Aroflo 125

Generic

Salmeterol + Fluticasone Propionate

 

Indications

This applies to conventional treatment of asthma with combination products (long-acting β2 agonists and inhaled corticosteroids): 

•  patients were not adequately controlled with inhaled corticosteroids and inhaled short-acting β2 agonists 'as needed' or 
   
• patients The patient has a adequate control of both inhaled corticosteroids and long-acting β2 agonists.

 

Pharmacology

Salmeterol xinafoate is a long-acting selective β2 agonist used to treat asthma and other forms of diffuse airway obstruction. Fluticasone propionate is a corticosteroid with mainly glucocorticoid activity. It is said that fluticasone propionate has a local effect on the lungs but no systemic effect at regular doses. 
 

Salmeterol can prevent symptoms, and fluticasone propionate can improve lung function and prevent the disease from getting worse. The preparation can provide a more convenient solution for patients receiving inhaled β-agonist and corticosteroid treatment at the same time. The respective mechanisms of action of the two drugs are discussed below: 
 

Salmeterol: Salmeterol is a selective long-acting (12 hour) β2 adrenergic receptor agonist with long side chains that bind to sites outside the receptor.

 

Dosage & Administration

Inhalation Aerosol:

• 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 Powder in 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 Powder in 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.

Inhalation Powder in 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 Maxhaler must be used daily for optimum benefit, even when asymptomatic.

Adults and Adolescents (12 years and older)-

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

Children (4 years and older)-

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

Inhalation Powder in Maxhaler (For COPD):

• Maxhaler: 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 Maxhaler: 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):

1. Take off the cap.
2. Shake the inhaler (at least six times) vigorously before each use.
3. 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.
4. Breathe out as full as comfortably possible & hold the inhaler upright.
5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
8. 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.
9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
10. 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.

 

Interactions

Patients with asthma should avoid selective and non-selective beta-blockers unless there is a compelling reason. Since the plasma concentration achieved after inhalation is very low, clinically significant drug interactions are impossible. Caution should be exercised when using known strong CYP3A4 inhibitors (such as ketoconazole, ritonavir) in combination, because systemic exposure to fluticasone propionate may be increased. 

Contraindications

It is contraindicated for patients with a history of allergy to any ingredient.

 

Side Effects

Since the preparation contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each compound can be expected. No additional adverse events occurred after the simultaneous administration of the two compounds. Adverse events related to salmeterol or fluticasone propionate are described below. 
 

Salmeterol: The pharmacological side effects of β2 receptor agonist treatment, such as tremor, subjective palpitations and headache, have been reported, but they are often short-lived and will be relieved by regular treatment. Arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extra contractions) may occur, usually in susceptible patients. Reports of joint pain and allergic reactions, including rash, edema, and angioedema. There are reports of oropharyngeal irritation. There are very few reports of muscle cramps. 
 

Fluticasone Propionate: Some patients may experience hoarseness of the mouth and throat and candidiasis (thrush). There have been reports of allergic skin reactions. Rare cases of facial and oropharyngeal edema have been reported. After using the salmeterol / fluticasone propionate inhaler, gargling with water can ease the incidence of hoarseness and yeast infections.

 

Pregnancy

Only when the expected benefit to the mother exceeds any possible risk to the fetus or child should the use of drugs during pregnancy and breastfeeding be considered. There is insufficient experience in the use of salmeterol xinafoate and fluticasone propionate during human pregnancy and lactation. There are no data on human breast milk.

 

Precautions

If there is an infection, additional corticosteroid treatment should be considered, including antibiotics. As with all inhaled corticosteroid-containing drugs, patients with active or inactive tuberculosis should use this preparation with caution. Patients with thyrotoxicosis should use this preparation with caution.

 

Therapeutic Class

Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids

 

Storage Conditions

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.

 

Pharmaceutical Name

Aristopharma Ltd.