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From Pfizer 12/16/2004 We at Pfizer understand that you and your patients may have questions about arthritis medications in light of recent developments in this area. Pfizer continues to stand behind the efficacy and safety of Bextra (valdecoxib tablets) as labeled. In October 2004, we communicated important information regarding our product Bextra to the public. As we described in those communications, Pfizer and the Food and Drug Administration (FDA) have had ongoing discussions regarding Bextra product labeling. These discussions have now been finalized and have resulted in an expansion of the previous warning concerning the risk of rare but serious adverse skin reactions associated with Bextra, as well as the inclusion of a detailed description of the available cardiovascular clinical trial safety data for the product. Please take a few minutes to carefully review the important information contained in this letter regarding Bextra. Bextra is indicated for the relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis, and for the treatment of primary dysmenorrhea. As you dispense Bextra, it is important for you to know that there are new components to the Bextra product labeling, a copy of which is appended to this letter. In order of prominence, the additional information now included in the Bextra product labeling is summarized in the following section: Serious Skin Reaction: A boxed warning regarding serious skin reactions has been added to the Bextra product labeling. The previous information concerning the occurrence of serious adverse skin reactions associated with Bextra has been expanded in the WARNINGS section of the product labeling. The complete boxed warning regarding serious skin reactions is reproduced below. Serious Skin Reactions -Serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving BEXTRA. Some of these reactions have resulted in death. -Patients appear to be at higher risk for these events within the first 2 weeks of treatment, but these may occur at any time during the treatment. -The reported rate of these serious skin events appears to be greater for BEXTRA as compared to other COX-2 agents. -BEXTRA should be  discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. (See WARNINGS-Serious Skin Reactions)   Cardiovascular Safety Information: New information regarding the available cardiovascular clinical trial safety data for Bextra (valdecoxib tablets) has been included in the CONTRAINDICATIONS, WARNINGS and CLINICAL STUDIES sections of the product labeling. Please note that Bextra is not approved for the treatment of post-operative pain in the settings described below. These labeling sections have been updated to reflect that patients treated with Bextra and parecoxib, the investigational IV prodrug of Bextra, in an investigational clinical setting evaluating these products for the treatment of pain immediately following coronary artery bypass graft (CABG) surgery, have a higher risk for cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications compared to patients receiving placebo. Bextra is therefore contraindicated for the treatment of postoperative pain immediately following CABG surgery and should not be used in this setting. In general surgery study, there was no significant difference in the overall safety profile including no increased risk of CV thromboembolic events vs placebo (in both treatment arms of the study-parecoxib/valdecoxib and placebo/placebo). Data describing an analysis of the cardiovascular safety of Bextra in patients treated for OA and RA (the approved indications) are now included in the package insert. Randomized controlled clinical studies with Bextra linger than twelve months have not been conducted, nor have studies powered to detect differences in cardiovascular events in a chronic setting been conducted. A meta-analysis of 10 clinical trials suggests no apparent differences were detected in the exposure-adjusted serious cardiovascular thromboembolic event rates among patients receiving Bextra, placebo and NSAIDS. Pfizer continues to stand behind the efficacy and safety of Bextra. We are planning further studies to assess the long-term CV safety of Bextra in patients who require chronic treatment for arthritis with a COX-2 inhibitor. As a partner ion healthcare, Pfizer is also developing information specific to Bextra, reflective of the changes outlined in this letter for physicians, managed care organizations, patients, and patient advocacy groups. Our goal is to continue to help support your discussions on this important topic with your patients and with other health care professionals. Inc losing, as with all of out medications, we believe health care professionals must consider all the available information displayed in the product labeling when making treatment decisions for their patients. Pfizer is fully committed to monitoring the safety of Bextra and will continue to provide you with any important update information in order to help ensure that the product is labeled and used appropriately. We stand committed to providing you with safe and effective treatment alternatives that meet the needs of your patients. As always, if you have any questions concerning this important safety information, please contact Pfizer Inc. Medical Information at 1-800-438-1985 Sincerely, Claire Wohlhuter, MD, PhD Pain and Arthritis Medical Group Leader Pfizer, Inc.

