Sodium cromoglicate capsules

Generic Name: Sodium Cromoglicate (Cromolyn Sodium)
Drug Class: Mast‑cell stabilizer; non‑steroidal anti‑allergy agent (systemic formulation)
Formulations: 100 mg hard gelatin capsules; also available as oral solution
Route: Oral administration
Primary Use: Prophylactic management of food allergies, mastocytosis, and related allergic gastrointestinal conditions

---

2. Mechanism of Action

Sodium cromoglicate stabilizes mast cell membranes in the gastrointestinal tract and other tissues, preventing release of histamine, leukotrienes, and inflammatory mediators. It reduces local immune response to allergens, thereby attenuating clinical symptoms of allergic disorders when taken regularly before exposure.

---

3. Pharmacokinetics

• Absorption: Very low; <1 % systemic absorption

• Peak levels: Negligible; most remains in GI tract where local effect occurs

• Elimination half‑life: Approximately 1–1.3 hours

• Excretion: Mostly unchanged via feces; trace amounts in urine

• Protein Binding / Metabolism: Minimal; not metabolized by hepatic enzymes

---

4. Indications

• Food allergy prophylaxis: Used to prevent clinical reactivity in individuals with confirmed food allergies when exposure is possible

• Systemic mastocytosis and mast cell activation syndromes: Relieves gastrointestinal and cutaneous symptoms such as diarrhea, abdominal pain, itching, flushing

• Allergic colitis/proctitis: In some cases, management of inflammatory gut conditions with allergic basis

---

5. Dosage & Administration

Capsules (100 mg each)

Adults and adolescents ≥14 years:

• Usual dose: 200 mg (2 capsules) four times daily, taken 30–60 minutes before meals and at bedtime

• Adjustment: If symptom control not achieved within 2–3 weeks, dose may be increased cautiously up to 40 mg/kg/day, with medical supervision

• Maintenance: Once symptoms stabilize, dose may be tapered to lowest effective level

Children aged 2–13 years:

• Usual dose: 100 mg (1 capsule) four times daily, taken similarly before meals and at bedtime

• Under 2 years: Use not recommended, except under specialist guidance

Administration Tips:

• Swallow capsules whole with a drink of water

• If swallowing is difficult, capsules can be opened: contents dissolved in hot (not boiling) water, cooled, then consumed fully

Oral Solution (e.g., 100 mg/5 mL ampoule)

• Adults: 200 mg (two ampoules) four times daily

• Children: 100 mg (one ampoule) four times daily

• Administer 15–30 minutes before meals

• Medication may be continued for several months under supervision

---

6. Contraindications

• Known hypersensitivity to sodium cromoglicate or any excipients

• Individuals with a history of severe allergic reaction or anaphylactic shock to food allergens should be under medical supervision before use

---

7. Precautions & Warnings

• Effectiveness depends on consistent and timely administration; not suitable for acute reactions

• Not effective if taken after ingestion of allergen

• Use with caution in patients with renal or hepatic impairment—though systemic absorption is minimal, prolonged ingestion may accumulate

• Discontinue if significant adverse effects or allergic reactions occur

• Patient education essential: pair with allergen avoidance strategies and, if prescribed, carry rescue epinephrine for anaphylaxis

---

8. Adverse Effects

Common (>1%):

• Gastrointestinal discomfort: nausea, diarrhea, abdominal pain

• Headache

• Skin rash or itching

• Joint or muscle pain

Uncommon / Rare:

• Mood or behavior change, fatigue

• Flushing, dizziness

• Very rare: hypersensitivity reactions, including urticaria or angioedema

Systemic effects:

• Extremely rare due to low systemic absorption

• No sedation, weight changes, or hormonal effects reported

---

9. Drug Interactions

• No significant interactions with systemic medications known

• May be co-administered with other allergy medications or mast cell stabilizers

• Always review concomitant medications—none are contraindicated but always inform healthcare provider of full regimen

---

10. Use in Special Populations

Pediatrics (2–13 years old):

• Ensure correct weight-based dosing; closely monitor response and tolerance

Elderly:

• No specific dose adjustments required, but cautious initiation advisable due to comorbidities

Pregnancy:

• Considered relatively safe (Category A in some countries); use only if benefits outweigh possible risks; systemic absorption minimal

Breastfeeding:

• Very unlikely to enter breast milk in significant amounts; use under guidance

Renal/Hepatic Impairment:

• No formal dose adjustment guidelines; caution advised, particularly in long-term use

---

11. Monitoring & Follow-Up

• Clinical assessment of allergic symptom frequency and severity over initial 2–3 weeks

• Monitor for gastrointestinal side effects or rash

• Periodic review of ongoing need; reduce dose if clinical control maintained

• Follow healthcare provider guidance; coordinate with allergist or gastroenterologist where applicable

---

12. Clinical Considerations

• Sodium cromoglicate capsules offer non‑steroidal, non‑systemic allergy prophylaxis suitable for food allergy or mast cell disorders

• Best used as part of a broader management plan: allergen avoidance, symptom education, and emergency action plan

• Not a substitute for acute treatment such as antihistamines or epinephrine in anaphylaxis

• May be preferable in pediatric patients or those intolerant of systemic allergy medications

• Regular dosing is critical: missed doses may reduce efficacy dramatically