Pharma Weblog

PREPARATIONS
Tablets: 5 mg, 10mg and 20 mg.

STORAGE
Tablets should be kept at room temperature between 15-30 C (59-86 F).

PRESCRIBED FOR
Tadalafil is used for the treatment of erectile dysfunction, or impotence.

DOSAGE
The recommended initial dose of Tadalafil is 10 mg per day, which have to be taken orally before sexual activity. This prescribed amount is a usual daily dose for the majority of men. This dose can be increased up to 20 mg or decreased to 5 mg per day depending on the feedback or side effects. The maximal duration of the Tadalafil's effect is 36 hours. Patients who take medicines extending the level of Tadalafil in the blood shouldn't surpass a total dose of 10 mg in 72 hours (See "DRUG INTERACTIONS"). As food doesn't influence on absorption of Tadalafil from the intestine the drug can be taken while eating as well as on an empty stomach.

DRUG INTERACTIONS
The following medicines can diminish the ability of the organism to destroy and eliminate Tadalafil: erythromycin, ketoconazole (Nizoral), itraconazole (Sporanox), indinavir (Crixivan) and ritonavir (Norvir). Hence these medications can heighten the level of Tadalafil in the blood. If these medicines have to be taken simultaneously with Tadalafil, its dose has to be reduced to avoid side effects, which can be provoked with high level of Tadalafil in the blood. When being taken simultaneously with nitrates, such as nitroglycerin, isosorbide dinitrate (Isordil), isosorbide mononitrate (Imdur, Ismo, Monoket), nitroglycerin (Nitro-Dur, Transderm-Nitro), which are usually prescribed for treatment of heart pain (angina), Tadalafil strengthens heart rate and lowers blood pressure. If the patient takes nitrates for angina, Tadalafil can become a reason of heart pain or perhaps even a heart attack as a result of strengthening of heart rate and lowering of blood pressure. So it's highly recommended not to take Tadalafil together with nitrates. Tadalafil can also heighten the blood pressure as it lessens effects of some alpha-blocking medicines, such as terazosin (Hytrin), which are principally used for treatment of high blood pressure or increment of the prostate. The patients, who take the alpha-blockers, have to take the stable dose of these drugs before starting to take Tadalafil. In these cases at the initial stage the lowest doses of Tadalafil should be taken. In cases of taking Tadalafil, the alpha-blockers should be taken beginning with the lowest dose. As Tadalafil like alcohol lower blood pressure it's highly recommended not to mix these substances, because as a result of such mixing there can be dizziness, headaches and increased heart rate.

PREGNANCY
The drug isn't approved for usage by women.

NURSING MOTHERS
Breastfeeding mothers were not testing for taking Tadalafil.

SIDE EFFECTS
When using Tadalafil the following accompanying effects can take place: headache, facial flushing (reddening), nausea, stomach upset, diarrhea, and flu-like symptoms. Tadalafil can also become the cause of low blood pressure, spasm of accommodation, breach of color perception and anomalistic ejaculation.
There were cases of continuous erections, or priapism (aching erection that lasts more than six hours) fixed after taking Tadalafil. If erection lasts more than four hours you have to recourse. There is causation between using of Tadalafil and chest pain, heart attack, palpitation, hastened heart rate, stroke and death, but it's not confirmed if these side effects are result of using Tadalafil or they are direct outcome of sexual activity itself.

Tadalafil should be taken orally. This medicine is used for therapy of erectile dysfunction, or impotence, consisting in lacking of ability to reach and keep in existence a penile erection. The drug class, which Tadalafil belongs to, is called phosphodiesterase inhibitors. Sildenafil (Viagra) and Vardenafil (Levitra) belong to this drug class too. When a penis is filling up with blood there a penile erection springs up. The blood vessels, which are responsible for bringing blood to male reproductive organs, extend in size what causes filling the penis up with large quantity of blood. While the blood vessels, responsible for transporting blood away from the penis, diminish in size, what causes taking much less blood away from the penis than under usual circumstances. Sexual excitement leading to a sterling erection determines the production and ejection of nitric oxide in the male genital organs. The nitric oxide provokes the production of an enzyme called guanylate cyclase that is a necessary condition for production of cyclic guanosine monophosphate (cGMP). This chemical compound controls extending and reducing of the size of the blood vessels that transport blood to and from the male reproductive organs. These changes of sizes condition erection.

