Budemet 400 Convicap

Indications

Asthma Management: This inhaler is designed for asthma treatment in individuals aged 12 and older. It is not suitable for immediate relief of acute bronchospasm.

Chronic Obstructive Pulmonary Disease (COPD) Maintenance: This inhalation capsule is specifically approved for the twice-daily maintenance of airflow obstruction in patients suffering from COPD, which includes chronic bronchitis and emphysema. This is the only authorized dosage for managing COPD-related airflow issues.

Description

This inhalation capsule is intended for use with a dry powder inhaler, exclusively for oral inhalation. It combines Formoterol Fumarate Dihydrate BP and Budesonide BP. Budesonide, a glucocorticosteroid, offers a dose-dependent anti-inflammatory effect when inhaled, leading to reduced symptoms and fewer asthma exacerbations, with milder side effects compared to systemic corticosteroids. While the exact mechanism of glucocorticosteroid action is not fully understood, Formoterol acts as a selective β2 adrenoceptor agonist, providing rapid and prolonged relaxation of bronchial smooth muscle in cases of reversible airway obstruction. Its bronchodilating effects begin within 1-3 minutes and last for at least 12 hours.

Pharmacology

Budesonide: This anti-inflammatory corticosteroid possesses strong glucocorticoid and mild mineralocorticoid properties. It combats inflammation—a key factor in asthma—by inhibiting various cell types and mediators involved in allergic and non-allergic inflammation.

Formoterol Fumarate Dihydrate: A long-acting, selective β2-adrenergic agonist with quick action, Formoterol acts locally in the lungs, promoting bronchodilation. Its mechanism involves stimulating intracellular adenyl cyclase, increasing cyclic AMP levels, which leads to relaxation of bronchial muscles and reduces the release of allergic mediators.

Dosage

For Asthma:

• Inhaler:
  • Adults and Adolescents (12+ years): Recommended maintenance is 1 puff twice daily or 2 puffs once daily (for 160/4.5 mcg/inhalation only). An additional puff may be taken as needed, with a maximum of 6 puffs at one time.
  • Children: Typical maintenance is 1-2 puffs once or twice daily, with a maximum of 4 puffs at once.
• Inhalation Capsules:
  • Adults and Adolescents (12+ years):
    • Maintenance: 100 & 200 Inhalation Capsules twice daily.
    • Reliever: 1 additional capsule as needed, not exceeding 6 capsules at a time.
  • Children (4+ years):
    • Maintenance: 100 Inhalation Capsule once daily.
    • Reliever: 1 additional capsule as needed, not exceeding 4 capsules at a time.

For COPD:

• Adults (40+ years):
  • 200 Inhalation Capsule: 2 capsules twice daily, max 4 capsules per day.
  • 400 Inhalation Capsule: 1 capsule twice daily, max 2 capsules per day.

Consult your healthcare provider for specific advice regarding medication use.

Administration

Using an inhaler correctly is crucial for effective treatment. Improper technique can reduce medication delivery to the lungs. Follow these guidelines from the National Asthma Guidelines:

1. Remove the cap.
2. Shake the inhaler vigorously at least six times before use.
3. For new or unused inhalers, release one puff into the air to ensure it’s working.
4. Exhale fully, holding the inhaler upright.
5. Place the mouthpiece between your teeth and close your lips around it.
6. Inhale deeply and slowly while pressing down on the canister.
7. Remove the inhaler from your mouth and hold your breath for at least 10 seconds.
8. If prescribed more than one inhalation, wait 1 minute between puffs.
9. Replace the cap after use and rinse your mouth with water.
10. Periodically check your technique in front of a mirror to ensure proper usage.

Cleaning Instructions: Clean your inhaler weekly. Remove the canister and rinse the plastic parts in warm water, avoiding the metal canister. Thoroughly dry before reassembling.

Consult your healthcare provider for specific advice regarding medication use.

Interactions

Avoid using with strong cytochrome P450 3A4 inhibitors (e.g., ritonavir) to prevent increased corticosteroid effects. Exercise caution when combining with monoamine oxidase inhibitors and tricyclic antidepressants, as they may enhance the effects of Formoterol on the vascular system. Beta-blockers may counteract the bronchodilatory effects of beta-agonists and induce severe bronchospasm. Use with diuretics carefully to avoid potential complications like hypokalemia.

Contraindications

This medication is contraindicated for:

• Primary treatment of status asthmaticus or acute asthma/COPD episodes requiring intensive intervention.
• Hypersensitivity to any component of this formulation.

Side Effects

Side effects associated with Formoterol Fumarate and Budesonide include:

• Formoterol: Common reactions are tremors, palpitations, and headaches; uncommon effects include cardiac arrhythmias and hypersensitivity reactions.
• Budesonide: Possible side effects include hoarseness, oropharyngeal candidiasis, throat irritation, and in rare cases, immunosuppression or growth effects in children.

Pregnancy & Lactation

There is limited clinical data on the use of this combination during pregnancy. While Budesonide has not shown adverse effects in animal studies, caution is advised. Budesonide is excreted in breast milk, but no adverse effects are anticipated at therapeutic doses. The safety of Formoterol during breastfeeding is not fully established.

Precautions & Warnings

Exercise caution in patients with diabetes, severe hypertension, or cardiovascular disorders. Monitor for paradoxical bronchospasm, which may necessitate discontinuation of the medication.

Special Populations

Regular monitoring of the growth of children on prolonged inhaled corticosteroids is advised. If growth is affected, consider dose adjustments or referral to a pediatric specialist.

Overdose Effects

Overdose may lead to symptoms typical of β2 agonist use, such as tremors and palpitations. In severe cases, monitor for tachycardia and other complications. Budesonide overdose is not typically a clinical concern, but chronic excessive doses can lead to systemic effects.

Storage Conditions

Inhalation capsules should not be swallowed and must be used with the appropriate inhalation device. Store away from light and moisture, at or below 25°C, and out of children’s reach. Remove capsules from blister packs immediately before use to ensure efficacy.