This preparation is indicated for the regular management of asthma in patients where a combination therapy of a long-acting β2-agonist and an inhaled corticosteroid is appropriate.
It is suitable for:

• Patients who are not adequately controlled with inhaled corticosteroids and as-needed short-acting inhaled β2-agonists, or
• Patients who are already well controlled on both inhaled corticosteroids and long-acting β2-agonists.

Salmeterol xinafoate is a selective, long-acting beta-2 agonist used in the treatment of asthma and other diffuse airway obstructive conditions. Fluticasone propionate is a corticosteroid with strong glucocorticoid activity. When inhaled at recommended doses, fluticasone produces a local anti-inflammatory effect in the lungs with minimal systemic effects. Salmeterol helps prevent bronchial symptoms, while fluticasone improves lung function and reduces the frequency of exacerbations. This combination provides a more convenient treatment option for patients requiring both a beta-agonist and inhaled corticosteroid.

Salmeterol: It is a selective long-acting (approximately 12-hour) beta-2 adrenoceptor agonist that binds to a specific exo-site on the receptor, producing prolonged bronchodilation.

Fluticasone Propionate: When administered by inhalation at recommended doses, it exerts potent local glucocorticoid anti-inflammatory effects in the lungs, leading to reduced asthma symptoms and fewer exacerbations, without the systemic adverse effects seen with oral corticosteroids.

Inhaler:

• Adults and adolescents 12 years and older: 2 puffs of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily or 2 puffs of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily.
• Children (4-12 years): 2 puffs of 25 µg salmeterol and 50 µg Fluticasone Propionate twice daily.

Inhalation capsule (for asthma):

• Adult and Adolescent (12 Years and Older): Salmeterol 50 µg & Fluticasone 100 µg or Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart).
• The recommended starting dosages for Salmeterol 50 µg & Fluticasone 100 µg & Salmeterol 50 µg & Fluticasone 250 µg for patients aged 12 years and older are based upon patients asthma severity.
• The maximum recommended dosage is Salmeterol 50 µg & Fluticasone 500 µg twice daily.
• Pediatric Patients (4 to 11 Years): For patients with asthma who are not controlled on an inhaled corticosteroid, the dosage is Salmeterol 50 µg & Fluticasone 100 µg twice daily (morning and evening, approximately 12 hours apart).

Inhalation capsule (For COPD): Salmeterol 50 µg & Fluticasone 250 µg twice daily (morning and evening, approximately 12 hours apart). Rinsing the mouth after each inhalation is advised.

Maxhaler (For Asthma): This is a moulded plastic device containing a foil strip with 60 regularly placed blisters containing pre-dispensed inhalation powder. Patients should be made aware that inhaler must be used daily for optimum benefit, even when asymptomatic.

Adults and Adolescents (12 years and older)-

• 50/100 inhaler: One Inhalation twice daily
• 50/250 inhaler: One Inhalation twice daily
• 50/500 inhaler: One Inhalation twice daily

Children (4 years and older)-

• 50/100 inhaler: One Inhalation twice daily. The maximum licensed dose of fluticasone propionate delivered by this inhaler in children is 100 mcg twice daily. There are no data available for use of this inhaler in children aged under 4 years.

Maxhaler (For COPD):

• Inhaler: One Inhalation twice daily
• Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of this in patients with hepatic impairment.
• Using the inhaler: This is a patient friendly, ready to use and easy to grip device. Use as per instructions for use.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.
Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as full as comfortably possible & hold the inhaler upright.
• Place the actuator into mouth between the teeth and close lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly and fully on the canister to release medicine.
• Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
• If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations).
• Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
• Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Both non-selective and selective β-blockers should generally be avoided in patients with asthma unless there are strong clinical indications. Because inhaled administration results in very low plasma levels, clinically significant drug interactions are unlikely. However, caution is advised when using strong CYP3A4 inhibitors (such as ketoconazole, ritonavir), as they may increase systemic exposure to fluticasone propionate.