Afterwards one more enzyme, which is called phosphodiesterase-5, demolishes the cGMP what makes blood vessels take their usual sizes, blood go away from the penis and thus the erection is over. Mechanism of action of Tadalafil consists in preventing phosphodiesterase-5 to ruin cGMP so the last one exists longer. The extended thus life of cGMP makes blood flow to the penis for longer period of time. The U.S. FDA approved Tadalafil in November, 2003.

 

WASHINGTON - For the first time, manufacturers of vitamins, herbal pills and other dietary supplements will have to test all of their products' ingredients. The Food and Drug Administration said Friday it is phasing in a new rule that is designed to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain ingredients claimed on the label.

Last year, the agency found that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that didn't contain the levels of Vitamin C or Vitamin A that were claimed.

If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges.

Dietary supplements — pills, liquids or other products — are a $22 billion industry.

Most companies already test their raw ingredients, said Steve Mister, president and CEO for the Council for Responsible Nutrition, a trade association representing about 65 manufacturers.

"This raises the bar so that all have to comply," Mister said.

The new rule goes into effect Aug. 24 and will have a three-year phase-in that gives smaller manufacturers more time to comply. Even the largest of the manufactures won't have to comply until June 2008.

The rule applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the U.S. It requires them to analyze the identity, purity and strength of all the ingredients that go into their products before they are distributed.

It also includes requirements for record keeping and handling consumer complaints.

Dr. Sidney Wolfe, who has testified before Congress on problems with dietary supplements, said the new rule does not ease his concern that unsafe supplements are too easy to bring to market.

"You still don't have to show the product is safe. You don't have to prove it works," said Wolfe, director of Public Citizen's Health Research Group.

Consumers Union, publisher of Consumer Reports, called the rule a good step toward improving consistency in the ingredients that go into supplements.

"However, consumers still have no idea if a given product works, or whether it is dangerous," said Janell Mayo Duncan, senior counsel for Consumers Union, publisher of Consumer Reports.

Congress limited the Food and Drug Administration's oversight of vitamins and other dietary supplements in 1994. The new rule is a product of that law, meaning that the rule took nearly 13 years to develop.

Under the old regulations, supplements were governed by the same rules that applied to producing foods, such as cans of soup.

"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Dr. Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition.

___

On the Net:

FDA: http://www.fda.gov/ More…

 

Confidence Inc. is recalling about 1,500 boxes of Long Weekend dietary supplements because representatives from the

Food and Drug Administration 

Food and Drug Administration found the product contains undeclared tadalafil, which makes the product an unapproved drug. Tadalafil is a drug used to treat erectile dysfunction. Tadalafil can interact with nitrates found in some prescription drugs and could lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, according to the FDA. No illnesses have been reported.

 

The product comes in three-capsule boxes. It was sold nationwide and in Puerto Rico, Canada, the United Kingdom, Russia and China. Details: by phone at 516-767-1870. More…

The root of a South African tree traditionally used to boost male potency could form the basis of a new drug.

Scientists believe they have found the active ingredient of the violet tree, and have applied for patents.

For centuries, the root of the tree has been chewed by South Africans suffering from erectile dysfunction.

Some of the profits from any drug could find their way back to the traditional healers who "prescribe" it.

The violet tree is found not only in northern South Africa, but also in other African countries.

Dr Marion Meyer, head of the botany department at the University of Pretoria, told a South African news agency that chemicals extracted from the root had been tested in the laboratory.

When it was added to samples of "smooth muscle" - the type of tissue found in the penis, the muscle relaxed to allow more blood to flow into it.

This suggests there is a possibility it could offer an alternative to exisiting drugs Viagra and Levitra, which also work by increasing blood flow into the penis.

Blockbuster drugs

Dr Meyer said that traditional healers would benefit should a drug based on the violet tree ever be registered.

"They are pleased to be getting recognition for something they have been using for centuries."

Viagra has proved to be one of the most successful drugs in recent pharmaceutical history, earning millions for maker Pfizer.

However, the violet tree will not be competing with it for a while, as it will be at least three years before human trials of the extract can start, and another two years before a drug could be launched.

Originaly from Source

Earlier this week I got an e-mail to tell me that someone called Levitra had commented on one of my entries on the VoxPolitics weblog.

Since it's a group weblog for "e-democracy titbits and crumbs", we get quite a few comments from random readers, and often they are useful and informative, so I read it with interest.

Sadly, it was not about the latest e-voting disasters in California - a topic of great interest to me - but a rather obvious piece of spam.

It said; "Interesting comments and a Superb Web Site" and then, like so many spam e-mails, had a link to a site that wanted to sell me a Viagra alternative.

