Symbion 4.5/80

Indications

Asthma Management:
This inhaler is designed to treat asthma in individuals aged 12 and above. It is not intended for immediate relief during acute bronchospasm episodes.

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

Description

This dry powder inhalation capsule is specifically designed for oral inhalation. It contains a combination of Formoterol Fumarate Dihydrate BP and Budesonide BP. Budesonide, a glucocorticosteroid, delivers a dose-dependent anti-inflammatory effect in the airways, reducing symptoms and lowering the frequency of asthma exacerbations. Its inhaled form offers fewer adverse effects compared to systemic corticosteroids. Although the exact mechanism of action is unknown, Formoterol is a selective β2 adrenoceptor agonist that quickly and effectively relaxes bronchial smooth muscles, providing relief within 1-3 minutes and lasting for at least 12 hours.

Pharmacology

Budesonide:
Budesonide is a potent anti-inflammatory corticosteroid that demonstrates significant glucocorticoid activity with minimal mineralocorticoid action. Inflammation plays a central role in asthma’s pathogenesis, and corticosteroids exhibit broad inhibitory effects on various cell types (e.g., mast cells, eosinophils) and mediators (e.g., histamine, leukotrienes), contributing to their effectiveness in treating asthma.

Formoterol Fumarate Dihydrate:
Formoterol is a fast-acting, long-lasting β2-adrenergic agonist. When inhaled, it works locally in the lungs as a bronchodilator. β2-adrenoceptor agonists stimulate intracellular adenyl cyclase, converting ATP to cyclic AMP, which relaxes bronchial muscles and inhibits hypersensitivity mediators, especially in mast cells.

Dosage

For Asthma Treatment (Inhaler):

• Adults & Adolescents (12 years+): The recommended dose is 1 puff twice daily or 2 puffs once daily. For some patients, 2 puffs twice daily may be more effective (for 160/4.5 mcg/inhalation). Up to 6 puffs can be taken on a single occasion if symptoms persist.
• Children: Typically, 1-2 puffs once or twice daily. No more than 4 puffs should be taken on a single occasion.

For Asthma Treatment (Inhalation Capsule):

• Adults & Adolescents (12 years+):
  • Maintenance dose: Budesonide and Formoterol 100 & 200 inhalation capsules twice daily.
  • Reliever dose: 1 additional capsule as needed, with up to 6 capsules allowed on a single occasion. Daily limits should not exceed 12 capsules.
• Children (4 years+): 1 inhalation capsule once daily, with up to 4 additional capsules as needed.

For COPD (Inhalation Capsule, Adults 40+):

• 200 Capsule: 2 capsules twice daily, max 4 capsules daily.
• 400 Capsule: 1 capsule twice daily, max 2 capsules daily.

Administration

Correct inhaler use is critical for medication effectiveness. Following the National Asthma Guidelines, these steps will ensure proper inhalation technique and prevent asthma attacks:

1. Remove the cap.
2. Shake the inhaler vigorously.
3. If unused for over a week, release one puff into the air to ensure proper function.
4. Breathe out, position the inhaler, and inhale slowly while pressing down the canister.
5. Hold your breath for 10 seconds after removing the inhaler.
6. If more puffs are needed, wait 1 minute between doses.
7. Rinse your mouth after use.

Inhaler Cleaning Instructions:
Clean weekly by removing the canister and rinsing the plastic actuator and cap. Do not submerge the metal canister in water. Let it dry thoroughly before reassembling.

Interaction

Avoid combining this medication with strong CYP450 3A4 inhibitors like ritonavir, as they may heighten systemic corticosteroid effects. Use caution when combining with monoamine oxidase inhibitors, tricyclic antidepressants, beta-blockers, or diuretics, as they may interact negatively.

Contraindications

Do not use this medication for:

• Immediate treatment of asthma or COPD episodes requiring intensive care
• Patients allergic to any ingredients in this formulation

Side Effects

The combination of Formoterol and Budesonide may cause common side effects like tremors, palpitations, and headaches. More rare reactions include muscle cramps, rashes, and hypersensitivity issues. Budesonide can cause throat irritation or hoarseness.

Pregnancy & Lactation

There is limited data on the effects of Formoterol and Budesonide during pregnancy. Budesonide is known to be excreted in breast milk, but effects on the infant are minimal. Consult a healthcare provider to weigh the risks and benefits before use.

Warnings

This medication should be used with caution in patients with diabetes, heart conditions, glaucoma, or untreated hypokalemia. Children on prolonged corticosteroid treatment should have their growth monitored regularly.

Overdose Effects

Overdosing on Formoterol may lead to symptoms like tremors or palpitations. Overdosing on Budesonide rarely causes significant issues unless taken chronically.

Storage

Store at or below 25°C in a dry place, out of direct light, and away from children. Only remove the capsule from its blister just before use.