RPhLink - Headlice

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From Dupont Pharmaceuticals : DuPont Pharmaceuticals makes LODOSYN® available at retail pharmacies.Demand for LODOSYN tablets (carbidopa) 25 mg has increased dramatically over the last few years because of the wide use of levodopa in carbidopa-levodopa products. Now, like other prescription medications, LODOSYN will be available at retail pharmacies. Now LODOSYN users simply fill a prescription with you.

LODOSYN is indicated for use with carbidopa-levodopa products or with levodopa for treating the symptoms of idiopathic Parkinson's disease. LODOSYN is indicated for use with carbidopa-levodopa products in patients for whom the combination product provides a less-than-adequate daily dosage of carbidopa (usually 70 mg daily).

LODOSYN has no antiparkinsonian effect when given alone. LODOSYN goes not decrease adverse reactions due to the central effects of levodopa. When LODOSYN is administered concomitantly with levodopa or carbidopa-levodopa products, the most common adverse reactions have included dyskinesias such as choreiform, dystonic, and other involuntary movements, and nausea.

Some people living with PD who take levodopa experience nausea and vomiting when they begin treatment. LODOSYN Tablets is an enzyme inhibitor that minimizes the breakdown of levodopa in the periphery making more levodopa available for transport to the brain. LODOSYN reduces the amount of levodopa required to produce a given response by about 75%. LODOSYN can help improve the ability of a person living with PD to tolerate levodopa. LODOSYN is used with levodopa in the occasional patient whose dosage requirements of carbidopa and levodopa necessitate separate titration of each entity. LODOSYN can reduce the incidence of nausea and vomiting associated with levodopa, permit more rapid dosage titration of levodopa, and provide a slightly smoother response to levodopa therapy.

For more information about LODOSYN (carbidopa) tablets, contact DuPont Pharmaceuticals.

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Pfizer Presents New Information on Head Lice Resistance.

We know that parents rely on your consultation about their health and the health of their children, and you're probably fielding more than a normal number of calls from parents who are confused and concerned about how they should treat an outbreak of head lice in their family.

Media coverage of head lice resistance has been melodramatic and at times, incomplete and inaccurate. The recent anecdotal reports of a resistant"super louse" and its resistance to conventional, proven therapies has produced an abundance of home treatments which cover the spectrum from dangerous to absurd-ie, kerosene, petroleum jelly, even mayonnaise.

Pfizer wants to try to differentiate fact from faction. The following is a summary of the current facts regarding resistance associated with three products available in the United States for the treatment of head lice:

Low-level resistance to lindane appeared upon its introduction over 50 years ago.

Resistance to permethrin ( a synthetic pyrethroid) has been suggested as a cause of treatment failures in the U.S. and elsewhere. Permethrin leaves an active residue, which diminishes over time, advancing the theory that a suboptimal level of pediculicide may cause some lice to survive and give rise to resistant strains.

Pyrethrin/piperonyl butoxide, the active ingredients in RID Shampoo, (pyrethrin is also known as pyrethrum extract) does not leave an active residue. Piperonyl butoxide has been show to suppress the development of resistance in sheep lice. The properties of pyrethrin/piperonyl butoxide preparations may hamper the ability of human head lice to develop resistance, a view supported by the lack of any documented evidence for this type of pediculicide resistance.

A recent trial conducted by the Harvard School of Public Health and published in Archive of Pediatrics and Adolescent Medicine studied the survival of head lice exposed to permethrin. The study concluded that head lice in the U.S. show some degree of resistance to permethrin. Pyrethrin/piperonyl butoxide was not studied.

Clinical Data: Both pyrethrin/piperonyl butoxide and permethrin formulas have met Food and Drug Administration standards for safety and effectiveness, have been used in the U.S. for nearly 20 years and are the preferred treatments today.

How can you be sure your recommendations are still the most effective ones? We, at Pfizer, believe that your recommendation of Maximum Strength RID Shampoo is well placed. It is proven safe and effective by rigorous clinical testing.

Pfizer's RID Shampoo, when used as directed, and in concert with careful lice egg removal, is a dependable, efficacious and safe therapy for the vast majority of patients who encounter a head lice infestation. However, lice treatment must be used properly. Reapplication of the shampoo and egg removal are required to ensure complete effectiveness. See label for important infomation on safety and effectiveness. Proper treatment is the best defense against head lice infestation.

Our multilanguage patient instruction material is unsurpassed in thoroughness, claity, and simplicity.

It is available to you at no cost. Please call 1-800-RID-LICE to obtain what you need. Our web site www.licerid.com also guides parents through the treatment process step by step.

Maximum Strength RID Shampoo will get rid of your patients' head lice problems. We guarantee it ...with a money-back guarantee.

