Generic

Salmeterol + Fluticasone Propionate

Indications

This is indicated in the regular treatment of asthma when a combination product (long-acting 2-agonist and inhaled corticosteroid) is appropriate: patients who are not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting 2-agonist or patients who are already adequately controlled on both inhaled corticosteroid and long-acting 2-agonist.

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 that has primarily glucocorticoid activity. Fluticasone propionate is said to have a local effect on the lungs and does not produce a systemic effect at common doses.

Salmeterol can prevent symptoms and fluticasone propionate can improve lung function and keep the disease from getting worse. This formulation may provide a more convenient solution for patients receiving treatment with both beta agonists and inhaled corticosteroids. The respective mechanisms of action of the two drugs are discussed below:

Salmeterol: Salmeterol is a selective long-acting (12 hours) β2-adrenergic receptor agonist with a long side that binds to sites outside the receptor Chain.

Fluticasone propionate: Fluticasone propionate administered by inhalation at the recommended dose has a strong anti-inflammatory effect of glucocorticoids in the lungs, thereby reducing symptoms and exacerbations of asthma, without the adverse effects seen when corticosteroids are administered systemically .

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):

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 add 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.

Interaction

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 concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. 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.

Contraindications

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

Side Effect

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 simultaneous administration of the two compounds. Adverse events associated with salmeterol or fluticasone propionate are shown below.

Salmeterol: Pharmacological side effects of β2 receptor agonist treatment, such as tremor, subjective palpitations, and headache, have been reported but are often short-lived and relieved by conventional treatment. Arrhythmias (including atrial fibrillation, supraventricular tachycardia, and additional contractions) can occur, usually in susceptible patients. Arthralgia and allergic reactions, including rash, edema and angioedema, have been reported. 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 skin allergic 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 infection.

Pregnancy & Lactation

Drugs should only be used during pregnancy and breastfeeding if the predicted benefit to the mother outweighs any potential harm to the foetus or child. Salmeterol Xinafoate and Fluticasone Propionate have inadequate expertise in human pregnancy and lactation. There is no information about human breast milk.

Precautions & Warnings

Additional corticosteroid treatments should be considered, as well as the use of antibiotics if an infection is present. This formulation, like all inhaled corticosteroid medications, should be used with care in patients with active or dormant pulmonary TB. In individuals with thyrotoxicosis, this medication should be used with care.

Therapeutic Class

Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids

Storage Conditions

Even if the canister seems to be empty, it should not be punctured, broken, or incinerated. Avoid storing in direct sunlight or in a hot environment. Keep it below 30°C. Keep your distance from the eyes. Keep your distance from youngsters.

Pharmaceutical Name

Healthcare Pharmaceuticals Ltd.

Flumetol Easy cap 50/250