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Composition |
|
Sodium Cromoglycate IP |
2% w/v |
Benzalkonium Chloride |
|
(As Preservative) |
0.01% w/v |
Sterile Aqueous Base |
q.s. |
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Dosage Form |
Ophthalmic Solution |
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Pharmacology |
sodium cromoglycate inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Sodium cromoglycate acts by inhibitating the release of histamine and various membrane derived mediators of inflammation from mast cells. |
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Indications |
Opticrom Eye Drops is indicated in the symptomatic treatment of vernal keratoconjunctivitis, vernal conjunctivitis and vernal keratitis. |
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Dosage & Administration |
1-2 drops in each eye 4-6 times in a day at regular intervals. Recommended dosage should not be exceeded. |
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Contraindications |
Hypersensitivity to any of the components of the formulation |
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Precautions |
Pregnancy category BThe safety of Opticrom Eye Drops in pregnant patients has not been studied. The potential benefits should be weighed against the risk before it is prescribed.
Lactation
Since it is not known if cromolyn sodium ophthalmic solution is distributed into milk in humans, the drug should be used with caution in lactating women
Pediatric Use
Safety and efficacy of cromolyn sodium ophthalmic solution in children younger than four years of age has not been establish
Undesirable effects The most frequently reported undesirable effects are transient ocular stinging or burning upon instillation. Immediate hypersensitivity reactions have been reported rarely and include dyspnoea, edema and rash. |
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Storage |
Store in a cool dry place. Protect from light. |
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Presentation |
Opticrom is available in plastic bottle of 5 ml. |
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