Archive for January, 2008

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Thursday, January 31st, 2008

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The METEOR trial examined AstraZeneca’s Crestor (rosuvastatin) in patients with early signs of atherosclerosis. C&I notes that because the METEOR study did not show regression of atherosclerosis, it ‘dashes hopes for an expanded label’ (C&I 2007, 7, 7). While METEOR did not show regression, this was not its primary endpoint.

A CONSUMER group has asked US regulators to ban AstraZeneca’s cholesterol lowering drug, Crestor, citing reports of dangerous reactions and one death. Public Citizen, the campaign group founded by the independent presidential candidate Ralph Nader, is a persistent critic of the science behind Crestor.

LONDON — AstraZeneca has received approval from regulators in The Netherlands to sell its cholesterol-lowering drug Crestor, and the comp any expects approvals from other European countries next year.

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The Dutch decision bodes well for Crestor’s U.S. prospects, as Crestor awaits final Food and Drug Administration approval.

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Thursday, January 31st, 2008

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Byline: John Leusch Daily Herald Sports Writer In the 1960s, when he was a young boy, Tom Proctor spent his summers at Arlington Park where his father, Willard, was training horses. Tom has vivid memories of watching some of the nation’s top 3- year-olds run during those summers in the Arlington Classic and American Derby.

Alpert, Carl

Jewish Advocate, The

03-04-2004

Shushan Purim (the 15th day of Adar) is the day on which Jews in Jerusalem and Shushan (in Iran) celebrate Purim. The Book of Esther explains that while the Jews in unwalled cities fought their enemies on the 13th of Adar and rested on the 14th, the Jews in the walled capital city of Shushan spent the 13th and 14th defeating their enemies, and rested on the 15th (Esther 9:20-22).
Although Mordecai and Esther decreed that only walled cities should celebrate Purim on the 15th, in commemoration of the battle in the walled city of Shushan, the Jewish sages noted that Jerusalem, the focus of Jewish life, lay in ruins during the events of the Book of Esther. To make sure that a Persian city was not honored more than Jerusalem, they made the determination of which cities were walled by referring to ancient cities walled during the time of Joshua. This allowed Jerusalem to be included on the basis of that criteria; paradoxically, they included Shushan as the exceptional case since the miracle occurred there, even though it did not have a wall in Joshua’s time.
The Megillah is also read on the 15th in a number of other cities in Israel—such as Jaffa, Acre, Safed, Tiberias and Hebron—but only as a custom based on a doubt over whether these cities were walled during the time of Joshua. These cities therefore celebrate Purim on the 14th, and the additional Megillah reading on the 15th is a stringency. Jews in these cities do not recite the blessings over the reading of the Megillah on the 15th.

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Thursday, January 31st, 2008

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SHIRE PHARMACEUTICALS, the UK’s third largest drug maker, has won approval to sell its blockbusting treatment for children with attention deficits for adult use as well.

The decision gives Shire access to the barely understood but potentially huge US market for drugs treating attention deficit hyperactivity disorder (ADHD) in over-18s. Its shares rose 11p to 462p, making it one of the best performers in the FTSE 100.

Specifically, Adderall XR is composed of the following proportions of active ingredients:

1/4 dextroamphetamine saccharate
1/4 dextroamphetamine sulfate
1/4 aspartate (racemic dextro/laevo-amphetamine)
1/4 sulfate (racemic dextro/laevo-amphetamine)

These four salts are metabolized at different rates and possess diverse half lives, therefore resulting in a less dramatic onset and termination of therapeutic action; as compared to single salt amphetamine preparations.
The average elimination half-life in adults for dextroamphetamine is 10 hours and 13 hours for l-amphetamine. Breakdown rates are affected by urinary and stomach pH, weight, gender, other medications, and age in the direction of +/- roughly 2 hours. Its effects are similar to other CNS stimulants of the same class and preparation (see amphetamine for details.).
Urinary and stomach pH levels can significantly affect (d,l)-amphetamine excretion and absorption. Co-administration of acidic substances (eg; citric acid) causes an accelerated excretion of (d,)-amphetamine while co-administration of alkaline agents (eg; antacids) causes a marked increase in both retention and absorption of amphetamines sometimes resulting in dangerously high amphetamine levels. For example, taking the pill with orange juice will cause the accelerated excretion, making the dose possibly ineffective.

