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Press Release From ALPHARMA 01/13/2004 New Alpharma Branded Products Division to Include Faulding's Kadian CII Alpharma, a market leader in generic pharmaceuticals products, has renamed its branded division. In 2001 the Alpharma acquisition of Faulding significantly enhanced Alpharma U.S. Human Pharmaceuticals. That acquisition included Faulding Laboratories, a branded division of Faulding, provided Alpharma entry into the U.S. branded pharmaceutical market. Today, Alpharma announced the renaming of the branded division, now t be known as Branded Products Division. The newly named branded division has been organized and resourced for growth. A newly expanded field sales force will place primary emphasis on Kadian Cll (Morphine Sulfate Sustained Release). Michael Nestor, President of Branded Products Division, U.S. Human Pharmaceuticals said "We believe the diverse product portfolio and multinational presence of the Alpharma Human Pharmaceuticals business brings strength to the branded division. The reorganization and renaming of the branded division as Branded Products Division demonstrates the strong commitment Alpharma has to expand the branded business. KADIAN, dosed once or twice a day, is the only sustained-release morphine that can be administered orally, by sprinkling on applesauce or via G-tube. KADIAN is available in 20, 30, 50, 60, and 100 mg capsules. Alpharma has recently restructured, closing some animal-health facilities and increasing the emphasis on its human pharmaceutical business. The company has capitalized on its advanced manufacturing processes, unique fermentation capabilities, and worldwide sales organization. Last year, Alpharma announced its renewed focus on developing and acquiring products in areas where profitability could be increased and the company could leverage its abilities to meet the growing demand for quality and cost-effective medications. The establishment of Alpharma Branded Products Division is an outgrowth of this focus. For further information about Alpharma U.S. Human Pharmaceuticals, Branded Products Division, contact Shelley Goldstein email:shelley.goldstein@alpharma.com phone 732-465-3653 |
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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 |
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PDR® PHYSICIANS DESK REFERENCE ADDENDUM Healthcare Professional Pfizer Inc is pleased to announce that VFEND (voriconazole) is now indicated for the treatment of esophageal candidiasis, and is also available as a 40 mg/mL powder for oral suspension. The recommended dosing regimen for the treatment of esophageal cnadidiasis is an oral dose of 200mg every 12 hours for patients weighing 40kg or more. Adult patients who weigh less than 40Kg should receive an oral dose of 100 mg every 12 hours. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms. VFEND is also indicated for the primary treatment of invasive asperfillosis and additionally for serious fungal infections caused by Scedosporium apiospermum and Fusarium spp incliding Fusarium solani, in patients intolerant of, or refractory to, other therapy, VFEND is also available in tablet (50 mg and 200 mg strengths) and IV (200 mg) dosage forms. The efficacy of VFEND in the primary treatment of esophageal candidiasis was demonstrated in a double-blind, double-dummy randomized study in immunocompromised patients with endoscopically proven esohageal candidiasis. Patients were treated for a median of 15 days (range 1 to 49 days) with either oral voriconazole 200 mg fluconazole were 98.2% vs 95%, respectively, in the per protocol population, as well as 87.5% vs 89.5% respectively, in the intent-to-treat population. Results with voriconazole showed comparable efficacy rates against esophageal candidiasis. VFEND is contraindicated in patients with a known hypersensitivity to voriconazole or its excipients, and in patients receiving terfenadine, astemizole, cisapride, quinidine, sirolimus, rifampin, carbamazepine, long-acting barbiturates, ritonavir (400 mg every 12 hours), efravirenz, rifabutin, and ergot alkaloids. The most frequently reported adverse events (all casualties) in the therapeutic trials were visuals disturbances, fever, rash, vomitting, nausea, diarrhea, headache, sepsis, peripheral edema, abdominal paon, and respiratory disorder. Voriconazole treatment-related visual disturbances are common. The effect of VFEND on visual function is not known if treatment continues beyond 28 days. If treatement continues beyond 28 days, visual function, including visual field and color perception, should be monitored. Patients should be advised not to drive at night while taking VFEND. If they perceive any change in vision, they should avoid potentially hazardous tasks, such as driving or operating machinery. In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with VFEND (clinical hepatitis, choletasis, and fulminanat hepatic failure, including fatalities). Therefore, liver function tests should be evaluated at the start of and during the course of VFEND therapy. VFEND should only be used in patients with sever hepatic insufficiency if the benefit outweighs the potential risk. Thomas Fleming, PharmD Manager, Professional Services & Chief Clinical Consultant |
