Usage
- Beclometasone + Levosalbutamol is prescribed for the prevention and management of asthma and chronic obstructive pulmonary disease (COPD). It is also indicated for managing bronchospasm in patients with reversible obstructive airway disease.
- Pharmacological Classification: This is a combination drug containing a corticosteroid (Beclometasone) and a bronchodilator (Levosalbutamol).
- Mechanism of Action: Beclometasone reduces inflammation and swelling in the airways. Levosalbutamol relaxes the muscles lining the airways, widening them and improving airflow.
Alternate Names
- Beclomethasone Dipropionate + Levosalbutamol/Levalbuterol
- Beclometasone + Levalbuterol (Levosalbutamol)
How It Works
- Pharmacodynamics: Beclometasone exerts its anti-inflammatory effect by binding to glucocorticoid receptors in the airways, reducing the production and release of inflammatory mediators. Levosalbutamol, a short-acting beta2-adrenergic agonist, relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors, leading to bronchodilation.
- Pharmacokinetics: Both drugs are administered via inhalation. Beclometasone has low systemic absorption, minimizing systemic side effects. Levosalbutamol is absorbed into the lungs, with some systemic absorption. Both are metabolized in the liver and excreted primarily through the kidneys.
Dosage
Standard Dosage
Adults:
- Initial: One to two puffs (40-80 mcg of beclometasone and levosalbutamol dosage will vary depending on the specific product) twice a day.
- Maintenance: Titrate to the lowest effective dose once asthma stability is achieved. The maximum dose generally should not exceed 320 mcg twice daily (Beclometasone component). Levosalbutamol dosage will vary based on the product.
Children:
- 4 to 11 years: Initial: One puff (containing 40 mcg of beclometasone, levosalbutamol dosage varies) twice daily.
- Maintenance: Dose can be increased up to 80 mcg beclometasone twice daily, with corresponding levosalbutamol dose adjustments. Titrate to the lowest effective dose for maintenance.
- Under 4 years: Not recommended.
Special Cases:
- Elderly Patients: Initiate therapy with a low dose and adjust carefully.
- Patients with Renal Impairment: Use with caution; dose adjustment may be necessary.
- Patients with Hepatic Dysfunction: Use with caution; dose adjustment may be necessary.
- Patients with Comorbid Conditions: Use cautiously in patients with diabetes, cardiovascular disease, hyperthyroidism, hypokalemia, and seizure disorders.
Clinical Use Cases
- Intubation, Surgical Procedures, Mechanical Ventilation, ICU Use, Emergency Situations: This combination is not typically used in these acute settings. Short-acting bronchodilators alone or in combination with systemic corticosteroids are preferred in these cases.
Dosage Adjustments
Dose adjustments should be made based on individual patient response, asthma severity, and any comorbid conditions. Patients with liver or kidney impairment may require lower doses.
Side Effects
Common Side Effects
- Headache
- Throat irritation
- Thrush (oral candidiasis)
- Hoarseness
- Runny nose
- Cough
Rare but Serious Side Effects
- Paradoxical bronchospasm
- Allergic reactions (angioedema, urticaria)
- Cardiac arrhythmias
Long-Term Effects
- Osteoporosis (with high doses of inhaled corticosteroids)
- Adrenal suppression (rare with inhaled corticosteroids)
- Growth retardation in children (with high doses of inhaled corticosteroids)
Adverse Drug Reactions (ADR)
- Severe bronchospasm
- Anaphylaxis
Contraindications
- Hypersensitivity to beclometasone, levosalbutamol, or any components of the formulation.
- Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.
Drug Interactions
- Beta-blockers (e.g., propranolol)
- Diuretics (e.g., furosemide)
- Cardiac glycosides (e.g., digoxin)
- Monoamine oxidase inhibitors (e.g., selegiline)
- Tricyclic antidepressants (e.g., amitriptyline)
- Other sympathomimetic agents (e.g., pseudoephedrine)
Pregnancy and Breastfeeding
- Pregnancy Safety Category: C (Consult a physician). Use only if the potential benefit justifies the potential risk to the fetus.
- Breastfeeding: It is unknown if beclometasone or levosalbutamol are excreted in breast milk. Use cautiously during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Corticosteroid reduces inflammation; bronchodilator relaxes airway muscles.
- Side Effects: Headache, throat irritation, thrush, hoarseness. Rarely: paradoxical bronchospasm, allergic reactions, cardiac arrhythmias.
- Contraindications: Hypersensitivity, acute asthma attacks.
- Drug Interactions: Beta-blockers, diuretics, digoxin, MAOIs, tricyclic antidepressants, sympathomimetics.
- Pregnancy & Breastfeeding: Use with caution. Consult a physician.
- Dosage: See detailed dosage section above.
- Monitoring Parameters: Lung function tests (FEV1, peak flow), blood glucose (in diabetics), bone mineral density (with long-term use).
Popular Combinations
Beclometasone + Levosalbutamol is itself a popular combination, generally not combined with other respiratory medications. Long-acting bronchodilators (like Formoterol) might be added to the treatment regimen by physician.
Precautions
- General Precautions: Monitor for side effects, especially thrush and hoarseness. Ensure proper inhaler technique.
- Specific Populations: Pregnancy and breastfeeding use caution.
- Lifestyle Considerations: Avoid smoking and exposure to allergens. Limit alcohol intake.
FAQs (Frequently Asked Questions)
A: See the detailed dosage section above. Dosage depends on age, asthma severity, and other medical conditions.
Q2: How should patients administer the inhaler?
A: Patients should be instructed on proper inhaler technique to ensure optimal drug delivery. This includes shaking the inhaler, exhaling completely, placing lips tightly around the mouthpiece, inhaling deeply while activating the inhaler, holding breath for 10 seconds, then exhaling slowly. A spacer device may be helpful for some patients.
Q3: What are the common side effects?
A: Common side effects include headache, throat irritation, thrush (oral candidiasis), and hoarseness.
Q4: What should I do if a patient experiences thrush?
A: Advise patients to rinse their mouths with water after each inhalation and consider using an antifungal mouthwash if thrush develops.
Q5: Can this medication be used during pregnancy?
A: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult a physician.
Q6: Are there any drug interactions I should be aware of?
A: Yes, see the drug interactions section above. This medication can interact with several other medications, including beta-blockers and certain antidepressants.
A: No, this medication is intended for long-term prevention and control of asthma, not for acute symptom relief. A short-acting bronchodilator (like Salbutamol) is usually prescribed as rescue medication.
A: Monitor patients for efficacy (lung function tests, symptom control) and potential side effects (thrush, hoarseness, changes in blood glucose, etc.). Regularly assess for adrenal suppression and growth effects in children.
Q9: What should a patient do if they miss a dose?
A: Instruct the patient to take the missed dose as soon as they remember, unless it is almost time for the next dose. Do not double the dose.