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A Case Study Illustrating Professional Care Judgement Within an Ethical Framework, by Julia C. Jean-Pierre, PT, MSH.

Physical Therapy in the long term care setting is a challenging profession. Because the occupation is called physical therapy, most people would assume that decisions about moving and positioning of individuals are the most crucial. However, sometimes even more important professional decisions can result from moral and ethical contemplation about whether to continue treatment or not with a particular patient.

Recently at my workplace, a favorite resident of our facility suffered a majorly debilitating cerebral vascular accident. Prior to this episode, the resident was conversive, ambulatory and independent in all activities of daily living. After the event, the resident was virtually non-responsive and dependent for all mobility skills and care. All three disciplines Occupational Therapy, Physical Therapy and Speech Therapy received orders from the resident's physician for evaluation and treatment as indicated. After a three day evaluation of the patient, it became obvious to me, having seen many individuals with similar medical backgrounds, age and cerebral vascular accidents that the prognosis for the patient was very poor. My decision was to set up a comprehensive range of motion and positioning program for the patient and to discharge him from physical therapy services in one week, when all nursing staff had been inserviced on the patient's program. Occupational and speech therapy decided to treat this resident on an on-going basis, seeing more potential in the patient's outcome and possibly not wanting to "give up" on this once vibrant resident of our facility. Part of my decision was that the physical therapy department would continue to communicate with occupational and speech therapy and personally screen this patient every two weeks to see if the condition improved to warrent re-initiation of physical therapy services. The decision to discontinue physical therapy treatment in this individual presented a conflict between my personal moral and professional codes, making it a difficult decision.

My personal moral code includes the principle of not depriving any individual of beneficial skilled physical therapy intervention. In this case this belief was intensified by the individual's high level of activity prior to the cerebral vascular accident. Another facet of the dilemma reflected the rights of the individual since my moral code also includes the belief that all people have the right to receive the best care possible. Even though nursing could perform the patient's range of motion and positioning program, a skilled physical therapist would most probably do a superior job. In another way, the principle of nonmaleficence was called upon. By not providing the daily skilled physical therapy service, was this ultimately goig to harm the patient by not allowing him to improve with a more vigorous program? The final moral principle that influenced me was justice. My feeling that all individuals, no matter what age or diagnosis should receive the same degree of healthcare made it difficult to decide whether the individual should continue to receive physical therapy services or not.

On the other hand, my professional code of ethics presented some opposing views. Although all of the moral principles apply to my professional code of ethics as well, the professional ethic of beneficence was applicable. Although the patient may benefit from continued physical therapy treatments, would the outcome from these treatments balance the cost? Even fifteen minutes of physical therapy treatment is very costly, and it isn't professionally ethical to keep a patient on a caseload for financial or personal reasons, even if you have the reasonable expectation that the patient will receive some benefit from these treatments. Additional professional direction is provided through the Medicare system in this instance. Medicare states clearly that the rehabilitation services should not be performed unless there is documentable progress in each case. This is an important part of the physical therapy code of ethics as well which implies we must not provide unneeded services just to increase financial gain. One final part of my professional code of ethics played a role in my decision, and this is discernment. It was very important that I was able to problem solve and reach my decision without being unduly influenced by personal attachment to this favorite resident or his rather assertive family which was resistant to the idea of discontinuing the resident's treatment.

There was a rather obvious conflict between moral code and principles and professional principles. In summary, morally I was drawn to the ideas of providing skilled service to this patient so that he might receive the best possible treatment, but professionally I knew that the cost versus benefit issue made continued treatment unreasonable.

Further conflict arose when occupational and speech therapy decided to continue daily treatment with this individual, both of these disciplines felt my decision was incorrect, even though the resident would continue to be considered for re-initiation of treatment, if any improvement in status was recognized. The conflict was resolved by realizing that part of my motivation for wanting to keep the patient active in occupational and speech therapy felt my decisionwas hasty and was not compassionate enough. There were several antagonistic discussions regarding the reasons and ramifications of my decision. Secondly, the patient did not receive the amount of range of motion exercises that I had deemed minimally necessary from nursing. This resulted in several frustrating attempts to increase carryover of my instructions, knowing had I kept the patient on my caseload the proper instructions would been followed. Thirdly, five weeks later, the patient died. This reaffirmed the fact that my decision was the appropriate one. Occupational therapy continued to see the patient until the end, showing what I perceive as misuse of silled therapeutic intervention.

In this instance, after being temporarily caught between apparently equal but conflicting principles, I was able to deliberate about the situation to come to a successful justification of my decision so that the patient received appropriate medical care for this particular situation. However all decisions of this sort are ethically very difficult since moral, emotional and professional factors come into play. Each new situation requires new deliberation.

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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.

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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.

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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

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