Wednesday, April 9, 2008

Doctors Alerted to Reported Medication Errors Between TOPAMAX(R) (topiramate) and TOPROL-XL(R) (metroprolol succinate)




Ortho-McNeil Neurologics, Inc., be launching an enriching warfare to alert outward appearance chariness professionals to the latent surrounded by enjoy a preference of medication error relating its article of exchange, TOPAMAX(R) (topiramate) tablets and TOPROL-XL(R)* (metroprolol succinate) extended-release tablets.



TOPAMAX(R) is voted for via the U.S. Food and Drug Administration (FDA) for epilepsy coverage and migraine blocking, and is open market by Ortho-McNeil Neurologics, Inc. TOPROL-XL(R) is a beta-blocker approved to immoderation soaring blood strain, angina and heart attack, and is marketed by AstraZeneca LP.



Reports of patients acceptance TOPAMAX(R) instead of TOPROL-XL(R), or vice versa, have be submit to the FDA and other health authorities. These reports refill prescription for TOPAMAX(R) and TOPROL-XL(R) that have been wrongly documentary, read, labeled and/or dispense, principal to patients getting the unsuitable medication.



Patients who receive in the wrong medication chance experiencing potentially essential health grades that be associated beside any unintended bringing to light to a medication or the non-attendance of a needed psychotherapy. For precedent, patients with epilepsy who are by the section of TOPAMAX(R) therapy can suffer seizure or increased commandeering frequency if TOPAMAX(R) therapy is interrupted. Patients with ischemic heart bug on TOPROL-XL(R) can experience angina or myocardial infarction if TOPROL-XL(R) therapy is brutally interrupted.



"Patient refuge is our crown preference," said Joseph Hulihan, M.D., vice president, Medical Affairs, Ortho-McNeil Neurologics, Inc. "Health care professionals unbend a pivotal role in unashamedly communicate oral and written prescriptions, and verify and accurately dispensing prescriptions to ensure that all patients receive their premeditated medications." The Ortho-McNeil Neurologics, Inc., communications campaign will encompass a facts to health care professionals standard, recommendation to remedy transcript database provider to nitty-gritty computer "pop-up" alerts, pharmacy shelf-talkers and frontage experience with national pharmacy chains and national and ground pharmacy lath and associations. Comprehensive educational information on the topic is also accessible on company-sponsored Web site, , ampills.com and Ortho-McNeil Neurologics, Inc., also offer the subsequent tips: Physicians are urge to: -- Be alert to the grace of medication errors in patients prescribed TOPAMAX(R) or TOPROL-XL(R).



-- Be rapt of the possibility of medication errors in patients reminder with surprise signs or symptom while on TOPAMAX(R) or TOPROL-XL(R).



-- Confirm the denounce and generic label and dosage prescribed on written and oral prescriptions.



-- Print legible prescriptions that include the brand and generic names, with observer.



-- Counsel patients roughly the brand name, indication and proper squander of all medication.



Pharmacists are urged to: -- Place TOPAMAX(R) and TOPROL-XL(R) foray from one another on the farm animals shelf.



-- Place the shelf-talker provide in the Dear Pharmacist message on the stock shelf.



-- Confirm the brand and generic names prescribed on written and oral prescriptions.



-- Confirm the brand and generic names when communicating the drug names inwardly the pharmacy.



-- Write full stirring and legible prescriptions for these products and expose oral prescriptions clearly.



-- Counsel patients about the brand name, indication and proper use of each medication.



Drug database on cloud nine providers are urged to: -- Install sound-alike/look-alike name alert warning for the name double act puzzlement with TOPAMAX(R) and TOPROL-XL(R).



-- Use "tall man" lettering to accentuate the termination of each name (e.g., topAMAX(R) and TOPROL-XL(R)).



-- Avoid the use of confounding or non-distinguishing drug mnemonics such in function of "TOP." -- Use brand and generic names when communicating the drug names.



Patients are urged to: -- Get printed information about the medication from the pharmacist when picking up their TOPAMAX(R) or TOPROL-XL(R) prescription.



-- Become larger informed about their medications - know the brand name of each medication, what the medications bear a correspondence to and what side effects they may experience.



-- Look at the medication until that incident they embezzle it - if it undertake not outer shell in close proximity to what they predominantly take, patients should contact their health care white-collar before they take the drug to realize why.



-- Keep medications in the inspired, labeled containers because this can preacher to them identify each dosage and track proper directions.



-- Ask their health care professional for more information if they have any question about their medications, also as the benefits and risk.



Health care professionals who perceive any medication errors involving TOPAMAX(R) are urged to whirr them exactly to Ortho-McNeil Neurologics, Inc., at 1-800-682-6532, and, if TOPROL-XL(R) is ensnared, also to AstraZeneca at 1-800-236-9933. Medication errors should also be report to the FDA's MedWatch Adverse Event Reporting Program (1-800-FDA-1088) and the USP Medication Error Reporting Program in reconciliation with the Institute for Safe Medication Practices (1-800-23ERROR; 1-800-FAIL-SAF).



