Opticrom (Sodium Cromolyn)



Sodium Cromoglycate


Action And Clinical Pharmacology: In the immediate reaction (Type I), the union of antigen with reaginic antibody leads to the formation and release of mediators of the local anaphylactic reaction. The principal effect of sodium cromoglycate is its specific ability to stabilize the membrane of the mast cell and thus prevent the release of mediators of anaphylaxis. The action appears to be specific for reaginic (immediate type) antigen/antibody reactions. No direct effect has been demonstrated on other types of immune reactions (Type II, III, and IV).

Sodium cromoglycate has no vasoconstriction, antihistaminic or anti-inflammatory activity. Within 2 to 3 days of commencing treatment one can expect improvement in the signs and symptoms of seasonal allergic conjunctivitis (itching, tearing, congestion, etc.) in most patients. Continued therapy will usually keep the patient free from ophthalmic allergy symptoms during the challenge period.

Indications And Clinical Uses: To help relieve and prevent symptoms associated with allergic conjunctivitis or hay fever conjunctivitis.

Contra-Indications: Those patients who have shown hypersensitivity to sodium cromoglycate or to benzalkonium chloride.

Manufacturers’ Warnings In Clinical States: The recommended frequency of administration should not be exceeded.

Sodium cromoglycate should only be used for allergic conditions of the eye. In some instances irritation or redness may be due to serious eye conditions such as infection, foreign body in the eye, or other mechanical or chemical corneal trauma requiring the attention of a doctor. If you experience eye pain, changes in vision, pain on exposure to light, acute redness of the eye, excessive discharge, abnormal pupils, if condition worsens or if relief is not obtained within 72 hours consult your doctor immediately.

Any remaining contents should be discarded 4 weeks after opening. Do not touch dropper tip to any surface since this may contaminate the solution.

Precautions: During treatment with sodium cromoglycate solution, soft contact lenses should not be worn.

Children: Safety and effectiveness in children below the age of 5 years has not been established.

Pregnancy: There has been to date, no adequate and well controlled studies in pregnant women.

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 is administered to a nursing woman.

Drug Interactions: Sodium cromoglycate has been used in association with other ophthalmic solutions in the rabbit including mydriatrics, antibiotics, steroids, vasoconstrictors and astringents. No drug-drug interactions have been observed in the rabbit eyes.

Adverse Reactions: The most frequently reported adverse reaction attributed to the use of sodium cromoglycate on the basis of reoccurrence following administration is transient ocular stinging or burning upon instillation.

The following adverse reactions have been reported as infrequent events; conjunctival injection, watery eyes, itchy eyes, dryness around the eye, puffy eyes, eye irritation and sties. It is unclear whether they are attributable to the drug.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There have been no reported cases in humans of overdosage of the drug. Symptomatic treatment is suggested should accidental ingestion occur.

Dosage And Administration: The effect of therapy is dependent upon its administration at regular intervals as directed in the labelling.

Symptomatic response to treatment (decreased itching, tearing, redness and discharge) is usually evident within 2 to 3 days. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

Adults and Children Over 5 Years: 2 drops in each eye 4 times daily at regular intervals. One drop contains approximately 0.8 mg of sodium cromoglycate.

SuppliedSupplied: Each plastic dropper bottle of a clear, colorless to pale yellow sterile solution, contains: sodium cromoglycate 2% w/v. Nonmedicinal ingredients: benzalkonium chloride as a preservative and edetate disodium. Bottles of 10 mL. Store at 15 to 30°C. Protect from direct sunlight. Discard opened bottle after 4 weeks.

OPTICROM® Allergan Sodium Cromoglycate Antiallergic

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