Bexitrol F Maxhaler 50/500 ug

100410500701903

Bexitrol F Maxhaler 50/500 ug

1,220.00৳ 

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Description

Indications

This is suggested in the routine treatment of asthma when a combination product (long-acting 2-agonist and inhaled corticosteroid) is used:

  • Patients who are not effectively managed with inhaled corticosteroids and ‘as required’ inhaled short-acting 2-agonists or antagonists
  • Patients were already well-controlled on inhaled corticosteroids and long-acting 2-agonists.

Pharmacology

Salmeterol Xinafoate is a long-acting, selective beta-2 agonist used to treat asthma and other types of diffuse airway obstruction. Fluticasone Propionate is a glucocorticoid-primarily corticosteroid. At the recommended dose, fluticasone propionate is said to have a topical impact on the lungs with no systemic effects.

Fluticasone Propionate improves lung function and avoids exacerbations of the disease, while Salmeterol protects against symptoms. For patients receiving concurrent -agonist and inhaled corticosteroid treatment, this preparation may provide a more convenient regimen. The following are the methods of action for both drugs:

Salmeterol is a selective long-acting (12-hour) beta-2-adrenoceptor agonist with a lengthy side chain that binds to the receptor’s exo-site.

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 the patient’s 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.

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.

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):

  • 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 fully as comfortably possible & hold the inhaler upright.
  • Place the actuator into the mouth between the teeth and close the lips around the mouthpiece.
  • While breathing deeply and slowly through the mouth, press down firmly and add fully on the canister to release medicine.
  • Remove the inhaler from the mouth. Continue holding your breath for at least for 10 seconds or as long as it is comfortable.
  • 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.
  • After use, replace the cap on the mouthpiece. After each treatment, rinse your 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 the mouthpiece, or you may not be breathing in as you press the can. This indicates a failure of the 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

Non-selective and selective -blockers should be avoided in asthma patients unless there are compelling reasons to take them. Clinically relevant medication interactions are unlikely due to the relatively low plasma concentrations obtained following inhalation treatment. When co-administering Fluticasone Propionate with known strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir), caution should be exercised since there is a risk of increased systemic exposure to Fluticasone Propionate.

Contraindications

This is not recommended for people who have had a history of hypersensitivity to any of the components.

Side Effects

Because this preparation contains Salmeterol and Fluticasone Propionate, the kind, and degree of adverse effects associated with each drug are possible. There is no evidence of any extra adverse effects occurring as a result of the two drugs being administered concurrently. The following are adverse occurrences related to Salmeterol or Fluticasone Propionate.

Salmeterol: Pharmacological adverse effects of beta-2-agonist medication, including as tremors, subjective palpitations, and headaches, have been described; however, these symptoms are usually transitory and disappear with continued treatment. Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia, and extrasystoles) can occur in vulnerable individuals. There have been reports of arthralgia as well as hypersensitivity responses such as rash, edema, and angioedema. Oropharyngeal irritation has been reported. Muscle cramps have been reported seldom.

Fluticasone propionate: Some individuals may have hoarseness and candidiasis (thrush) of the mouth and throat. There have been reports of cutaneous hypersensitivity responses. There have been a few reports of the face and oropharyngeal edema. Gargling with water after using the Salmeterol/ Fluticasone Propionate Inhaler can help reduce hoarseness and the occurrence of candidiasis.

Pregnancy & Lactation

Drug administration during pregnancy and breastfeeding should be undertaken only if the predicted benefit to the mother outweighs any potential harm to the fetus or child. There is inadequate data on the usage of Salmeterol Xinafoate and Fluticasone Propionate during pregnancy and lactation in humans. There is no information available about human breast milk.

Precautions & Warnings

Additional corticosteroid treatments, as well as antibiotic medication, should be considered 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

Respiratory corticosteroids, long-acting selective-adrenoceptor stimulants

Storage Conditions

Even if the canister seems to be empty, do not puncture, shatter, or incinerate it. Store in a cool, dry place away from direct sunlight or heat. Store at temperatures below 30°C. Keep your hands away from your eyes. Keep children at a distance.

Generic

Salmeterol + Fluticasone Propionate

Pharmaceutical Name

Beximco Pharma Ltd