Cromolin

• Approved Indications:
• Prevention and treatment of allergic conjunctivitis, including seasonal and perennial allergic conjunctivitis.
• Management of vernal keratoconjunctivitis.
• Relief of ocular itching, redness, and irritation caused by allergens.
• Off-label Uses:
• Adjunct therapy for other ocular allergic conditions as determined by a healthcare professional.
• Prophylactic use before anticipated allergen exposure to minimize allergic symptoms.

• Adults and Children (≥4 years):
• Instill 1 drop of 4% sodium cromoglicate solution into the affected eye(s) four times daily.
• In severe cases, dosing may be increased to one drop every 2 hours while awake, up to a maximum of 6–8 times per day.
• For prevention, treatment should start several days prior to expected allergen exposure and continued throughout the exposure period.
• Elderly:
• No dosage adjustment necessary.
• Renal/Hepatic Impairment:
• No dose adjustment needed due to negligible systemic absorption.
• Route of Administration:
• Topical ocular use only.
• Duration:
• Use regularly during the allergen season or as directed by a healthcare provider.

Sodium cromoglicate acts by stabilizing mast cells and preventing the release of histamine and other inflammatory mediators such as leukotrienes and prostaglandins. It inhibits calcium influx into mast cells, thus preventing degranulation triggered by allergen exposure. This inhibition reduces the allergic inflammatory response in ocular tissues, alleviating symptoms like itching, redness, and swelling.

• Absorption: Minimal systemic absorption after topical ocular administration.
• Distribution: Primarily localized to ocular tissues; systemic distribution is negligible.
• Metabolism: Due to minimal absorption, metabolism is negligible.
• Excretion: Any absorbed drug is mainly eliminated unchanged via the kidneys.
• Onset of Action: Therapeutic effects may take several days to manifest with regular use.
• Half-life: Not well-defined systemically owing to minimal absorption.

• Pregnancy: Classified as FDA pregnancy category B. Animal studies reveal no harm to fetus; however, controlled human studies are lacking. Use only if clearly indicated.
• Lactation: Limited data on excretion into breast milk; systemic absorption is minimal. Use caution when administered to breastfeeding mothers.

• Primary therapeutic class: Mast cell stabilizer
• Subclass: Ophthalmic anti-allergic agent

• Known hypersensitivity to sodium cromoglicate or any formulation components.
• Presence of active ocular infection or severe eye surface disease.

• Avoid contamination of the dropper tip by not touching the eye or any surface with it.
• Discontinue use if hypersensitivity reactions or severe eye irritation develop.
• Not intended for immediate relief of acute allergic symptoms; more effective as prophylactic or maintenance therapy.
• Caution in patients with dry eye or corneal epithelial defects.

• Common: Mild, transient stinging or burning sensation upon instillation.
• Less Common: Conjunctival hyperemia, eyelid edema, allergic reactions including conjunctivitis.

• No clinically significant drug interactions reported due to minimal systemic exposure.
• Can be safely co-administered with antihistamine eye drops or ocular lubricants.

• Current guidelines emphasize starting prophylactic treatment ahead of allergen exposure to optimize symptom control.
• No new safety warnings or dosing changes have been reported recently.

• Store at 15°C to 25°C (59°F to 77°F).
• Protect from light and moisture.
• Keep bottle tightly closed when not in use.
• Discard 4 weeks after opening to prevent microbial contamination.