CROMAL FORTE Eye Drops (Sodium cromoglycate 4%)

Table of Content

Composition

Sodium Cromoglycate, IP …........4% w/v
Benzalkonium chloride, NF (preservative) .. 0.01% w/v
Sterile aqueous vehicle …...................q.s.

Dosage Form

Ophthalmic solution

Pharmacology

Pharmacodynamics

In vitro and In vivo animal studies have shown that sodium cromoglycate inhibits the degranulation of sensitized mast cells, which occurs after exposure to specific antigens. Sodium cromoglycate acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxis) from mast cells. Sodium cromoglycate has demonstrated activity, In vitro, to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglycate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.

Sodium cromoglycate has no intrinsic vasoconstrictor, antihistaminic or anti-inflammatory activity.

Pharmacokinetics

Sodium cromoglycate is poorly absorbed. When multiple doses of sodium cromoglycate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of sodium cromoglycate is absorbed into the systemic circulation (presumably by way of the eyes, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglycate dose penetrate into the aqueous humour 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 sodium cromoglycate is absorbed following administration to the eyes.

Indications

Sodium cromoglycate ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis and vernal keratitis.

Dosage and Administration

One to two drops in each eye, four to six times in a day at regular intervals,

Patients should be advised that the effect of sodium cromoglycate 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 6 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 cromoglycate ophthalmic solution. The recommended dosage should not be exceeded.

Contraindications

The product is contraindicated in patients who have shown hypersensitivity to sodium cromoglycate, benzalkonium chloride or to any of the other ingredients.

Warnings and Precautions

General

Patients may experience a transient stinging or burning sensation following instillation of sodium cromoglycate ophthalmic solution. The recommended frequency of administration should not be exceeded.

As with all eye drops, instillation of these eye drops may cause a transient blurring of vision.

Drug Interactions

None known.

Pregnancy

Pregnancy Category B
The safety of Sodium cromoglycate ophthalmic solution in pregnant patients has not been studied. The potential benefits should be weighed against the risk before it is prescribed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sodium cromoglycate ophthalmic solution is administered to a nursing mother.

Pediatric Use

Safety and efficacy of sodium cromoglycate ophthalmic solution in children younger than 4 years of age has not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Undesirable Effects

The most frequently reported undesirable effects are 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 eyes; puffy eyes; eye irritation; and styes.

Immediate hypersensitivity reactions have been reported rarely and include dyspnoea, oedema and rash.

Overdosage

No action other than medical observation should be necessary

Incompatibility

None known.

Shelf-life

3 years.

Storage and Handling Instructions

Store in a cool, dark place.

Packaging Information

CROMAL FORTE Eye Drops: Vial of 5 ml

Information For Patients

Discard any remaining contents 4 weeks after opening the bottle. As with other ophthalmic solutions containing benzalkonium chloride, soft contact lenses should not be worn during the treatment period.