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GENERIC NAME(S): SILDENAFIL CITRATE
Sildenafil is used to treat male sexual function problems (impotence or erectile dysfunction -ED). In combination with sexual stimulation, sildenafil works by increasing blood flow to the penis to help a man get and keep an erection.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Sildenafil is also available in other brands and strengths for treating high blood pressure in the lungs (pulmonary hypertension ). Do not take this medication with any other product that contains sildenafil or other similar medications for erectile dysfunction -ED or pulmonary hypertension (such as tadalafil, vardenafil).
How to use Viagra
Read the Patient Information Leaflet provided by your pharmacist before you start taking sildenafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
To treat erectile dysfunction -ED, take this drug by mouth as directed by your doctor, usually as needed. Take sildenafil at least 30 minutes, but no more than 4 hours, before sexual activity (1 hour before is the most effective). Do not take more than once daily.
A high-fat meal may delay how quickly the drug begins to work.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Tell your doctor if your condition does not improve.
Dizziness. headache. flushing, or stomach upset may occur. Vision changes such as increased sensitivity to light, blurred vision. or trouble telling blue and green colors apart may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Sexual activity may put extra strain on your heart. especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex. stop and get medical help right away: severe dizziness, fainting. chest/jaw/left arm pain, nausea .
Rarely, sudden decreased vision. including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking sildenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease. diabetes. high cholesterol. certain other eye problems (“crowded disk”), high blood pressure. if you are over 50, or if you smoke.
Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking sildenafil and get medical help right away if these effects occur.
In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction. including: rash. itching /swelling (especially of the face/tongue /throat), severe dizziness, trouble breathing .
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure. a severe loss of body water (dehydration), penis conditions (such as angulation, fibrosis/scarring, Peyronie’s disease ), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia. leukemia, multiple myeloma ), eye problems (such as retinitis pigmentosa. sudden decreased vision, NAION).
This drug may make you dizzy or cause vision problems. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This brand of the drug is usually not used in women. During pregnancy, sildenafil should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
A product that may interact with this drug is: riociguat.
Sildenafil can cause a serious drop in your blood pressure when used with nitrates. A serious drop in blood pressure can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use sildenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called “poppers” containing amyl nitrate, amyl nitrite, or butyl nitrite.
If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of sildenafil to minimize your risk of low blood pressure.
Other medications can affect the removal of sildenafil from your body, which may affect how sildenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as ritonavir, saquinavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), mifepristone, rifampin, among others.
Do not take this medication with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil).
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe dizziness, fainting, painful/prolonged erection.
Do not share this medication with others.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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Viagra a Triple Threat? Top 10 Multi-Use Drugs
WATCH Selling Sex To Women
Viagra is well recognized for its primary use. But who knew it would show promise as a cancer fighter, too?
Medical advances can be slow — a fact frustrating to some who want the “latest and greatest” cure for their ailment, and don’t want to wait out the testing process.
But once a drug has been approved for one use, doctors can prescribe it “off-label” when it is shown to be useful for something else. And an increasing number of drugs are prescribed in this manner. Off-label use of medicines accounts for about one-fifth of all prescriptions, according to a past study in the New England Journal of Medicine.
Viagra. for example, is a triple threat — it’s most commonly used to treat erectile dysfunction and is FDA-approved to treat pulmonary hypertension, but it can also be used to increase blood flow as a way to avoid amputations. And now, researchers may have found yet another use for the extremely popular drug: to help treat prostate cancer when used in combination with another cancer drug.
Many of these off-label uses meet with controversy and questions about their value, particularly since the FDA has not yet approved the uses. (As a result, drug companies cannot advertise off-label uses.)
Though the hair loss drug finasteride is recommended by some medical organizations as a preventative measure against prostate cancer, many doctors say that such a use is inefficient and ill-advised.
But in many other cases, the alternative uses are well-known in the medical community — though perhaps not among the general public — and are regularly exploited.
Get Your Questions Answered at the OnCall+ Men’s Health Center
Viagra is approved for use as a treatment for erectile dysfunction, and is also marketed under the name Revatio to treat pulmonary hypertension, a buildup of pressure in blood vessels leading to the lungs.
