Usage
Beclometasone + Formoterol is prescribed for the regular long-term treatment of asthma in adults and children 12 years and older not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta2-agonists or whose asthma is already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. It is also used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults.
Pharmacological Classification:
- Beclometasone: Inhaled Corticosteroid (ICS)
- Formoterol: Long-acting Beta2-adrenergic Agonist (LABA)
Mechanism of Action: This combination medication works through two distinct mechanisms:
- Beclometasone: Reduces inflammation in the airways by suppressing inflammatory cells and mediators, thus decreasing swelling and irritation.
- Formoterol: Relaxes the muscles around the airways, leading to bronchodilation and improved airflow to the lungs.
Alternate Names
There are no widely recognized alternate generic names. “Beclometasone Dipropionate + Formoterol Fumarate Dihydrate” represents the full chemical names of the components.
Some popular Brand names Foster, Fostair
How It Works
Pharmacodynamics:
- Beclometasone: Exerts its anti-inflammatory effects by binding to glucocorticoid receptors in the airways, inhibiting the production of inflammatory cytokines and other mediators. This leads to reduced airway hyperresponsiveness and inflammation.
- Formoterol: Stimulates beta2-adrenergic receptors in the lungs, causing smooth muscle relaxation and bronchodilation, improving airflow.
Pharmacokinetics:
- Beclometasone: Inhaled beclometasone dipropionate is rapidly absorbed through the lungs. It undergoes extensive first-pass metabolism by esterase enzymes to its active metabolite, beclometasone-17-monopropionate. Systemic absorption is relatively low, minimizing systemic side effects. It is primarily metabolized in the liver and eliminated via biliary and renal excretion.
- Formoterol: Rapidly absorbed after inhalation with peak plasma concentrations occurring within 30 minutes to 1 hour. It is metabolized primarily by direct glucuronidation and O-demethylation and excreted in the urine. Formoterol demonstrates a longer duration of action compared to short-acting beta2-agonists.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation:
- Beclometasone: Binds to glucocorticoid receptors.
- Formoterol: Stimulates beta2-adrenergic receptors.
Elimination Pathways:
- Beclometasone: Hepatic metabolism and biliary/renal excretion.
- Formoterol: Primarily renal excretion.
Dosage
Standard Dosage
Adults (Asthma):
- Maintenance Therapy: 1-2 inhalations twice daily.
- Maintenance and Reliever Therapy (MART): Regular maintenance dose (1-2 inhalations twice daily) plus additional inhalations as needed for symptom relief (maximum 6 reliever puffs per day, maximum total daily dose 8 puffs).
Adults (COPD):
- 2 inhalations twice daily.
Children (12-17 years - Asthma):
- Same as adult asthma dosing.
Special Cases:
- Elderly Patients: No dose adjustment needed.
- Patients with Renal Impairment: Use with caution; monitor renal function.
- Patients with Hepatic Dysfunction: Use with caution; monitor liver function.
- Patients with Comorbid Conditions: Close monitoring for patients with hypertension, heart disease, diabetes, hyperthyroidism, hypokalemia, or seizures.
Clinical Use Cases
Beclometasone + Formoterol is not indicated for:
- Intubation
- Surgical Procedures
- Mechanical Ventilation
- Intensive Care Unit (ICU) Use
- Emergency Situations (e.g., status epilepticus, cardiac arrest). A short-acting bronchodilator should be used for acute exacerbations.
Dosage Adjustments
Dose adjustments may be necessary based on individual patient response and tolerability. The lowest effective dose should be used.
Side Effects
Common Side Effects:
- Throat irritation
- Hoarseness
- Cough
- Oral candidiasis (thrush)
- Headache
- Tremor
- Palpitations
- Dizziness
Rare but Serious Side Effects:
- Paradoxical bronchospasm
- Severe allergic reactions (anaphylaxis)
- Hypokalemia
- Hyperglycemia
- Cardiac arrhythmias
- Adrenal suppression (with prolonged high doses)
- Pneumonia
Long-Term Effects:
- Osteoporosis (with high doses)
- Growth retardation in children (with high doses)
- Cataracts
- Glaucoma
Adverse Drug Reactions (ADR):
Contraindications
- Hypersensitivity to beclometasone, formoterol, or any of the excipients.
