For the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) including emphysema and chronic bronchitis.
Salmeterol Xinafoate is a selective, long-acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airway obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose. Salmeterol protects against symptoms, Fluticasone Propionate improves lung function and prevents exacerbations of the condition. This preparation can offer a more convenient regime for patients on concurrent β-agonist and inhaled corticosteroid therapy. The respective mechanisms of action of both drugs are discussed below:
Salmeterol: Salmeterol is a selective long-acting (12-hour) beta-2-adrenoceptor agonist with a long side chain that binds to the exo-site of the receptor.
Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, without the adverse effects observed when corticosteroids are administered systemically.
Asthma
Adults and Adolescents (12 years and older): 50/100, 50/250, 50/500 : One Inhalation twice daily
Children (4 years and older):50/100: One Inhalation twice daily
The maximum licensed dose of fluticasone propionate delivered by in children is 100 mg twice daily.
There are no data available for use of inhaler in children aged under 4 years.
COPD
Adults: 50/500: One Inhalation twice daily
Please discuss with physician your dosage and how to use.
Both non-selective and selective β-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. 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.
Not for primary treatment of status asthmaticus or other acute attacks of asthma. Pulmonary TB, severe CV disorders, heart rhythm abnormalities, DM, thyrotoxicosis, hypokalaemia. Patients at risk of decreased bone mineral content (e.g. smoking, old age, sedentary lifestyle, poor nutrition, family history of osteoporosis or long term use of drugs that may decrease bone mass (e.g. anticonvulsants & corticosteroids). Do not stop therapy abruptly; therapy should be down titrated. Advise patient to rinse mouth after inhalation. Monitor height of child on prolonged therapy. Pregnancy, lactation.
Mouth & throat candidiasis, throat irritation, hoarseness/dysphonia, nasopharyngitis, lower resp tract infections (e.g. pneumonia & bronchitis), hypokalaemia, headache, tremors, palpitation, muscle cramps. Prolonged high dose use may cause Gushing’s syndrome, Cushingoid features, adrenal suppression, retardation of growth in child & adolescents, BMD decrease, cataract & glaucoma. Paradoxical bronchospasm.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and any potential adverse effects on the breastfed child.
No human over dosage data has been reported for this combination inhaler; however data on overdose with both drugs are given below:
Salmeterol: The signs and symptoms of Salmeterol overdose are seizures, angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Other signs of overdosage may include hypokalemia and hyperglycemia. Treatment consists of discontinuation of Salmeterol together with appropriate cardioselective beta-blocking agents, which should be used with caution in patients with a history of bronchospasm.
Fluticasone Propionate: Acute inhalation of Fluticasone Propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days. Chronic overdose of inhaled Fluticasone Propionate may lead to adrenal suppression. Monitoring of adrenal reserve may be necessary. In cases of Fluticasone Propionate overdose this combination inhaler therapy may still be continued at a suitable dosage for symptom control.
Pressurised canister, do not puncture, break or incinerate even when apparently empty. Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from eyes. Keep away from children.
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