Usage
Salbutamol + Sodium Cromoglycate is prescribed for the prophylaxis and treatment of bronchial asthma, chronic bronchitis, and other conditions with reversible airway obstruction. This combination medication is classified as a bronchodilator and mast cell stabilizer. Salbutamol acts as a short-acting beta-2 agonist, relaxing bronchial smooth muscle, while Sodium Cromoglycate prevents mast cell degranulation, inhibiting the release of inflammatory mediators like histamine and leukotrienes.
Alternate Names
This combination is not commonly known by other generic names internationally. Brand names can vary regionally. Some popular brand names include Intal-Plus and Cromosal.
How It Works
Pharmacodynamics: Salbutamol stimulates beta-2 adrenergic receptors in the lungs, leading to bronchodilation. Sodium Cromoglycate stabilizes mast cells, preventing the release of inflammatory mediators that cause bronchoconstriction.
Pharmacokinetics: Salbutamol is rapidly absorbed after inhalation, reaching peak plasma concentration in 1-3 hours. It is metabolized in the liver and excreted primarily in urine. Sodium Cromoglycate is poorly absorbed after inhalation, acting locally in the lungs. Minimal systemic absorption occurs, with excretion mainly through bile and urine.
Mode of Action: Salbutamol activates adenylate cyclase through the beta-2 receptor, increasing intracellular cAMP, which leads to smooth muscle relaxation. Sodium Cromoglycate blocks chloride ion channels in mast cells, preventing calcium influx, therefore inhibiting mast cell degranulation and release of inflammatory mediators.
Receptor Binding, Enzyme Inhibition or Neurotransmitter Modulation: Salbutamol binds to beta-2 adrenergic receptors. Sodium Cromoglycate’s exact mechanism is not fully elucidated but it modulates chloride ion channels in mast cells.
Elimination Pathways: Salbutamol is metabolized by the liver and excreted renally. Sodium Cromoglycate undergoes minimal metabolism and is excreted via bile and urine.
Dosage
Standard Dosage
Adults:
Salbutamol: 2-4 mg via nebulizer 3 or 4 times daily. Alternatively, metered-dose inhaler (MDI): 2 puffs (100mcg/puff) every 4-6 hours as needed.
Sodium Cromoglycate: MDI: 2 puffs (2mg/puff) four times daily at regular intervals, or via nebulization: 20mg (1 vial) 4 times daily.
Combination products may have different strengths and dosing regimens. Always follow product-specific instructions.
Children:
Salbutamol: Nebulizer: 0.15mg/kg/dose (maximum 2.5 mg/dose) up to 4 times daily. MDI: 1-2 puffs (100mcg/puff) every 4-6 hours as needed.
Sodium Cromoglycate: MDI: 1 puff (2mg/puff) every 4 hours up to 4 times daily, or Nebulizer: 20 mg (1 vial) 4 times daily.
Combination products should be used with caution in children under 2 years old.
Special Cases:
- Elderly Patients: Start with the lowest effective dose and titrate cautiously.
- Patients with Renal Impairment: Sodium Cromoglycate dosage reduction may be necessary. Monitor renal function.
- Patients with Hepatic Dysfunction: Sodium Cromoglycate dosage reduction may be necessary. Monitor liver function.
- Patients with Comorbid Conditions: Caution is advised in patients with cardiovascular disease, diabetes, and hyperthyroidism. Monitor closely.
Clinical Use Cases
This combination is typically not used in clinical scenarios like intubation, surgical procedures, mechanical ventilation, or ICU care, where rapid bronchodilation is needed. In emergency situations like status asthmaticus, Salbutamol alone would be the preferred option initially.
Dosage Adjustments
Adjust doses based on patient response, pulmonary function tests, and tolerance to adverse effects. Monitor serum potassium levels for hypokalemia, especially in patients with severe asthma.
Side Effects
Common Side Effects:
- Salbutamol: Tremor, palpitations, tachycardia, headache, muscle cramps, and restlessness.
- Sodium Cromoglycate: Cough, throat irritation, and unpleasant taste.
