Flutisal 100

Generic

Salmeterol + Fluticasone Propionate.

Indications

This is indicated in the regular treatment of asthma where the use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate:

• patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting β2-agonist or
• patients already adequately controlled on both inhaled corticosteroid and long-acting β2-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 efficient impacts at a normal dose.

salmeterol ensures against indications; Fluticasone Propionate progresses lung work and avoids exacerbations of the condition. This arrangement 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:

Salmeterol: Salmeterol may be a particular long-acting (12 hours), beta-2-adrenoceptor agonist, with a long side chain that ties to the exo-site of the receptor.

Fluticasone Propionate: Fluticasone Propionate given by inward breath at suggested measurements encompasses a strong glucocorticoid anti-inflammatory activity inside the lungs, coming about in diminish.

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 molded 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.

Administration

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 the 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 the mouth. Continue holding your breath for at least 10 seconds or as long as it is comfortable.
8. If the 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 your 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 the 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 the 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 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 is impossible. Care ought to be taken when co-administering knew 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 components should avoid this.

Side Effect

As this planning contains Salmeterol and Fluticasone Propionate, the sort and seriousness of unfavorable responses related to each of the compounds may be anticipated. There's no frequency of extra antagonistic occasions taking after the concurrent organization of the two compounds. Unfavorable occasions, which have been related to Salmeterol or Fluticasone Propionate, are given below.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 temporal and decrease with customary treatment. Cardiac arrhythmia (counting atrial fibrillation, supraventricular tachycardia, and additional systoles) may happen, more often than not in helpless patients. There have been reports of arthralgia and touchiness responses, counting hasty, edema, and angioedema. There have been reports of an oropharyngeal disturbance. There have been uncommon reports of muscle cramps.

Pregnancy & Lactation

Drugs should only be administered during pregnancy and lactation if the predicted benefit to the mother outweighs any potential danger to the fetus or child. Salmeterol Xinafoate and Fluticasone Propionate have insufficient expertise in human pregnancy and lactation. There is no information about human breast milk.

Precautions & Warnings

Thought ought to be given to extra corticosteroid treatments, and to count the organization of anti-microbials in the event that contamination is a display. As with all breathed-in pharmaceuticals containing corticosteroids, this planning ought to be managed with caution in patients with dynamic or tranquil aspiratory tuberculosis. This arrangement ought to be managed with caution in patients with thyrotoxicosis.

Therapeutic Class

Respiratory corticosteroids, long-acting selective -adrenoceptor stimulants.

Storage Conditions

Even if the canister appears 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

Incepta Pharmaceuticals Ltd.