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Cromolyn (sodium cromoglicate) (ophthalmic): Pediatric drug information

Cromolyn (sodium cromoglicate) (ophthalmic): Pediatric drug information
(For additional information see "Cromolyn (sodium cromoglicate) (ophthalmic): Drug information" and see "Cromolyn (sodium cromoglicate) (ophthalmic): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Therapeutic Category
  • Mast Cell Stabilizer
Dosing: Pediatric
Conjunctivitis and keratitis

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

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely needed due to low systemic absorption.

Dosing: Adult

(For additional information see "Cromolyn (sodium cromoglicate) (ophthalmic): Drug information")

Conjunctivitis and keratitis

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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

Contraindications

Hypersensitivity to cromolyn or any component of the formulation

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic, as sodium:

Generic: 4% (10 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Cromolyn Sodium Ophthalmic)

4% (per mL): $3.72

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

For ophthalmic use. Wash hands prior to use. Instill into conjunctival sac avoiding contact of bottle tip with skin or eye. Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Ref). Patients should not wear contact lenses during treatment.

Administration: Adult

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/Stability

Store at 15°C to 25°C (59°F to 77°F). Protect from light. Store in original carton.

Use

Treatment of vernal conjunctivitis, vernal keratoconjunctivitis, and vernal keratitis (FDA approved in ages ≥4 years and adults)

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies following SubQ administration. Systemic absorption following ophthalmic application is limited (~0.03%).

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 (Adult Data Unless Noted)

Onset of action: Response to treatment: May be seen within a few days; treatment for up to 6 weeks is often required

Absorption: ~0.03%

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (QA) Qatar: Cusicrom
  1. Cromolyn Sodium Ophthalmic Solution [prescribing information]. Bridgewater, NJ: Bausch & Lomb; August 2016.
  2. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  3. Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553. [PubMed 6704011]
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