Label: CROMOLYN SODIUM solution/ drops

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%); Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1% and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.0).                   

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.

Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Cromolyn Sodium Ophthalmic Solution USP, 4% is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.

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; and styes.

Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema and rash.

The dose 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.

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 USP, 4%.

Cromolyn Sodium Ophthalmic Solution USP, 4% is supplied in a white, opaque, plastic ophthalmic dispenser in the following sizes:

10 mL NDC 71205-230-10

Storage: Store between 15° - 30°C (59°- 86°F). Protect from light-store in original carton. Keep tightly closed and out of the reach of children.

Rx Only

9007073-0811

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc.

Princeton, NJ 08540

Printed in USA

August 2011

Relabeled by

Proficient Rx LP

Thousand Oaks, CA 91320

PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Information for the Patient

Cromolyn Sodium Ophthalmic Solution USP, 4%

Sterile

It is important to use Cromolyn Sodium Ophthalmic Solution USP, 4% regularly, as directed by your physician.

1.

Thoroughly wash your hands.

2.

Remove safety seal (Figure 1).

3.

Remove cap (Figure 2).

4.

Sit or stand comfortably, with your head tilted back (Figure 3).

5.

Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4).

6.

Hold the Cromolyn Sodium Ophthalmic Solution USP, 4% bottle upside down. Place dropper tip as close as possible to the lower eyelid and gently squeeze out the prescribed number of drops (Figure 5).

7.

Do not touch the eye or eyelid with the dropper tip.

8.

Blink a few times to make sure the eye is covered with the solution.

9.

Close your eye and remove any excess solution with a clean tissue.

10.

Repeat process in the other eye.

SPECIAL TIPS

1.

Avoid placing Cromolyn Sodium Ophthalmic Solution USP, 4% directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of the eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5 on the previous page.

2.

To avoid contamination of the solution, do not touch dropper tip to the eye, fingers, or any other surface. Replace cap after use. It is recommended that any remaining contents be discarded after the treatment period prescribed by your physician.

3.

Store between 15°-30°C (59°-86°F). Protect from light - store in original carton.

4.

Keep tightly closed and out of the reach of children.

5.

Do not use with any other ocular medication unless directed by your physician. Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution USP, 4%.

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc.

Princeton, NJ 08540

Printed in USA

Relabeled by

Proficient Rx LP

Thousand Oaks, CA 91320

Rev. December 2018

NDC 71205-230-10       

Cromolyn

Sodium

Ophthalmic

Solution USP

4%

Rx Only

STERILE

10 mL