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Wednesday, January 30th, 2008

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Today, the most common indications for digoxin are probably atrial fibrillation and atrial flutter with rapid ventricular response. High ventricular rate leads to insufficient diastolic filling time. By slowing down the conduction in the AV node and increasing its refractory period, digoxin can reduce the ventricular rate. The arrhythmia itself is not affected, but the pumping function of the heart improves owing to improved filling.
The use of digoxin in heart problems during sinus rhythm was once standard, but is now controversial. In theory the increased force of contraction should lead to improved pumping function of the heart, but its effect on prognosis is disputable and other effective treatments are now available. Digoxin is no longer the first choice for congestive heart failure, but can still be useful in patients who remain symptomatic despite proper diuretic and ACE inhibitor treatment. It has fallen out of favor because it was proven to be ineffective at decreasing morbidity and mortality in congestive heart failure. It is shown to increase quality of life, however.
Digoxin is usually given by mouth, but can also be given by IV injection in urgent situations (the IV injection should be slow, heart rhythm should be monitored). The half life is about 36 hours, digoxin is given once daily, usually in 125 μg or 250 μg dosing. In patients with decreased kidney function the half life is considerably longer, calling for a reduction in dosing or a switch to a different glycoside (such as digitoxin which although having a much longer elimination half-life of around 7 days, is mainly eliminated from the body via the liver, and thus not affected by changes in renal function).
Effective plasma levels are fairly well defined, 1-2.6 nmol/l. In suspected toxicity or ineffectiveness, digoxin levels should be monitored. Plasma potassium levels also need to be closely controlled (see side effects below).

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Wednesday, January 30th, 2008

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The FDA last month approved Risperdal Consta (risperidone long-acting injection) for treating schizophrenia. It is the first long-acting, atypical antipsychotic the FDA has approved, reported Janssen Pharmaceutica, who is marketing the product.

Business Editors and Health/Medical Writers

CAMBRIDGE, Mass.–(BW HealthWire)–Aug. 9, 2002

Alkermes, Inc. (Nasdaq:ALKS) today announced that its partner, Johnson and Johnson Pharmaceutical Research & Development (J&JPRD), has received approval from The Medicines Control Agency to market Risperdal Consta(TM) (risperidone) in the United Kingdom. The UK approval follows the recent approval of Risperdal Consta in Germany. The product will be launched in both countries next week. Risperdal Consta is in late-stage regulatory review in number of other countries.

Risperdal Consta is administered once every two weeks, rather than daily, for the management of schizophrenia — a brain disorder affecting 1-2% of the world’s population. Until now, long-acting injection formulations of antipsychotics have been available only for older, conventional treatments. However, these conventional antipsychotics are more likely to cause serious movement disorders and are not considered by most experts to be as effective in treating “negative” symptoms (such as social withdrawal and apathy), as they are in alleviating “positive” symptoms (including hallucinations and delusions).

Risperdal Consta is a long-acting injection formulation of Risperdal(R) that uses Alkermes’ Medisorb(R) drug-delivery technology. Risperdal Consta will be manufactured by Alkermes and the product will be marketed by Janssen-Cilag in the United Kingdom and Germany.

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Risperdal Consta was developed by J&JPRD to combine the advantages of long-acting delivery with the established benefits of oral risperidone. Risperdal has been marketed in tablet form in the United States by Janssen Pharmaceutica Products, L.P., since 1994, and is the most widely prescribed atypical antipsychotic in the world. In a study published in a January issue of The New England Journal of Medicine, Risperdal was found to be significantly more effective in reducing the risk of relapse than haloperidol, a conventional antipsychotic long considered the “gold standard” in treatment of psychHow much does risperdal .5mg cost
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Wednesday, January 30th, 2008