TOPAMAX(R) is symbolize as first monotherapy in adults and offspring 10 years of age and elder with partial-onset or opening generalized tonic-clonic seizures. Effectiveness be demonstrated in a controlled suffering in patients with epilepsy who have no beyond two seizures in the three months prior to enrollment. Safety and effectiveness in patients who be converted to monotherapy from a above regimen of other anticonvulsant drugs have not been confirmed in controlled trial. TOPAMAX(R) is indicated as adjunctive therapy for adults and pediatric patients ages two-16 years with partial-onset seizures or primary generalized tonic-clonic seizures, and in patients two years of age and older with seizures associated with Lennox-Gastaut syndrome. TOPAMAX(R) is also indicated for prophylaxis of migraine headache in adults with the only one of its point utility. TOPAMAX(R) have not been studied for acute treatment of migraine.



TOPROL-XL(R) is indicated to treat hypertension as monotherapy or in balance with other antihypertensive agents, long-term treatment of angina pectoris and heart failure NYHA Class II or III. TOPROL-XL(R) has a boxed restraining opposed to rough cessation of therapy. Patients with ischemic heart disease who are on TOPROL-XL(R) can experience angina or myocardial infarction if TOPROL-XL(R) therapy is abruptly interrupted.



TOPAMAX(R) Important Safety Information for Migraine TOPAMAX(R) is contraindicated in patients with a precedent of hypersensitivity to any aspect of this product. TOPAMAX(R) has been associated with serious adverse dealings, including: hyperchloremic, non-anion split metabolic acidosis-lowering of bicarbonate even in the blood. Measurement of baseline and intermittent serum bicarbonate is recommended. Acute myopia and lower angle line of tapestry glaucoma patients should be caution to confidence medical focus if they experience blurred perception or optical agony. Oligohidrosis and hyperthermia-decreased sweat and increased article heat, particularly in scorching weather. The majority of reports have been in children.



Cognitive/psychiatric side effects, including cognitive dysfunction, psychiatric/behavioral disturbances and somnolence and fatigue. The possibility of end contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with TOPAMAX(R). Patients should be instruct to maintain up an tolerable liquor intake in go round to minimize the risk of renal core core.



In adjunct, the zenith rampant adverse events associated with TOPAMAX(R) 100 mg vs placebo were: paresthesia, 51 percent vs 6 percent; anorexia, 15 percent vs six percent; fatigue, 15 percent vs 11 percent; nausea, 13 percent vs eight percent; diarrhea, 11 percent vs four percent; make amends decrease, nine percent vs one percent; tang alteration, eight percent vs one percent.



Please see full U.S. Prescribing Information at or call upon 1-800-682-6532 for more information.



TOPAMAX(R) Important Safety Information for Epilepsy TOPAMAX(R) has been associated with serious adverse events, including: hyperchloremic, non-anion gap metabolic acidosis (lowering of serum bicarbonate levels)-measurement of baseline and periodic serum bicarbonate levels is recommended; acute myopia and secondary angle closure glaucoma patients should seek medical attention if they experience blurred vision or ocular pain; oligohidrosis and hyperthermia progress most repeatedly in hot weather and in children; cognitive/psychiatric side effects, including somnolence and fatigue, cognitive dysfunction, and psychiatric/behavioral disturbances; hyperammonemia with or lacking encephalopathy associated with the concomitant use of valproic penetrating; and kidney stones patients should maintain an adequate fluid intake to minimize the risk of renal stone formation. In women taking combination oral contraceptives with TOPAMAX(R), a central decrease in estrogen exposure has been shown at TOPAMAX(R) dose .200 mg/day. The possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered.



As monotherapy, the most common side effects of TOPAMAX(R) (in the 400 mg/day kink and at a rate highly developed than the 50 mg/day group) in adults were: paresthesia, weight decrease, somnolence, anorexia, light-headedness and snare with remembrance; and in children: weight decrease, upper respiratory tract infectivity, paresthesia, anorexia, diarrhea and flag difficulties.



In combination with other antiepileptic drugs (AEDs), the most common side effects of TOPAMAX(R) in adults (200 to 400 mg/day) were somnolence, dizziness, shyness, ataxia, fatigue, lecture turmoil and coupled problems, psychomotor slow, out of the tedious vision, difficulty with memory, paresthesia and diplopia; and in children (5 to 9 mg/kg/day), fatigue, somnolence, anorexia, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive counterattack and weight decrease.



For more information, read the full U.S. Prescribing Information, upon will by calling 1-800-682-6532 or by visit or Headquartered in Titusville, NJ, Ortho-McNeil Neurologics, Inc., focus exceptionally on providing treatment that arrange differently neurological health. The friendship perfectly very soon market products for Alzheimer's disease, epilepsy and acute and preventive migraine treatment. Ortho-McNeil Neurologics, Inc., in conjunction with interior and outside research partner, continue to inspect fresh opportunity to come together solutions for unmet health care requirements in neurology.



* TOPROL-XL(R) is a project trademark of the AstraZeneca group of company.




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