RPhLink - Fosamax - Dyrenium - Dibenzyline - Paxil - Aggrenox

RPhLink.com The Pharmaceutical Care Network!

RPhLink.com The Pharmaceutical Care Network!

RPhLink.com The Pharmaceutical care Network!

From Boehringer Ingelheim

Boehringer Ingelheim Introduces Aggrenox (aspirin/extended release dipyridamole) to Reduce Risk of Stroke After Stroke or TIA.

Boehringer Ingelheim Pharmaceuticals, Inc. is pleased to introduce AGGRENOX (aspirin/extended-release dipyridamole) 25 mg/200mg capsules, a new antiplatelet agent to reduce risk of stroke in patients with prior stroke or TIA.

The largest stroke prevention trial ever conducted established the efficacy of new AGGRENOX. In the two-year, 6602-patient European Stroke Prevention Study 2 (ESPS 2),AGGRENOX reduced the risk of stroke by 37% compared with placebo, and by 22% compared with aspirin, 50 mg/day.

AGGRENOX is a new formulation consisting of aspirin plus extended-release dipyridamole. The efficacy of AGGRENOX results from the additive antithrombotic actions of aspirin plus dipyridamole. AGGRENOX is equally effective in women and men.

To increase both clinical interest and prescribing activity, the introduction of AGGRENOX is being supported by: extensive advertising directed toward physicians; major pre and post-introductory public relations effort; large numbers of CME and other educational programs; 660 member professional sales force; favorable pricing.

AGGRENOX offers excellent safety and tolerability. The AGGRENOX safety profile is a reflection of the safety and tolerability of both aspirin and dipyridamole. Dipyridamole has been in clinical use for more than 35 years, and aspirin for more than 100 years.

In the ESPS 2 study, the most common adverse event, in patients receiving AGGRENOX, was headache (39.2% v 32.9% for placebo), which was more frequent at onset of therapy, but reported to have diminished over time.

The incidence of gastrointestinal bleeding reported in patients taking AGGRENOX vs placebo, was 4.1% vs 2.1% respectively.

The recommended regimen is one AGGRENOX capsule twice daily.

During the initial stocking period, AGGRENOX will not be available in bottles with child-resistant closures. Dispense AGGRENOX capsules in light-resistant containers with child-resistant closures (unless non-child resistant packaging is requested). Do not dispense more than a 30 day supply (60 capsules), if a non-manufacturer container is used.

AGGRENOX is contraindicated in patients with hypersensitivity to dipyridamole, aspirin, or any of the other product components. Due to the aspirin content, AGGRENOX is also contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug products, and in patients with the sydrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma).

Dipyridamole has a vasodilatory effect and should be used with caution in patients with severe coronary artery disease (eg, unstable angina or recently sustained myocardial infaction).

To learn more about new AGGRENOX, contact the Boehringer Ingelheim Pharmaceuticals Drug Information Unit at 1-800-542-6257.

Back to previous page

RPhLink Online Pharmacy Discussion Boards Summer 2001 Pharmacy Intership Program

Pharmacy Class 2001

Secundum Artem

Pharmacy History Where is the site of America's First Licensed Pharmacist and who was He? send us an e-mail!

Student's Lounge

Summer 01 Pharmacy Internship Program for Pharmacy Students go to student's lounge....

Top News:

LODOSYN® from DuPont Pharmaceuticals

RPhLink.com offers Pharmacists and Pharmacy Techs a wide range of Pharmacy Business opportunities. Pharmacists and Techs are Linking to the site to get current Pharmacy Business News and Great Job Opportunities..

Allergan presents ACULAR PF, the only preservative-free topical NSAID

In the largest single first-line study of post menopausal women with advanced breast cancer

Femara provided:

Significantly greater objective response rate: 30% with Femara vs 20% with Tamoxifen (P=.0006)

A comparable side-effect profile: The incidence of peripheral thromboembolic events, cardiovascular events, and cardiovascular events was < 2%

Convenient 2.5-mg, once-daily dosing without regard to meals

No differences were seen in duration of tumor response

Commonly reported adverse events for Femara vs Tamoxifen were bone pain (20% vs 18%), hot flushes (18% vs 15%), back pain (17% vs 17%), nausea (15% vs 16%), arthralgia (14% vs 13%), dyspnea (14% vs 15%), fatigue (11% vs 11%), coughing (11% vs 10%, constipation (9% vs 9%), chest pain (8% vs 8%), and headache (8% vs 7%).

