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 could be a selective, long acting beta-2 agonist utilized within the treatment of asthma and other shapes of diffuse aviation routes obstacle. Fluticasone Propionate may be a corticosteroid with primarily glucocorticoid action. Fluticasone Propionate is expressed to apply a topical impact on the lungs without precise impacts at normal dose. Salmeterol ensures against side effects, Fluticasone Propionate makes strides lung work and avoids exacerbations of the condition. This planning can offer a more helpful administration for patients on concurrent β-agonist and breathed in corticosteroid treatment. The individual instruments of activity of both drugs are examined below:

Administration & Dosage

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

Both non-selective and specific β-blockers ought to be dodged in patients with asthma, unless there are compelling reasons for their utilize. Due to the exceptionally moo plasma concentrations accomplished after breathed in dosing clinically critical sedate intuitive are improbable. Care ought to be taken when co-administering known solid CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there's potential for expanded systemic introduction to Fluticasone Propionate.

Contraindications

Patients with a history of hypersensitivity to any of the ingredients should avoid this.

Side Effects

As this arrangement contains Salmeterol and Fluticasone Propionate, the sort and seriousness of unfavorable responses related with each of the compounds may be anticipated. There's no rate of extra antagonistic occasions taking after concurrent organization of the two compounds. Antagonistic occasions, which have been related with Salmeterol or Fluticasone Propionate, are given below.

Pregnancy & Lactation

Salmeterol: The pharmacological side impacts of beta-2-agonist treatment, such as tremor, subjective palpitations and cerebral pain, have been detailed, but tend to be transitory and diminish with normal treatment. Cardiac arrhythmia (counting atrial fibrillation, supraventricular tachycardia and additional systoles) may happen, ordinarily in vulnerable patients. There have been reports of arthralgia and extreme touchiness responses, counting hasty, oedema and angioedema. There have been reports of oropharyngeal aggravation. There have been uncommon reports of muscle cramps.

Precautions & Warnings

Organization of drugs amid pregnancy and lactation ought to as it were be considered on the off chance that the anticipated advantage to the mother is more prominent than any conceivable chance to the baby or child. There's inadequately encounter of the utilize of Salmeterol Xinafoate and Fluticasone Propionate in human pregnancy and lactation. There are no information accessible for human breast drain.

Therapeutic Class

Long-acting selective β-adrenoceptor stimulants, Respiratory corticosteroids

Storage Conditions

Protect from light and moisture by storing below 30°C. Keep the medicine out of children's reach.

Protide 250 unicap