Indications and Usage : Cromolyn sodium ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. Symptomatic response to therapy (decreased itching, tearing, redness and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution. Users of soft (hydrophilic) contact lenses should refrain from wearing lenses while under treatment with cromolyn sodium ophthalmic solution (see Contraindications ). Wear can be resumed within a few hours after discontinuation of the drug. Description : Crolom® (Cromolyn Sodium Ophthalmic Solution USP, 4%) is a clear, colorless, sterile solution for topical ophthalmic use. Pharmacologic Category : Mast cell stabilizer. EACH mL CONTAINS : ACTIVE: Cromolyn Sodium 40 mg (4%); INACTIVES: Edetate Disodium 0.1% and Purified Water. 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, antihistaminic 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. A study on corneal epithelial wound healing in albino rabbits failed to demonstrate any significant difference in the rate of corneal re-epithelialization between cromolyn sodium ophthalmic solution, sterile saline solution, no treatment and an ophthalmic corticosteroid. Contraindications : Cromolyn sodium ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients. As with all ophthalmic preparations containing benzalkonium chloride, patients are advised not to wear soft contact lenses during treatment with cromolyn sodium ophthalmic solution. Precautions: General : Patients may experience a transient stinging or burning sensation following spplication of cromolyn sodium ophthalmic solution. The recommended frequency of administration should not be exceeded. The dose for adults and children is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. Carcinogenesis, Mutagenesis, and Impairment of Fertility : Long-term studies in mice (12 months intraperitoneal treatment followed by six months observation), hamsters (12 months intraperitoneal treatment followed by 12 months observation) and rats (18 months subcutaneous treatment) showed no neoplastic effect of cromolyn sodium. No evidence of chromosomal damage or cytotoxicity was obtained in various mutagenesis studies. No evidence of impaired fertility was shown in laboratory animal reproduction studies. Pregnancy : Teratogenic effects : Pregnancy Category B. Reproduction studies with cromolyn sodium administered parenterally to pregnant mice, rats and rabbits in doses up to 338 times the human clinical doses produced no evidence of fetal malformations. Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers : It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cromolyn sodium ophthalmic solution is administered to a nursing woman. Pediatic Use : Safety and effectiveness in children below the age of 4 years have not been established. Adverse Reactions : The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation. The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributable to the drug: Conjunctival injection Watery eyes Itchy eyes Dryness around the eye Puffy eyes Eye irritation Styes Dosage And Administration : The dose for adults and children is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium. Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed. FOR OPHTHALMIC USE ONLY How Supplied : Crolom® (Cromolyn Sodium Ophthalmic Solution USP, 4%) is supplied in a plastic bottle individually cartoned with a controlled drop tip in the following sizes: 10 mL bottle (NDC 24208-300-10)–AB30709 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage : Store between 15°-30°C (59°-86°F). Protect from light. Keep tightly closed. Replace cap immediately after use. KEEP OUT OF REACH OF CHILDREN. Rx only Bausch & Lomb Pharmaceuticals, Inc. 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