Salmeterol xinafoate, fluticasone propionate.
Each puff delivers salmeterol xinafoate equivalent to salmeterol 25 mcg and fluticasone propionate 125 mcg or 250 mcg.
Pharmacology: Aroflo hydrofluoroalkane (HFA) inhaler is a combination of salmeterol and fluticasone propionate. Salmeterol is a selective, long-acting β2-agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone propionate is corticosteroid with potent anti-inflammatory activity. Fluticasone propionate is stated to exert a topical effect on the lungs without systemic effects at usual dose.
Regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate: Patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting β2-agonist; patients already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
Adults and Adolescents ≥12 years: Aroflo 125 mcg/25 mcg: Two (2) puffs twice daily.
Aroflo 250 mcg/25 mcg: Two (2) puffs twice daily.
Hypersensitivity to any of the components of Aroflo.
Aroflo HFA inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Aroflo HFA inhaler should not be stopped abruptly. It should be administered with caution in patients with pulmonary tuberculosis.
Aroflo HFA inhaler should be used with caution in patients with severe cardiovascular disorders, heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalemia or patients predisposed to low levels of serum potassium.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.
Renal Impairment: There is no need to adjust the dose in patients with renal impairment.
Hepatic Impairment: There are no data available for use of Aroflo HFA inhaler in patients with hepatic impairment.
Use in pregnancy: There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy. Administration of drugs to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Use in lactation: There are no data available for human breast milk. Administration of salmeterol and fluticasone propionate to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
Use in the elderly: There is no need to adjust the dose in elderly patients.
Pregnancy: There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy. Administration of drugs to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Lactation: There are no data available for human breast milk. Administration of salmeterol and fluticasone propionate to women who are breastfeeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child.
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 2 compounds. The pharmacological side effects of β2-agonist treatment eg, 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 oropharyngeal 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 Aroflo. Symptomatic candidiasis can be treated with topical antifungal therapy while still continuing with the Aroflo HFA inhaler. Possible systemic effects in children include adrenal suppression, growth retardation, decrease in bone mineral density.
Both nonselective and selective β-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 (ie, ketoconazole, ritonavir) and salmeterol-fluticasone as there is an increased risk of systemic side effects of individual component.
Instructions for Use and Handling: Test Inhaler: Before using the inhaler for the 1st time or if it has not been used for ≥1 week, shake the inhaler well and perform a "test fire" ie, release 1 puff into the air.
Using The Inhaler: 1. Remove the cap from the mouthpiece of the actuator. Make sure there is nothing in the mouthpiece before use.
2. Hold canister upright. Shake vigorously for at least 10 sec.
3. Breathe out gently and immediately place the mouthpiece in the mouth between the teeth. Do not bite.
4. Tilt head slightly backward. Start breathing slowly through the mouth. At the same time, press down firmly at the top of the canister to release medicine. Continue to breathe in steadily and deeply.
5. Remove the inhaler from the mouth and hold breath for 10 sec or as long as it is comfortable. Then breathe out gently. If the patient take a 2nd inhalation, wait for at least 1 min before repeating steps 3 and 4.
6. Replace mouthpiece cap after use.
Note: Do not rush steps 4 and 5. It is important to start breathing in slowly as possible just before releasing the dose. Practice in front of a mirror for the 1st few times. If a mist is seen coming from the top of the inhaler or the sides of mouth, start again from step 2. This escaping mist indicates incorrect technique.
Cleaning The Inhaler: 1. Remove the metal canister from the actuator (plastic casing) of the inhaler and remove the mouthpiece cap.
2. Immerse the actuator (plastic casing) and the mouthpiece cap in warm water for few minutes and then rinse under running water. But do not put the metal canister into water.
3. Leave actuator and mouthpiece cap to dry in warm place. Avoid excessive heat.
4. Replace the canister and the mouthpiece cap correctly.
Clean the inhaler at least once a week.
Tips for Children: Children and others who have weaker hands may have difficulty pressing down on the top of the canister with just 1 hand. Patients can use both hands to make inhaler work.
Keep away from sunlight and heat.
Store below 30°C. Do not freeze.
R03AK06 - salmeterol and fluticasone ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.
25 mcg/125 mcg inhaler 120 puffs. 25 mcg/250 mcg inhaler 120 puffs.