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Administration | 15-05-2009 14:56:01

What is Viagra®?

Viagra® is the first significant oral medication for the treatment of Erectile Dysfunction (ED).  The medicine was originally developed as a cardiovascular medicine designed to improve blood flow in the vessels of the heart.  However, during initial studies the medication was found to have a profound side effect.  Individuals began to report a remarkable difference in their ability to achieve and maintain an erection.  Further studies were completed and on March 27, 1998, the medication was approved by the FDA for the treatment of (ED).              

How does Viagra® work?

Viagra® is dispensed as a pill and ingested orally.  Approximately 30-60 minutes later the drug is absorbed in the bloodstream.  Viagra® then functions as an inhibitor to an enzyme called phosphodiesterase type (PDE5) which is found primarily in the penis.  By inhibiting PDE5, smooth muscle in the penis remains relaxed for a longer period.  This allows for increased blood flow into the cavernous tissue of the penis thereby generating an erection.  Viagra® is unique in that it increases a natural occurring process, therefore, only through sexual stimulation will an erection occur. 

What is the appropriate dose? 

The standard dose is 50mg one hour prior to sexual activity.  However, if you are older than age 65 or have a serious kidney or liver disease some physicians will recommend starting with the minimal dose of 25mg.  Viagra® should not be taken more than once per any 24-hour period and doses should not exceed 100mg.  The half-life of Viagra®, the time the drug remains effective after ingestion, is approximately four hours.  

What clinical studies have been done?

Viagra® was administered to more than 3000 patients (age 19-87 years) with (ED) of various etiologies (organic, psychogenic or mixed) with a mean duration of 5 years.  Viagra® demonstrated statistically significant improvement as compared to a placebo in all studies.  In one particular study concerning the frequency of successful penetration during sexual activity and maintaining erection after penetration, 83% of these patients reported an improved erection on Viagra® verses 12% on a placebo medication

How much time must surpass before Viagra® is effective?

Viagra is rapidly absorbed.  Maximum observed plasma concentrations are reached within 30 to 120 minutes (median time 60 minutes) of oral dosing on an empty stomach.  Note: when Viagra® is taken with a high fat content meal, the rate of effectiveness can be significantly diminished.

What happens if there is no sexual stimulation following the ingestion of Viagra®?

Viagra® is naturally eliminated from your body in a few hours.

What are the side effects of Viagra®?

  • The side effects of Viagra® are relatively few and if they do occur, they are usually short lived.  However, some patients have reported the following side effects:
  • Congestion
  • Diarrhea
  • Facial Flushing
  • Headaches
  • Urinary Tract Infections
  • Visual Changes (mild and temporary changes in blue/green colors or increased sensitivity to light)  

What are precautions/warnings concerning Viagra®?

Men who are taking medicines that contain nitrates (Nitroglycerin) of any kind must never use Viagra®.  Patients should not take Viagra® even if you only take nitroglycerin medication occasionally.  (Please see list of nitrates)  There is also a potential for cardiac risk during sexual activity in patients with preexisting cardiovascular disease.  Therefore, Viagra® should not be used in men where sexual activity is inadvisable because of their underlying cardiovascular status.  Several medications are known to interact with Viagra®.  Therefore, one should inform their physician concerning all medications they are taking, including those medications acquired by a prescription as well as over the counter medicines.  The use of Viagra® offers no protection against sexually transmitted diseases, including HIV.  Patients should continue to use protective measures necessary to guard against these diseases.  In case of an overdose, call your physician immediately.

Can I use Viagra® with other medications?

Yes, it is generally safe to use Viagra® while on other medications, however some medicines may potentiate the effects of Viagra®.  Individuals should always consult with their healthcare provider prior to taking any medication.  Note Viagra® does have one absolute contraindication; individuals who are taking medication-containing nitrate (even intermittently) should not take Viagra®.

Why is Viagra® absolutely contraindicated in individuals who are currently taking medications containing nitrates?

Viagra® has been shown to potentiate the hypotensive effects of nitrates to life threatening levels.  Therefore, individuals who are currently using nitrates in any form even intermittently should not take Viagra®.  Nitrates are available in many medications; sprays, ointments, skin patches, pastes and tablets dissolved in the mouth.  Nitrates are also found in illicit drugs such as amyl nitrate or nitrite "Poppers".  If you are unsure if you are currently taking nitrates please value your health and consult with your local physician or pharmacist. 

Can I get Viagra® over the counter?

No, Viagra® should only be taken by prescription from a licensed physician.  FDA regulations do not permit Viagra® to be taken without prescription.  A Licensed Physician will review your medical history and patient profile.  If approved for a Viagra® prescription, we will have your order shipped discretely to your home or office

For what types of ED is Viagra® proving to be especially effective? 

Viagra® is showing optimal results in individuals who experience ED secondary to high levels of anxiety (performance anxiety) and individuals with mild ED. 

Is Viagra® less effective in treating ED that is secondary to certain underlying medical conditions?

This question is somewhat difficult to answer right now.  More data is expected in the near future.  Some initial data suggests that men, who have undergone radical prostatectomy (surgical removal of their prostate), using nerve-sparing procedures, are not achieving the same positive results with Viagra. 

Can Viagra® be combined with other treatments for erectile dysfunction?

The use of such combined treatments is not recommended, since no studies have been done to access Viagra's® safety and effectiveness.

Is there a potential for Viagra® to be used in the treatment of ED in women?

There are currently several medical research centers that are studying whether Viagra® is a viable oral therapy for woman with ED.  The problem is, secondary to anatomy, we know less concerning female ED than male ED. Historically, research has focused on male ED.  Until we have a better understanding of the physiological processes causing Ed in women are ability to treat the condition is limited.  Although some physicians are prescribing Viagra® to their female patients, it is important to note, the FDA has not approved the medication for the treatment of ED in women.