Drug Interactions
- Beta-blockers: Reduce the bronchodilating effects of formoterol.
- Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): May increase systemic exposure to beclometasone.
- Other sympathomimetics: May potentiate cardiovascular effects.
- Diuretics, Xanthine derivatives, Steroids: May exacerbate hypokalemia.
- MAO inhibitors, Tricyclic antidepressants: May increase the risk of cardiovascular adverse events.
Pregnancy and Breastfeeding
- Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Limited human data. Animal studies show adverse effects at high doses.
- Breastfeeding: Beclometasone is excreted in breast milk in small amounts. Use with caution. Monitor infant for potential side effects.
Drug Profile Summary
- Mechanism of Action: Beclometasone: Anti-inflammatory (corticosteroid); Formoterol: Bronchodilator (LABA)
- Side Effects: Throat irritation, hoarseness, cough, oral candidiasis, headache, tremor, palpitations. Rarely: paradoxical bronchospasm, hypokalemia, hyperglycemia, cardiac arrhythmias, adrenal suppression.
- Contraindications: Hypersensitivity to components.
- Drug Interactions: Beta-blockers, strong CYP3A4 inhibitors, sympathomimetics, diuretics.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: Asthma (adults/children ≥12 years): 1-2 inhalations twice daily (maintenance), + additional inhalations PRN (MART); COPD (adults): 2 inhalations twice daily.
- Monitoring Parameters: Lung function (FEV1, PEF), blood glucose, serum potassium, signs of thrush, growth in children.
Popular Combinations
Beclometasone and formoterol are typically used in a fixed-dose combination inhaler. Combining an ICS and LABA provides synergistic effects, achieving better asthma/COPD control compared to either drug alone.
Precautions
- General Precautions: Monitor for adverse effects, including oral candidiasis, hyperglycemia, and hypokalemia.
- Specific Populations: Use with caution in patients with cardiac disease, diabetes, hyperthyroidism, and hypokalemia. Monitor growth in children receiving long-term treatment.
- Lifestyle Considerations: Rinsing mouth after each inhalation and regular dental hygiene can help prevent oral thrush. Advise patients to avoid smoking and exposure to respiratory irritants.
FAQs (Frequently Asked Questions)
A: For adults and children 12 years and older with asthma, the usual maintenance dose is 1 or 2 inhalations twice daily. In the MART regimen, the same maintenance dose is used with additional inhalations taken as needed for symptom relief, up to a maximum of 6 reliever puffs per day and a total daily dose of 8 puffs. For adults with COPD, the recommended dose is 2 inhalations twice daily.
A: No. Beclometasone + Formoterol is not for acute bronchospasm. Patients should have a separate short-acting bronchodilator (e.g., albuterol) for acute symptom relief.
Q3: What are the common side effects?
A: Common side effects include throat irritation, hoarseness, cough, oral candidiasis, headache, tremor, and palpitations.
Q4: Are there any drug interactions I should be aware of?
A: Yes. Avoid concurrent use with beta-blockers. Caution should be exercised with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole). Inform patients about potential interactions with other medications they are taking, including over-the-counter drugs and supplements.
Q5: Can this medication be used during pregnancy and breastfeeding?
A: Use during pregnancy only if the benefits outweigh the risks. It is excreted in breast milk, so use with caution during breastfeeding.
A: Monitor lung function, blood glucose, serum potassium levels, and signs of oral candidiasis. For children, monitor growth regularly.
Q7: How should patients clean their inhaler?
A: Patients should wipe the mouthpiece with a dry cloth or tissue regularly. Do not wash or put the inhaler in water.
Q8: What should a patient do if they experience paradoxical bronchospasm?
A: Stop Beclometasone + Formoterol immediately and use a short-acting reliever inhaler. Seek immediate medical advice.
Q9: What is the difference between maintenance and reliever therapy (MART)?
A: MART utilizes a single inhaler (like Beclometasone + Formoterol) for both regular maintenance and as-needed symptom relief. This simplifies treatment and potentially improves adherence.
Q10: Is there a specific age restriction for this medication?
A: It is contraindicated in children under 12 years of age for asthma and under 18 for COPD. The safety and efficacy have not been established in younger children.
