Chromodrops®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KROMODROPS® (CROMODROPS)

Composition:

Active substance: sodium cromoglicate;

1 ml of solution contains sodium cromoglicate 20 mg;

Excipients: benzalkonium chloride solution, disodium edetate, water for injections.

Pharmaceutical form. Eye drops, solution.

Main physicochemical properties: clear, colourless or slightly yellow solution.

Pharmacotherapeutic group. Ophthalmological agents. Other antiallergic agents.

ATC code: S01GX01.

Pharmacological properties.

Pharmacodynamics.

Sodium cromoglicate prevents the release of mediators of type I allergic reactions, including histamine and cysteinyl leukotrienes (slow-reacting substance of anaphylaxis [SRS-A]), from sensitized mast cells following the formation of antigen-antibody complexes. Sodium cromoglicate inhibits IgE-mediated release of mediators (e.g. histamine, cysteinyl leukotrienes) from mast cells. The drug also less effectively inhibits type III reactions (late-phase allergic reactions, Arthus phenomenon). The action of sodium cromoglicate on mast cells is not limited to antigen-induced secretion, as it has been shown that the drug also inhibits secretion induced by other mast cell secretagogues (e.g. compound 48/80).

Sodium cromoglicate appears to inhibit phospholipase A-induced mast cell degranulation and subsequent release of chemical mediators in vitro. It is presumed that the drug may block calcium channels in mast cell membranes. It has also been suggested that sodium cromoglicate may inhibit histamine release from mast cells by regulating the phosphorylation of a specific mast cell protein involved in secretory mechanisms.

Pharmacokinetics.

Absorption. Sodium cromoglicate is only minimally absorbed from the eye following local administration. Studies on drug elimination involving healthy volunteers show that approximately 0.03% of the ophthalmic dose of cromoglicate in solution form is systemically absorbed. After administration of sodium cromoglicate as eye drops, improvement in allergic eye conditions is typically observed within several days; sometimes treatment for up to 6 weeks may be required. Trace amounts (less than 0.01%) of sodium cromoglicate penetrate into intraocular fluid and are completely eliminated within 24 hours after discontinuation of treatment.

Distribution. At physiological pH levels, sodium cromoglicate is predominantly ionized. Since both the ionized and free acid forms of the drug are highly polar and lipid-insoluble, they do not penetrate most biological membranes. It is unknown whether the drug penetrates into breast milk.

Elimination. The elimination half-life of sodium cromoglicate has been reported to be 81 minutes.

Clinical characteristics.

Indications.

For relief of symptoms and treatment of seasonal and chronic allergic conjunctivitis.

Contraindications.

Hypersensitivity to sodium cromoglicate or to any other components of the medicine.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with other topical ophthalmic medications, a 15-minute interval should be maintained between administrations.

Special precautions for use

Cromodrops® should not be used when the patient is wearing contact lenses. Rigid lenses must be removed prior to instillation, and at least 15 minutes should elapse before reinserting them. The solution contains benzalkonium chloride, which may deposit onto soft contact lenses and cause discoloration. Therefore, soft contact lenses should not be worn during treatment with Cromodrops®.

Due to limited data, there is no difference in the adverse event profile in children compared to adults. However, children's eyes generally exhibit a stronger reaction to this irritant than adult eyes. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eye, and may affect the tear film and corneal surface. Caution should be exercised when administering to patients with "dry eye" or corneal damage. Patients should be monitored during prolonged use. Sodium cromoglycate may be used prophylactically.

When instilling eye drops, care should be taken to avoid any contact between the dropper tip and the eye or skin.

The shelf life after opening the bottle is 28 days.

Use during pregnancy or breastfeeding

Pregnancy

Although animal studies have not revealed any direct or indirect harmful effects of sodium cromoglycate on pregnancy, embryonic/fetal development, parturition, or postnatal development, clinical data on the use of the drug in pregnant women are lacking. Cromodrops® should be prescribed during pregnancy only with caution, after careful assessment of the benefits versus risks.

Breastfeeding

There is no information indicating that the use of sodium cromoglycate has any adverse effects on the infant. It is unknown whether sodium cromoglycate passes into breast milk. Therefore, caution should be exercised when prescribing these eye drops to breastfeeding women, and they should be used only if the expected benefit outweighs the potential risk.

Ability to influence reaction rate while driving or operating machinery

The drug does not affect the ability to drive or operate machinery. However, transient stinging or blurred vision may occur after instillation. Therefore, after administering the drops, patients should wait several minutes until vision returns to normal before driving or operating machinery.

Method of Administration and Dosage

For adults and children aged 4 years and older: 1 or 2 drops in each eye 4 to 6 times daily at regular intervals, or as directed by a physician.

When administering eye drops, avoid any contact between the dropper tip and the eye or skin.

The medication may be used both for prophylaxis and for long-term therapy. In cases of seasonal allergic conjunctivitis or keratoconjunctivitis, treatment should be initiated immediately upon the first symptoms or prophylactically—prior to exposure to the allergen.

During prolonged therapy, the therapeutic effect should be monitored regularly. Consult a physician before discontinuing treatment.

Hands should be thoroughly washed before instillation, and contact between the dropper tip and the eye or skin should be avoided. The dropper bottle should be closed immediately after use.

Children

For use in children aged 4 years and older.

Overdose

Cases of overdose have not been reported. Sodium cromoglicate is poorly absorbed through the eyes and gastrointestinal tract. In the event of overdose, observation and symptomatic treatment are recommended.

Adverse reactions.

In isolated cases, local reactions such as burning, foreign body sensation, chemosis, conjunctival hyperemia, irritation, tearing, transient blurred vision, and hypersensitivity reactions may occur. There have been rare reports of severe generalized anaphylactic reactions including bronchospasm associated with the use of sodium cromoglicate.

As a preservative, the product contains benzalkonium chloride, which may also cause allergic reactions or disturbances in taste sensation.

Shelf life. 3 years.

After opening the bottle, do not store for longer than 28 days.

Storage conditions. Store in the original packaging at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging. 5 ml or 10 ml in a dropper bottle; 1 dropper bottle per cardboard box.

Prescription status. Prescription only.

Manufacturer. Micro Labs Limited.

Manufacturer's address and location of business operations.

Plot Nos. 113-116, Phase IV, KIADB Industrial Area, Bommasandra, Bangalore, India.