A A A

Cromil (Ophthalmic Solution)

COMPOSITION

Each ml contains:
Sodium Cromoglycate B.P………………..40mg.
with:  Benzalkonium chloride 0.005% sodium chloride, edetate disodium phenyl ethyl alcohol, hydroxypropyl methylcellulose 0.2% and purified water.

ACTION

Cromil is an anti-allergic produact. Disodium cromoglycate inhibits the release of allergic reactions mediators from sensitized mast cells. Such mechanism prevents both immediate and delayed response to immunologic and other stimuli. Disodium cromoglycate activity seems to be connected to the intracellular reduction in ca++, the increase of cAMP due to the phosphodiesterase enzyme inhibition and to the phosphorylation of a 78,000- dalton membreance protein. In vitro, disodium cromoglycate has not a direct effect on preparation of unstriated musculature nor does it carry out an antagonistic activity on acetylcholine or histamine.
When administered orally, disodium cromoglycate is very poorly absorbed (about 1%) in the gastrointestinal tract and is excreted  mainly through the urine and bile. Under ideal circumstances, 10% or less of inhaled disodium cromoglycate is systemically absorbed. Peak concentration in plasma occur within 15 minutes of inhalation and the biological half-life ranges from 45 to 100 minutes. The terminal half-time of elimination following intravenous administration is about 20 minutes. Several pharmacokinetic studies have demonstrated that systemic absorption following topical administration is poor. Repeated administration of an ophthalmic solution 4% has produced 0.03% absorption. Through the nasolacrymal duct the drug reaches the gastrointestinal tract where it is absorbed. After instillation in the conjunctival sac low concentrations of drug have been found the ocular and cerebral tissues.

INDICATIONS

Cromil Eye Drops is used primarily in the prophylaxis of allergic eye conditions such as hay-fever conjunctivitis. Acute and chronic allergic coniunctivitis, vernal keratoconjunctivitis and giant papillary conjunctivitis.

CONTRAINDCATIONS

It should not be given to the patients with known hypersensitivity to any of its components.

ADVERSE REACTIONS

A transient stinging or burning sensation may occur after instillation, which usually disappears with continued use.

PRECAUTIONS

During the first three months of pregnancy, the product should be administered only in case of real need and under strict medical control. Do not wear soft contact lenses during treatment. Lense may be worn within a few hours after discontinuation of the drug.

DOSAGE & ADMINISTRATION

One to two drops into the conjunctival sac(s) four times daily. Or as directed by the Ophthalmologist.

Systemic response to therapy (decreased itching, redness & discharge) is usually evident within a few days but treatment for up to 6 weeks is sometimes required. Effect of therapy depends upon administration at intervals. Continue therapy as long as needed to sustain improvement. Corticosteroids may be used concomitantly.

 HOW SUPPLIED

Cormil Eye Drops is available as a sterile solution in 10 ml pilfer proof plastic dropper bottles (Gamma Irradiated).

STORAGE

Protect from sunlight. Keep away from children’s reach. Do not freeze. Store below 25˚C.
After opening the bottle, use within 4 weeks.