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MensHealth | 12-05-2009 14:31:21

What is Propecia?

Propecia (finasteride) us the first oral medication that effectively treats male pattern hair loss. Propecia is primarily effective in treating hair loss on the vertex (top of the head) and the mid-scalp area.

How does Propecia work?

Researchers have recently discovered that men who suffer from male pattern hair loss have increased levels of dihydrotestosterone (DHT). DHT is produced from testosterone through the activity of an enzyme called 5-alpha-reductase. Biochemical analysis reveals elevated levels of 5-alpha-reductase in the scalp of balding men and the lack of the hair loss in men with 5-alpha-reductase deficiencies. Propecia inhibits 5-alpha-reductase, thus blocking the formation of DHT. This appears to interrupt a key element in the development of male pattern hair loss.

What is dyihydrotesterone (DHT)?

DHT is one of several male hormones in the body. DHT is responsible for the development of the external genitals in the male fetus, However, as an adult DHT appears to cause:

Male pattern hair lossshortening of the growing phase of hairprogressive miniaturization of hair folliclesdecreasing number of visible hairsProstate enlargementAcne.

What is male pattern hair loss?

Male pattern hair loss is a common condition in which individuals experience a thinning of the hair on the scalp.  Often, this results in a receding hairline and/or balding at the vertex of the head.  These changes typically begin gradually in men in their early twenties.  Physicians believe male pattern hair loss is secondary to a genetic disposition and is dependent on hormones..

What clinical studies have been done concerning Propecia?

Clinical studies were conducted in men age 18 to 41 with mild to moderate degrees of male pattern hair loss.  All individuals treated with Propecia received a tar based shampoo (Neutrogena T/Gel shampoo) and were instructed to wash their hair at least once per day.  Clinical improvements were seen as early as three months into the treatment with Propecia.  In men with vertex hair loss, global photographs revealed hair re-growth in 66 percent of men.  Furthermore, hair counts with these men indicated that 83 percent of the recipients had no further hair loss over the two-year clinical trial period.

Will Propecia work for all men?

For most men, Propecia increases the number of scalp hairs, helping to fill in thin areas of the scalp.  Men treated with Propecia also noted a slowing of hair loss.  Although results will vary, generally men will not re-grow all of the hair they have lost.  Male pattern hair loss occurs gradually over time, Propecia can significantly reduce or delay the hair loss process.

How long does it take before individuals start to notice the benefits of Propecia?

Hair naturally grows at a rate of about a half an inch per month, so it may take up to sixth months for the effects of Propecia to be visible.  However, most men begin to see some results early in the first three months.  These results include a decrease in the amount of hair loss, general improvement in the condition of the hair with noticeable re-growth occurring after sixth months.

What are the side effects of Propecia?

Similar to all prescription medications, Propecia may cause some side effects.  In clinical studies, side effects associated with Propecia were uncommon and did no affect most men.  In fact, more individuals discontinued the placebo as compare to Propecia secondary to adverse experiences.  A very small percentage of men (less than 2 percent) experienced sexual side effects (which may be attributable to the placebo effect).

Resolution occurred in all men who discontinued therapy with Propecia.  The side effects also resolved in 58 percent of the men who continued to take the medication.

Is Propecia appropriate for women or children?

No, Propecia is for the treatment of hair loss in men only.  Furthermore, women who are or may potentially be pregnant must not use Propecia and should not handle crushed or broken tablets.  Propecia may cause a potential risk to the development of the male sex organs in the fetus.  Propecia tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablet has not been broken or crushed.

Is it safe for a man taking Propecia to conceive a child with his spouse?

Yes, it is quite safe.  Propecia does not effect a man's ability to have a child (fertility).  There have been no studies that even suggest any risk to the fetus if the father is taking Propecia.

Are there any known drug interactions that occur while taking Propecia?

No dug interactions of clinical importance have been identified.  Compounds that have been tested in man include: digoxin, propanolol, theophylline, warfarin, etc.  Additionally, although no specific interaction studies were performed on the following medications, finasteride doses of 1 mg or more were concomitantly used in clinical studies with the following: acetaminophen, a-blockers analgesics, angiotension-converting enzymes (ACE) inhibitors, anticonvulsants, benzodiazepines, betablockers, calcium-channel blockers, cardiac nitrates, diuretics H2-antagonists, HMG-Coa reductase inhibitors, prostaglandin synthetase inhibitors (NSAIDS), etc. without evidence of clinically significant adverse interactions.

Does Propecia effect any routine tests?

Yes, men undergoing a prostatic-specific antigen (PSA) test while taking Propecia, consideration should be given to doubling the PSA level.  In clinical studies with Propecia men 18-41 years of age, the mean value of PSA decreased from 0.7 Ng/ml at  baseline to 0.5 Ng/ml at month 12.  When finasteride is used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50 percent.  Note:  There is no correlation between Propecia and Prostate cancer.

What is the recommended dose?

The recommended dose is 1 mg once per day.  Propecia may be administered with or without meals.  If a dose is missed do not take an extra tablet; just take the medication as usual.  There are no added benefits to taking more than the recommended dose.

What about an overdose of Propecia?

Should a significant overdose of Propecia occur, individuals should seek immediate medical attention.

How is Propecia supplied?

Propecia tablets, 1 mg, are tan, octagonal, film coated convex tablets with the code MRK 71 on one side and the Propecia label on the other. 

NDC 0006-0071-31 unit bottle of 30 NDC 0006-0071-61 Propak carton of 3 unit bottles of 30

How should Propecia be stored?

 

Propecia should be stored at room temperature, 15-30 C (59-86 F) Keep container closed and out of the reach of children.

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