Symbion

Indications

Asthma Management: This inhaler is specifically designed for the management of asthma in individuals aged 12 and older. It is not suitable for treating acute bronchospasm.

COPD Maintenance: This inhalation capsule is intended for the twice-daily maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is the sole approved dosage form for managing airflow obstruction in COPD.

Description

This inhalation capsule is a dry powder inhaler used exclusively for oral inhalation. It combines Formoterol Fumarate Dihydrate BP with Budesonide BP. Budesonide, a glucocorticosteroid, provides a dose-dependent anti-inflammatory effect when inhaled, leading to symptom reduction and fewer asthma exacerbations. Unlike systemic corticosteroids, inhaled Budesonide has a lower risk of severe adverse effects. Formoterol, a selective β2 adrenoceptor agonist, offers rapid and sustained relaxation of bronchial smooth muscle, with effects lasting at least 12 hours after a single dose.

Pharmacology

Budesonide: This potent anti-inflammatory corticosteroid demonstrates significant glucocorticoid activity with minimal mineralocorticoid effects. It inhibits a wide range of inflammatory cells and mediators, contributing to its efficacy in asthma management.

Formoterol Fumarate Dihydrate: A long-acting β2-adrenoceptor agonist with a rapid onset of action, Formoterol acts locally in the lungs to induce bronchodilation. It stimulates intracellular adenyl cyclase, increasing cyclic AMP levels, which relaxes bronchial smooth muscle and suppresses the release of immediate hypersensitivity mediators.

Dosage

For Asthma (Inhaler):

• Adults and Adolescents (12 years and older): Typically, 1 puff twice daily or 2 puffs once daily. In some cases, 2 puffs twice daily may be suitable. An additional puff can be taken as needed, with a maximum of 6 puffs per occasion.
• Children: Generally, 1-2 puffs once or twice daily. An additional puff can be used as needed, with a maximum of 4 puffs per occasion.

For Asthma (Inhalation Capsule):

• Adults and Adolescents (12 years and older): Maintain with 100 or 200 Budesonide and Formoterol Inhalation Capsules twice daily. Use an additional capsule as needed, up to 6 capsules per occasion. A total daily dose of up to 12 capsules can be used temporarily.
• Children (4 years and older): Maintain with 100 Budesonide and Formoterol Inhalation Capsules once daily. Use an additional capsule as needed, up to 4 capsules per occasion. A total daily dose of up to 8 capsules can be used temporarily.

For COPD (Inhalation Capsule):

• Adults (40 years and older): Use 2 capsules of 200 or 1 capsule of 400 twice daily, with a maximum daily dose of 4 or 2 capsules, respectively.

Administration

Proper use of the inhaler is crucial for effective treatment. Follow these steps:

1. Remove the cap.
2. Shake the inhaler vigorously (at least six times) before each use.
3. If new or unused for over a week, release one puff into the air to ensure functionality.
4. Exhale fully, hold the inhaler upright, and place it between your teeth, closing lips around the mouthpiece.
5. Breathe in deeply and slowly while pressing the canister to release the medication.
6. Remove the inhaler and hold your breath for at least 10 seconds.
7. If multiple puffs are prescribed, wait 1 minute between puffs, shaking the inhaler each time.
8. Replace the cap and rinse your mouth with water after each use.
9. Check technique in a mirror; if you see a mist, you might not have sealed your lips properly or breathed in correctly. Repeat the process if necessary.

Cleaning Instructions: Clean the inhaler weekly. Remove the canister and rinse the plastic parts in warm water. Dry thoroughly before reassembling.

Interactions

Avoid co-administration with strong CYP3A4 inhibitors (e.g., ritonavir) and exercise caution with Monoamine oxidase inhibitors and tricyclic antidepressants. Beta-blockers may reduce the effectiveness of β2-agonists, and diuretics may worsen hypokalemia.

Contraindications

Do not use this inhaler for the primary treatment of acute asthma or COPD episodes requiring intensive measures. It is contraindicated in individuals with hypersensitivity to any ingredients.

Side Effects

Formoterol Fumarate: Common side effects include tremor, palpitations, and headache. Rare effects may include cardiac arrhythmias and muscle cramps.

Budesonide: Possible side effects include hoarseness, oral thrush, and throat irritation. Long-term use may cause growth suppression in children, as well as other systemic effects.

Pregnancy & Lactation

There is limited data on the use of this combination during pregnancy. Budesonide is excreted in breast milk, but no adverse effects are expected at therapeutic doses. The safety of Formoterol in breastfeeding is not well established.

Precautions & Warnings

Exercise caution in patients with diabetes, cardiovascular issues, glaucoma, and other conditions. Monitor for paradoxical bronchospasm and discontinue use if symptoms worsen.

Use in Special Populations

Regularly monitor the growth of children on prolonged corticosteroid therapy and adjust treatment as necessary.

Overdose Effects

Overdosing on Formoterol may lead to tremor, headache, and palpitations. Overdosing on Budesonide is generally not a clinical concern, but chronic excessive use may cause systemic effects.

Storage Conditions

Do not swallow inhalation capsules. Store in a cool, dry place, away from light and moisture, and out of reach of children. Use capsules immediately after removing from the blister pack.

Always consult with a healthcare professional for proper medication use and management.