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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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IMPORTANT SAFETY INFORMATION From Janssen Pharmaceuticals Products, L.P. and Ortho Biotech Products, L.P. March 22, 2004                       Janssen Pharmaceutica Products, L.P. and Ortho Biotech Products, L.P. would like to inform you of recent labeling changes made for PORANOX (itraconazole) Capsules, SPORANOX (itraconazole) Oral Solution and SPORANOX (itraconazole) Injection.   The revisions to the labeling have been made as a result of the company's ongoing review of the safety data and knowledge of potential cytochrome P450 3A4 drug interactions.  Clinicians are advised to review the pertinent sections of the prescribng information carefully.  Apackage insert for each formalation has beeen enclosed for your review. We wish to draw your attention to the Boxed Warning, Special Populations, Contraindications, Warnings, Drug Interactions, Pregnancy, and Post-marketing experience sections of the revised SPORANOX labeling that includes these important changes. Underline words denote newly added information. THE FOLLOWING CHANGES APPLY TO THE SPORANOX(ITRACONAZOLE) CAPSULES, ORAL SOLUTION, AND INJECTION: BOX WARNING Drug Interactions: Coadministration of  cisapride, pimozide, quinidine, dofetilide, or levacetylmethadol (levomethadyl)with SPORANOX (itraconazole) Capsules, injection or Oral Solution is contraindicated.  SPORANOZ, a potent cytochrome P450 3A4 isoenzyme system (CYP3A4) inhibitor, may increase plasma concentrations of drugs metabolized by this pathway.  Serious cardiovascular events, including QT prolongation, torsades depoints, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using cisapride, pimozide, levacetymethadol (levomethadyl). or quinidine, concomitantly with SOPRANOX and/or other CYP3A4 inhibitors.  See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Drug Interactions for more information. CONTRAINDICATIONS Drug Interactions: Concomitant administration of SPORANOX (itraconazole) Capsules, Injection, or Oral Solution and certain drugs metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) may result in increaded plasma concentrations of those drugs, leading to potentially serious and/or life-threatening adverse events.  Cisapride, oral midazolam, pimozide, quinidine, dofetilide, triazolam, and levacetylmethadol (levomethadyl) are contraindicated with SPORANOX. HMG CoA-reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, are also contraindicated with SPORANOX. Ergot alkaloids metabolized by CYP3A4 such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) and contraindicated withSPORANOX. (See BOX WARNING, and PRECAUTIONS: Drug Interactions.) WARNINGS Cardiac Dysrhythmias:  Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using cisapride, pimozide, levacetylmethadol (levomethadyl)  or quinidine concomitantly with SPORANOX and/or other CYP3A4 inhibitors.  Concomitanty administration of these drugs with SPORANOX is contraindicated.  (See BOX WARNING, CONTRAINDICATIONS, and PRECAUTIONS: Drug Interactions. ) DRUG INTERACTIONS The following drugs have been added to Table 1: Selected Drugs that are predicted to alter the plasma concentration of itraconazole or have their plasma concentration altered by SPORANOX: Disopyramide, levacetylmethadol (levomethadyl), ergot alkaloid, halofantrine, budesonide, dexamethasone, cilostazol, eletriptan. This List is not all-inclusive. Excerts from the revised labeling related to these drug interactions are listed below: The class IA antiarrhythmic disopyramide has the potential to increase the QT interval at high plasma concentrations.  Caution is advised when SPORANOX  and disopyramide are administered concomitntly. Levacetylmethadol (levomethadyl) is known to prolong the QT interval and is metabolized by CYP3A4. Co-administration of levacetylmethadol with SPORANOX could result in serious cardiovascular events.  Therefore, concomitant administration of SPORANOX is contraindicated. Elevated concentation of ergot alkaloids can cause ergotism, i.e. a risk for vasospasm potentially leading to cerbral ischemia and/or ischemia of the extremities. Concomitant administration of ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) with SPORANOX contraindicated. Halofantrine has the potential to prolong the QT interval at high plasma concentrations.  Caution is advised when SPORANOX and halofantrine are administered concomitantly. SPORANOX may inhibit the metabolism of certain glococorticosteroids such as budesonide, dexamethasone and methylprednisolone. Colostazol and eletriptan are CYP3A4 metabolized drugs that should be used with caution when co-administered with SPORANOX. Pregnancy: During post-marketing experience, cases of congenital abnormalities have been reported: (See ADVERSE REACTIONS, Post-marketing Experience.) POST-MARKETING EXPERIENCE This section has been revised to include the following adverse events: Anaphylactic, anaphylactoid and allergic reactions, and photosensitivity.  There is limited information on the use of SPORANOX during pregfnancy.  Cased of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience.  