Femara is contraindicated in patients with knows hypersensitivity to Femara or any of its excipients.

Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients.

Femara may cause fetal harm when administered to pregnant women.

There is no clinical experience to date on the use of Femara in combination with other anticancer agents.

Reference: 1. Data on file. Novartis Oncology.

for more information on Femara, call toll free 1-88-NOW-NOVARTIS, or visit www.femara.com.

From: Metro-East Pharmacists Association of Highland, Illinois

On April 16, 2001, Paxil, the anxiolytic antidepressant, received approval to treat generalized anxiety disorder (GAD). This marks the fifth FDA-approved indication for this well-established SSRI (the order indications are depression, social anxiety disorder, panic disorder and OCD.) Therefore, paxil is approved for the treatment of more anxiety disorders than any other SSRI.

GAD is a condition of chronic worry

GAD is a highly chronic condition that causes significant impairment in occupational or social functioning. It is characterized by excessive and uncontrollable worry about a number of events or activities occurring more days than not for at least 6 months.

GAD is a chronic disorder. Many patients often believe their anxiousness is simply part of their personality and suffer for up to 10 years before diagnosis and treatment. While affected patients may not seek treatment for worry, anxiety or tension, they frequently seek treatment for the symptoms associated with GAD, such as restlessness or sleep disturbance. In fact, in the primary care setting patients with GAD are some of the highest utilizers of medical services.

"Around one-third of GAD cases seek medical help for their symptoms...most commonly from family doctors."

GAD is highly comorbid with depression and other anxiety disorders

GAD is highly comorbid with depression and other anxiety disorders. Besides complication diagnosis, comorbidty can mean even greater functional impairment for you patients. Overall, in up to 90% of patients with anxiety disorders, depression exists as a comorbid condition

" An important advantage of the SSRI's [Paxil is the only SSRI FDA-approved for GAD] is their efficacy in treating depression and anxiety disorders frequently comorbid with GAD, such as panic disorder, social anxiety disorder, or OCD."

Paxil is highly effective in the treatment of GAD

This new indication for Paxil based on by data from 2 multicenter, placebo-controlled trials. In these trials, Paxil clearly and consistently demonstrated superior efficacy and a reduction of the signs and symptoms of GAD. Consider the data from the primary efficacy measure alone: Paxil substantially improved the overall clinical condition of patients with GAD, as evidence by a significant reduction in HAM-A total scores. Based on these studies, 20 mg/once daily was established as the recommended starting and effective dose. Efficacy and safety were established in a dose range of 20 mg and 50 mg daily.

With an oral suspension and 4 tablet strengths, Paxil provides dosing flexibility and convenience without a significant increase in cost. It is also the leading choice of physicians, patients and MCOs-rated the #1 prescription SSRI for anxiolytic uses 4 years in a row; #1 in patient satisfaction; and #1 in managed care formulary coverage.

If you have any questions, or need further information, regarding this exciting new indication, please contact the Medical Information Department at (800) 366-8900 X5231.

Stephen Kalinowski, Senior Manager Pharmacy Affairs

Most common adverse events (incidence of 5% or greater and incidence for Paxil at least twice that for placebo) in depression, OCD, panic disorder, social anxiety disorder or GAD studies include asthenia, infection, sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, dizziness, insomnia, libido decreased, tremor, nervousness, yawn, abnormal ejaculation, female genital disorders and impotence. Concomitant use of Paxil in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated.

© 2000 RPhLink.com The Pharmaceutical Care Network! is designed and published by RPhLink. Inc. All Rights Reserved. Owned and Operated by Pharmacists for Pharmacists and Better Pharmaceutical Care. RPhLink.com is designed by RPhs for Pharmacists & Pharmacy Techs. For information use only! Disclaimer.

RPhLink.com The Pharmaceutical care Network!

From WellSpring Pharmaceutical

Important Notice Concerning DYRENIUM ® and DIBENZTLINE ® and the Medicaid Program

WellSpring Pharmaceutical Corporattion ("WellSpring") owns the prescription drugs DYRENIUM® and DIBENZYLINE®. As you may know, WellSpring does not particiapate as a supplier in any state Medicaid program.

