Symbion Bexicap 6/100

Indications

Asthma Treatment: Our inhaler is intended for individuals aged 12 and above for managing asthma. It is not meant for immediate relief of acute bronchospasm.

Chronic Obstructive Pulmonary Disease (COPD) Maintenance: This inhalation capsule is prescribed twice daily to maintain airflow in patients with COPD, including chronic bronchitis and emphysema. It is the approved dosage for treating airflow obstruction in COPD.

Description

This dry powder inhaler is specifically designed for oral inhalation. Combining Formoterol Fumarate Dihydrate BP and Budesonide BP, it leverages Budesonide’s anti-inflammatory properties to reduce asthma symptoms and exacerbations with fewer side effects compared to systemic corticosteroids. Formoterol, a selective β2 adrenoceptor agonist, provides rapid and sustained relaxation of bronchial smooth muscle, with effects lasting at least 12 hours per dose.

Pharmacology

Budesonide: An anti-inflammatory corticosteroid, Budesonide’s glucocorticoid activity targets various cells and mediators involved in asthma-related inflammation.

Formoterol Fumarate Dihydrate: A long-acting β2-adrenergic agonist, Formoterol acts locally to dilate bronchial passages through increased cyclic AMP levels.

Dosage

Inhaler (For Asthma): Recommended maintenance dosage for adults and adolescents is 1 or 2 puffs daily. Additional puffs may be taken as needed, not exceeding 6 puffs at a time.

Inhalation Capsule (For Asthma and COPD): Dosage varies by age and condition, with specific guidelines provided for both maintenance and relief.

Administration

Proper inhaler use is crucial for effective treatment. Follow these steps for optimal results, ensuring maximum medicine delivery to the lungs.

Interaction

Avoid concurrent use with strong CYP3A4 inhibitors, monoamine oxidase inhibitors, tricyclic antidepressants, or beta-blockers without careful consideration of potential interactions.

Contraindications

This inhaler is contraindicated in acute asthma or COPD episodes requiring intensive treatment, and in individuals with hypersensitivity to its components.

Side Effects

Common side effects include those typical of both Formoterol and Budesonide, with details provided on expected adverse reactions.

Pregnancy & Lactation

Limited clinical data are available on its use during pregnancy and breastfeeding; consult healthcare professionals before use.

Precautions & Warnings

Exercise caution in patients with specific medical conditions such as diabetes, severe cardiovascular disorders, and glaucoma. Paradoxical bronchospasm may occur and requires immediate discontinuation of medication.

Use in Special Populations

Regular monitoring of children’s growth is recommended during prolonged treatment with corticosteroids.

Overdose Effects

Symptoms of overdose and appropriate management strategies are outlined, with specific considerations for both Formoterol and Budesonide.

Storage Conditions

Store inhalation capsules at room temperature away from light and moisture, ensuring they remain out of reach of children and are used promptly after removal from packaging.