Seroxyn Acucap^®

Seroxyn ® Acucap is a combination of Salmeterol Xinafoate and Fluticasone Propionate. Salmeterol Xinafoate is a selective, long acting β₂ agonist; it attaches to β₂ receptors on the smooth muscle cells that surround the airways, causing the muscle cells to relax and opening the airways. Fluticasone Propionate is a synthetic corticosteroid which is a glucocorticoid receptor agonist with mainly potent anti-inflammatory activity.

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Seroxyn ® Acucap is indicated for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β₂ adrenoceptor agonist) is appropriate and in patients with severe COPD.

Asthma
Adult and Child over 5 years:
Seroxyn ® 50/100 Acucap Inhaler-1 Acucap twice daily.

Adult and Child over 12 years:
Seroxyn ® 50/100 Acucap Inhaler-1 Acucap twice daily.
Seroxyn ® 50/250 Acucap Inhaler-1 Acucap twice daily.
Seroxyn ® 50/500 Acucap Inhaler-1 Acucap twice daily.

COPD
Seroxyn ® 50/250 Acucap Inhaler-1 Acucap twice daily.
Seroxyn ® 50/500 Acucap Inhaler-1 Acucap twice daily.

There is insufficient experience of the use of this combination in human pregnancy & lactation. Administration of this combination 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.

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. Thiscombination inhaler should be administered with caution in patients with thyrotoxicosis.

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 isno 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 β₂ 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 and oropharyngeal irritation.
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.

This combination inhaler is contraindicated in patients with a known history of hypersensitivity to any of the ingredients.

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 β blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrationsachieved after inhaled dosing clinically significant drug interactions are unlikely.

No human overdosage 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 cardio selective 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. Incases of Fluticasone Propionate overdose this combination inhaler therapy may still be continued at a suitable dosage for symptom control.

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Seroxyn ® Acucap must not be swallowed and can be used with any inhaler device. Remove Acucap capsule from the blister pack just prior to use, as Acucap exposed to moisture may not tear easily.
Avoid storage in direct sunlight or heat. Store below 30°C. Keep away from children.

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