CROMOLYN SODIUM OPHTHALMIC SOLUTION USP, 4% Sterile

Rx only

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 Water for Injection. It has a pH of 4.0 to 7.0; Preservative: Benzalkonium chloride 0.01%.

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.

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

Cromolyn Sodium Ophthalmic Solution 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, 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 attributed 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 Sodium Chloride Ophthalmic Solution.

Cromolyn Sodium Ophthalmic Solution USP 4% is supplied as 10 mL of solution in an opaque polyethylene bottle with a controlled dropper tip. NDC 17478-291-11

Information for the Patient

Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile

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

1. Thoroughly wash your hands.
2. Remove safety seal (Figure 1).Figure 1
3. Remove cap (Figure 2).Figure 2
4. Sit or stand comfortably, with your head tilted back (Figure 3).Figure 3
5. Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4).Figure 4
6. Hold the Cromolyn Sodium Ophthalmic Solution 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).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 directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of 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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 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.

Akorn
Manufactured By:
AKORN, INC.
Lake Forest, IL 60045
Rev. 06/16

Principal Display Panel Text for Container Label:

NDC 17478-291-11

Cromolyn

Sodium

Ophthalmic

Solution, USP

4%

Rx only Sterile 10 mL

FOR OPHTHALMIC USE ONLY

Principal Display Panel Text for Carton Label:

NDC 17478-291-11

Cromolyn

Sodium

Ophthalmic

Solution, USP

4%

FOR OPHTHALMIC USE ONLY

Sterile

10 mL

Rx only Akorn Logo