Rare but Serious Side Effects:
- Salbutamol: Hypersensitivity reactions, paradoxical bronchospasm, hypokalemia, and arrhythmias.
- Sodium Cromoglycate: Eosinophilic pneumonia.
Long-Term Effects:
Long-term use of Salbutamol may lead to downregulation of beta-2 receptors. Long-term safety data for Sodium Cromoglycate is limited.
Adverse Drug Reactions (ADR):
Severe hypersensitivity reactions or anaphylaxis can occur with Salbutamol. Monitor for any signs of worsening respiratory distress after administration.
Contraindications
- Hypersensitivity to Salbutamol, Sodium Cromoglycate, or any component of the formulation.
Drug Interactions
- Beta-blockers antagonize the bronchodilatory effects of Salbutamol.
- Co-administration with other sympathomimetics may potentiate cardiovascular side effects.
- Monitor patients taking digoxin and diuretics for hypokalemia.
- Salbutamol can increase blood glucose levels and may require dosage adjustments in diabetic patients.
Pregnancy and Breastfeeding
- Salbutamol: Pregnancy Category C. Use only if the benefits outweigh the risks.
- Sodium Cromoglycate: Pregnancy Category B. Safety in breastfeeding is not established.
Drug Profile Summary
- Mechanism of Action: Salbutamol: Beta-2 adrenergic agonist, bronchodilator. Sodium Cromoglycate: Mast cell stabilizer.
- Side Effects: Salbutamol: Tremor, palpitations. Sodium Cromoglycate: Cough, throat irritation.
- Contraindications: Hypersensitivity to components.
- Drug Interactions: Beta-blockers, sympathomimetics, digoxin, diuretics.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: Adult/pediatric dosage varies; see above sections for details.
- Monitoring Parameters: Pulmonary function tests, serum potassium, blood glucose (in diabetics).
Popular Combinations
Salbutamol is commonly used with inhaled corticosteroids for long-term asthma management. Sodium Cromoglycate is not usually combined with other drugs in a single formulation besides Salbutamol.
Precautions
- Caution in patients with cardiovascular disease, diabetes, hyperthyroidism, and renal or hepatic impairment.
- Avoid excessive or prolonged use of Salbutamol.
- Regular use is crucial for Sodium Cromoglycate to be effective. Do not discontinue abruptly.
- Monitor for paradoxical bronchospasm.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Salbutamol + Sodium Cromoglycate?
A: Dosing varies depending on age, formulation, and severity of symptoms. Refer to the detailed dosage section above.
Q2: How should Salbutamol + Sodium Cromoglycate be administered?
A: The most common route is via inhalation, either with an MDI or nebulizer, depending on the specific product.
Q3: What are the common side effects of this combination therapy?
A: Common side effects include tremor, palpitations, tachycardia (Salbutamol), and cough, throat irritation (Sodium Cromoglycate).
Q4: Can this combination be used during pregnancy or breastfeeding?
A: Use with caution in pregnancy and breastfeeding. Consult with a specialist to assess risks and benefits.
Q5: Is Salbutamol + Sodium Cromoglycate effective in treating acute asthma attacks?
A: Primarily used for prophylaxis. Salbutamol alone or in combination with other rescue medications is preferred for acute attacks.
Q6: What are the contraindications for using this combination medication?
A: Hypersensitivity to either drug is a contraindication.
Q7: What are the potential drug interactions with Salbutamol + Sodium Cromoglycate?
A: Beta-blockers, certain antidepressants (TCAs), and digoxin can interact with this combination. Refer to the drug interaction section for more information.
Q8: What is the mechanism of action of Sodium Cromoglycate?
A: It stabilizes mast cells, preventing the release of inflammatory mediators that contribute to bronchoconstriction.
Q9: Can this combination be used in children?
A: Yes, but with caution and appropriate dosage adjustments. It’s not recommended for children under 2 years old without specialist consultation.
Q10: What monitoring is necessary for patients on this combination?
A: Monitor pulmonary function, serum potassium levels, heart rate and rhythm, and blood glucose (in diabetics).
