CROMOLYN SODIUM- cromolyn sodium solution/ drops
Bausch & Lomb Incorporated
Rx only
DESCRIPTION
Cromolyn Sodium Ophthalmic Solution, USP 4% is a clear, colorless, sterile solution for topical ophthalmic use.
Cromolyn sodium is represented by the following structural formula:
cromolyn sodium (structural formula)
C23 H14 Na2 O11 Mol. Wt. 512.34
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. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 � 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.
