Usage
Sodium Cromoglycate is prescribed for the prevention and treatment of various allergic conditions. Its primary use is in managing allergic rhinitis, asthma, allergic conjunctivitis, and mastocytosis. It is also used off-label for food allergies.
It is pharmacologically classified as a mast cell stabilizer.
Sodium Cromoglycate works by stabilizing mast cells, preventing the release of histamine, leukotrienes, and other inflammatory mediators responsible for allergic symptoms.
Alternate Names
Sodium Cromoglicate, Cromolyn Sodium, Cromoglicic Acid
Brand Names: Intal, Opticrom, Nalcrom, Gastrocrom, Rynacrom (and others, which may vary regionally)
How It Works
Pharmacodynamics: Sodium Cromoglycate acts locally to stabilize mast cell membranes. This prevents degranulation and the release of mediators like histamine, leukotrienes, and prostaglandins, which are responsible for the inflammatory response in allergic reactions. It also inhibits the activation of sensory nerves involved in the cough reflex.
Pharmacokinetics: Sodium Cromoglycate is poorly absorbed orally (<1%). Inhaled drug is also minimally absorbed from the lungs and the remaining drug that is swallowed is poorly absorbed from the GI tract. Peak plasma concentration is typically reached within 15 minutes to 1 hour after inhalation, depending on the formulation. When administered intranasally, it can be absorbed locally in the nasal cavity, offering direct targeting of mast cells in that region. It is excreted primarily unchanged in the bile and urine. The half life is approximately 80 minutes.
Mode of Action: The precise mechanism is not fully elucidated but involves inhibiting calcium influx into mast cells, thus preventing degranulation. No specific receptor binding or enzyme inhibition is identified. It doesn’t modulate neurotransmitters directly, but by preventing mediator release, it indirectly affects neurogenic inflammation.
Elimination: Primarily excreted unchanged in the bile (87%) and urine (10%), with minimal metabolism.
Dosage
Standard Dosage
Adults:
- Oral (Capsules): 200 mg four times daily, 15-20 minutes before meals. This may be doubled if symptoms aren’t controlled, not to exceed 40 mg/kg/day.
- Inhalation (Nebulizer): 20 mg four times daily.
- Eye Drops: 1-2 drops in each eye four times daily.
- Nasal Spray: One spray in each nostril several times daily.
Children:
- Oral (Capsules): 100 mg four times daily, 15-20 minutes before meals. Maximum dose: 40 mg/kg/day.
- Inhalation (Nebulizer): 10-20 mg four times daily. Pediatric safety for those under 2 years old has not been established.
- Eye Drops: 1-2 drops in each eye four times daily.
- Nasal Spray: One spray in each nostril several times daily.
Special Cases:
- Elderly Patients: Start at the lower end of the dosing range due to potential for reduced renal/hepatic function.
- Patients with Renal Impairment: Dose reduction may be necessary.
- Patients with Hepatic Dysfunction: Dose reduction may be necessary.
- Patients with Comorbid Conditions: Dosage should be individualized, considering potential drug interactions.
Clinical Use Cases
The primary usage of sodium cromoglycate does not involve intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its main clinical utility lies in prophylactic management of allergic conditions. While some research suggests potential neuroprotective effects, it is not a standard treatment in those settings.
Dosage Adjustments
Adjustments are based on patient response, renal/hepatic function, and other clinical factors. Therapeutic drug monitoring is not routinely performed.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea
- Headache
- Nasal irritation (with nasal spray)
- Eye irritation (with eye drops)
- Cough
- Throat irritation (with inhaler)
Rare but Serious Side Effects:
- Allergic reactions (rash, itching, swelling, difficulty breathing)
- Myositis
- Pneumonitis
- Anaphylaxis (rare)
Long-Term Effects:
No specific long-term side effects are typically associated with sodium cromoglycate.
Adverse Drug Reactions (ADR):
Severe allergic reactions are rare but require immediate medical attention.
Contraindications
- Hypersensitivity to sodium cromoglycate.
Drug Interactions
No significant drug interactions are typically reported.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Generally considered safe during pregnancy, but should only be used if clearly needed.
- Breastfeeding: Limited information suggests it’s likely safe during breastfeeding, but caution is advised.
Drug Profile Summary
- Mechanism of Action: Mast cell stabilizer, preventing degranulation and release of inflammatory mediators.
- Side Effects: Nausea, headache, local irritation (depending on route of administration). Rare but serious: allergic reactions, myositis, pneumonitis.
- Contraindications: Hypersensitivity to sodium cromoglycate.
- Drug Interactions: None clinically significant.
- Pregnancy & Breastfeeding: Likely safe but use with caution if clearly needed.
- Dosage: See detailed dosage guidelines above.
- Monitoring Parameters: Primarily symptom control; no routine blood monitoring required.
Popular Combinations
Sodium cromoglycate is typically used as a single agent.
Precautions
- General Precautions: Assess for any history of hypersensitivity.
- Specific Populations: No specific precautions beyond dosage adjustments for renal/hepatic impairment and elderly patients.
- Lifestyle Considerations: No specific lifestyle restrictions are associated with sodium cromoglycate use.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Sodium Cromoglycate?
A: See the detailed dosage guidelines above, which vary based on the route of administration, age, and indication.
Q2: How does Sodium Cromoglycate differ from antihistamines?
A: Sodium Cromoglycate prevents the release of histamine and other mediators from mast cells, while antihistamines block the action of histamine after it has been released. Sodium Cromoglycate is therefore preventative, while antihistamines treat existing symptoms.
Q3: Can Sodium Cromoglycate be used in children?
A: Yes, but the dosage is adjusted based on age and weight. Safety in children under 2 is not established for all formulations.
Q4: What are the most common side effects of Sodium Cromoglycate?
A: The most common side effects are mild and include nausea, headache, and local irritation at the site of application (e.g., nasal irritation with nasal spray, eye irritation with eye drops).
Q5: Are there any serious side effects I should be aware of?
A: While rare, serious side effects can include severe allergic reactions, myositis, and pneumonitis. Anaphylaxis is extremely rare.
Q6: Can Sodium Cromoglycate be used during pregnancy or breastfeeding?
A: It is generally considered safe for use during pregnancy and breastfeeding, but should only be used if the potential benefit outweighs any risks. Discuss with your patient and assess their individual circumstances.
Q7: How long does it take for Sodium Cromoglycate to start working?
A: It can take several weeks of regular use to see the full benefits of sodium cromoglycate. Advise patients not to discontinue use prematurely.
Q8: Can Sodium Cromoglycate cure allergies?
A: No, it does not cure allergies. It helps manage and control symptoms by preventing the release of inflammatory mediators.
Q9: Is Sodium Cromoglycate available over the counter?
A: This varies depending on the country and formulation. Some formulations may be available over the counter, while others require a prescription.
Q10: What should I do if a patient experiences side effects?
A: Advise patients to report any side effects. Mild side effects may resolve on their own, but more severe side effects warrant discontinuation of the medication and a reevaluation of their treatment plan.
