New Drug Update 2009-2010 - LAFP

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Omeprazole Capsules, delayed-release: 10, 20, 40 mg Y Rx Tablets, delayed-release: 20 mg Y OTC Suspension, delayed-release granules: 2.5, 10 mg Y Rx Pantoprazole Tablets, delayed-release: 20, 40 mg Y Rx Granules for suspension, delayed-release: 40 mg N Rx Injection, powder for solution: 40 mg N Rx Rabeprazole Tablets, delayed-release: 20 mg N Rx CONCLUSION: Dexlansoprazole is another proton pump inhibitor. Although present with a longer residence time because of the dual delayed-release formulation, neither longer acid suppression nor a clinical advantage has been demonstrated relative to lansoprazole or other proton pump inhibitors. The Medical Letter (3/23/09) concluded “It is not surprising that dexlansoprazole (Kapidex) is an effective PPI, because it was approved for use in a dose that is twice the dose of lansoprazole, which will soon be available generically. PPIs appear to have little dose-related toxicity in the short term, but their long-term safety is unclear.” Name Change March 4, 2010 The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant. Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex (bicalutamide) to treat men with advanced prostate cancer and Kadian (morphine sulfate), 58
MILNACIPRAN - Savella by Forest/Cypress 1S INDICATIONS: Milnacipran is indicated for the management of fibromyalgia. The Food and Drug Administration (FDA)-approved indications for the serotonin and norepinephrine reuptake inhibitors (SNRIs) are summarized in Table 1. Table 1. FDA-Approved Indications for SNRIs Indication Duloxetine Desvenlafaxine Milnacipran Venlafaxine Diabetic peripheral neuropathic pain Fibromyalgia X X X Generalized anxiety disorder X X Major depressive disorder X X X Panic disorder Social anxiety disorder CLINICAL PHARMACOLOGY: Milnacipran is an SNRI. It does not affect postsynaptic cholinergic, adrenergic, histaminergic, dopaminergic, or serotonergic receptor sites. Milnacipran binds to both serotonin and norepinephrine transporters with high affinity, but preferentially blocks norepinephrine reuptake compared with serotonin reuptake by an approximately 3:1 ratio. The exact mechanism of the central pain inhibitory action and fibromyalgia symptom improvement effects are unknown. In healthy young subjects, milnacipran at dosages of up to 100 mg daily or 50 mg twice daily for 7 days did not affect cognitive function or psychomotor performance. In elderly volunteers, milnacipran at single doses of up to 75 mg did not affect cognitive function and had no detrimental effects on psychomotor performance. PHARMACOKINETICS: Peak concentrations are reached about 2 to 4 hours after oral administration. Steady-state levels are reached within 36 to 487 hours. Absolute oral bioavailability is 85% to 90%. Absorption is not affected by food. Milnacipran exposure increases dose proportionately over the therapeutic dosage range. Plasma protein binding is low (less than 13%). The milnacipran half-life is 6 to 8 hours; the active d-milnacipran enantiomer has a longer half-life (8 to 10 hours) than the l-milnacipran enantiomer (4 to 6 hours). Approximately 55% of the dose is excreted in the urine as unchanged drug, with another 14% to 30% excreted as the glucuroconjugate and the remainder as inactive metabolites. Milnacipran pharmacokinetics were not substantially altered in patients with mild to moderate hepatic function impairment. In patients with severe hepatic impairment, mean exposure (area under the curve [AUC]) was increased by 31% and the half-life was increased by 55%. Renal clearance of milnacipran is reduced in patients with renal function impairment; pharmacokinetic changes are proportional to the degree of renal failure. In patients with severe renal function impairment, the half-life was increased approximately 3-fold. Mean exposure (AUC) was increased by 16%, 52%, and 199%, and half-life was increased by 38%, 41%, and 122% in patients with mild (creatinine clearance [CrCl], 50 to 80 mL/min), moderate (CrCl, 30 to 49 mL/min), and severe (CrCl, 5 to 29 mL/min) renal impairment, respectively. In elderly patients, the peak concentration and AUC were about 30% higher than in younger patients because of age-related reductions in renal function. The peak concentration and AUC were about 20% higher in women than in men. Table 2 compares the pharmacokinetics of duloxetine and milnacipran, the 2 SNRIs indicated for the management of fibromyalgia. The primary pharmacokinetic difference between these agents is in the X X 59
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New Drug Update 2009-2010 C. Wayne
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FDA MedWatch Information 9/9/2006 C
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pediculocides, to improve outcomes.
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DENOSUMAB - Prolia by Amgen INDICAT
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New Drug Update 2009-2010 - LAFP

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