A distributing development has come to our attention in connection with prescriptions for DYRENIUM® and DIBENZYLINE® presented by Medicaid beneficiaries. We understand that some pharmacies have been using the nationsl drug code (NDC) number assigned to another pharmaceutical company for the purpose of obtaining reimbursement from the Medicaid program for these particular medications, even though the drugs were labled as WellSpring pharmacueticals. This activity is causing WellSpring to suffer financial damage, and may subject a pharmacy engaging in such activity to liability under federal and state laws dealing with the Medicaid program, flase claim submission and a variety of other issues.

Accordingly, this is to advise all pharmacies that are improperly billing Medicaid to cease and desist immediatley from using incorrect NDC numbers in submitting claims for DYRENIUM® and DIBENZYLINE® to the Medicaid program. Pharmacies must use the NDC number that is on the label of the prodct that is being dispensed to the Medicaid patient. Although we hope it will be unnecessary, we are prepared to take immediate and definitive steps to protect WellSpring's rights and interests should this conduct continue.

We would like you to know that our decision to opt out of the Medicaid program was a difficult one, based on peculiar mechanics in the law that would require WellSpring to pay Medicaid a substantional amount of money in excess of the paymenr that we would receive from Medicaid for the sale of these medications.

If your pharmacy has not been billing improperly Medicaid for DYRENIUM® and DIBENZYLINE® we apologize for any confusion that his letter may have caused. On the other hand, if your pharmacy has been using incorrect NDC numbers in connection with bilings for these medications, we trust that you can appreciate our situation and we thank you for your anticipated cooperation.

Wendy M. Shusko, VP Finance

RPhLink.com The #1 Link for Pharmacists and Pharmacy Techs

Fosamax

POMONA, N.Y., Sept 5 -From Barr Laboratories, Inc. (NYSE:BRL) today announced that it has initiated a challenge of the patents protecting Merck & Co., Inc.'s Fosamax (alendronate Sodium) Tablets, USP 70mg from generic competition. Fosamax Tablets, USP 70mg has current annual sales of approximately $762.7 million. The company indicated that it is not the first to file an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for the 70mg tablet product.

Fosamax(R) is indicated for the treatment and prevention of osteoporosis in postmenopausal women and for the treatment of Paget's disease of bone in men and women.

"A successful challenge of the patents protecting Fosamax could provide patients suffering with osteoporosis a more affordable version of this critical therapy years earlier than might have otherwise occurred," said Bruce L. Downey, Barr's Chairman and CEO. "As America ages, and consumers seek medicines to enhance the quality of life, the opportunity to bring a generic version of Alendronate to consumers further demonstrates the value of the patent challenge process and the potential value it may create for consumers."

Barr filed an ANDA for alendronate sodium tablets with the U.S. Food and Drug Administration (FDA) in June 2001, and received notification of the application's acceptance for filing in July. Following receipt of notice from FDA, Barr notified Merck & Co., Inc. On August 31, 2001, Merck filed suit in U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of this product. This action formally initiated the patent challenge process.

Barr recently announced that the Company has entered into a merger agreement with Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD), a developer, manufacturer and marketer of prescription drug products, focusing on women's health and the hormone replacement therapy markets. The transaction is subject to customary approvals and other conditions, and is expected to close early in Barr's second fiscal 2002 quarter.

Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

Safe Harbor Statement: To the extent that any statements made in this release contain information that is not historical, these statements are essentially forward-looking. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the timing and outcome of legal proceedings; including Eli Lily's appeal to the Supreme Court, the difficulty of predicting the timing of U.S. Food and Drug Administration ("FDA") approvals; the difficulty in predicting the timing and outcome of FDA decisions on patent challenges; market and customer acceptance and demand for new pharmaceutical products; ability to market proprietary products; the impact of competitive products and pricing; timing and success of product development and launch; availability of raw materials; the regulatory environment; fluctuations in operating results; and, other risks detailed from time-to-time in the Company's filings with the Securities and of words such as "expects," "plans," "will," "believes," "estimates," "intends," "may," and other words of similar meaning. Should known or unknown risks or uncertainties materialize, or should our assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly update any forward-looking statements.