A causal relationship wth SPORANOX has not been established. THE FOLLOWING CHANGE APPLIES TO SPORANOX IV: CLINICAL PHARMACOLOGY Special Populations                                                                                                                                      Renal Insufficiency: In patients with mild to moderate renal impairment, SPORANOX IV should be used with caution.  Serum creatinine levels should be closely monitored and, if renal toxicity is suspected, consideration should be given to changing to SPORANOX Capsules. THE FOLLOWING CHANGE APPLIES TO SPORANOX ORAL SOLUTION: WARNINGS Treatment of Severely Neutropenic Patients: SPORANOX Oral Solution as treatment for oropharyngeal and/or esophageal candidiasis was not investigated in severely neutropenic patients.  Due to its pharmacokinetic properties.  SPORANOX Oral Solution is not redommended for initiation of treatment in patients at immediate risk of systemic candidiasis. SPORANOX (itraconazole) Injection and SPORANOX (itraconazole) Oral Solution are distributed by Ortho Biotech Products, L.P. SPORANOX (itraconazole) Capsules are distributed by Janssen Pharmaceutica Products, L.P. Janssen Pharmaceutical and Ortho Biotech are committed to providing you with the most current product information available for the management of your patients receiving SPORANOX.  You can further our understanding of adverse events by reporting all cased to Janssen or Ortho Biotech at the contact numbers listed below or to the FDA MedWatch Program by phone at 1-800-FDA-1088.  The FDA MedWatch Program may also be reached by fax at 1-800-FDA-0178, by mail (using postage-paid form) MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or via www.FDA.gov/medwatch. Please rfefer to the enclosed full Prescribing Information for additional details regarding SPORANOX.  For additional medical information, please call between 9AM to 4:30 PM EST, Monday through Friday. SPORANOX Capsules:                                                                           1-800-JANSSEN (526-7736) SPORANOX Oral Solution or SPORANOX , Injection       Ortho Biothech Medical Information: 1-800-325-7504, Prompt#2 Sincerely, Christine Cote, M.D.     Vice President, Medical Affairs        Janssen Pharmaceutica Products, L.P.   Marc Kamin, M.D.    Vice President, Clinical Affairs     Ortho Biotech Products, L.P.

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12/09/04 From Duramed Subsidiary of Barr Pharmaceuticals, Inc. Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., is pleased to announce the acquisition of Plan B (levonorgestrel) tablets, 0.75 mg- now the only marketed emergency contraceptive. Plan B, currently available by prescription, is a progestin-only pill. Since Preven  (levonorgestrel) 0.25 mg/ethinyl estradiol 0.05 mg tablet USP) has been discontinued and is no longer manufactured, Plan B provides a safe and effective alternative for emergency contraception. If you receive any prescription for Preven, you should contact the prescriber and offer Plan B as the safe and effective alternative. Plan B is not an abortifacient; it is not effective if a women is already pregnant. Plan B can prevent pregnancy in cases of contraceptive failure or unprotected intercourse. For optimal efficacy, a woman must take the first tablet as soon as possible within 72 hours and the second tablet 12 hours later. Plan B can reduce the risk of pregnancy by 89% when taken as directed. Each packet of Plan B contains a single, 2 tablet course of treatment. The NDC number is 51285-038-93. Plan B May be appropriate when a woman -Engaged in intercourse without contraception protection -Used a barrier methods of contraception that failed during intercourse or failed to follow their contraceptive regimen -Was raped Plan B broadens the contraceptive options Duramed offers to women. Our sales force will provide you with materials to support the use of Plan B. Information for professionals and patients is available at www.go2planB.com. Our Plan B information line can be accessed toll free at 1-800-330-1271 from 8AM to 7PM EST. Stocking Plan B is the critical first step. Order Plan B now from your wholesaler or call 1-800-330-1271. We hope you will help Duramed Pharmaceuticals provide access to women in need of emergency contraception. Stocking Plan B is especially important, since timing is critical to the efficacy of Plan B. Very Truly Yours, Ericka Higgins Product Manager PS: Coming soon! Duramed Pharmaceuticals will be conducting a full-scale launch of Plan B, complete with new materials for professionals and patients in the near future. In the interim, our sales representatives will be calling on you with patient materials and literature for professionals. Plan B is contraindicated in women with known or suspected pregnancy, hypersensitivity to any component of the product, or undiagnosed abnormal genital bleeding. Plan B is not recommended for routine use as a contraceptive. Plan B is not effective in terminating an existing pregnancy. Plan B does not protect against HIV infection and other sexually transmitted diseases (STDs). Menstrual bleeding may be heavier or lighter after taking Plan B. If menses are delayed beyond one week, pregnancy should be considered. Severe abdominal pain may signal a tubal (ectopic) pregnancy. Common side effects associated with the use of Plan B include nausea, abdominal pain, fatigue, headache, and menstrual changed.

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