Student Essay From: D. S.   @   WSU 02/07/2005 It's amazing how we start out as a single helpless cell and grow into a multicellular, living, breathing organism. Everyday our bodies know which cells need to divide and which shouldn't and the rate at which this takes place. Our cells know just what to do with the food we take in and allow us to run, jump , and dance the night away. But in some of us, our cells get confused and grow rapidly causing us to get the life threatening condition known as cancer. This is where I come into the picture. I plan to become a nuclear pharmacist. I want to be able to help those rebel cells and save people's lives. I want to be a part of the answer to the questions on how to stop the spread and maybe one day we will have the answer to all the types and degrees of cancer. My knowledge will have doctors coming to me with all their questions and I can explain to the patients and their families what the options are and exactly what the drug is doing to help them regardless of the side effects. I will be their hope and sunshine. And to keep myself sane dealing with such tough cases, I plan to be a mom and an aerobics instructor. When I become old and gray and the kids are off on their own, I plan to teach and do research in either the area of cancer or diabetes therapies. Making sure our children have a good education is always a worthwhile endeavor and I want to put in mu two cents for the future. I also have lots of questions about cancer and diabetes and sometimes, the bets way to get the answer is to go and find out for yourself. Hopefully, I will be able to help the millions of people that suffer from these conditions and provide a sound future for them by teaching their future doctors. I know what I plan to do will be tough but if I work hard I will be able to achieve my dreams and hopefully make the dreams of several families come true in the process.

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From: Ortho McNeil Re: Topamax                                    12-2003 Important Drug Warning The Prescribing information for Topamax (topiramate/topiramate capsules) Tablets/Sprinkle Capsules has been revised to include a warning that TOPAMAX causes hypercloremic, non-anion gap metabolic acidosis (decreased serum bicarbonate). TOPAMAX is approved and marketed for the adjunctive treatment of partial-onset seizures, generalized tonic-clonic seizures associated with the Lennox-Gastaut syndrome in adults and children two years of age and older. Data on hyperchloremic, non-anion gap metabolic acidosis are derived from placebo-controlled trials and post-marketing experience in over 2.5 million patients. In clinical trials, the rate of occurrence of a persistently decreased serum bicarbonate ranges from 23-67% for patients treated with topiramate and 1-10% for placebo. The incidence of markedly low serum bicarbonate in clinical trials ranges from 3-11% for topiramate and 1 to <1% for placebo. Generally, decreases in serum bicarbonate occur soon after initiation of topiramate, although they can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate, with an average decrease of 4mEQ/L at daily doses of 400 mg in adults and approximately 6 mg/kg/day in pediatric patients. Rarely, patients can experience decrements to values below 10 mEq/L. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate. Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such s fatigue and anorexia, or more sever sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face of persistent acidosis, alkali treatment should be considered. The following has been added to TOPAMAX prescribing information. Under WARNINGS Metabolic Acidosis Hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with topiramate treatment. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase. Such electrolyte imbalance has been observed with the use of topiramate in placebo-controlled clinical trials and in the post-marketing period. Generally, topiramate-induced metabolic acidosis occurs early in the treatment although cases can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate (average decrease of 4mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10mEq/L. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate. In adults, the incidence of persistent treatment-emergent decreases in serum bicarbonate (levels of <20 mEq/L at two consecutive visits or at the final visit) in controlled clinical trials for adjunctive treatment of epilepsy was 32% for 400 mg/day, and !% for placebo. Metabolic acidosis has been observed at doses as low as 50 mg/day. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5 mEq/L decrease from pretreatment) in these trials was 3% for 400 mg/day, and 0% for placebo. Serum bicarbonate levels have not been systematically evaluated at daily doses greater than 400 mg/day. In pediatric patients (<16 years of age), the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adjunctive treatment of Lennox-Gastaut Syndrome or refractory partial onset seizures was 67% for TOPAMAX (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for TOPAMAX and 0% for placebo. Cases of moderately severe metabolic acidosis have been reported in patients as young as 5 months old, especially at daily doses above 5 mg/kg/day. Although not approved for the prophylaxis of migraine, the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adults for prophylaxis of migraine was 44% for 200 mg/day, 39% for 100 mg/day, 23% for 50 mg/day, and 7% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value<17 mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for 200 mg/day, 9% for 100 mg/day, 2% for 50 mg/day, and 1% for placebo. Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as Rickets in pediatric patients) and / or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rates may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone related sequelae has not been systematically investigated. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face or persistent acidosis, alkali treatment should be considered. Under Precautions: Laboratory Tests Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended ( see WARNINGS). Pediatric Use: Safety and effectiveness in patients below the age of 2 years have not been established. Topiramate is associated with metabolic acidosis. Chronic untreated metabolic acidosis in pediatric patients may cause osteomalacia (rickets) and may reduce growth rates. A reduction  in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated (see Warnings). Under OVERDOSE: Topiramate overdose has resulted in severe metabolic acidosis (see WARNINGS). You can further our understanding of adverse events by reporting all cases to Ortho-McNeil at the contact numbers listed below or to the FDA MedWatch Program by phone (1-800 FDA 1088), by fax (1-800-FDA-0178, by mail (using postage paid form to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787) or via www.accessdata.fda.gov/scripts//medwatch/. A copy of the full Prescribing Information is enclosed for your reference. If you have any questions regarding TOPOMAX tablets and TOPOMAX Sprinkle Caplets, please feel free to call Ortho-McNeil Medical Affairs Division at 1-800-682-6532 Sincerely, Joseph Hulihan, MD Group Director, CNS Research Ortho-McNeil Pharmaceutical, Inc. 1000 Route 202, PO Box 300 Raritan, NJ  08869-0602       908-218-6000 Telephone