Sodium cromoglicate eye drops

1. Generic Name

Sodium Cromoglicate (also known as Cromolyn Sodium)

---

2. Drug Class

Mast Cell Stabilizer
Topical ophthalmic anti-allergic agent

---

3. Form and Administration Route

Formulation: Sterile ophthalmic solution
Concentration: 2% w/v (20 mg/mL)
Route of Administration: Topical instillation into the conjunctival sac

---

4. Therapeutic Indications

• Seasonal allergic conjunctivitis (hay fever-related ocular symptoms)

• Perennial allergic conjunctivitis (year-round allergens like dust or dander)

• Vernal keratoconjunctivitis (chronic seasonal allergic inflammation, especially in children and adolescents)

• Giant papillary conjunctivitis (often contact lens-related)

• Prophylaxis of ocular allergic reactions

---

5. Mechanism of Action

Sodium cromoglicate exerts its effect by stabilizing the membrane of conjunctival mast cells. It prevents calcium influx into mast cells, thereby inhibiting degranulation and release of histamine, leukotrienes, and other inflammatory mediators. Its action is prophylactic rather than curative, requiring regular use for sustained effect.

---

6. Dosage and Administration

Adults and Children over 6 years:

• Instill 1–2 drops into each eye

• 4 times daily at regular intervals

Duration of Treatment:

• Continue throughout allergen exposure period

• Maximum benefit may take several days to weeks of consistent use

• Treatment may be continued for several weeks to maintain control

Contact Lens Advice:

• Remove contact lenses before instillation

• Wait at least 15 minutes before reinserting lenses

• Preservative-free formulations preferred for contact lens users or those with dry eye

---

7. Pharmacokinetics

• Absorption: Minimal systemic absorption via ocular route

• Distribution: Localized to ocular tissues

• Metabolism: Not significantly metabolized

• Elimination: Excreted unchanged via the kidneys (if systemically absorbed in trace amounts)

• Half-life: Short; frequent dosing necessary to maintain therapeutic effect

---

8. Contraindications

• Hypersensitivity to sodium cromoglicate or any excipients

• Not recommended for children under 4 years of age (depending on product labeling)

---

9. Precautions and Warnings

• For topical ophthalmic use only

• Do not touch the dropper tip to any surface or the eye to avoid contamination

• If signs of infection or worsening inflammation occur, discontinue and consult a physician

• Instruct patients to seek medical attention if no improvement occurs within several days

• Do not use continuously for extended periods without medical supervision

---

10. Use in Special Populations

Pediatrics:

• Safe for children above 4–6 years (varies by product)

• Vernal keratoconjunctivitis is a key indication in pediatric patients

Geriatrics:

• No dosage adjustment needed

• Well-tolerated in elderly patients

Pregnancy:

• Use only if clearly needed

• Systemic absorption is negligible, but precautionary principle applies

Lactation:

• Unknown whether excreted in breast milk

• Consider risk-benefit assessment

Hepatic/Renal Impairment:

• No dose adjustment necessary due to low systemic exposure

---

11. Adverse Effects

Very Common / Common (≥1%):

• Transient stinging or burning sensation

• Mild eye irritation

• Blurred vision immediately after instillation

• Watery eyes or increased lacrimation

Uncommon (<1%):

• Eyelid swelling

• Foreign body sensation

• Redness or conjunctival hyperemia

• Itching or pruritus

Rare:

• Hypersensitivity reaction

• Periorbital swelling

• Anaphylaxis (extremely rare)

Systemic effects:

• Not expected due to low absorption

• No sedation, weight gain, or hormonal effects

---

12. Drug Interactions

• No significant systemic drug interactions known

• If used with other topical ocular medications, allow a 5–15 minute interval between applications

• Avoid simultaneous use with other eye drops that contain benzalkonium chloride if patient is sensitive

---

13. Storage and Handling

• Store at room temperature, away from direct light and heat

• Do not freeze

• Use within 4 weeks after opening multi-dose bottle

• Discard unit-dose vials immediately after use

• Keep out of reach of children

---

14. Clinical Considerations

• Best used prophylactically; less effective if started after full onset of symptoms

• Ineffective in non-allergic conjunctival inflammation

• May be combined with oral antihistamines or nasal sprays for full allergic rhinitis management

• Alternative for patients unable to tolerate topical corticosteroids

• Safe for long-term use when monitored

• Non-sedating and does not affect concentration or alertness