Bufocort 400

Indications

Asthma Treatment: This inhaler is prescribed for asthma treatment in patients aged 12 and above, excluding relief for acute bronchospasm.

COPD Maintenance: For chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, this inhalation capsule is for twice-daily maintenance treatment to manage airflow obstruction.

Description

This dry powder inhaler is for oral inhalation and combines Formoterol Fumarate Dihydrate BP and Budesonide BP. Budesonide, a glucocorticosteroid, exerts dose-dependent anti-inflammatory action in the airways, reducing asthma symptoms. Formoterol, a selective β2 adrenoceptor agonist, delivers rapid and long-lasting relaxation of bronchial smooth muscle, alleviating reversible airways obstruction.

Pharmacology

Budesonide: This corticosteroid possesses potent glucocorticoid activity, mitigating inflammation, a key component in asthma pathogenesis.

Formoterol Fumarate Dihydrate: A long-acting, selective β2 – adrenergic agonist, it acts as a bronchodilator, relaxing bronchial smooth muscles, and enhancing airflow.

Dosage

Inhaler (For Asthma):

• Adults and Adolescents (12 years and above): Recommended maintenance dose is 1 puff twice daily or 2 puffs once daily. Additional puff can be taken as needed, not exceeding 6 puffs per occasion.

Inhalation Capsule (For Asthma and COPD):

• Adults and Adolescents (12 years and above): Maintenance dose varies based on inhalation capsule strength. Additional inhalation capsule can be taken as needed, with a maximum daily limit.

Administration

Correct usage of the inhaler is essential for optimal treatment efficacy. Follow these steps:

• Remove the cap and shake the inhaler vigorously.
• Breathe out fully, hold the inhaler upright, and place the mouthpiece between teeth.
• Press down the canister while breathing deeply and slowly through the mouth.
• Hold breath for 10 seconds post-inhalation and replace the cap after use.

Interaction

Avoid co-administration with strong cytochrome P450 3A4 inhibitors or beta-blockers due to potential adverse effects.

Contraindications

Avoid in primary treatment of status asthmaticus or acute episodes of asthma/COPD and in case of hypersensitivity to any ingredient.

Side Effects

Adverse reactions may include tremors, palpitations, headache, hoarseness, candida infection, and respiratory tract infections.

Pregnancy & Lactation

Clinical data on exposed pregnancies are unavailable; use during pregnancy or lactation should be based on risk-benefit analysis.

Precautions & Warnings

Exercise caution in patients with diabetes, severe hypertension, or cardiovascular disorders. Monitor children’s height regularly during prolonged corticosteroid therapy.

Overdose Effects

Symptoms of overdose include tremors, headache, and palpitations. Supportive treatment may be necessary.

Storage Conditions

Store inhalation capsules away from light and moisture, at or below 25°C, and keep out of reach of children.