Over the next few days I got 20 more, most offering Viagra substitutes but one featuring a cable TV scam - presumably for the times when I would have used up all my Viagra supplies.

Every one of them was posted as a comment on the blog, and they could only be removed individually through the administrative pages of the site, which takes ages.

It felt like the digital equivalent of flyposting - coming home one day to find your windows covered with posters for dodgy clubs and bands you have never head of.

Although the term flyblog has been used already to mean either blogging about flying, or blogging while flying, I would like to claim it for the practice of posting spam comments to people's blogs like this: I have just been comprehensively flyblogged.

Clever program

A quick online search revealed that the problem has been around for a while, but until recently it was largely done by individuals who would visit blogs and post their adverts, along with a link to whatever dodgy website they were promoting.

It had not happened to any of the sites I am involved with, so I had not noticed it or heard about it.

Now, however, it seems to have been automated: some clever programmer working for one of these iniquitous outfits has written a tool that goes around a list of weblogs and collects information on the various posts made to it.

It then creates the right HTML to fool the blogging software into thinking that a comment has been entered, and the resulting advert is posted to the blog as if it was legitimate.

That would explain why my colleague and fellow VoxPolitics poster James Crabtree is now getting 20 to 30 of these spam comments a day, reaching the point where he no longer has the time to remove them.

What is worse, there is no obvious way to block these posts without putting serious obstacles in the way of those who have legitimate comments to make.

Asking people to register before they post comments, or making them validate their comments by sending an e-mail and waiting for a reply, just get in the way. Building blacklists of sites that flyblog will be as ineffective as attempts to blackmail e-mail spam.

Blogs evolved out of a desire to remove barriers to online conversation, and restricting their ability to add comments would seriously reduce the sort of lively debate that makes them so interesting.

Perhaps the worst thing about flyblogging is that it is not covered by any of the spam laws that I am aware of, and probably is not illegal under data protection or hacking laws.

After all, a public blog with an accessible comments page is hardly a closed system, and even if you have an acceptable use policy saying what sort of postings you welcome, that is not legally binding either.

It is hard at first to see why the spammers are doing this. I am unlikely to be reading the comments on the latest mobile voting trials when I suddenly come across an advert for vicodin and feel so interested that I click on it.

Search rankings

One theory is that the real target is Google. A spammer's site with lots of references in well-indexed blogs will have a higher Google PageRank, so that anyone foolish enough to actually go searching for the product will find the spammer's site.

It is an interesting, but as yet unproven, hypothesis.

Whatever the reason, it is moving from a minor to major irritant. None of the other blogs I contribute to or run has been affected yet, but I can only assume it is a matter of time before the spammers move in, as they did first with UseNet and then with e-mail.

It depresses me to think that any open medium can be so easily undermined by people with no scruples, no sense of responsibility and no idea of the damage they are doing.

It also feels a lot more personal and intrusive than e-mail or UseNet spam.

A blog is a place to express your views in a public arena, and having some unknown people fill the space with advertising is the online equivalent of finding that someone has pinned a card advertising "private massage" to your coat when you were not looking.

I feel quite upset by this, and angrier with the spammers and their lack of respect for the principles of online co-operation than I have been for years. 

 

---

By Bill Thompson, a regular commentator on the BBC World Service programme Go Digital.
Originaly from Source

 

In recent weeks spam has rolled on—clumsy, repetitive come-ons for cut-rate Viagra, bank loans, urgent appeals for help moving money out of Nigeria, strident demands that you “verify” your bank account information, and on and on.

Then on May 30, Federal authorities arrested the man they called the Spam King: 27-year-old Richard Alan Soloway. In a Seattle courtroom he was arraigned on charges of mail fraud, fraud in connection with electronic mail, aggravated identity theft, and money laundering.

And last week, with Soloway sequestered, the flow of spam rose 8 percent.

Communications security firm Postini Inc. of San Carlos, CA, which posts the number of spam it filters for its clients on an ongoing basis, tallied 2.8 billion spams over the most recent seven day period, as opposed to 2.6 billion in the seven days previous to that when the Spam King was still at large. (Huge as the numbers are, they involve only the e-mail bound for Postini’s corporate clients. Postini figures that about 82 percent of e-mail traveling the Internet is spam, so the actual figure is approximately 100 billion daily.)

Royal spammers

It turns out that, despite press announcements put out by the Department of Justice

 

Department of Justice, the Spam King was actually barely a member of the Spammer Royal Family.