Doctors have also used it off-label to increase the blood flow to damaged areas as a way to avoid amputation and the onset of gangrene.
And new promising research may also lead to another use of Viagra: as a treatment for prostate cancer in combination with another cancer drug, doxorubicin.
Researchers from Virginia Commonwealth University discovered that in mice, the combination of Viagra and doxorubicin effectively killed prostate cancer cells and also offered a protection against the well-known cardiac effects of doxorubicin, including cardiomyopathy and heart failure. The study is published in the latest issue of the journal Proceedings of the National Academy of Sciences.
“Doxorubicin has been used for more than 40 years and continues to be one of the most effective drugs against cancer, but the problem is the cardiac effects of this drug,” said Rakesh Kukreja, professor of internal medicine at Virginia Commonwealth University in Richmond, Va. and one of the study’s authors.
Kukreja said the drug combination was also effective against ovarian cancer and stomach cancer, and the findings show it has great potential as a cancer treatment.
Other experts are not convinced of that treatment potential.
“Everything works against mouse tumors,” said Dr. Derek Raghavan, chair and director of the Cleveland Clinic Taussig Cancer Institute. He is not connected with the Viagra study.
“These types of data are what have been seen in the field for years and are doubtful to give a long and/or significant impact to tumor growth,” said Robert Gertzenberg, professor of urology at the Johns Hopkins University School of Medicine. He is also not connected with the current research.
Approved for the treatment of enlarged prostate, Avodart, like Propecia. has been tested for prevention of prostate cancer as well.
But the drug from GlaxoSmithKline, chemically known as dutasteride, finds a third use: preventing baldness. Smaller studies have shown some encouraging results.
“It seems to have more benefit [than finasteride] in regrowing hair from pattern hair loss,” said Dr. Amy Newburger of Dermatology Consultants of Westchester, N.Y. noting that “it is not yet approved for this indication.”
That Avodart would work makes some sense. Like Propecia. the drug targets the pathway that converts testosterone to DHT, which is the suspected culprit in hair loss.
“There are good studies that show it is effective,” said Dr. Marc Avram, clinical associate professor of dermatology at Weill Medical College at Cornell Medical Center. “There are doctors who do give it out there for hair loss.
“Doctors are using it off-label for men,” Avram said. “It absolutely should not be used off-label for women.”
While women should not use the drug because of the risk of birth defects, questions also remain about its safety as a baldness remedy for men.
In a review article last October in the Journal of the American Academy of Dermatology, Avram and Dr. Nicole Rogers, a hair loss specialist with Old Metairie Dermatology in Metairie, La. wrote that “phase III FDA trials appear to be on hold for using dutasteride to treat male pattern hair loss. It is unclear exactly why, but we hypothesize it is because of concerns about side effects.”
Dutasteride lasts much longer in the body than finasteride, and among the side effects the doctors noted was a reduced sperm count among men using the drug.
“The sexual side effect, if you get it, lasts a lot longer than with Propecia,” Avram said. “If it affects sperm, they’re going to need to do long-terms studies to approve it.
“My feeling is they [GSK] are not really going strong for approval, because to do that, they’re going to have to prove that sperm is not affected in any long-term ways,” he said.
Avram said he does not typically prescribe the drug.
“My feeling is Propecia works in most men, and between Propecia and Rogaine, we can stop their hair loss,” he said.
Efudex, a skin cream that has been used for years to combat the early stages of skin cancer, may one day have a second use as a wrinkle-buster.
So suggests a small study of 21 subjects, commissioned by Valeant Pharmaceuticals, which makes the cream. The study is published in the June issue of the journal Archives of Dermatology.
Study participants who applied the cream twice daily for two weeks were able to reduce the number of potentially pre-cancerous spots on their faces. But in addition to this, researchers also found through clinical evaluation that the subjects enjoyed other improvements in aging-related damage, including fewer wrinkles, fewer dark skin spots and less hyperpigmentation.
The drug, of course, also had side effects — primarily in the form of redness and irritation shortly after the application of the cream. And even though a number of currently available cosmetic skin treatments have similar or worse side effects, for some consumers these downsides could outweigh the benefits.
