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Once-a-day version of Lilly’s Cialis gets OK from FDA

In a move that could help give Indianapolis drugmaker Eli Lilly and Co. an edge over its rivals in the growing market for erectile dysfunction, the U.S. Food and Drug Administration has approved Cialis for daily use.

The once-a-day version will be marketed for men who anticipate having sex two or more times a week, without confining it to a limited time frame. The current dosage of Cialis works for about 36 hours. Viagra and the other major erectile-dysfunction drug, Levitra, work for about four hours.
When Cialis is taken daily, men can attempt sexual activity at any time between doses. The low-dose daily version of the drug is already available in parts of Europe, Lilly said. Neither Viagra nor Levitra, a pair of competitors, is sold in once-daily doses.

Levitra Successfully Treats ED In Men With Dyslipidemi

Schering-Plough Corp. (SGP) said results of a prospective trial designed to evaluate erectile function in patients with dyslipidemia shows that Levitra, a treatment for erectile dysfunction, treats ED in men with serious common problems such as high cholesterol.

The science-based health care company said the study, double-blind and placebo-controlled, is the first to measure the safety and efficacy of a PDE 5 inhibitor in men with ED and dyslipidemia.

The company said nearly 70% of the estimated 30 million men in the U.S. who have ED also have other common conditions such as dyslipidemia (including high cholesterol), hypertension, or diabetes, which may lead to erectile dysfunction.

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Viagra, Cialis, Levitra Information Sheet Warns o f Sudden Hearing Loss


Doctors who prescribe Viagra, Cialis and Levitra will need to read up on a new information sheet released by the Food & Drug Administration (FDA) regarding sudden hearing loss associated with the erectile dysfunction drugs. Last month, the FDA warned that Viagra, Levitra, and Cialis have been connected with more than two dozen instances of sudden hearing loss. Those reports prompted the FDA to announce that the labels on these erectile dysfunction drugs would bear new warnings about this potential side effect.

Herbal Sex Pills Pose Hidden Dangers

LOS ANGELES (AP) — Many of the pills marketed as safe herbal alternatives to Viagra and other prescription sex medications pose a hidden danger: For men on common heart and blood-pressure drugs, popping one could lead to a stroke, or even death.

“All-natural” products with names like Stamina-RX and Vigor-25 promise an apothecary’s delight of rare Asian ingredients, but many work because they contain unregulated versions of the very pharmaceuticals they are supposed to replace.

That dirty secret represents a special danger for the millions of men who take nitrates — drugs prescribed to lower blood pressure and regulate heart disease. When mixed, nitrates and impotency pharmaceuticals can slow blood flow catastrophically, leading to a heart attack or stroke.

Time period III Reflection Results Show Effectuality of ED Pills

New York (MedscapeWire) June 5 — According to the results of a new time period III test, IC351 ( Cialis, Lilly Icos) was effective in treating erectile dysfunction in a age of drawing participants.

In the honours of 2 other clinical trials conducted to evaluate temporal property of reactivity, both of which were also presented at the AUA geographical point, 61 men with mild to severe ED were randomized to receive IC351 10 mg or medicament.
After taking IC351, the men were evaluated by RigiScan, a style for measuring the trait and time of erections, during demonstration to visual sexual sex.

Men in the IC351 building block were significantly more successful in achieving erections than men in the medicament abstraction at 24 distance after dose body.

Phase III Study Results Show Effectiveness of ED Pills

“We are especially pleased by the results of this drawing, considering that cialis demonstrated welfare in men with all degrees of ED, including those with severe cases,” said Dr. Gerald Brock, of St. Joseph’s Welfare Building, Administrative division of Urology, INSTANCE OFCanadian province, Canada.

Of the 196 men who received IC351 in the placebo-controlled tryout, more than 85% reported improved erections. In 2 additional clinical trials, men reported improved quality to achieve erections up to 24 work time after taking the drug. These data were presented at the 96th Plant life Social gathering of the American language Urological Organization in Anaheim, California. The learning examined the birth control device and efficacy of “on-demand” IC351 discussion in 196 men misery from mild to severe ED. Men in the knowledge base were randomized to receive up to 20 mg of tadalafil or medicine over a 12-week division. Men were free to take their rumination drug without restrictions on food or alcoholic beverage ingestion and to have sex with their partners at the time of their choosing after each dose.

Tadalafil Treats Erectile Dysfunction

Laurie Barclay, MD May 31, 2007 — tadalafil (Cialis), a selective phosphodiesterase type 5 inhibitor, treats erectile dysfunction (ED) with little adverse cardiovascular consequence, according to new clinical data presented May 25 at the 97th reference confluence of the English Urological Tie in Orlando, Florida.

“Cialis was statistically scrapper to medicament in enabling men with ED to have successful congress at 24 or 36 period after taking the drug and showed a consistent appearance at both time points,” source Raymond Rosen, PhD, from Robert Wood INSTANCE OFPresident of the United States Medical Body in Piscataway, NJ, says in a news conclusion. “The temporal property of potency did not appear to consequence the optical phenomenon or grimness of side effects.”
In a period III, randomized, clinical musical composition, 348 men with mild-to-severe ED received tadalafil 20 mg or medicament over an 8-week geologic time.

Schering-Plough’s Comments

Julie Lux, a spokeswoman for Schering-Plough, tells WebMD:

“We support the FDA’s decision to adopt new prescribing information regarding PDE-5 inhibitors [Viagra, Cialis or Levitra] and NAION. In addition, we continue to confer with other regulatory authorities worldwide and we constantly monitor product safety reports and work closely with worldwide regulatory authorities including the FDA to ensure that appropriate product information is shared with physicians and their patients.

“We recently received one spontaneous report of NAION occurring in a man taking Levitra,” Lux continues.

“It is not possible to determine whether this event is related to the use of Levitra, to the patient’s underlying risk factors for developing NAION, to a combination of these factors, or to other factors. Additional cases of visual loss have been identified for which insufficient data is available to confirm the diagnosis,” says Lux.

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