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IMPOTENCE and SEXUAL DYSFUNCTION
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CONTENTS
1. VIAGRA, a safe and effective medication for male erectile dysfunction
2. What about Viagra and women?
3. What other treatment options might be available?
4. Impotence and sexual dysfunction - What kind of information resources do I have?
1. VIAGRA, a safe and effective medication for male erectile dysfunction
Interested in knowing more about VIAGRA®, visit our links below:
US government information on Viagra:
A comprehensive information package on Viagra:
NOTE! IMPORTANT:
These pages are not for medical advice; you are in all your health problems strongly encouraged to contact your local personal doctor. However, the following facts and guidelines might assist patients and their physicians in the correct usage of Viagra. The points listed first for US residents are based on the Viagra prescribing information approved by the U.S. Food and Drug Administration. Viagra will be approved in Europe by September 15, 1998; under its own heading similar precautions and instructions relevant for Europeans will be presented; they are based on the statement from the European Agency for the Evaluation of Medicinal Products:
Information relevant to U.S. residents
- First of all, check the revised prescribing information from FDA's pages, you should avoid using Viagra if you have recently had an acute myocardial infarction or if you have high (more than 170/110) blood pressure or you have unstable angina pectoris;
- Patients taking nitrates in any form, including nitroglycerin and long-acting nitrates commonly used for chest pain, should not take Viagra. In addition, patients taking Viagra should not be administered nitrates. Large and sudden drops in blood pressure can occur with the co-administration of these two drugs.
- Viagra was developed to treat men with erectile dysfunction (male impotence). Viagra has not been officially approved for use in female sexual dysfunction. Clinical trial testing is on-going in women, but no conclusive results are available yet.
- Viagra should be considered for use only after a clinical evaluation that involves a physical exam and medical history to confirm a diagnosis of erectile dysfunction (impotence) and to assess the appropriateness of Viagra therapy, as well as only under medical surveillance.
- Because erectile dysfunction (impotence) often is associated with serious medical conditions such as diabetes and hypertension, Viagra’s labeling (in the U.S.) notes that a medical exam can be important in identifying potential underlying causes that may themselves require treatment.
- There is a degree of cardiovascular risk associated with sexual activity, particularly among older patients with known cardiovascular disease. Because sexual intercourse, like other forms of physical exertion, increases the heart rate as well as the cardiac work load, physicians may wish to assess their patients’ cardiovascular status prior to their resumption of sexual activity or initiation of any treatment for erectile dysfunction (male impotence).
Information relevant to European (EU) residents
- Viagra (sildenafil citrate) is indicated for the treatment of erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for sildenafil to be effective, sexual stimulation is required.
- Sildenafil will be available only on medical prescription. It is indicated for use in men over 18 years of age who have undergone a medical history and physical examination by a physician to diagnose erectile dysfunction, determine any potential underlying causes and decide if pharmacological treatment is appropriate. Prior to initiating any treatment for erectile dysfunction physicians should consider the cardiovascular status of their patients.
- Viagra is not indicated for use by women.
- Patients should not be prescribed sildenafil if they are taking nitrates, which are often for the relief of angina pectoris, or nitric oxide donors, e.g. amyl nitrite ('poppers'). Similarly patients should not be prescribed sildenafil if they have recently had a stroke or a heart attack, have low blood pressure, severe heart or liver problems, or certain rare inherited eye diseases (such as retinitis pigmentosa).
- In addition, caution should be exercised before prescribing sildenafil for patients with sickle cell anaemia (abnormal red blood cells), leukaemia (cancer of blood cells), multiple myeloma (bone marrow cancer), bleeding disorders, active peptic ulceration, or any disease or deformity of the penis.
- Viagra must not be used together with other treatments for erectile dysfunction.
In Germany and Austria additional warnings in the labelling will not be excluded, since these countries were in favour for stricter warnings in the EMEA meeting on August 24, 1998.
For additional safety information, see Viagra SafetyOnline
2. What about VIAGRA and women?
As "Sunday Times" June 7, 1998 reported, VIAGRA success with men is currently trying to be repeated with women. In Europe, Pfizer (the manufacturer of Viagra) is finalizing clinical trials with approximately 500 women. According to "Sunday Times", the British newspaper, the initial results of these trials show impressive efficacy, releasing hope that VIAGRA, the new miracle drug for male impotence, can also be used as an orgasm drug for women in the near term future.
At least nine companies are going full speed ahead with development of products aimed at heightening women's libido and making sex more enjoyable.
The prevalence (number of existing cases in a certain population) of female sexual dysfunction is 31 %, according to a study presented in the 8th World Meeting on Impotence Research
3. What other treatment options might be available?
Other medical treatment options, except VIAGRA, currently include alprostadil:
Caverject
Caverject®, a prescription drug used to treat impotence, is self-injected into the side of the penis. The active ingredient in Caverject, alprostadil, is identical to a naturally occurring substance found in your body that helps keep blood vessels open and increases blood flow. In clinical studies, Caverject caused an erection firm enough for sexual intercourse in approximately 80 % of men, regardless of cause or age.
More on Caverject, see below:
Caverject:
MUSE
MUSE® (alprostadil) is a pre-filled, single-use, plastic applicator containing micro-pellet of the drug alprostadil. The medication is delivered transurethrally, and acts locally to increase blood flow and rapidly produces an erection. MUSE is currently being launched in several countries, including Sweden.
Further information on MUSE can be found, e.g., in links below:
MUSE:
MUSE:
MUSE:
You have also the option to use vacuum pumps and prostheses, see the links for impotence.
Future therapeutic options
There are a number of pharmaceuticals in the pipeline, including apomorphine (Spontane), IC351 (currently in Phase II trials in order to get approval), phentolamine mesylate (Vasomax; approved in Mexico). Viagra is developed further to be absorbed sublingually, and to have effect in 15 - 20 minutes. Alprostadil is also being developed as a gel.
Vasomax and Spontane as well as alprostadil are also studied with women in the United States. On July 15, Zonagen, Inc., a Texas company, filed for FDA approval of Vasomax, an oral treatment that, like Viagra, enhances blood flow into the genitals. Studies suggest the origin of sexual dysfunction among women may be the same as it is for men: insufficient blood flowing into the genitals. And the problems become worse with the narrowing of arteries that comes with aging. The company is currently launching large-scale studies with women.
Drugs containing the substance apomorphine are being tested by at least two companies. Apomorphine causes blood vessels to dilate, but it also works on the central nervous system, so it affects sexual desire. About a third of women with sexual dysfunction have diminished desire.
4. Impotence and sexual dysfunction - What kind of information resources do I have?
There is a vast and growing information resource for impotence and sexual dysfunction in the Internet.
For further information, you can, e.g., visit the links below:
Impotence and sexual dysfunction:
Impotence and sexual dysfunction:
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