“It is possible that for some patients, topical fluorouracil may have an important role against photo-aging,” lead study author Dr. Daniel Sachs of the University of Michigan Medical School in Ann Arbor said in a press release. “For others, however, it may not be cosmetically acceptable given that a standard course of therapy may last two to three weeks and the ensuing reaction can persist for several more weeks.”
Still, the idea that the drug could one day enter the cosmetic armamentarium is not an outlandish one.
“Undoubtedly, there will be patients who desire a therapy such as topical fluorouracil for cosmetic purposes given the relatively low cost of this therapy compared with. laser resurfacing,” Sachs said.
On Tuesday, two medical organizations — the American Society of Clinical Oncology (ASCO) and the American Urological Association (AUA) — announced new guidelines that recommend that millions of men over age 55 who are regularly screened for prostate cancer speak with their doctor about taking a drug which might reduce their risk of the disease.
This drug is finasteride — a drug that has been shown in studies to help ward off prostate cancer, but which is perhaps more well-known as the hair-loss drug Propecia.
Indeed, in a 2003 study involving 18,000 men, finasteride was shown to cut the risk of prostate cancer by around 8 percent.
“If a man is getting screened because he’s worried about prostate cancer, taking the drug is a very rational thing to do along with screening,” Dr. Otis Brawley, chief medical officer of the American Cancer Society, told ABC News.
But at the estimated cost of $90 a month, the drug is expensive. And in the earlier trials there was some evidence that the drug might cause high-grade cancers. While proponents have denied such findings, other doctors have voiced their concern over this potential use of the drug.
“There are way too many side effects, and I believe that if they get cancer on finasteride, it’s going to be biologically more aggressive,” said Dr. Aaron Katz, director of the Center for Holistic Urology at Columbia University. “This is not the way to prevent cancer of the prostate.”
“I still do not feel that this is ready for prime time,” agreed Robert Getzenberg, director of urology research at the Brady Urology Institute at Johns Hopkins Hospital. “There are too many important questions that are unanswered.”
In a pinch, doctors may look to the erectile dysfunction drug Viagra as a means to increase blood flow to tissues in the body that need it. Such was the case when 20-year-old college sophomore Jamie Schanbaum suffered meningitis and, shortly thereafter, an infection that threatened her fingers and legs.
Dr. Peter Lin, Schanbaum’s doctor, who treated her at St. Joseph’s hospital outside of Houston, said his team used the drug to see if it would be possible to spare Schanbaum the extensive amputations some physicians suggested as the only way to control the gangrene in her arms and legs.
“Viagra stimulates blood flow,” Lin told ABCNews.com. “We wanted as much blood flow to get to the damaged area as possible.”
While Viagra’s usefulness in this regard has yet to be confirmed, an Australian study this year looked at the possibility that the drug might help increase blood flow to the uterus in pregnant women, which could in turn help developing fetuses receive more oxygen. Other studies have also taken a look at whether the drug could one day be used to increase blood flow to the brains of patients with multiple sclerosis. as well as whether it could help travelers deal with jet lag.
It’s a drug whose name has become synonymous with cosmetic treatment. But many forget that Botox — the most commonly known brand name for botulinum toxin type A — had its humble start in the treatment of crossed eyes and spastic conditions as early as the 1970s.
However, the reputation of the drug changed forever in 2002 when the U.S. Food and Drug Administration approved it for the treatment of facial frown lines. Injecting the solution into the faces of their patients, doctors could selectively paralyze certain muscles implicated in the formation of wrinkles.
Now, doctors are further stretching the drug’s usefulness by treating patients who experience certain type of hyperlacrimation — in other words, the overproduction of tears in response to certain stimuli.
For 58-year-old Patricia Webster of Maidstone, England, who had been living with the degenerative nerve condition known as Guillain-Barre syndrome, the occasional shot straight into her tear ducts means freedom from an embarrassing symptom of her condition in which she would appear to cry whenever she ate.
“For the last 18 years of my life I’ve done nothing, and the embarrassment of my eyes was a major part of this,” she told ABCNews.com.
Still, even Webster was skeptical when her doctor first offered up the treatment.
“Of course, I’m thinking, ‘Botox. it’s a cosmetic treatment.’ I thought, ‘He’s not worried about my eye, he’s telling me that I’m wrinkly,'” Webster said.
