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P hysicians sometimes turn a skeptical eye toward generic versions of brand name productsand with good reasonHistoricallynot every generic medication in ophthalmology has performed as well as its branded counterpartFor exampleprednisolone wasn’t as effective at controlling inflammation as branded Pred ForteAllerganIrvineCalifand diclofenacwhich is the generic version of Voltarenhad instances of corneal melts in patientsleading to withdrawal from the marketsaid LJay KatzM.DWills Eye InstitutePhiladelphiaSo naturally when branded XalatanPfizerNew Yorkwhich reduces elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertensionwent to generic latanoprost in Marchdoctors had questionsGenerics can often work wellbut sometimes there’s a question of efficacy and tolerabilitysaid DrKatzThe brand name and generic products are not identicalOne is called Xalatan and the other is called latanoprostsaid Nathan RadcliffeM.Dassistant professor of ophthalmologyWeill Cornell Medical CollegeNew YorkThe bottle is going to look different so to your patientsthere’s a differenceand there may be confusionLatanoprost doesn’t have the same pricewhich is a differenceDifferent bottle designs can be problematic for some peopleespecially glaucoma patients who tend to be older and may struggle with drop delivery due to arthritistremorsand other mobility issuesDoesthe bottledeliver the drug the same wayasked DrKatzDoes too much come out or does too little come outIs it easy for someone who’s 90 years old to get the drop outRegulations don’t govern drop administrationbottle designor rigidity of the bottlehe saidso in reality there can be noticeable differences between the generic and branded designIn terms of the specific formulationthoughboth must include the same active ingredients in the same concentrationas well as the same preservativesAccording to spokesmen for the FDAthere is no qualitative or quantitative difference between the two versionsSince the product is a solution and has the same active and inactive ingredientsthere viagra generico contrareembolso, viagra generico contrareembolso, viagra generico contrareembolso, viagra generico contrareembolso, viagra generico contrareembolso, viagra generico contrareembolso. would be no difference in performancesaid Lisa KubaskaL.C.D.RU.SPublic Health ServiceFDAWe assure that a generic version of any product works the same in the bodyDrRadcliffe would prefer to see data from human trials that supports the safety and efficacy of generic ophthalmic medicationsManufacturers are not required to release the concentrations of the inactive ingredients of branded medicationshe saidGenerics are typically created using reverse engineering practiceshe saidSince you’re not recreating it from the identical recipe and manufacturing processthere may be some small differencesA number of different companies produce generic latanoprost including ApotexWestonFlaBauschLombRochesterN.YFalcon Pharmaceuticalsaffiliate of AlconFort WorthTexasGreenstonePeapackN.Jand MylanCanonsburgPaThe problem for patients and physicians is neither know which company’s version of the product will end up in patientseyesit may change month to month by the filling pharmacyWe don’t have any control over thatsaid DrKatzPatients may do fine or there may be an issue with tolerabilityThere may be side effects they didn’t have beforePerhaps there’s a chance it might not be as effectiveThe only way to know is to try itAt least one major positive difference between the two drugs is costGenerally speakingthe generic is much cheaper than the brandedalthough exact price varies widely depending on location and insurance planThe cheapest I’ve heard was around15 a bottle totally out of pocketsaid DrKatzThat’s with no copayIf you’re considering switching a patient to latanoprostit’s important to have a direct conversation with him or her about what you know and what you don’t know about the drugNot every patient will want the generic versionSome may be totally opposed and insist on the brandedWe don’t want to make assumptions regarding how much savings a patient will be gettingand we don’t want to assume that savings is something the patient is determined to pursuesaid DrRadcliffeWe’ve got to talk to the patientsRight nowif a physician writes Xalatana lot of people come back with the generic formulation anywaysaid DrKatzMany patients are willing to do thatbut some people prefer not to use genericsIf it turns out that a patient isn’t happy with the generic version for whatever reasonit’s probably best to switch him to a competitor in-brandIf the patient does switch medicationsit’s a good idea to follow him a little more closely to make sure his pressure levels are controlledIf you’re switching the patient to a genericyou’ve got to think twice before you sayI’ll see you in 6 monthssaid DrRadcliffeI believe the generic versions are safeI believe there may be small differences we will learn about over the next few yearsThese differences could also be between genericsIf they should all be lumped together under one headline remains to be seenAre they all the exact same thingI don’t think we know thatsaid DrKatzThey’ve been out such a short period of time that we can’t tell yetWe’re waiting to see some papers come out that are an independent analysis of the composition of each of the bottlesassuring us they are all pretty much the same
Reactivation of Herpes Simplex keratitis has been reported during treatment with XALATANXALATAN should be used with caution in patients with a history of herpetic keratitisXALATAN should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.
METHODSThis multicenterrandomizedinvestigator-maskedparallel-group study allocated 266 patients with OH or POAG in a 1:1 ratio to latanoprost or Xalatan administered once daily for 6 weeksThe primary endpoint was the mean change in 8:00 AM IOP of the study eye from baseline to week 6Secondary endpoints included mean change in 8:00 AM IOP from baseline to week 2and in 12:00 noon and 4:00 PM IOP from baseline to week 2 and week 6The safety and tolerability of both drugs were also assessed.
Dryness of the eyesincreased tearingeye painand other eye-related discomfort.
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