Cromolyn Sodium Ophthalmic Solution 4% (10 ml) (Manufacturer may vary)

Cromolyn Sodium Ophthalmic Solution is a anti-inflammatory eye drop. It works to prevent inflammation by blocking receptors in the body. It is commonly used in the treatment of allergies, conjunctivitis, or other conditions affecting the eye. It helps reduce symptoms such as itching, burning, redness, and swelling. If your pet has been diagnosed with an inflammatory eye condition, your veterinarian may prescribe an ophthalmic solution such as Cromolyn Sodium.

Key Benefits

• Prevents & relieves at the source by blocking a step in the allergic reaction, unlike decongestants which only relieve symptoms
• Targeted, antihistamine-free action means no interaction with other drugs and no systemic effects
• topical sodium cromoglycate solutions for ocular allergies

Indications

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

View Cromolyn Sodium Ophthalmic Solution Drug Facts Sheet.

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.

For Ophthalmic Use Only

Contraindications:

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

Precautions:

General: Patients may experience a transient stinging or burning sensation following application of Cromolyn Sodium Ophthalmic Solution.

The recommended frequency of administration should not be exceeded (see Dosage And Administration).

Information for Patients: Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week): hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects. The average daily maximum dose levels administered in these studies were 192.9 mg/m² for mice, 47.2 mg/m² for hamsters and 385.8 mg/m2 for rats. These doses correspond to approximately 6.8, 1.7, and 14 times the maximum daily human dose of 28 mg/m².

Information for the Patient

It is imortant to use Cromolyn Sodium Ophthalmic Solution, reguarly as directed by your physician.

1. Thoroughly wash your hands.
2. Remove safety seal.
3. Remove cap.
4. Sit or stand comfortably, with your head tilted back.
5. Open eyes,look up, and draw the lower lid of your eye down gently with your index finger.
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.
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.

Cromolyn sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes.

No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m²) in males and 100 mg/kg/day (600 mg/m²) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m².

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 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.

To report Suspected Adverse Reactions, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Storage:

Store between 15°-25°C (59°-77°F). Protect from light store in original carton. Keep tightly closed. Replace cap immediately after use.

Special Tips:

1. Avoid placing Cromolyn Sodium Ophthalmic Solution, USP 4% 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 between 15°-25°C (59°-77°F). Protect from light store in original carton. Keep tightly closed. Replace cap immediately after use.
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%.