Bilexa Inhalation Capsule 25 mcg+200 mcg
Bilexa Inhalation Capsule 25 mcg+200 mcg Uses, Dosage, Side Effects, Food Interaction and all others data.
25/100 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 100 mcg25/200 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 200 mcg| Trade Name | Bilexa Inhalation Capsule 25 mcg+200 mcg |
| Generic | Vilanterol Trifenatate + Fluticasone Furoate |
| Weight | 25 mcg+200 mcg |
| Type | Inhalation Capsule |
| Therapeutic Class | Respiratory corticosteroids |
| Manufacturer | Beximco Pharmaceuticals Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
This is indicated in- Long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Once-daily treatment of asthma in patients aged 18 years and older. Important limitation of use: Not indicated for relief of acute bronchospasm.Bilexa Inhalation Capsule 25 mcg+200 mcg is also used to associated treatment for these conditions: Asthma, Bacterial Sinusitis, Chronic Obstructive Pulmonary Disease (COPD), Chronic Sinusitis, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis
How Bilexa Inhalation Capsule 25 mcg+200 mcg works
Fluticasone furoate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. In vitro experiments show fluticasone furoate activating glucocorticoid receptors, inhibiting nuclear factor kappa b, and inhibiting lung eosinophilia in rats.
Dosage
Bilexa Inhalation Capsule 25 mcg+200 mcg dosage
This inhalation capsule must not be swallowed. Only to be used with the device. Remove the capsule from the blister pack only immediately before using it in the inhalation device. After inhalation, rinse your mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.Route of administration: Oral inhalation.Maintenance treatment of COPD: 1 inhalation of 25/100 mcg once daily.Asthma: 1 inhalation of 25/100 mcg or 25/200 mcg once daily.How to use the Nasal Spray
- Shake the bottle gently and remove the dust cover.
- Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine mist comes out from the container.
- Gently blow the nose to clear the nostrils.
- Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white collar of nasal applicator firmly down once to release a spray.
- Breathe out through your mouth.
- Repeat the above steps in the same/other nostril for consecutive doses.
Side Effects
COPD: Most common adverse reactions (incidence ≥3%) are nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, and pyrexia.Asthma: Most common adverse reactions (incidence ≥2%) are nasopharyngitis, oral candidiasis, headache, influenza, upper respiratory tract infection, bronchitis, sinusitis, oropharyngeal pain, dysphonia, and cough.Toxicity
Fluticasone furoate administered nasally may be associated with adrenal suppression or an increase in QTc interval though the association has not been well demonstrated in studies. Fluticasone furoate requires no dosage adjustment in renal impairment but must be used in caution in hepatic impairment due to the elimination mechanisms. Fluticasone furoate is not associated with carcinogenicity, mutagenicity, or impairment of fertility. There are no well controlled studies in pregnancy or lactation though animal studies have shown teratogenicity and hypoadrenalism in the offspring of treated mothers and other corticosteroids are known to be excreted in breast milk. Generally, there are no reported adverse effects with fluticasone in pregnancy. Pediatric patients should be given the lowest possible dose and monitored for reduction in growth velocity. There is insufficient evidence to determine whether geriatric patients respond differently to other patients. Systemic exposure may be 27-49% higher in Japanese, Korean, and Chinese patients compared to Caucasian patients. Caution should be exercised in these patients and the benefit and risk should be assessed before deciding on a treatment.
Precaution
LABA monotherapy increases the risk of serious asthma-related events. Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms. Do not use in combination with an additional medicine containing a LABA because of risk of overdose. Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia. Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to this inhalation capsule. Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue this inhalation capsule slowly. If paradoxical bronchospasm occurs, discontinue this inhalation capsule and institute alternative therapy. Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. Assess for decrease in bone mineral density initially and periodically thereafter. Glaucoma and cataracts may occur with long-term use of ICS. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use this inhalation capsule long term. Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. Increased blood glucose levels have been reported. Also, be alert to hypokalemia.Interaction
Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects. Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on vascular system. Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may worsen with concomitant beta-agonists.Volume of Distribution
608L at steady state for intravenous administration of fluticasone furoate. Other reports suggest the mean volume of distribution at steady state is 661L. A study of 24 healthy Caucasian males showed a volume of distribution at steady state of 704L following intravenous administration.
Elimination Route
Intranasal exposure of fluticasone furoate results in patients swallowing a larger portion of the dose. However, absorption is poor and metabolism is high, therefore there is negligible systemic exposure with a nasal bioavailability of 0.50% and oral bioavialability of 1.26%. Inhaled bioavailability is 13.9%. A study of 24 healthy Caucasian males showed an inhaled bioavailability of 6.3-18.4%.
Half Life
15.1 hours for intranasal fluticasone furoate and 24 hours for the inhaled formulation. A study of 24 healthy Caucasian males showed a half life of 13.6 hours following intravenous administration and 17.3-23.9 hours followed inhalation.
Clearance
57.8L/h for fluticasone furoate. A study of 24 healthy Caucasian males showed a clearance of 71.8L/h following intravenous administration.
Elimination Route
Fluticasone furoate is eliminated ≥90% in the feces and 1-2% in the urine.
Pregnancy & Breastfeeding use
Insufficient data on the use of this preparation in pregnant women and lactating mother.Contraindication
Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures. Severe hypersensitivity to milk proteins or any ingredients.Special Warning
Use in Children & Adolescents: This is not indicated for use in children and adolescents. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.Hepatic impairment: Fluticasone furoate systemic exposure may increase in patients with moderate or severe impairment. Monitor for systemic corticosteroid effects.Acute Overdose
There are no data available from clinical trials on overdose with this inhalation capsule.Storage Condition
Avoid storage in direct sunlight or heat. Store in a cool & dry place. Keep away from eyes. Keep out of reach of children.Innovators Monograph
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