RPhLink.com The Pharmaceutical Care Network! New SKUS from Alpharma

June 2002

From Abbott

Dear Pharmacist:

I am writing to ensure you have the most up-to-date information about Abbott's prescription obesity medication, Meridia® ( sibutramine HCl monohydrate) C-IV capsules. Attached is a press release detailing the outcome of a recent meeting of Europe's Committee for Proprietary Medicinal Products (CPMP). I would like to highlight the key points:

The CPMP issued a positive opinion reaffirming the favorable risk/benefit profile of sibutramine capsules for the treatment of obesity. The CPMP's conclusion reconfirms those of Abbott and leading experts in the treatment of obesity. It is consistent with the conclusions made by the U.S. Food and Drug Administration (FDA) in 1997 during the new drug approval process. The CPMP's conclusions were supported by an extensive analysis of data provided by Abbott that included more than 100 clinical studies of sibutramine in 12,000 obese patients, dating back to 1989.

The CPMP review, conducted on behalf of the 15 European Community member states, represents one of the most extensive reviews of sibutramine data to date. Sibutramine has been prescribed to more than 8.5 million people in over 70 countries. Meridia is the most extensively studied prescription medication currently available for the treatment of obesity.

Meridia is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. Meridia is recommended for obese patients with an initial body mass index > 30 kg/m², or > 27 kg/m² in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).

Meridia is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs), patients with anorexia nervosa, those with hypersensitivity to sibutramine or any ingredients of Meridia, and those taking other centrally acting appetite-suppressant drugs.

Meridia substantially increases blood pressure in some patients. Regular monitoring of blood pressure is required when prescribing Meridia. For patients who experience a sustained increase in blood pressure or pulse rate while receiving Meridia, either a dose reduction or discontinuation should be considered.

Meridia should not be used in patients with a history of coronary artery disease arrhythmia, congestive heart failure, or stroke. Meridia should not be used in patients with uncontrolled or poorly controlled hypertension, severe hepatic dysfunction, or severe renal impairment. Meridia should be used with caution in patients with narrow-angle glaucoma or a history of seizures.

Meridia® (sibutramine HCl monohydrate) C-IV capsules inhibits semitonic reawake; in general, it should not be administered with other semitone agents. However, if such a combination is clinically indicated, appropriate observation of the patient is warranted. Women who are pregnant of planning to become pregnant or who are breast-feeding their infant should not use Meridia.

Most common adverse events include headache (30%), dry mouth (17%), anorexia (13%), constipation (12%), and insomnia (11%).

Should you have any questions regarding Meridia, please see the enclosed Full Prescribing Information, or visit www.Meridia.net, or contact our Medical Information Department at (800) 633-9110.

Sincerely,

Cheryl Renz, M.D. Medical Director and Global Project Head for Sibutramine Abbott Laboratories

Meridia® News Updates | more news | discussions | front page

From Alpharma. Did you Know?

Alpharma's family of sterile respiratory products has grown. It now includes the products you and your customers need most-Albuterol Sulfate 0.083%, Cromolyn Sodium 20mg/2ml, and Ipratropium Bromide 0.02% inhalation solutions.

This newly expanded line means you have another option for quality respiratory products that are: manufactured and filled in a sterile environment in compliance with the most recent FDA guidelines; packaged in pre-mixed, single-use vials for dosing convenience and to maintain product integrity; boxed in quantities suited to varied operations, such as monthly maintenance programs.It also means you can turn to the nation's leading manufacturer of liquid and topical generic pharmaceuticals for another essential line of generics.

Giving you a new choice for a comprehensive respiratory product line is the latest way Alpharma supports your business's profitability. Look to Alpharma for generic medicines...extraordinary solutions. For more information check the website at www.alpharmauspd.com

RPhLink.com The Pharmaceutical Care Network

Link to previous page

RPhLink.com The Pharmaceutical Care Network!

Centocor Presents Medications for Use in the Intervention and Management of Chest Pain.

Today, new healthcare services, improved clinical outcomes and progressive technology in the intervention and management of chest pain are leading to changes within the hospital setting. With this, the clinical pharmacist is becoming ever more instrumental in driving the patient care delivery process.

Centocor is excited about the opportunity to work with you to improve patient care through the use of RETAVASE (reteplace, ReoPro (abciximab) and FRAGMIN (dalteparin sodium injection). Centocor is also dedicated in helping you optimize your resources in your quest to provide cost-effective, integrated, high-quality care in today's clinical environment.

If you are interested in learning more about Centocor's products or for full prescribing information, visit one of Centocor's websites at www.retavase.com, www.reopro.com, or www.centocor.com.

RPhLink.com The Pharmaceutical Care Network!

Back to previous page

More News from Kinray| Previous News | Front Page!

General Pharmacy Classified | Pharmacy Antiques | Pharmacy Collectibles | Pharmacy Archives