Pharmacy & Therapeutics - June 2008 - (Page 329)

NEW DRUGS NEW INDICATIONS Fluticasone/Salmeterol (Advair) For COPD Exacerbations A combination of fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder (Advair Diskus, GlaxoSmithKline 250/50) has been approved for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the U.S. Patients who are experiencing worsening COPD symptoms often require additional treatment, such as antibiotics, oral corticosteroids, and sometimes hospitalization. Symptoms include coughing, shortness of breath, or coughing up excess mucus beyond normal variations. The FDA also expanded the use of Advair Diskus 250/50 to include COPD associated with chronic bronchitis as well as with emphysema or both. Advair 250/50 was originally approved in 2003 for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. Patients should take only one inhalation twice a day. Advair should not be used with long-acting beta2-agonists, and it should not be used to treat sudden symptoms. (Source: GlaxoSmithKline, May 1, 2008.) DRUG NEWS Atomoxetine is not indicated for those patients who have taken a monoamine oxidase inhibitor antidepressant within the previous two weeks; who have glaucoma; or who are allergic to any of the drug’s ingredients. (Sources: Eli Lilly, May 8, 2008; www. strattera.com.) disorder with or without psychotic features in pediatric patients 10 to 17 years of age and for the maintenance treatment of schizophrenia in adolescents 13 to 17 years of age. Aripiprazole is also indicated as adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in patients 10 to 17 years of age. The injection form is indicated for the acute treatment of agitation associated with bipolar I disorder, manic or mixed, in adults. The FDA also approved a new recommended starting and target dose of 15 mg daily for aripiprazole alone in treating bipolar I disorder in adults. (Sources: Bristol-Myers Squibb/Otsuka, May 8, 2008.) Lubiprostone (Amitiza) For Irritable Bowel Syndrome With Constipation The FDA has approved lubiprostone (Amitiza, Sucampo/Takeda) to treat irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older. IBS affects at least twice as many women as men. The safety and efficacy of lubiprostone were established in two major studies involving 1,154 patients with IBS-C. About 92% of the patients were women. More treated patients reported symptom relief over a 12-week period compared with patients who received placebo. The medication is also approved for patients with chronic idiopathic constipation. Lubiprostone is discussed in this month’s Pharmaceutical Approval Update on page 362. (Source: FDA, April 30, 2008.) Atomoxetine (Strattera) For ADHD Maintenance In Children and Adolescents Atomoxetine HCI (Strattera, Eli Lilly) has been approved for the maintenance treatment of attention-deficit/hyper activity disorder (ADHD) in children and adolescents. This selective norepin ephrine reuptake inhibitor is the first FDA-approved nonstimulant indicated for treating ADHD in children, adolescents, and adults. In an 18-month, relapse-prevention trial of 600 children and adolescents six to 15 years of age, atomoxetine was superior to placebo in maintaining continuous efficacy in patients. At the end of the trial, patients taking the study drug had lower relapse rates (2.5%), compared with patients taking placebo (12.2%). The mean final dose was approximately 1.54 mg/kg per day after 12 months and 18 months of treatment. In some children and teenagers, atomoxetine increased the risk of suicidal thoughts, but a similar analysis in treated adults did not reveal this risk. Bipolar Indication, New Dose For Aripiprazole (Abilify) Bristol-Myers Squibb and Otsuka have announced updated labeling for ari piprazole (Abilify) as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults. Aripiprazole also received expanded indications in bipolar I disorder and schizophrenia. It is now indicated for the maintenance treatment of manic and mixed episodes associated with bipolar I NEW FORMULATIONS Delivery System (Mixject) For Testosterone Inhibitor (Trelstar) in Prostate Cancer Watson Pharmaceuticals, Inc., has announced the FDA’s approval of Mixject, a deliver y system for triptorelin pamoate (Trelstar), an injectable suspension for the palliative treatment of advanced prostate cancer. Developed by Medimop (a subsidiary of West Pharmaceutical Services), Mixject combines the efficacy of Trelstar Depot 3.75 mg and long-acting (LA) Trelstar 11.25 mg. Trelstar is a synthetic luteinizing hormone–releasing hormone (LHRH) ago- Vol. 33 No. 6 • June 2008 • P&T® 329 http://www.strattera.com http://www.strattera.com

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Editorial Aliskiren Reduces Plasma Renin Activity Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Challenges in Evaluating and Standardizing Medical Devices in Health Care Facilities California e-Pedigree Rules Pose Challenges For Pharmacies Pharmaceutical Approval Update American Psychiatric Association At a Glance: Dermatology Trends in Managed Care

Pharmacy & Therapeutics - June 2008

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