide combination, it should be treated immediately with an inhaled, short-acting bronchodilator, formoterol/ budesonide combination should be discontinued immediately, and alternative therapy should be instituted.Immediate hypersensitivity reactions may occur after administration of formoterol/ budesonide combination, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm.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. You should check all the possible interactions with your doctor before starting any medicine.Interaction with alcohol is unknown. 2018 [cited 19 June 2018]. It has a high ratio of topical to systemic activity.Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity. If such effects occur, the dosage of formoterol/budesonide combination should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms.As with other inhaled medications, formoterol/ budesonide combination can produce paradoxical bronchospasm, which may be life threatening. After oral administration of budesonide, peak plasma concentration was achieved in about 1-2 hours and the absolute systemic availability was 6–13%, due to extensive first pass metabolism. Protein binding was constant over the concentration range (1-100 nmol/L) achieved with, and exceeding, recommended inhaled doses. An inhaled, short-acting beta -agonist, not When beginning treatment with formoterol/budesonide combination, patients who have been taking oral or inhaled, short-acting beta -agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs.As with other inhaled drugs containing beta -adrenergic agents, formoterol/budesonide combination should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABA, as an overdose may result. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. In addition consideration should be given to referring the patient to a pediatric respiratory specialist.Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide will ultimately achieve their adult target height. In animal studies formoterol has caused adverse effects in reproduction studies at very high systemic exposure levels.Data on approximately 2000 exposed pregnancies indicate no increased teratogenic risk associated with the use of inhaled budesonide. Not more than 6 inhalations should be taken on any single occasion.A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up of 12 inhalations could be used for a limited period. The accumulation index for the group that received two inhalations twice daily was 1.32 for budesonide.In a repeat dose study, the highest recommended dose of formoterol/budesonide combination (160/4.5 mcg, two inhalations twice daily) was administered to patients with moderate asthma and healthy subjects for 1 week. CiplaMed. The initiation of formoterol/budesonide combination in this setting is not appropriate.Increasing use of inhaled, short-acting beta -agonists is a marker of deteriorating asthma.

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