UNIBROM EYE DRPS 5ML

Posology and method of administration\nAdults and Children : One or two drops into each eye up to four times a day or as indicated by the doctor.\n\nElderly: There is no current evidence for alteration of the dose.\n\nRoute of administration: Topical ophthalmic.\n\nSpecial warnings and precautions for use\nThis formulation of Sodium Cromoglicate Eye Drops contains 0.1mg/ml (4.5 micrograms per dose) benzalkonium chloride as a preservative which may be deposited in soft contact lenses. Hence, Sodium Cromoglicate Eye Drops should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.\n\nBenzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.\n\nPatients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their physician?s advice concerning the continued use of present multi-dose container. There have been reports of bacterial keratitis associated with the use of topical ophthalmic products.\n\nFertility, pregnancy and lactation\nFertility:\n\nIt is not known whether sodium cromoglicate has any effect on fertility.\n\nPregnancy:\n\nAs with all medication, caution should be exercised especially during the first trimester of pregnancy. Cumulative experience with sodium cromoglicate suggests that it has no adverse effects on foetal development. It should be used in pregnancy only where there is a clear need.\n\nLactation ;\n\nIt is not known whether Sodium Cromoglicate is excreted in human breast milk, but based on its physicochemical properties this is considered unlikely Therefore caution should be exercised when the eye drops are administered to nursing mothers.\n\nEffects on ability to drive and use machines\nTransient stinging or blurring of vision may occur on instillation of the drops. Do not drive or use machinery until normal vision is restored.\n\nUndesirable effects\nTransient stinging and burning on instillation of the drops. Rarely, other symptoms of local irritation.\n\nPharmacodynamic properties\nPharmacotherapeutic group: Opthalmologicals; Other antiallergics, ATC code : SO1GX01\n\nIn vitro and in vivo animal studies have shown that Sodium cromoglicate inhibits the degranulation of sensitised mast cells which occurs after exposure to specific antigens. Sodium cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators from the mast cell.\n\nSodium cromoglicate has demonstrated the activity in vitro to inhibit the degranulation of non-sensitised rat mast cells by phospholipase A and subsequent release of chemical mediators. Sodium cromoglicate did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.\n\nSodium cromoglicate has no intrinsic vasoconstrictor or antihistamine activity.\n\nPharmacokinetic properties\nSodium cromoglicate is poorly absorbed. When multiple doses of Sodium cromoglicate ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of Sodium cromoglicate is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the sodium cromoglicate does penetrate into the aqueous humour and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.\n\nIn normal volunteers, analysis of drug excretion indicates that approximately 0.03% of Sodium cromoglicate is absorbed following administration to the eye.