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ScienceDirect ® is a registered trademark of Elsevier B.V.URL: https://www.sciencedirect.com/science/article/pii/B9780444537171009562URL: https://www.sciencedirect.com/science/article/pii/S0378608005804611URL: https://www.sciencedirect.com/science/article/pii/B9780323023948000231URL: https://www.sciencedirect.com/science/article/pii/S0378608009031213URL: https://www.sciencedirect.com/science/article/pii/B9781455707379000898URL: https://www.sciencedirect.com/science/article/pii/B9781437706031000211URL: https://www.sciencedirect.com/science/article/pii/S0378608009031390URL: https://www.sciencedirect.com/science/article/pii/B978012801238305042XURL: https://www.sciencedirect.com/science/article/pii/S0378608008000391URL: https://www.sciencedirect.com/science/article/pii/S0378608010320472Becker-Shaffer's Diagnosis and Therapy of the Glaucomas (Eighth Edition)Retinal toxicity of systemic and topical medicationsCorticotrophins, corticosteroids, and prostaglandinsA worldwide yearly survey of new data and trends in adverse drug reactions and interactionsScienceDirect ® is a registered trademark of Elsevier B.V. Robert A. Mittra, William F. Mieler, in Retina (Fifth Edition), 2013. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9. Based on 5 years clinical experience, increased iris pigmentation has not been shown to have any negative clinical sequelae and latanoprost eye drops can be continued if iris pigmentation ensues. Generally, latanoprost is well tolerated with a safety margin between clinical ocular dose and systemic toxicity of at least 1,000 times. The control group was untreated. Cutaneous and Ocular Toxicology: Vol. A chronic topical ocular toxicity study was conducted to support the initial registration of latanoprost ophthalmic solution. Adverse reactions are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000), not known (frequency cannot be estimated from the available data).Iris hyperpigmentation; mild to moderate conjunctival hyperaemia; eye irritation (burning grittiness, itching, stinging and foreign body sensation); eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation and number of eyelashes).Punctate keratitis, mostly without symptoms; blepharitis; eye pain; photophobia; conjunctivitisPeriorbital and lid changes resulting in deepening of the eyelid sulcus.Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.In two short term clinical trials (≤ 12 weeks), involving 93 (25 and 68) paediatric patients the safety profile was similar to that in adults and no new adverse events were identified. Latanoprost acid systemic exposure was approximately 2-fold higher in 3 to < 12 years olds and 6-fold higher in children < 3 years old compared with adults, but a wide safety margin for systemic adverse events was maintained (see section 4.9). No data are available for preterm infants (less than 36 weeks gestational age). Latanoprost Toxicity Data With Reference. juvenile open angle glaucoma, aphakic glaucoma) subgroup showed similar results as the PCG subgroup.
Recommended therapy is one eye drop in the affected eye(s) once daily. This should be performed immediately following the instillation of each drop. Data in the age group < 1 year (4 patients) are limited (see section 5.1).As with any eye drops, to reduce possible systemic absorption, it is recommended that lachrymal sac is compressed at the medial canthus (punctal occlusion) for one minute. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. In animal studies, latanoprost has not been found to have sensitising properties.In the eye, no toxic effects have been detected with doses of up to 100 micrograms/eye/day in rabbits or monkeys (clinical dose is approximately 1.5 micrograms/eye/day).
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