Cialis - Viagra Alternative

Viagra is the world's most famous pharmaceutical brand name. Surveys show it's
better known than Tylenol -- and everyone knows what it does.

But very soon, there will likely be some new choices for men fighting impotence
and erectile dysfunction.

When Viagra went on the market back in 1998, it was an instant success: Drug

maker Pfizer claims it has helped more than 16 million men worldwide improve
their sex lives. Doctors say it's made it easier for men to deal with an age-old
problem.

"One thing that Viagra really has done is that it has brought this issue

to most men so they don't or should not feel embarrassed coming to doctors and
talking about it," said Dr. Geoffery Sklar, director of urology at the
University of Maryland Medical Center.

Sklar said that, before Viagra, his male patients refused to even talk about

impotence. Now they come in asking for Viagra by name.

Now two new drugs are being marketed as alternatives to Viagra -- Cialis and

Levitra. Both new treatments work like Viagra, but the new drugs have some appealing
differences.

For instance, Viagra doesn't work for everyone. Studies have shown that 30

percent of the men who take the drug are not able to have sex. Research has
also found that Viagra can affect the patient's heart, vision, and blood sugar
levels. And for some, it works too slowly, if at all.

"It does take a while to work. Because sex is usually a spontaneous event,

it sometimes turns into a planned event, because on average it takes about 40
minutes to the time a man takes the pill until they are able to have an erection,"
Sklar said.

He also said the fat content of a meal may affect Viagra's absorption -- the

higher the fat content, the slower the effects.

Meanwhile, research found that Cialis helped 88 percent of men achieve erection

in 30 minutes or less, and it was effective for up to 48 hours. Viagra lasts
for only about four to six hours.

Studies also show that Levitra works faster than Viagra and has fewer interactions

with high-fat foods. As of now, both new drugs have been shown to be as effective
as Viagra, with few side effects. They offer men more options.

Doctors say that there are many causes of impotence, but the experts estimate

about 60 percent of the time it's a physical problem, such as impaired blood
circulation to the penis. Viagra allows blood to circulate to the male organ
by blocking an enzyme known as PDE5, which slows down blood flow in the body,
the other drugs work in a simliar fashion.

"I think the main advantage these two drugs have is not that they are

particularly better than Viagra, but it may allow for individualized therapy
if we find out that these drugs work better in certain situations," Sklar
said.

Both Cialis and Levitra were supposed to be on the market by the end of last

year, but the Food and Drug Administration granted only conditional approval,
seeking further study on each drug. Both drugs are now available in Europe.

Viagra Faces Stiff Competition against Cialis

There was a time when discussions about sexual dysfunction were limited to the
bedroom. Viagra brought it to the living room, and now every night, it and two
rivals, Levitra and Cialis, battle on the airwaves.

viagra "Well, it's a war, and it's a very expensive war," said Jim
Mathews, of the Mathews Evans Advertising.

The competing drug makers are spending $300 million a year on advertisements,

trying to tap into the 17 percent of men over 40 who experience erectile dysfunction.

"There's a lot at stake. They're projecting $6 billion in sales in this

category by the year 2006, which is not all that far off," Mathews said.

Urologist Dr. Dan Keiller credits the advertisements with prompting men to

finally get help for what sometimes turns out to be an underlying condition,
like diabetes or high cholesterol.

"I think advertising, even though it has the ploy of selling medications

has been wonderful for the community of men and getting us to speak about our
health," Keiller said.

Getting that discussion going without being vulgar or generating giggles is

a challenge for the drug rivals, each trying to carve out a niche with different
themes.

Although the three drugs are competing against each other, they're not starting

a price war because each pill still costs about $10. Instead, they are using
advertising to try to increase their brand recognition.

Viagra focuses on depicting happy men in their ads. Levitra uses a woman's

testimonial and sports star Mike Ditka.

Cialis, which is more subtle and longer-lasting, focuses on the relationship.

The advertisements clearly tap into men's insecurities, according to communication
professor Ric Pierson.

"I think it's sort of playing on the construction of masculinity in that

somehow your value as a man is sort of tied into your sexual performance,"
Pierson said.

That's why critics worry that the drugs are used by some just for enhancement.

Keiller agreed and runs into that problem on occasion.

"I refuse to give it to a man unless he's willing to talk about it a little

bit," Keiller said.

