Bexitrol-F

Salmeterol and Fluticasone Propionate

Inhalation Aerosol
Description discussed below :
Bexitrol®-F metered dose inhaler is a combination of Salmeterol Xinafoate INN and Salmeterol: Salmeterol is a selective long-acting (12 hour) beta-2-adrenoceptor
Fluticasone Propionate BP. Salmeterol Xinafoate is a selective, long acting beta-2 agonist with a long side chain which binds to the exo-site of the receptor.
agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate: Fluticasone Propionate given by inhalation at recommended
Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting
Fluticasone Propionate is stated to exert a topical effect on the lungs without in reduced symptoms and exacerbaions of asthma, without the adverse effects
systematic effects at usual dose. observed when corticosteroids are administered systemically.
Indications Pharmaceutical Precautions
Bexitrol®-F is indicated in the regular treatment of asthma where use of a combination Pressurised canister, do not puncture, break or incinerate even when apparently
product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: empty.
- patients not adequately controlled with inhaled corticosteroids and "as needed" Avoid storage in direct sunlight or heat.
inhaled short-acting beta-2-agonist or, Store below 300C.
- patients already adequately controlled on both inhaled corticosteroids and long- Keep away from eyes.
acting beta-2-agonist Keep away from children.
Recommended Doses Commercial Pack
Adults and adolescents 12 years and older- Bexitrol®-F 25/250 : Each canister contains 120 metered doses, each actuation
Two inhalations of 25 µg Salmeterol and 50 µg Fluticasone Propionate twice daily. or, delivers Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol and Fluticasone
Two inhalations of 25 µg Salmeterol and 125 µg Fluticasone Propionate twice daily. or, Propionate BP 250 µg.
Two inhalations of 25 µg Salmeterol and 250 µg Fluticasone Propionate twice daily. Bexitrol®-F 25/125 : Each canister contains 120 metered doses, each actuation
Contraindications delivers Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol and Fluticasone
Bexitrol®-F is contraindicated in patients with a history of hypersensitivity to any of the Propionate BP 125 µg.
ingredients. Bexitrol®-F 25/50 : Each canister contains 120 metered doses, each actuation delivers
Special Warnings and Special Precautions Salmeterol Xinafoate INN equivalent to 25 µg Salmeterol and Fluticasone Propionate
Consideration should be given to additional corticosteroid therapies, and to including BP 50 µg.
administration of antibiotics if an infection is present. As with all inhaled medication

160105
containing corticosteroids, Bexitrol®-F should be administered with caution in patients
with active or quiescent pulmonary tuberculosis. Bexitrol®-F should be administered Manufactured by
with caution in patients with thyrotoxicosis. BEXIMCO PHARMACEUTICALS LTD.
Precaution for Paediatric Use TONGI, BANGLADESH
Orally inhaled corticosteroids may cause a reduction in growth velocity when ® REGISTERED TRADEMARK BL 3406
administered to paediatric patients. The long-term effects of this reduction including the
Before using your inhaler, please read this part and follow the instructions carefully
impact of final adult height are unknown.
Drug Interaction HOW TO USE YOUR INHALER CORRECTLY
Both non-selective and selective β-blockers should be avoided in patients with asthma, • Before using your inhaler for the first time, or if it has not been used for a week or more,
unless there are compelling reasons for their use. Due to the very low plasma ‘test fire’ it, i.e. release one puff into the air (Pic-1).
concentrations achieved after inhaled dosing clinically significant drug interactions are • Remove the mouthpiece cover, and check the mouthpiece thoroughly to see that it is
unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors clean. Shake the inhaler vigorously (Pic-2&3).
(e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to • Hold the inhaler as shown between index finger and thumb. Breathe out gently through
Fluticasone Propionate. your mouth and immediately place the mouthpiece in your mouth between your teeth (Do
Use During Pregnancy and Lactation not bite it) (Pic-4&5).
Administration of drugs during pregnancy and lactation should only be considered if
• Grip the mouthpiece firmly with your lips. Tilt your head slightly backwards. Start
the expected benefit to the mother is greater than any possible risk to the foetus or
breathing in slowly through your mouth. At the same time press the canister as shown, to
child. release one dose while continuing to breathe in steadily and deeply (Pic-6&7).
There is insufficient experience of the use of Salmeterol Xinafoate and Fluticasone
Propionate in human pregnancy and lactation. There are no data available for human • Remove the inhaler from your mouth. Hold the breath at least for 10 seconds, or as long
breast milk. as it is comfortable. Breathe out slowly (Pic-8&9).
Undesirable Effects • If another dose is required, wait for at least 1 minute and repeat the whole process. After
As Bexitrol®-F contains Salmeterol and Fluticasone Propionate, the type and severity use, place the cover to close the mouthpiece.
of adverse reactions associated with each of the compounds may be expected. There
is no incidence of additional adverse events following concurrent administration of the 1 2 3
two compounds. Adverse events, which have been associated with Salmeterol or
Fluticasone Propionate, are given below.
Salmeterol: The pharmacological side effects of beta-2-agonist treatment, such as
tremor, subjective palpitations and headache, have been reported, but tend to be
transient and reduce with regular therapy. Cardiac arrhythmia (including atrial
4 5 6
fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in
susceptible patients. There have been reports of arthralgia and hypersensitivity
reactions, including rash, oedema and angioedema. There have been reports of
oropharyngeal irritation.
There have been rare reports of muscle cramps.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat 7 8 9
can occur in some patients. Cutaneous hypersensitivity reactions have been reported.
Rare cases of facial and oropharyngeal oedema have been reported. Both hoarseness
and incidence of candidiasis may be relieved by gargling with water after use of
Salmeterol/ Fluticasone Propionate Inhaler.
Salmeterol/ Fluticasone Propionate clinical trials:
The following undesirable effects were commonly reported:
Hoarseness/dysphonia, throat irritation, headache, candidiasis of mouth and throat
SHAKE WELL BEFORE EACH USE
and palpitations. How to clean your inhaler :
Overdose 1. Gently pull the metal canister out of the plastic body of the inhaler,
There are no data available from clinical trials on overdose with Bexitrol®-F. remove the mouthpiece cover.
Pharmacodynamic Properties 2. Rinse the plastic body and the mouthpiece cover in warm water but do
Mechanism of action not put the metal canister into water.
Bexitrol®-F contains Salmeterol and Fluticasone Propionate, which have different 3. Leave to dry in warm place, avoid excessive heat.
modes of action. Salmeterol protects against symptoms, Fluticasone Propionate 4. Replace the canister and the mouthpiece cover correctly.
improves lung function and prevents exacerbations of the condition. Bexitrol®-F can
offer a more convenient regime for patients on concurrent β-agonist and inhaled CLEAN YOUR INHALER AT LEAST ONCE A WEEK
corticosteroid therapy. The respective mechanisms of action of both drugs are

150x232 mm