In addition to hyperlacrimation, some doctors are also using Botox to help relieve chronic pain.
Many glaucoma patients using an eye drop known as bimatoprost to improve their vision have enjoyed an unexpected side effect — thicker, more luxurious eyelashes.
The effects of the medication were so pronounced, in fact, that the FDA recently approved the drug for this cosmetic use. Allergan, the company that manufactures the glaucoma drug known as Lumigan, rebranded it under the new name Latisse.
Dr. Scott Whitcup, Allergan’s executive vice president of research and development, told ABCNews.com that researchers noted the eyelash-enhancing side effects of the eye drops during the Phase 3 trials for the drug.
“At the time, we began thinking of developing Lumigan as a treatment for eyelash growth,” Whitcup said.
Essentially, the drug works by keeping hairs in their growth phase — the phase during which they become longer, thicker and darker. Of course, the eyelash-enhancing effects of Latisse are not permanent once the drug is discontinued. And at $120 for a 30-day supply, Latisse is not cheap. But it is still far cheaper (and most likely less risky) than surgical procedures designed to achieve the same end.
Strange but true: When it comes to trying to get pregnant, some women look to a remedy more associated with coughs and colds than conception. That remedy is Robitussin.
So far there is no reliable evidence to show that the syrup does much, if anything, to increase the odds of a woman getting pregnant. The theory, however, is that in much the same way the drug can thin the mucus in your nose and throat, it may also thin the cervical mucus. Thinner cervical mucus means that sperm may have an easier time making it into the uterus to fertilize a waiting egg.
While proof of this remedy remains elusive, it is far from the only home-grown cure that many women look to when it comes to getting pregnant. Some aspiring moms try dietary changes. for example. But because so many factors contribute to a woman’s ability to conceive, doctors warn that changing any one variable is not likely to have a huge overall effect on the chances of pregnancy.
Among the plethora of drugs used in the cosmetic realm, it’s a safe bet that few would recognize the name phosphatidylcholine. But in many clinics around the world, this soybean-based, FDA-approved treatment to break down fat in the blood is also being injected under the more familiar names lipostabil or lipodissolve as a surgery-free fat buster.
That’s not to say, however, that the treatment is safe. Indeed, cosmetic surgeons and dermatologists agree that these injections should be avoided by consumers shopping around for a slimmer look.
“There is really not a single scientific study to show that it definitely works,” Dr. Malcolm Roth, director of plastic surgery at Maimondes Medical Center in Brooklyn, N.Y. told ABCNews.com. “Are these chemicals safe when injected into fat? And what happens to this fat? Where does it go?”
Despite the dangers of the procedure, however, the growing number of clinics offering the treatment is a testament to its continued legal status in the United States. Still, the procedure is banned for cosmetic purposes in Brazil and other countries.
“Most physicians performing this procedure do not have training in liposuction, plastic surgery or dermatologic surgery,” said Dr. Carolyn Jacob, a board-certified dermatologist in Chicago. “Even dentists are doing it.”
More often associated with its use as a club drug, ecstasy has captured the attention of researchers who hope that the illicit pill may one day be used to help treat post-traumatic stress disorder, or PTSD.
In the late 1970s, a group of psychiatrists found that the drug had an effect on levels of serotonin, a brain chemical that is known to regulate mood. Indeed, before ecstasy was made illegal in 1985, some psychotherapists were giving the drug to patients, citing its usefulness as an effective therapeutic tool.
In 2004, despite the illegality of the drug, the U.S. government authorized a human study of its potential to help those suffering from the emotional scars of a traumatic event.
However, while some patients in the study felt that they had benefited from the drug, today it remains on the government’s list of Schedule I drugs — a classification that includes heroin, cocaine and methamphetamines. Still, some hope that the restrictions on the drug’s use may one day be lifted to help soldiers returning from war deal with psychological trauma.
Few drugs have as controversial a reputation as thalidomide. First marketed in 1957 to stave off morning sickness in pregnant women, the drug was soon found to be linked with severe birth defects ranging from cleft palates to missing and abnormal limbs, spinal cord deformities and organ abnormalities.
