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Advise patients that to prevent eye injury or contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children. Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX ® for retinal vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%). Low blood pressure, swelling or coldness of your hands, feet and extremities, caused by constriction of your blood vessels Intraocular surgical procedures and injections have been associated with endophthalmitis. Proper aseptic technique must always be used with administering DURYSTA ®, and patients should be monitored following the administration. Tricyclic antidepressants (TCAs) can blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of TCAs with COMBIGAN ® in humans can interfere with the IOP-lowering effect. Caution is advised in patients taking TCAs, which can affect the metabolism and uptake of circulating amines.
retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation, since these have been observed during treatment with LUMIGAN. Some of these changes may be permanent, and may lead to impaired field of vision and differences in appearance between the eyes when only one eye is treated (see section 4.8). Let go of the lower lid, and close your eye. Press your finger against the corner of your eye (the side where your eye meets your nose) for one minute. Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve and defects in visual acuity and fields of vision. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.
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Despite these disturbing numbers, doctors stress that eye drop recalls have not been common in the past, and they’re incredibly rare in known brand names. “The vast majority of products available on the shelves in the United States are cleared by the FDA and subject to investigations if there is a safety issue with a product,” says Zimmerman. Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to prostaglandin F 2α (PGF 2α), that does not act through any known prostaglandin receptors. Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called prostamides. The prostamide receptor, however, has not yet been structurally identified.
Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites. Allergic reaction, eye and/or eyelid swelling/puffiness, itchy eyes, red eye, infection of the eye, inflammation of the eye (surface or inside), bleeding of the retina, swelling of central retina (light-sensitive layer of the eye), headache, accidental injury caused by the tip of the dropper touching the eye, increased pressure in the eye, blurred and/or diminished vision. Eye drops are intended to be sterile, especially due to a heightened risk for infection since they bypass some of the body's natural defenses by being applied directly into the eyes. As of this writing, Kilitch Healthcare India Limited “has not received any reports of adverse events related to this recall,” according to a news release posted by the FDA.
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FDA investigators detected issues with sterility in manufacturing these drops. Some production areas also contained bacteria.
Severe Cardiovascular Disease: Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. Nandini Venkateswaran , M.D., an ophthalmologist and member of the Cornea and Refractive Surgery Service at Mass Eye and Ear, agrees. “Eye infections can affect not only the front of the eye but also the inside of the eye and can cause vision loss,” she says. What eye drops should I avoid?
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COMBIGAN ® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% Important Information Prostaglandin analogues including LUMIGAN can induce periorbital lipodystrophic changes which can lead to deepening of the eyelid sulcus, ptosis, enophthalmos, eyelid retraction, involution of dermatochalasis and inferior scleral show. Changes are typically mild, can occur as early as one month after initiation of treatment with LUMIGAN, and may cause impaired field of vision even in the absence of patient recognition. PAP is also associated with periocular skin hyperpigmentation or discoloration and hypertrichosis. All changes have been noted to be partially or fully reversible upon discontinuation or switch to alternative treatments.
Torn or Ruptured Posterior Lens Capsule: OZURDEX ® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX ® use.You or your doctor can also report adverse events or quality issues to the FDA’s MedWatch Adverse Event Reporting program. Potentiation of Vascular Insufficiency: ALPHAGAN ® P may potentiate syndromes associated with vascular insufficiency. ALPHAGAN ® P should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans. FDA has not received any adverse event reports of eye infection associated with these products at this time. FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
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