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From: Pfizer Re: XANAX XR

Xanax XR (alprazolam extended-release tablets) is now approved for panic disorder, with or without agoraphobia. This new extended release formulation offers the convenience or once-daily dosing. The efficacy of Xanax XR was established in two 6 week, placebo-controlled studies, in which XANAX XR was superior to placebo in the treatment of patients with panic disorder.

XANAX XR Tablets is available in four convenient doses:

-0.5 mg-Available now

-1.0 mg-Available now

-2.0 mg-Available now

-3.0 mg-Available now

XANAX XR Tablets should be taken whole and are not to be chewed or crushed.

Important Considerations

XANAX XR is contraindicated in patients with known sensitivity to this drug or other benzodiazepines, in patients with acute narrow-angle glaucoma, and in patients taking potent CYP3A inhibitors, such as ketoconazole and itraconazole.

Certain adverse events are a direct consequence of physical dependence to alprazolam. These include a spectrum of discontinuation symptoms, the most important being the possibility of seizure.

The most common observed adverse events in patients treated with XANAX XR in controlled clinical trials (greater than or equal to 5% and at least twice the incidence observed for placebo) were: sedation, somnolence, memory impairment, dysarthria, abnormal coordination, ataxia, and decreased libido.

Please refer to the enclosed full prescribing information for XANAX XR. Please visit us on the web at www.xanaxxr.com

If you need further information about XANAX XR, please contact US Medical Information at 800-323-4204.

Sincerely,

John Gillespie, MD

Medical Director

Depression and Anxiety DMT

Pfizer, Inc.

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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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From: GlaxoSmithKline 02/04

Lamictal
New FDA-Approved Indication

GlaxoSMithKline is Excited to announce the US Food and Drug Administration's (FDA) approval of Lamictal (lamotrigine) Tablets for the maintenance treatment of adults with bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. Additionally, the FDA has noted that findings for Lamictal were more robust in bipolar depression-one of the most significant medical needs in the treatment of this devastating illness. The effectiveness of Lamictal in the acute treatment of mood episodes has not been established. The effectiveness of Lamictal as maintenance treatment was established in 2 placebo-controlled trials of 18 months' duration. Lamictal is the first FDA-approved therapy since lithium for the long-term maintenance of bipolar I disorder.

The new indication for bipolar I disorder expands the clinical usefulness of lamictal beyond the treatment of epilepsy. Should you or your customers have any questions about Lamictal, or if you would like a free copy of the Lamictal for Bipolar Disorder Informational Booklet for patients, please contact the GlaxoSmithKilne Customer Response Center at 1-888-825-5249. For more information about Lamictal, log on to www.lamictal.com

Lamictal has been available in the US since 1994. It is available in more than 90 countries and has more than 5 million patient exposures worldwide

Lamictal also is indicated as adjunctive therapy for partial seizures in adults and pediatric patients(> 2 years of age); as adjunctive therapy for the generalized seizures of Lennox-Gastraut syndrome (LGS) in adult and pediatric patients (> 2 years of age); and for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug.

In the treatment of epilepsy, the safety and effectiveness of Lamictal have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from non-enzyme-inducing antiepileptic drugs (eg, valproate), or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs). Safety and effectiveness in patients below the age of 16, other than those with partial seizures and the generalized seizures of LGS, have not been established.

Help Prevent Dispensing Errors

Pharmacists are more aware of the importance of correctly dispensing prescriptions than anyone, and no one is in a better position to help ensure that all patients receive the treatment they need.

Important Dispensing Information

Dispensing errors have occurred involving Lamictal. Your assistance is requested in clearly communicating oral and written prescriptions to help avoid dispensing errors. Please alert patients for whom you are dispensing these medications that they should carefully check the medication they receive and promptly bring any questions or concerns to your attention.

Important Note: Dispensing errors have occurred between Lamictal and other medications, most commonly Lamisil, lamivudine, Ludiomil, labetalol, and Lomotil. Patients who do not receive Lamictal would be inadequately treated and could experience serious consequences. Conversely, patients erroneously receiving Lamictal, especially high initial doses, would be unnecessarily subjected to serious side effects.

If you become aware of a prescription dispensing error involving Lamictal, please contact GlaxoSmithKline at 1-800-334-4135; the USP Medication Errors Reporting Program at 1-800-233-7767; or the US Food and Drug Administration's MedWatch program at 1-800-FDA-1088.

Important Safety Information

Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal, some of which have included Stevens-Johnson syndrome. In clinical trials of bipolar and other mood disorders, incidence of these rashes was 0.08% (0.8/1000) in adult patients receiving Lamictal as initial monotherapy and 0.13% (1.3/1000) in adults on adjunctive therapy for epilepsy. For further safety information on the increased risk of serious rash in pediatric patients with epilepsy, please see full Prescribing information.

In a prospectively followed cohort of 1,983 pediatric patients with epilepsy taking adjunctive Lamictal, there was one rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis (TEN) and/or rash-related death have been reported, but their numbers are too few to permit a precise estimate of the rate.

Lamictal ordinarily should be discontinued at the first sign of rash, unless the rash is clearly not drug-related.

The risk of nonserious rash is increased when the recommended initial dose and/or the rate of dose escalation of Lamictal is exceeded. There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by 1) coadministration of Lamictal with valproic acid; 2) exceeding the recommended initial dose of Lamictal; or 3) exceeding dose escalation of Lamictal. However, cases have been reported in the absence of these factors. Therefore, it is important that the dosing recommendations be followed closely.

Please consult accompanying complete Prescribing information for Lamictal.