According to data tabulated by the London-based Spamhaus Project, an international anti-spam organization, about 80 percent of the world’s spam is generated by a coven of about 130 separate spammers or gangs. Soloway was on the list, but he was not in the top ten, which consists of four Russians, two Ukrainians, and an Israeli, an Australian, an American, and a Hong Kong resident. One of the Ukrainian operations has its own bogus online bank.

The American was not Soloway, incidentally, but a Californian who operates servers that host other spam operations.

The wages of gullibility

But why do they bother? What profit can there be in sending out torrents of misspelled “Viagra” promotions?

“The vast majority of recipients throw it away, but spam is so cheap to send that the spammers can make money even with an infinitesimally small response rate—maybe one in a million,” John Levine of Trumansburg, NY, co-author of “Fighting Spam for Dummies,” told LiveScience. “Soloway supported himself for years sending spam, and reportedly made $700,000 per year at it."

While e-mail dispenses with the expense of paper, envelopes, and stamps, spammers go one step beyond that and use other people’s computers—infected machines that spew out spam in the background, Levine explained. Doing so multiplies the amount of spam that they can send, to the point that they can send millions of messages daily. The tactic also makes it harder to track the original spammer down.

Some of the larger spammers listed by Spamhaus also specialize in pump-and-dump schemes, where they send out spam touting a little-known stock that they have bought. Almost invariably, enough recipients buy it so that the price goes up, allowing the spammer to sell at a profit.

• Record-Setting Spam Effort Turns Computers into Zombies
• Virtual Virus is First Simulation of an Entire Life Form
• Top 10 Aphrodisiacs

• Original Story: Spam King Gone, Spam Rolls On

Visit LiveScience.com for more daily news, views and scientific inquiry with an original, provocative point of view. LiveScience reports amazing, real world breakthroughs, made simple and stimulating for people on the go. Check out our collection of Science, Animal and Dinosaur Pictures, Science Videos, Hot Topics, Trivia, Top 10s, Voting, Amazing Images, Reader Favorites, and more. Get cool gadgets at the new LiveScience Store, sign up for our free daily email newsletter and check out our RSS feeds today! More…

 

WASHINGTON - Patients who suffer from a rare disease that causes continuous high blood pressure in the arteries of the lungs received a new treatment choice Friday.

The Food and Drug Administration

nd Drug Administration said it approved Letairis to treat pulmonary arterial hypertension. The condition causes continuous high blood pressure in the arteries that carry oxygen-poor blood from the heart to the lungs. As the arteries narrow, the heart must pump harder, which weakens it with time. The disease affects about 100,000 people in the United States.

 

The drug, known generically as ambrisentan, is made by Gilead Sciences Inc., based in Foster City, Calif. The company said the drug would be available next week.

The drug comes with strong warnings as it may cause birth defects and shouldn't be used by women who are pregnant or may become pregnant. It also can cause liver damage. Patients taking the once-daily tablets must undergo monthly blood tests to check for injury to the liver, the FDA said.

A second pharmaceutical company, Encysive Pharmaceuticals Inc., was awaiting word on whether its drug to treat the same condition had been approved. The status of that drug, Thelin, or sitaxsentan sodium, wasn't immediately clear Friday. An FDA spokeswoman referred questions on the drug's status to the company. A spokesman said the Houston company had heard nothing.

Other approved medications to treat the condition include Tracleer and Revatio, a lower dose of the same key ingredient in the impotency pill Viagra.

Originaly from Source

 

TUESDAY, May 22 (HealthDay News) — Worried about jet lag? Researchers think they might have just the ticket to perk you up: Viagra.

 

While it's too early to know if it will work in humans, Argentinean researchers are reporting that the drug sildenafil — better known by the brand name Viagra — appears to reduce symptoms of jet lag in hamsters.

 

Viagra does come with potential side effects, and some men might not appreciate experiencing a temporary respite from erectile dysfunction at 30,000 feet. Still, a sleep specialist called the research promising. More…

 

TUESDAY, May 22 (HealthDay News) — Pharmaceutical giant GlaxoSmithKline isn't wasting any time.

 

On Monday, about a month before its over-the-counter (OTC) weight-loss drug alli® will actually be on store shelves throughout America, the company opened a multimedia exhibit in the much-shopped and often congested Union Square area of Manhattan.

 

This "look, learn, but don't buy" preview of the only weight-loss medication currently approved by the U.S. Food and Drug Administration

Food and Drug Administration and available without a prescription is getting the same sort of advance media play that kicked off campaigns for prescription drugs such as Viagra and the sleeping aid Lunesta. More…