Medication Monitor

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  • October 24, 2011


    Treatment of males for conditions associated with a deficiency or absence of endogenous testosterone

    Testosterone transdermal system has been approved in a new smaller-sized and lower-dose patch strength of 2 mg and 4 mg per day, according to a Watson news release. Approval of the lower-dose formulation was based on data showing that 97% of patients achieved testosterone concentrations within the normal range after 28 days of daily therapy. In the study, 94% of patients achieved normal testosterone levels by day 8 with the 4 mg/day formulation.

    The new formulation is expected to be available next month.

  • October 20, 2011

    Exenatide is now approved as add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone, according to an Amylin and Lilly news release.

    Approval was based on data from a double-blind clinical trial involving 261 patients receiving insulin glargine with or without metformin and/or a TZD who were randomized to receive exenatide 10 mcg or placebo. After 30 weeks of treatment, glycosylated hemoglobin (A1C) decreased by 1.7% and 1% in patients randomized to exenatide or insulin glargine alone, respectively (P < 0.001). In addition, the proportion of patients achieving an A1C of 7% or less was 60% in the exenatide group compared with 35% in the insulin glargine alone group (P < 0.001). Weight was lower in the exenatide group by approximately 1.8 kg (4 pounds), while those on insulin glargine alone gained an average of 0.9 kg (2 pounds) (P < 0.001).

    Nausea was the most commonly reported adverse event, and it occurred significantly more often in the exenatide group (41% vs. 8%). The rate of hypoglycemia was similar in both groups.

  • October 11, 2011


    Management of MDD, OCD, bulimia, and panic disorders

    The first 60 mg tablet of fluoxetine has been approved by FDA, according to an announcement on Edgemont’s website. The tablets are indicated for the treatment of major depressive disorder (MDD), obsessive compulsive disorder (OCD) in adults and pediatrics, and bulimia nervosa and panic disorder in adults.

    The availability of these tablets has not been determined. Edgemont says to check its site in the coming weeks for more information.

    Fluoxetine is already available as tablets or capsules in 10 mg, 20 mg, and 40 mg dosage strengths, a weekly 90 mg dosage strength, and a 20 mg/5 mL oral solution.

  • October 10, 2011


    Treatment of men with signs and symptoms of BPH and men with both ED and signs and symptoms of BPH

    FDA has approved tadalafil for the treatment of men with signs and symptoms of benign prostatic hyperplasia (BPH) as well as men with both BPH and erectile dysfunction (ED), according to an Eli Lilly news release. How tadalafil reduces BPH symptoms has not been determined, but phosphodiesterase type 5 (PDE5) enzymes are located in the prostate and bladder.

    Approval of tadalafil for these indications was based on data from three placebo-controlled studies involving 1,989 men. Two studies were of men with BPH and one study was specific to those with both ED and BPH. Results from these trials showed that men treated with tadalafil 5 mg once daily had significantly improved scores on the International Prostate Symptom Score (IPSS), a questionnaire evaluating symptoms of BPH. Those with ED and BPH also had improvements on the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual function.

    The combination of tadalafil with alpha-blockers for the treatment of BPH is not recommended. The combination has not been adequately studied and may increase the risk of hypotension. In addition, tadalafil should not be used in men taking nitrates such as nitroglycerin because those agents taken together may also trigger an unsafe drop in blood pressure.

    Tadalafil was originally approved in 2003 for the treatment of ED.

  • October 10, 2011


    Management of type 2 diabetes and elevated cholesterol

    The first fixed-dose combination tablet containing sitagliptin and simvastatin for the management of type 2 diabetes and elevated cholesterol levels has been approved, according to an FDA news release. The tablets will be marketed in dosage strengths of sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. In addition, the manufacturer is planning on developing tablets that contain sitagliptin 50 mg, as sitagliptin/simvastatin 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg doses.

    Approval of this new combination was based on previous experience with the individual components and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. The most common adverse effects of sitagliptin/simvastatin include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation, and nausea.

    The agency noted that it has recently become aware of the potential for statins to increase blood glucose levels in patients with type 2 diabetes. This risk appears to be very small and is outweighed by the benefits of statins for reducing heart disease in patients with diabetes. In addition to warnings in the product labeling, the manufacturer will be required to conduct a postmarketing clinical trial comparing the glucose-lowering effects of sitagliptin alone compared with sitagliptin given with simvastatin.