Symbion 12/400 Bexicap

Indications

• Asthma Management: Designed for treating asthma in patients aged 12 and older. Note: Not suitable for immediate relief of acute bronchospasm.
• Chronic Obstructive Pulmonary Disease (COPD): For ongoing management of airflow obstruction in COPD patients, including those with chronic bronchitis and emphysema. This inhalation capsule is the sole approved dosage for COPD.

Description

Product Overview: This dry powder inhalation capsule combines Formoterol Fumarate Dihydrate and Budesonide. Budesonide, a glucocorticosteroid, provides anti-inflammatory benefits when inhaled, leading to reduced asthma symptoms and fewer exacerbations. Formoterol, a selective β2 adrenergic agonist, offers rapid and long-lasting bronchial relaxation, with effects beginning within 1-3 minutes and lasting at least 12 hours.

Pharmacology

• Budesonide: A potent anti-inflammatory corticosteroid with minimal mineralocorticoid activity. It targets multiple inflammatory cell types and mediators, aiding in asthma management.
• Formoterol Fumarate Dihydrate: A long-acting β2-adrenergic agonist that stimulates intracellular adenyl cyclase, enhancing bronchial smooth muscle relaxation and reducing hypersensitivity mediator release.

Dosage

• Asthma Inhaler:
  • Adults & Adolescents (12+): Start with 20 mg/day, with adjustments up to 80 mg/day if needed. Maximum of 6 puffs per occasion.
  • Children: Typically 1-2 puffs once or twice daily, not exceeding 4 puffs per occasion.
• Asthma Inhalation Capsules:
  • Adults & Adolescents (12+): 1-2 capsules twice daily for maintenance; up to 12 capsules daily in total if needed.
  • Children (4+): 1 capsule once daily for maintenance; up to 8 capsules daily in total if required.
• COPD Inhalation Capsules:
  • Adults (40+): 200 mcg capsules twice daily (max 4/day) or 400 mcg capsules twice daily (max 2/day).

Administration

Inhaler Use: Follow correct technique to ensure medicine reaches the lungs effectively. Shake before use, exhale fully before inhaling, and hold breath for at least 10 seconds. Clean the inhaler weekly and monitor technique regularly.

Interaction

Drug Interactions: Avoid strong cytochrome P450 3A4 inhibitors, use caution with MAO inhibitors, tricyclic antidepressants, and beta-blockers. Be mindful of interactions with diuretics and other CNS-active drugs.

Contraindications

Avoid Use: In cases of hypersensitivity to ingredients or primary treatment of severe asthma/COPD episodes requiring intensive measures.

Side Effects

• Common: Tremors, palpitations, headache, hoarseness, and oral thrush.
• Rare: Cardiac arrhythmias, muscle cramps, skin rashes, and systemic corticosteroid effects.

Pregnancy & Lactation

Pregnancy: Use only if necessary; limited data available. Budesonide is excreted in breast milk; Formoterol’s presence is unknown. Consider risks versus benefits for breastfeeding.

Precautions & Warnings

Monitoring: Caution in diabetes, cardiovascular disorders, and glaucoma. Watch for paradoxical bronchospasm and adjust treatment as necessary.

Special Populations

Children: Monitor growth during prolonged corticosteroid use. Consider referral to a specialist if growth issues arise.

Overdose Effects

Symptoms: Tremor, headache, palpitations, and potential cardiovascular effects. Supportive care and symptomatic treatment are recommended.

Storage Conditions

Storage: Keep inhalation capsules away from light and moisture. Store below 25°C and out of reach of children. Only remove capsules from packaging immediately before use.