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Oxycodone is made, commercially, from thebaine, an opiate alkaloid and minor component of opium[3]. The 14′ hydroxy group increases potency by about 50% over hydrocodone.[citation needed]
The chemical structure of oxycodone is the methylether of oxymorphone: 3-methyl-oxymorphone. It could also be described as 14-hydroxy-7,8-dihydro-codeinone. It is principally supplied as its hydrochloride salt: oxycodone hydrochloride. The terephtalate salt of oxycodone is present in some formulations such as Percodan as 7.6 per cent of the weight of the oxycodone salts content of the product, viz. 5 mg of oxycodone in Percodan is 4.62 mg hydrocloride and 0.38 mg terephtlalate. There does not appear to be a significant difference in the action of the salts. The hydrochloride-terephtalate mixture appears to be part of the original formulation of Percodan by its German manufacturers from more than 75 years ago.[citation needed]
Other oxycodone salts used around the world include the phosphate, sulphate, pectinate, tartrate, bitartrate, citrate and iodide.
Oxycodone can be administered orally, intranasally, via intravenous/intramuscular/subcutaneous injection, or rectally. The bioavailability of intranasal administration averages 60-87%, with rectal administration yielding the same results. Injecting oxycodone will result in a stronger effect and quicker onset.[4] Similar to codeine and hydrocodone, oxycodone requires demethylation by the cytochrome CYP2D6 enzyme in order to become activated and any analgesic effect to occur .[5]

Two 5mg oxycodone/APAP tablets

Oxycontin tablets of varying dose

Percocet tablets (oxycodone with acetaminophen) are routinely prescribed for post-operative pain control. Oxycodone is also used in treatment of moderate to severe chronic pain. Both immediate-release and sustained-release oxycodone are now available (OxyNorm and OxyContin in the UK). There are no comparative trials showing that oxycodone is more effective than any other opioid.[6] In palliative care, morphine remains the gold standard.[7] However, it can be useful as an alternative opioid if a patient has troublesome adverse effects with morphine.
It is effective orally and is marketed in combination with aspirin (Percodan, Endodan, Roxiprin) or paracetamol/acetaminophen (Percocet, Endocet, Roxicet, Tylox) for the relief of pain. More recently, ibuprofen has been added to oxycodone (Combunox). It is also sold in a sustained-release form by Mundipharma, and in the US by Purdue Pharma under the trade name OxyContin (the name is actually short for Oxycodone Continuous release) as well as generic equivalents, and instant-release forms Endone, OxyIR, OxyNorm, Percolone, OxyFAST, Supeudol, and Roxicodone. OxyNorm is available in 5, 10 and 20mg gelcapsules, and favoured among IV injecting opioid users because they contain only 2 inert binders, buth unsoluble, making it easy to prepare them for injection. OxyNorm is also available as 10mg/ml concentrated liquid in 100ml bottles in some countries, and OxyNorm 1ml injection ampoules of 10mg/ml are currently in their trial stage by the CFK. Roxicodone is available in 20 (white), 40 (green), and 80 (light blue) mg tablets. OxyContin was briefly available in: 5 (white), 10 (white), 15 (pink), 20 (pink), 30 (yellow), 40 (yellow), 45 (yellow), 60 (beige), 80 (green) and 160 (blue) mg tablets.[8] (although note that not all of these dosages are marketed in the USA) and, due to its sustained-release mechanism, is effective for eight to twelve hours. The 160 mg tablets were removed from sale due to problems with overdose, but have been re-introduced for limited use under strict medical supervision. On October 18, 2006, the FDA gave approval for three new dosage strengths, 15mg, 30mg, and 45mg.[9] OxyNorm is available in 5, 10, and 20 mg capsules and tablets; also as a 1 mg/1 ml liquid in 250 ml bottles and as a 10 mg/1 ml concentrated liquid in 100 ml bottles. Available in Europe and other areas outside the United States, Proladone® suppositories contain 15 mg of oxycodone pectinate and other suppository strengths under this and other trade names are less frequently encountered. Injectable oxycodone hydrochloride or tartrate is available in ampoules and multi-dose phials in many European countries and to a lesser extent various places in the Pacific Rim. For this purpose, the most common trade names are Eukodol and Eucodol.
Nausea, drowsiness, constipation, lightheadedness, rash or itchiness, dizziness, and emotional mood disorders are the most frequently reported side effects. Other side effects can also include dry mouth and slightly decreased testosterone levels in men. Oxycodone accumulates in patients with renal or liver impairment, and dose reductions may be needed.

