Antiasthmatic & COPD Preparations

Aroflo® HFA inhaler is indicated in the regular treatment of asthma where use of a combination product (long-acting ß2-agonist and inhaled corticosteroid) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting ß2-agonist or patients already adequately controlled on both inhaled corticosteroid and long-acting ß2-agonist.

Each puff delivers Salmeterol Xinafoate BP equivalent to Salmeterol 25 μg and Fluticasone Propionate BP 125 μg

120 puffs / Box

Adults and adolescents 12 years and older: 2 puffs of 25 μg Salmeterol and 125 μg Fluticasone Propionate (Aroflo®-125) twice daily or 2 puffs of 25 μg Salmeterol and 250 μg Fluticasone Propionate (Aroflo®-250) twice daily.

Aroflo® HFA inhaler is contraindicated in patients with hypersensitivity to any of the active substances or to the excipient of this preparation.

As Aroflo® HFA 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. The pharmacological side effects of ß2-agonist treatment, such as tremor, palpitations and headache have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrythmia may occur. There have been reports of arthralgia and hypersensitivity reactions, including rash, oedema and angioedema. There have been reports of oropharyngial irritation. Due to the Fluticasone Propionate component, hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Both hoarseness and incidence of candidiasis may be relieved by gargling with water after using the product. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Aroflo® HFA inhaler. Possible systemic effects in children include adrenal suppression, growth retardation, decrease in bone mineral density.

Both non-selective and selective ß-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Care should be taken while co-administering of CYP3A4 inhibitors (i.e. Ketoconazole, Ritonavir) & Salmeterol-Fluticasone as there is an increased risk of systemic side effects of individual component.

Aristopharma Ltd., Bangladesh.