Seroxyn 50/100 Acucap

Generic

Salmeterol + Fluticasone Propionate

Indications

This has been shown in the routine treatment of asthma, where the use of combination products (long-acting beta 2 agonists and inhaled corticosteroids) is appropriate: 
patients cannot adequately control inhaled corticosteroids and short-acting inhaled beta 2 agonists "as needed" or  Patients whose inhaled corticosteroids and long-acting β2 agonists have been adequately controlled.

Pharmacolgy

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 undergoing simultaneous therapy of β-agonists and inhaled corticosteroids. 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.

Interaction

Patients with asthma should avoid non-selective and selective beta blockers unless there is a compelling reason. Because the plasma concentration after inhalation is very low, clinically significant drug interactions are unlikely to occur. Caution should be used when co-administering known potent CYP3A4 inhibitors (such as ketoconazole, ritonavir), because fluticasone propionate may increase systemic exposure.

Contraindications

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

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 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. 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, gargle with water can alleviate the incidence of hoarseness and yeast infections.

Pregnancy & Lactation

The use of medications during pregnancy and lactation should only be considered when the expected benefit to the mother outweighs any possible risk to the fetus or child. Salmeterol and fluticasone propionate have insufficient experience in human pregnancy and lactation. There are no data on human breast milk.

Precautions & Warnings

Additional corticosteroid therapy should be considered and antibiotics should be considered if there is an infection. As with all inhaled corticosteroid-containing medications, patients with active or resting 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

Do not puncture, rupture, or incinerate pressurized containers, even if they are obviously empty. Avoid storing in direct sunlight or high temperature. Store below 30°C. Keep out of eyes. Keep away from children.

Pharmaceutical Name

ACI Limited