Despite these tragic and high-profile outcomes, a small group of patients did benefit from using the drug — those with a severe and debilitating leprosy-associated complication known as erythema nodosum leprosum (ENL).
Considering the small number of people today who live with leprosy. it may come as little surprise that the silver lining of this devastating drug remains relatively secret. And the World Health Organization still recommends against the use of the drug to treat the ravages of ENL due to birth defects.
Nonetheless, in 1998 the FDA cleared the drug’s use for leprosy under strict supervision. Women who are candidates for receiving the drug are required to undergo pregnancy testing both before and during their treatment with the drug. Men using the drug are required to use a condom whenever they have sex with a woman, and all patients are limited to a 28-day supply and must see a doctor before getting more of the drug.
Reports from Emily Friedman, Radha Chitale and Bob Woodruff contributed to this report.
Do you want to know more about men’s health issues such as proper nutrition, strength training and sports injuries? Visit the ABCNews.com OnCall+ Men’s Health Center to get all your questions answered.
Say the name Viagra and most people will automatically think of a drug to treat impotence.
But doctors are finding it is good at boosting parts of the body other than the penis, such as the blood vessels of the heart and lungs – as has been seen in the case of premature baby Lewis Goodfellow.
This is not altogether surprising given that Viagra was originally designed to lower blood pressure and treat angina.
It was during early testing that its developers noticed the drug aided the male erection – a curious and, as it turned out, very lucrative side effect.
Pfizer therefore decided to market it for erectile dysfunction, rather than as a heart drug, and after more safety tests Viagra was finally licensed as an impotence treatment in 1998.
It was originally looked at as a heart drug
Vicky Styman of the British Heart Foundation
Years later Viagra is turning full circle and doctors are re-exploring its use for treating circulatory problems involving the heart and lungs.
The drug, also known as sildenafil, does not directly give a man an erection. It works by boosting blood flow to the penis.
It does this by specifically blocking a particular enzyme called phosphodiesterase type 5 (PDE 5).
This action means the drug is also good at improving blood flow elsewhere in the body.
Vicky Styman of the British Heart Foundation explained: “It is a potent vasodilator, opening up the blood vessels and it was originally looked at as a heart drug.”
But there have been concerns about whether it is safe for men with heart disease on particular medications that work in the same way.
I suspect we will see a generation of drugs coming out from the sildenafil group which are actually designed for working on the heart
Ian Banks of the Men’s Health Forum
Doctors are told not to prescribe Viagra along with these angina drugs called nitrates as the mix could lower blood pressure to dangerous levels.
It appears to be safe in other heart patients, but Ms Styman added: “If you have a heart condition you should check with your doctor before taking Viagra.”
As erectile dysfunction and cardiovascular diseases have common risk factors, many of the patients who might benefit from Viagra also have cardiovascular diseases.
Ian Banks of the Men’s Health Forum said: “It was a very attractive drug for cardiac conditions and lowering blood pressure.
“Indeed, I’ve noticed that when I prescribe Viagra to patients with a heart condition it actually improves their heart condition as well as their erectile dysfunction.
“It does what it originally said on the tin. But Pfizer knew they were on to a winner with the erectile dysfunction line.
“But people are still interested in using it for other conditions and I suspect we will see a generation of drugs coming out from the sildenafil group which are actually designed for working on the heart because it is so effective.”
Studies suggest the drug could treat a variety of conditions other than erectile dysfunction.
Scientists have shown it can help thicken up the lining of the womb in women experiencing fertility problems and reduce the risk of a complication of pregnancy called pre-eclampsia.
The best evidence so far of an alternative use is for treating high blood pressure in the vessels of the lungs, known as pulmonary hypertension.
There have been reports of cases where doctors have used Viagra to save the lives of babies with this potentially fatal condition.
Dr Alan Fenton, consultant neonatologist Newcastle’s Royal Victoria Infirmary, has first hand experience of this.
He explains: “The problem we see in premature babies with breathing difficulties is although we can blow oxygen into their lungs to help them, there isn’t enough blood supply to various areas of the lungs to take the oxygen around the rest of the body.
“What sildenafil does is open up the blood vessels so they can capture the oxygen and take it around the body.”