Cromolyn-sodium Ophthalmic Solution

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.

Do not wear contact lenses while using this medication, or when you have allergy symptoms affecting your eyes.

During treatment with cromolyn sodium ophthalmic, avoid using any other eye medications that your doctor has not prescribed.

The most frequently reported adverse reaction attributed to the use of OPTICROM (cromolyn sodium ophthalmic solution, USP) 4%, 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.

Read the entire FDA prescribing information for Opticrom (Cromolyn Sodium Ophthalmic Solution)

CROMOLYN SODIUM (KROE moe lin SOE dee um) helps to relieve seasonal eye allergies.

This drug also comes in other forms, including Oral solution, Inhalation powder, pressurized, Inhalation solution, Nasal solution, spray

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• itchy, watery eyes

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• burning or stinging right after use

This medicine is only for use in the eye. Do not take by mouth. Follow the directions on the prescription label. Wash hands before and after use. Tilt your head back slightly and pull your lower eyelid down with your index finger to form a pouch. Try not to touch the tip of the dropper to your eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Close the eye for a few moments to spread the drops. Use your doses at regular intervals. Do not use your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this medicine may be prescribed for children as young as 4 years for selected conditions, precautions do apply.

They need to know if you have any of these conditions:

• wear soft contact lens
• an unusual or allergic reaction to cromolyn, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.

Do not wear contact lenses while using this medicine. Ask your doctor or health care professional for advice if you wear contact lenses.

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Keep container tightly closed. Throw away any unused medicine after the expiration date.