Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic, as sodium:
Generic: 4% (10 mL)
Pharmacology
Mechanism of Action
Mast cell stabilizer that inhibits the in vivo and in vivo release of histamine and slow-reacting substance of anaphylaxis (SRS-A) associated with antigen-mediated reactions.
Pharmacokinetics/Pharmacodynamics
Absorption
~0.03%
Onset of Action
Response to treatment: May be seen within a few days; treatment for up to 6 weeks is often required
Use: Labeled Indications
Conjunctivitis/keratitis: Treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis
Contraindications
Hypersensitivity to cromolyn or any component of the formulation
Dosage and Administration
Dosing: Adult
Conjunctivitis and keratitis: Ophthalmic: Instill 1 to 2 drops in each eye 4 to 6 times daily. Symptomatic response is often evident within a few days; continue therapy as long as required.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Conjunctivitis and keratitis: Children ≥4 years and Adolescents: Ophthalmic: Instill 1 to 2 drops in each eye 4 to 6 times daily at regular intervals
Administration
For ophthalmic use only. Wash hands prior to use. Instill drops inside the lower eyelid; avoid instilling directly on the cornea. To avoid contamination, do not touch dropper tip to eye, eyelid, fingers, or any other surface. Do not wear contact lenses during treatment.
Storage
Store at 15°C to 25°C (59°F to 77°F). Protect from light. Store in original carton.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Frequency not defined.
Ocular: Conjunctival injection, dryness around the eye, edema, eye irritation, immediate hypersensitivity reactions, itchy eyes, puffy eyes, styes, rash, watery eyes
Respiratory: Dyspnea
Warnings/Precautions
Concerns related to adverse effects:
- Irritation: May cause transient burning or stinging upon instillation.
Special populations:
- Contact lens wearers: Some products may contain benzalkonium chloride which may be absorbed by contact lenses; do not wear contact lenses during treatment.
Other warnings/precautions:
- Appropriate use: For topical ophthalmic use only; not for injection. To avoid contamination, do not touch dropper tip to eye, eyelid, fingers, or any other surface when placing drops in eyes.
Pregnancy
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events have not been observed in animal reproduction studies following SubQ administration. Systemic absorption following ophthalmic application is limited (~0.03%).
Patient Education
What is this drug used for?
- It is used to ease allergy signs.
- It is used to treat eye irritation.
Frequently reported side effects of this drug
- Stinging
- Burning
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
