AKORNCROM

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AKORNCROM (CROMOLYN SODIUM OPHTHALMIC SOLUTION USP, 4%, Sterile)

DESCRIPTION

Cromolyn Sodium Ophthalmic Solution USP, 4% is a clear, colorless, sterile solution intended for topical ophthalmic use.
Cromolyn Sodium is represented by the following structural formula:
Chemical Name: disodium 5-5’ – [(2-hydroxytrimethylene)dioxy] bis [4-oxo-4H-1-benzopyran-2-
carboxylate].
Pharmacologic Category: Mast cell stabilizer.
Each mL contains: Active: Cromolyn sodium 40 mg (4%); Inactives: Edetate disodium 0.1% and
Purified Water, USP. It has a pH of 4.0 to 7.0; Preservative: Benzalkonium chloride 0.01%.

CLINICAL PHARMACOLOGY

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of
sensitized mast cells which occurs after exposure to specific antigens. Cromolyn sodium acts by
inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the
mast cell.
Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the
degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of
chemical mediators. Another study showed that cromolyn sodium did not inhibit the enzymatic
activity of released phospholipase A on its specific substrate.
Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or anti-inflammatory activity.
Cromolyn sodium is poorly absorbed. When multiple doses of cromolyn sodium ophthalmic solution
are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium
is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal
cavity and gastrointestinal tract).

Trace amounts (less than 0.01%) of the cromolyn sodium dose
penetrate into the aqueous humor and clearance from this chamber is virtually complete within 24
hours after treatment is stopped.
In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn
sodium is absorbed following administration to the eye.

INDICATIONS AND USAGE

Cromolyn Sodium Ophthalmic Solution is indicated in the treatment of vernal keratoconjunctivitis,
vernal conjunctivitis, and vernal keratitis.

CONTRAINDICATIONS

Cromolyn Sodium Ophthalmic Solution is contraindicated in those patients who have shown
hypersensitivity to cromolyn sodium or to any of the other ingredients.

PRECAUTIONS

General: Patients may experience a transient stinging or burning sensation following application of Cromolyn Sodium Ophthalmic Solution.
The recommended frequency of administration should not be exceeded (see DOSAGE AND ADMINISTRATION).Read More