But overwhelmingly, he said, the ads are bringing men to him who have overcome

being embarrassed to talk about a once-taboo subject.

Cialas - How it works on erectile disfunction

The BIG Discovery: cyclic guanosine monophosphate (cGMP)

Some very smart scientists discovered that cyclic guanosine monophosphate (cGMP) was the key to sustaining an erection.

They discovered that when a man gets sexually stimulated, a chain reaction occurs in the tissue of the penis that results in elevated levels of a substance called cyclic guanosine monophosphate (cGMP).

As long as there are sufficient levels of cGMP, the penis can remain erect. The more cGMP, the more robust and durable the erection.

If you inhibit the degradation of cGMP it stays around in the penis longer, producing a more durable erection.

Another way you can think of Cialas (and all other similar medicines) is that it preserves the elevated levels of cGMP that are created when a man is sexually stimulated for a stronger, more lasting erection.

That's how Cialas works - Cialas blocks the enzyme phosphodiesterase-5 (PDE5) which is responsible for the neutralization of cGMP. Cialas (tadalafil) is a highly selective inhibitor of PDE5. (PDE5 is not the only phosphodiesterase involved in the erectile physiology but it appears to be the most important one).

The nice thing about PDE5 blockers is that they shouldn't cause erections at inappropriate times because they only block degradation of cGMP produced in reaction to sexual stimulation, such as thinking about something sexy. If you are not being sexually stimulated, there is no cGMP to protect, so the drug remains in the background.

Absorption, Onset, Bioavailability

Cialas is readily absorbed from the bloodstream. It is about 16% bioavailable. Tadalafil is about 94% bound to plasma protein. Maximum plasma concentration of Tadalafil was achieved 2 hours post dose. The Cialas label states that It can be taken from 30 minutes to 12 hours prior to sexual activity. Efficacy of tadalafil may persist up to 24 hours post-dose.

Metabolism, Half Life, Excretion

Cialas is mostly metabolized in the liver by an enzyme known as CYP3A4 and to a lesser extent CYPC2. Tadalafil breakdown products are excreted in the feces (61%) and in the urine (36%). Cialas' mean half life is 17.5 hours in healthy men.

If you are going to take any of the PDE5 inhibitors such as Cialas, it is very important that your doctor be aware if you have a liver condition (such as cirrhosis) or kidney condition ( such as if you are on dialysis) because you may need a special dosage adjustment.

Likewise, if you try to obtain Cialas on the internet, please make sure that the person authorizing your prescription knows the true status of your liver function and your kidney function.

Cialas - Impotence pill approved by FDA

WASHINGTON, Nov. 21 - A third pill to treat impotence was approved for sale in the United States on Friday, intensifying competition in a billion-dollar slice of the drug market. The new pill will be sold under the name Cialas. It joins Viagra, the oral drug that went on the market in 1998, and Levitra, which was approved earlier this year by the Food and Drug Administration.

All three drugs act on an enzyme that helps prompt and maintain erections by relaxing muscles in the penis and blood vessels. The duration and onset of the drug action is different, however, with each pill.

Cialas, manufactured by Eli Lilly & Co., was found in studies to stay longer in the body than Viagra. Studies suggest that a 20 mg dose of Cialas is active for 24 to 36 hours. In France, where the drug has been on the market for some time, Cialas is called “Le weekend” pill. Levitra and Viagra reach their full effectiveness in an hour, on average.

Some market studies suggest that about 30 million men over the age of 40 have symptoms of impotence. The sales of Viagra last year were reported at $1.2 billion.


SPECIAL REPORT
Cialas, whose chemical name is tadalafil, was tested in trials with 4,000 men. The studies found that it helped promote erection within a half hour and enhanced that ability for up to 36 hours.

The drug is not recommended for patients on some heart medications, such as nitroglycerin tablets or some alpha blockers, because the combination can cause a sharp drop in blood pressure. This can cause fainting or even death in some men.

Recommendations call for dosage limitations of Cialas for patients with kidney or liver disorders. The drug should not be taken by men for whom sexual activity is inadvisable because of heart conditions.

The most common reported side effects from clinical trials of Cialas were headache, indigestion, back pain, muscle aches and flushing.

