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Eye drops with preservatives. This type often comes in multidose bottles and contains preservatives that discourage growth of bacteria once the bottle has been opened. The preservatives may irritate your eyes, especially if you have moderate or severe dry eyes. Our Dry or Tired 50+ Eye Drops contain the naturally derived ingredients chamomile and mallow, which are ideal for reducing eye strain, restoring eyes and providing instantly long-lasting relief to dry or tired eyes. Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops for Potential Safety Reasons Nov 13, 2023 | Audience: Consumers
Our older eye treatment drops are designed to deliver fast, effective, and long-lasting relief from the pain of dry eyes. They contain patented cross-linked hyaluronic acid 0.3%, which means they have a higher viscosity than other eye drops and can keep eyes lubricated for longer. Refreshing, calming ingredients If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was The goal of screening the marketed artificial tear formulations was to give health care providers a formulary of artificial tears classified based on their active ingredients and biologically active excipients. The options of preservative-free single dose units, if available, has also been included in our data tables. The compiled information should assist the healthcare providers to make a stepwise and rational selection of appropriate artificial tears for the patients based on the active ingredients and biologically active excipients. Preservative-free eye drops. This type has fewer additives and is generally recommended if you apply artificial tears more than four times a day, or if you have moderate or severe dry eyes. Preservative-free eye drops may come in single-dose vials.Osmoprotectants are agents that protect cells against hyperosmolar stress-mediated injury. Since hyperosmolarity is one the characteristics of dry eye, osmoprotectants are emerging ingredients of artificial tears. Levocarnitine (L-carnitine) is present in prokaryotic and eukaryotic cells, including human corneal and conjunctival epithelia [ 11, 12]. Erythritol is polyol used as a low-calorie sweetener. In vitro studies using cultured human corneal epithelial cells demonstrate that osmoprotectants are taken up by the dehydrated cells, then restore volume and prevent protein denaturation [ 13, 14]. Trehalose is a naturally occurring disaccharide consisting of two alpha-glucose units joined by glucoside bond. Trehalose has also been shown to protect corneal epithelial cells from desiccation and high osmolarity [ 15, 16, 17]. Our data analysis demonstrated that erythritol, L-carnitine, and trehalose are present in some Refresh ® brand artificial tears, which contain CMC as the main demulcent ( Table 1). Clear Eyes Once Daily, Eye Allergy Itch Relief: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781.
Vision may be temporarily blurred when this product is first used. Also, minor burning/stinging/irritation may temporarily occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. November 13, 2023– Mumbai, Maharashtra, Kilitch Healthcare India Limited is voluntarily recalling the eye drops products listed in the table below to the consumer level with all lots within expiry with expiration dates ranging from November, 2023 to September, 2025 for all the below mentioned products. These products are being recalled due to potential safety concerns after FDA investigators found insanitary conditions. Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter (OTC) products used for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun and the product used as a protectant against further irritation or to relieve dryness of the eye. Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because drug applied to the eyes bypass some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three (3) adverse events related to these listed products. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC. If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
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. Cases with moderate to high increase in osmolarity and significant ocular surface staining invariably require prescription based anti-inflammatory drops. The importance of lifestyle and dietary modification should be emphasized during counseling and is helpful for all types of dry eye patients. Warm compresses and lid hygiene are also critical for meibomian gland dysfunction. Use of gels and nighttime ointments is also an option for moderate cases. Ointments are exclusively for nighttime use but some gel formulations (Refresh Liquigel ®, Refresh Celluvisc ®, Refresh Optive Gel ®, Systane Gel Drops ®, Blink Gel Tears ®) can be used during both the day and nighttime. Patients need to be counselled on transient blurring of vision with the daytime use of gels. Brimonidine Tartrate Ophthalmic Solution, 0.15%, NDC numbers 60505-0564-1, 60505-0564-2 and 60505-0564-3. 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: Refresh Celluvisc, Refresh Liquigel, Refresh Optive Advanced PF, Refresh Optive Advanced, Refresh Optive Mega-3, Refresh Optive PF, Refresh Optive, Refresh Plus, Refresh Relieva, Refresh Repair, Refresh Tears, Sterile Lubricant, TheraTears Nighttime, Theratears PF, Theratears, Ultra Fresh
The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections Oct 31, 2023 | Audience: Consumer, Health Professional, Ophthalmology, Pharmacy These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Velocity Pharma LLC. Refresh ® brand of artificial tears have several formulations containing 0.5% CMC alone, with additional demulcents and biologically active excipients like osmoprotectants erythritol, l-carnitine, and trehalose. L-carnitine and erythritol have been shown to attenuate hyperosmolar stress-mediated increase in MAP kinases, pro-inflammatory cytokines, and matrix metalloproteases in corneal epithelial cells [ 27, 28, 29, 30]. Clinical studies demonstrate that artificial tears containing L-carnitine and erythritol reduce tear osmolarity and provide symptomatic relief [ 31, 32, 33]. Studies in animal models of dry eye and clinical studies with trehalose containing eye drops demonstrate many beneficial effects, including increased tear production, tear stabilization, reduced corneal staining, and a decrease in corneal epithelial cell apoptosis [ 34, 35, 36, 37]. Humectant sodium hyaluronate in Refresh ®, Oasis ® and Blink ® tears can offer significant additional relief in dry eye in preventing or treating corneal epithelial damage since in vitro studies demonstrate that sodium hyaluronate promotes corneal epithelial cell migration and proliferation, thus facilitating healing [ 38, 39, 40]. Topical application of sodium hyaluronate in rabbits and mice has been shown to promote wound healing and relieve dry eye symptoms [ 41, 42]. Castor oils and flaxseed oil in some Refresh ® Brand tears will offer the additional benefit of reduced tear evaporation in patients with evaporative dry eye. Purite, the preservative present in Refresh ® brand artificial tears, is stabilized oxychloro complex (SOC) containing 99.5% chlorite, 0.5% chlorate. In solution, its bactericidal action is mediated by the oxidizing action of chlorine dioxide free radical. It belongs to the vanishing class of artificial tears since upon instillation, it is converted to sodium chloride, oxygen, and water [ 43, 44]. Animal studies demonstrate that purite is significantly less toxic to corneal epithelium compared to benzalkonium chloride but has some degree of detrimental effect compared to preservative-free artificial tears [ 43, 44, 45, 46, 47]. Given the wide variety of options, a patient can be started on Refresh ® tears with CMC alone either with or without preservatives depending upon the frequency of instillation required and if the dry eye relief is inadequate, Refresh ® tears with additional biologically active excipients can be tried.Tell all of your health care providers that you take TheraTears Nighttime (carboxymethylcellulose). This includes your doctors, nurses, pharmacists, and dentists. Our screen eye protection drops contain hyaluronic acid 0.1%, a trusted ingredient when it comes to eye lubrication. Found naturally in many areas of the body, including the eyes, skin and joints, this substance helps to keep your eyes feeling moist and fresh. Preservative-free on the eye
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