This preparation is contraindicated in patients with known hypersensitivity to salmeterol xinafoate, fluticasone propionate, or any of the excipients. It is also contraindicated for the primary treatment of status asthmaticus or acute asthma attacks requiring intensive emergency management.

Since this preparation contains both salmeterol and fluticasone propionate, side effects may reflect those associated with each component. No additional adverse effects have been observed with their combined use.

Salmeterol: Common beta-2 agonist effects include tremor, palpitations, and headache, which are usually mild and temporary and tend to reduce with continued use. Cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, and extrasystoles may occur, mainly in susceptible individuals. Arthralgia, hypersensitivity reactions (rash, oedema, angioedema), oropharyngeal irritation, and rarely muscle cramps have also been reported.

Fluticasone Propionate: Hoarseness and oral or throat candidiasis (thrush) may occur. Skin hypersensitivity reactions have been reported. Rare cases of facial and oropharyngeal oedema have also been observed. Rinsing the mouth after inhalation may reduce hoarseness and candidiasis.

Pregnancy: Use during pregnancy should be considered only when the expected benefit to the mother outweighs any potential risk to the fetus. There is limited experience with salmeterol and fluticasone in human pregnancy. Animal studies have shown fetal effects at high systemic exposure levels of beta-2 agonists and corticosteroids.

Lactation: Use during breastfeeding should be considered only if the expected benefit outweighs potential risk. Plasma levels after inhaled doses are very low, so breast milk levels are expected to be minimal. Animal studies support low transfer into milk, but human data are insufficient.

Use in asthma patients: This inhalation capsule should not be started during an acute asthma attack, exacerbation, or in patients with unstable or rapidly worsening asthma. It is not intended for relief of acute symptoms, for which a fast-acting bronchodilator (e.g., salbutamol) should be used. Patients should always keep their rescue medication readily available.

Asthma-related adverse events: Serious asthma-related events or worsening of symptoms may occur during treatment. Patients should continue therapy but seek medical attention if symptoms are not controlled or become worse after starting this inhaler.

Paradoxical bronchospasm: As with other inhalation therapies, paradoxical bronchospasm may occur, presenting as immediate worsening of wheezing after use. This should be treated immediately with a fast-acting bronchodilator. The inhaler should be discontinued, the patient evaluated, and alternative therapy started if necessary. Beta-2 agonist side effects such as tremor, palpitations, and headache are usually mild and tend to reduce with continued use.

Use in COPD patients: An increased incidence of pneumonia has been reported in COPD patients using salmeterol/fluticasone. Physicians should monitor for pneumonia, as its symptoms may overlap with COPD exacerbations.

Corticosteroids: This inhaler contains fluticasone propionate, an inhaled corticosteroid. Systemic effects may occur, especially at high doses or long-term use, including Cushing’s syndrome, adrenal suppression, growth retardation in children, decreased bone mineral density, cataracts, glaucoma, and rarely behavioral changes in children and adolescents. Patients should be regularly reviewed and maintained on the lowest effective dose.

In paediatric patients, inhaled corticosteroids may reduce growth velocity. The long-term impact on final adult height is not yet known.

No specific human overdose data is available for this combination inhaler, but effects of individual components are described below:

Salmeterol: Overdose may cause seizures, chest pain (angina), high or low blood pressure, rapid heart rate, arrhythmias, tremor, headache, muscle cramps, dry mouth, palpitations, nausea, dizziness, fatigue, malaise, and insomnia. It may also cause hypokalaemia and hyperglycaemia. Treatment involves stopping salmeterol and providing supportive care; cardioselective beta-blockers may be used cautiously.

Fluticasone Propionate: Acute overdose may temporarily suppress adrenal function, which usually recovers within a few days without emergency treatment. Long-term excessive use may lead to adrenal suppression; monitoring may be required. Treatment can generally be continued at an appropriate dose for symptom control.

Long-acting selective β-adrenoceptor agonists, Respiratory corticosteroids

Pressurised canister: Do not puncture, break, or incinerate even when empty. Avoid exposure to direct sunlight or heat. Store below 30°C. Keep away from eyes and out of reach of children.