Cialas is FDA Approved ED Drug, Q & A

Questions and Answers for Cialas (tadalafil)

1. What is Cialas used to treat?

Cialas is approved for the treatment of men who experience difficulty having and maintaining an erection (impotence).

2. How does Cialas work?

Cialas works by enhancing the effects of one of the chemicals the body normally releases into the penis during sexual arousal. This allows an increase of blood flow into the penis. An erection is the result of an increase in blood flow into certain internal areas of the penis.

3. How is Cialas different from the currently approved products for erectile dysfunction (ED)?

Cialas is different from other currently approved products for ED in that it stays in the body longer. However, there were no studies that directly compared the clinical efficacy and safety of Cialas to other products.

4. How do I take Cialas?

Cialas is taken orally before sexual activity, not more than once daily. Cialas may be taken with or without food. In some patients, the dose strength and maximum frequency of use may be adjusted. For more detailed information consult with your health care provider.

5. Are there any side effects with Cialas?

As with any drug product, there may be side effects. The most commonly reported side effects in patients treated with Cialas during the testing of the product were:

* headache
* indigestion
* back pain
* muscle pain
* flushing
* stuffy nose

Patients who get back pain and muscle aches usually get them 12 to 24 hours after taking Cialas and these usually go away by themselves within 48 hours. A small number of patients taking Cialas also reported abnormal vision.

6. What important information should you know about Cialas?:

· Cialas can cause your blood pressure to drop suddenly to an unsafe level if it is taken with any nitrate medication or with any alpha-blocker medication (alpha blockers are medicines used to treat benign prostatic hyperplasia and high blood pressure) other than FLOMAX (tamsulosin) 0.4 mg daily. You could get dizzy, faint or have a heart attack or stroke.

· Tell your healthcare provider that you take Cialas. If you need emergency medical care for a heart problem, it will be important for your health care provider to know when you last took Cialas.

· After taking a single tablet, some of the active ingredient of Cialas remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

7. What should I talk to my doctor about when considering if Cialas is right for me?

Because sexual activity can increase the work of the heart, your doctors should talk to you about your heart’s general condition and if Cialas is right for you. Patients who have a condition called "left ventricular outlet obstruction" from valvular problems or heart muscle enlargement may get side effects such as fainting or light-headedness. Because patients with recent heart attacks or stroke, heart pains (angina), heart failure, uncontrolled blood pressure or uncontrolled irregular heart beats, severe liver disease, and retinal eye problems were not studied with Cialas, Cialas is not recommended for these patients. There may be rare occurrences of priapism or painful, prolonged erections. This is a serious condition that requires immediate medical attention. Patients should seek prompt medical attention if their erection lasts longer than four hours.

8. Who should not take Cialas?

Cialas should not be used by patients taking nitrates (such as nitroglycerin tablets or patches) or any alpha blocker other than FLOMAX 0.4mg daily because the combination of these with Cialas could significantly lower blood pressure and lead to fainting or even death in some men.

9. Can Cialas be used with other treatments for impotence?

The safety and effectiveness of Cialas when used with other treatments for impotence has not been studied. Combined use could lead to additional lowering of blood pressure, possibly to unsafe levels. Therefore the use of such treatments in combination with Cialas is not recommended.

10. What if I am taking other drugs?

Always discuss with your health care practitioner ALL of the medications you are taking (prescription and over-the-counter) that way, you can receive the best advice for your own situation. Cialas is not recommended for people taking any form of nitroglycerin and most alpha-blockers, other than FLOMAX, because the combination may lower blood pressure to an unsafe level.

11. How will Cialas be supplied?

Cialas will be available as oral tablets in 5mg, 10mg and 20mg strengths.

12. Will Cialas be prescription or OTC (over-the-counter)?

Cialas will be available by prescription only.

13. When will Cialas be available to pharmacies?

FDA has no control over when products are available in pharmacies after FDA approval for marketing. The decision of availability is completely up to the company marketing the product. For further information contact your pharmacist or Eli Lilly and Company directly.

14. How can I report a serious side effect with Cialas to FDA?

FDA encourages anyone aware of a serious side effect, including consumers or patients, to make a MedWatch report.

You can report an adverse event in two ways:

• Visit www.fda.gov/medwatch and click on "Submit Report" in the blue sidebar
• Call 1-800-FDA-1088