Drug Topics- August 11, 2008

22 DRUG TOPICS AUGUST 11, 2008 www.drugtopics.com Rx Care New combination pill approved for Type 2 diabetes Mary Choy, Pharm.D. and repaglinide had a statistically significant improvement in HbA1c and fasting plasma glucose compared with both monotherapy arms (p<0.05). PrandiMet is administered twice daily with meals. The starting dose should be individualized, based on the patient’s current regimen, effectiveness, and tolerability. For patients who have inadequate glycemic control with metformin monotherapy, the initial recommended dose of PrandiMet is 1 mg repaglinide/500 mg metformin and titrated to reduce the risk of hypoglycemia with repaglinide. To reduce gastrointestinal side effects associated with starting metformin therapy, the recommended initial dosage for patients inadequately controlled with repaglinide therapy and starting PrandiMet is 1mg replaglinide/500 mg metformin, or 2 mg repaglinide/500 mg metformin. PrandiMet can be given two to three times a day, but it should not exceed the maximum recommended daily dose of 10 mg repaglinide/2500 mg metformin. The total dose per meal should not exceed 4 mg repaglinide/1000 mg. Since PrandiMet contains the component metformin, there is a potential for lactic acidosis due to metformin accumulation; this is mentioned as a black box warning. Lactic acidosis is a serious but rare complication that patients need to be aware of and the risk is intensified with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure. As a preventative measure against lactic acidosis, PrandiMet should be temporarily discontinued prior to radiologic studies involving intravascular iodinated contrast materials and restarted after 48 hours of stabilized renal function. Patients’ ≥ 80 years old should not be prescribed this medication unless there is a determination of normal renal function. Additionally, patients with existing renal impairment may have an increased risk TIPS TO REMEMBER PrandiMet of lactic acidosis; it is important to remember Take PrandiMet within 15 minutes prior to meals. that metformin is contraindicated in those If patients skip a meal, they should skip the PrandiMet dose with serum creatinine levels of ≥ 1.5 mg/dL for that meal. for males or ≥ 1.4 mg/dL for females. Other contraindications include using PrandiMet is contraindicated in patients receiving gemfibrozil or itraconazole. this medication in patients with metabolic acidosis and diabetic ketoacidosis. PrandiCounsel patients to avoid alcohol since it increases the effect Met should also be avoided in patients with of metformin on lactate metabolism. hepatic impairment. PrandiMet is available in two tablet strengths (repaglinide/ metformin): 1 mg/500 mg and 2 mg/500 mg. THE AUTHOR is a writer based in New York. A new fixed-dose combination pill from Novo Nordisk and Sciele Pharma will now offer patients with diabetes mellitus another treatment option. The Food and Drug Administration (FDA) approved PrandiMet, the first and only fixed-dose combination that comprises a fast-acting secretagogue repaglinide (Prandin) and insulin sensitizer, metformin, for patients unable to achieve glycemic control using the single therapy of meglitinide or metformin. According to Novo Nordisk and Sciele Pharma, PrandiMet works to optimize glycemic control by counteracting the three abnormalities of Type 2 diabetes: impaired insulin secretion, insulin resistance, and excessive hepatic glucose production. “This new combination drug brings together two anti-diabetic agents with different mechanisms of action,” Sum Lam, Pharm.D., CGP, BCPS, assistant clinical professor at St. John’s University, said. Repaglinide reduces postprandial glucose (PPG) by stimulating the release of insulin from the pancreas after a meal. Metformin decreases hepatic glucose production, increases peripheral glucose uptake, and improves insulin sensitivity. While compliance to medications is important, Lam believes that it is also necessary for patients to pay attention to diet and exercise regimen to optimize blood glucose control. PrandiMet’s approval was based on a clinical trial in which 83 patients with Type 2 diabetes with inadequate glycemic control on metformin were randomized to receive add-on repaglinide, repaglinide monotherapy, or continued treatment with metformin monotherapy. Patients receiving combination therapy of metformin http://www.drugtopics.com

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Drug Topics- August 11, 2008 Contents Latebreakers Letters DEA Proposes Rule To Allow Electronic Prescriptions for Controlled Substances Merger, Medicare Reform Could Mean Broader E-Prescribing Adoption New Combination Pill Approved for Type 2 Diabetes New Eczema Guildlines Promote Use of Emollients, Then Topical Corticosteroids Agencies Flush Original Strategies in Favor of Promoting Drug Take-Back Programs JP at Large: You Laughing at Me? Pharmacists Find Themselves at Mercy of Prior Authorization State Law Requiring PBM Transparency See Some Gains, Some Losses Global Counterfeiting Still Growing, Says U.S. Commerce Official FDA Saftey Page: Prophylthiouracil Still Confused with Purinethol (mercaptopurine) New Products Bring Lice Treatment to a Head NACDS Marketplace Showcases New Product that Fill Unmet Needs Update on Respiratory Tract Infections Execs Share War Stories About Adopting Technology in their Stores New Products Advertisters Index Classified Viewpoint: Medicare Part D Revisions sorely needed

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