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Tuesday, January 29th, 2008

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Business Editors & High-Tech Writers

RSA Conference 2000

Booth No. 340

BEDFORD, Mass.–(BUSINESS WIRE)–Jan. 18, 2000

RADGUARD, the leading producer of IPSec Virtual Private Network (VPN) solutions, announced today the release of cIPro-VPN 4.1 and cIPro-client 2.3, the latest versions of the company’s IPSec VPN products.

The two important product upgrades will be revealed at the RSA 2000 Data Security Conference and Expo, Jan. 16-20 at the San Jose McEnery Convention Center (Booth No. 340).

Among the new capabilities introduced in cIPro-VPN 4.1 and cIPro-client 2.3 are support for Quality of Service (QoS), Proactive Key Exchange and strong user authentication with Lightweight Directory Access Protocol (LDAP) servers .

Quality of Service

Version 4.1 of the cIPro-VPN further advances the product’s networking capabilities by adding compatibility with Type of Service (TOS) traffic prioritization. Through the transmission of standard TOS flags through the IPSec protected datagram, cIPro-VPN 4.1 enables the specification of QoS across the public network, guaranteeing that corporate communications are transmitted across VPNs according company priorities and information distribution neeNew kind of cipro - even better!
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Tuesday, January 29th, 2008

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Premarin (conjugated estrogens) tablets are approved for the prevention of postmenopausal osteoporosis. The tablets are available in 0.3 mg and 0.45 mg dosage strengths. For more information, contact Wyeth Pharmaceuticals, 800-934-5556, www.premarin.com.

Drug manufacturers seeking approval to market a generic version of Wyeth-Ayerst’s Premarin say they’re a step closer to their goal despite the refusal of key Food and Drug Administration (FDA) advisors to resolve the scientific controversy surrounding these products.

At stake in the dispute: a share of the fast-growing market for conjugated estrogen drugs, which Wyeth-Ayerst has had to itself for decades due to the difficulty of formulating a generic equivalent for the company’s $600-million-a-year Premarin.

According to Scott-Levin’s 2000 Managed Care Formulary Drug Audit Report, Wyeth-Ayerst’s Premarin was the prescription drug with the highest level of formulary acceptance, while GlaxoSmithKline’s Relenza was the drug …

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Tuesday, January 29th, 2008

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As the new year begins, supplements for weight loss are being advertised everywhere (and this magazine is no exception). One of these supplements is CLA, or conjugated linoleic acid. Recently published studies have shed some light on how this fat-loss aid may work.

"We have identified a specific isomer (trans-10, cis-12) of CLA that causes mature human fat cells to lose their fat and become smaller," explains Michael McIntosh, PhD, RD, of the University of North Carolina-Greensboro, who headed the study (published in the September 9, 2005 issue of the Journal of Biological Sciences). Unfortunately, the study also found that this isomer prevents human fat cells from taking up glucose and fatty acids, which could increase blood sugar and lipids and as a result increase the risk of diabetes and cardiovascular disease. More research is needed on the trans-10, cis-12 CLA isomer of CLA in humans and potential side effects.

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Monday, January 28th, 2008

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In the United Kingdom tablets of amlodipine from different suppliers may contain different salts. The strength of the tablets is expressed in terms of amlodipine base. i.e. without the salt. Tablets containing different salts are therefore considered interchangeable.

NEW YORK — Pfizer Inc. has announced plans to combine two of its top-selling drugs into a single pill by 2003. According to company executives, Pfizer will blend its cholesterol-lowering drug Lipitor with its antihypertensive Norvasc to create a medication that would attack both problems simultaneously. Persons with high …

Hypertension or angina: 5 or 10 mg once daily.

Some side effects[1] of the use of amlodipine may be:

Very often: peripheral edema (feet and ankles) - in 1 of 10 users
Often: dizziness, palpitations, muscle, stomach or headache, dyspepsia, nausea - in 1 in 100 users
Sometimes: blood disorders, development of breasts in men (gynecomastia), impotence, depression, insomnia, tachycardia - in 1 in 1,000 users
Rarely: erratic behavior, hepatitis, jaundice - in 1 in 10,000 users
Very rarely: hyperglycemia, tremor, Stevens-Johnson syndrome - in 1 in 100,000 users

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