Indications
Seroxyn ® inhaler is indicated in the regular treatment of asthma where use of a combination (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 corticosteroids and long acting beta-2 agonist.
Dosage and Administration
Adults and adolescents aged 12 years and older:
Seroxyn ® 25/125 Inhaler- 2 inhalations (puffs) twice a day. or,
Seroxyn ® 25/250 Inhaler- 2 inhalations (puffs) twice a day.
Side Effects
As the combination inhaler 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 or Fluticasone Propionate, are given below: 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. Cardiac arrhythmia (including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions including rash, oedema and angio-oedema. There have been also reports of oropharyngeal irritation. There have been rare reports of muscle cramps.
Only for the use of medical professionals Fluticasone Propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after use of Salmeterol/ Fluticasone Propionate Inhaler. Symptomatic candidiasis can be treated
with topical anti-fungal therapy whilst still continuing with this combination inhaler.
Precautions
Consideration should be given to additional corticosteroid therapies and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, this combination inhaler should be administered with caution in patients with active or quiescent pulmonary tuberculosis. This combination inhaler should be administered with caution in patients with thyrotoxicosis. Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long term effects of this reduction including the impact of final adult height are unknown.
Pregnancy and lactation
There is insufficient experience of the use of Salmeterol Xinafoate & Fluticasone Propionate in human pregnancy & lactation. Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
Contraindications
This combination inhaler is contraindicated in patients with a history of hypersensitivity to any of the ingredients.
Drug Interactions
Care should be taken when co administering known strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
Both non-selective and selective beta-2 blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely.
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