Sincerely,

Robert A. Leadbetter, MD

Senior Director, Therapeutic Area of Bipolar Disorder and Schizophrenia

Clinical Development and Medical Affairs

GlaxoSmithKline

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From: TAP PHARMACEUTICAL PRODUCTS INC.                                                02/23/04

PREVACID NapraPAC APPROVED BY U.S. FOOD AND DRUG ADMINISTRATION FOR PATIENTS TAKING NSAIDS FOR THE TREATMENT OF ARTHRITIS WHO ARE AT RIST FOR RECURRENT GASTRIC ULCERS

                    - First Combination pack of Its Kind Provides New Option-

        LAKE FOREST, Ill., November 192003 - TAP Pharmaceutica Products Inc. today announced that the U.S. Food and Drug Administration (FDA) approved PREVACID NapraPAC (lansoprazole delayed-release capsules and naproxen tablets kit), a first of its kind combination package containing two widely used medications in one prescription. PREVACID NapraPAC contains the nonsteroidal anti-inflammatory drug (NSAID) NAPROSYN (naproxen tablets) and the acid suppressor PREVACID (lansoprazole), the most prescribed* proton-pump inhibitor(PPI) in the U.S., in one convenient package. PREVACID NapraPAC is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer that require the use of an NSAID for treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Controlled studies did not extend beyond 12 weeks.

         It is estimated that 20 million people in the United States have osteorathritis (OA) and 2.1 million adults have rheumatoid arthritis (RA). NSAIDs are commonly prescribed for the relief of pain and inflammation in these patients. In fact, NSAIDs are the most prescribed class of medicines in the world.

          "NAPROSYN, like most NSAIDs, is vbery effective at relieving pain associated with arthritis, but it has been recognized as being associated with serious gastrointestinal side effects, like stomach ulcers," said A. Mark Fendrick, M.D., associate professor of Internal Medicine in the School of Medicine at the University of M8ichigan Health System. "PREVACID NapraPAC represents an easy-to-use option in one prescription for arthritis patients who must take anti-inflammatory agents to relieve their pain, but who also need to reduce the risk of reccurrence of stomach ulcers."

NSAID Toxicity and Ulcer Risk                                                                                                                                                                                        NSAIDs can cause ulcers by interfering with the stomach's ability to protect itself from gastric irritants, such as acid. Gastric ulcers are round or oval sores where the lining of the stomach has been eaten away by stomach acid and digestive juices. NSAIDs, such as aspirin and naproxen, can irritate the stomach lining and can cause ulcers.

        In the United States, it is estimated that 14 million people take an NSAID on a daily basis. Approximately 100,000 patients are hospitalized and between 10,000-20-000 patients die each year from NSAID-related ulcer complications. The risk of NSAID-induced GI events is increased two- to four-fold in patients with a history of prior ulcer disease or complications. This is the most significant rist factor for NSAID-induced complications.

PREVACID Shown to Reduce the Risk of Recurrent Gastric Ulcers

A multi-center. dpib;e-blind placebo- and misoprostol-controlled study examined more than 500 patients who required chronic use of NSAIDs and who had a history of a documented gastric ulcer. Patients were randomized to received 15 mg or 30 mg PREVACID once daily, 200 mcg misoprostol four times a day or placevo for 12 weeks. Data from this study demonstrated that significantly more patients remained ulcer free with PREVACID compared to placebo. In fact, after 12 weeks of the study, 80 percent of patients on PREVACID 15 mg, 82 percent on PREVACID 30 mg, and 93 percent on misoprostol 200 mcg remained ulcer free compared to only 51 percent taking placebo.

        Futhermore, in a dubset analysis of study data from 119 patients, 89 percent of patients taking PREVACID 15 mg plus naproxen, with or without aspirin, remained free of recurrent stomach ulcers after 12 week versus 83 percent of patients taking misoprostol and 33 percent taking placebo plus naproxen. Conconitant aspirinwas used in 15 percent of patients.

About PRAVACID Napra PAC                                                                                                                   PREVACID NapraPAC is available as a daily dose of one PREVACID 15 mg delayed release capsule and two NAPROSYN tablets of either 375mg or 500 mg. NAPROSYN is an NSAID with analgesic and antipyretic properties that has been prescribed for over 25 years for relief from pain associated with conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

       A monthly course of PREVACID NapraPAC is conveniently supplied in weekly blister cards. The easy-to-use blister card indicates which pills to take on which days, an important convenience for patients. PREVACID NaPraPAC opens easily, and provides simple and clear directions. The package also meets the Consumer product Safety Commision's criteria for child-resistance.

        PREVACID NapraPAC is contraindicated in patients with known hypersensitivity to any component of the formulations of lansoprazole or naproxen.

         Naproxen is also contraindicated in patients in whom aspirin or other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps. Both types of reactions have the potential of being fatal. Other naproxen-containg products should not be used concomitantly.

          Serious GI toxicity such as bleeding, ulceration, and perforation can occur with or without warning symptoms with chronic NSAID therapy.

        In the risk-reduction study of PREVACID for NSAID-associated ulcers, the incidence of diarrhea was 5% and 3% for the PREVACID and the placebo groups, respectively. Symptomatic response to PREVACID does not preclude the presence of gastric malignancy.

        For further importand information on PREVACID NapraPAC, please see the complete prescribing information, log onto www.prevacid.com/naprapac/pi or call 800-622-2011.

About TAP Pharmaceutical Products Inc.

         TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint e\venture between Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd., of Osaka, Japan. TAP also markets Lupron Depot (leuprolide acetate for depot suspension).

          For more information on TAP Pharmaceutical Products Inc. and its products, wisit the company's web site at www.tap.com.

NAPROSYN and NapraPAC are trademakes of Syntex Pharmaceuticals International, Limited.

*IMS HEALTH, National Prescription Audit Plus 7 Weekly, November 2003.