Bexitrol-F 50/250

Indications of Bexitrol-F 50/250

This has been shown in the routine treatment of asthma, where the use of a combination product (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.

 

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.

 

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 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 as follows: 

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 potent 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 of Bexitrol-F 50/250

Inhaled aerosol: 

Adults and adolescents 12 years and older: 2 mouths of 25 µg of salmeterol and 50 µg of fluticasone propionate twice daily or 2 mouths of 25 µg of salmeterol and 125 µg of fluticasone propionate or 2 twice daily Mouth 5 µg of fluticasone and 25 µg fluticasone propionic acid twice a day. 

children (4-12 years): inhaled 25 µg of salmeterol and 50 µg of fluticasone propionate twice daily. 4,

capsules of powder for inhalation (for asthma): 

adults and adolescents (12 years and older): 50 micrograms of salmeterol and 100 micrograms of fluticasone or 50 micrograms of salmeterol and 250 micrograms of fluticasone, twice daily (per morning and evening, approximately 12 hours apart). Salmeterol 50 micrograms and fluticasone 100 micrograms, salmeterol 50 micrograms and fluticasone 250 micrograms The recommended starting dose for patients over 12 years of age is based on the severity of the patient's asthma. The maximum recommended dose of is salmeterol 50 µg and fluticasone 500 µg twice daily. pediatric patients (4 to 11 years): For patients with asthma that cannot be controlled with inhaled corticosteroids, the dose was 50 micrograms of salmeterol and 100 micrograms of fluticasone, twice daily (morning and night, approximately 12 hours Of diference).inhalation powder capsule (for COPD): salmeterol 50 µg and fluticasone 250 µg, twice daily (morning and evening, approximately 12 hours apart). It is recommended to rinse your mouth after each inhalation.

Inhalation Powder in Maxhaler (for Asthma) -

This is a molded plastic device containing an aluminum strip with 60 regularly placed ampoules containing pre-dispensed inhalation powder. Patients should be informed that Maxhaler should be used daily for the best benefit, even when they are asymptomatic. 

Adults and adolescents (from 12 years) 
50/100 Maxhaler: inhalation twice a day 
50/250 Maxhaler: inhalation twice a day 
50/500 Maxhaler: inhalation twice a day

Children (4 years and older)

50/100 Maxhaler: Inhale twice a day. The maximum authorized dose of fluticasone propionate administered by Maxhaler in children is 100 ug twice a day. There is no data available for the use of Maxhaler by children under 4 years of age.  

powder for Maxhaler inhalation (for COPD): Maxhaler:

inhalation twice a day Special patient group: elderly or renal insufficiency patients do not need to adjust the dose. There are no available data on its use in patients with liver damage. 
Maxhaler use-This is a patient-friendly, readily available, easy-to-grip device. Follow the instructions for use.

Using an inhaler may seem simple, but most patients do not know how to use it properly. If the inhaler is not used properly, less medicine reaches the lungs. The correct and regular use of the inhaler will prevent or reduce the severity of an asthma attack. 

Following a few simple steps can help you use your inhaler effectively (according to the "National Asthma Medical Specialist Guidelines" issued by the Asthma Association):  Remove the cap. 
Shake the inhaler vigorously (at least six times) before each use. 
If the inhaler is new or has not been used for a week or longer, shake it well and inhale air to ensure it works properly. 
Exhale as fully as possible and keep the inhaler upright. 
Place the actuator in your mouth between your teeth and close your lips around the mouthpiece. 
Breathe slowly and deeply with your mouth, while pressing hard and completely adding the medicine canister to release the medicine. 
Remove the inhaler from the mouth. Continue to hold your breath for at least 10 seconds or as long as you feel comfortable. 
If your doctor prescribes multiple puffs with each treatment, wait 1 minute between puffs (puffs). Shake the inhaler well and repeat steps 4-7. After using replace the mouthpiece cap. After each treatment, rinse your mouth with water. 
Check your technique in front of the mirror from time to time. If you see white haze when inhaling, it may be that your lips are not properly closed around the mouthpiece, or you are not breathing when you press the can. This indicates the failure of the technology. If this happens, carefully repeat the process from step 4. 

Inhaler cleaning instructions: Clean the inhaler at least once a week. Take out the container and rinse the plastic actuator and lid with warm water, but do not put the metal container in the water. Dry the actuator and lid thoroughly, and carefully replace the metal container on the actuator by twisting it. Place the cap on the mouthpiece.

 

Interaction of Bexitrol-F 50/250

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

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

 

Side-Effects of Bexitrol-F 50/250

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 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 skin hypersensitivity 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

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 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 tanks, even if they are obviously empty. Avoid storing in direct sunlight or high temperatures. Store below 30 ° C. Keep out of eyes. Keep away of children.

 

Generic Name of Bexitrol-F 50/250

Salmeterol + Fluticasone Propionate

 

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