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History of Discovery

The first clinical studies of sildenafil citrate, an active ingredient in the blockbuster, started in the year 1992 in Sandwich town (Great Britain) by the Pfizer pharmaceutical company’s professionals, who believed that the recently synthesized drug could become a real breakthrough in heart disease treatment. Sildenafil citrate was meant to improve the blood flow to the heart muscle and lower the blood pressure.

Unfortunately for pharmacists (and fortunately for the sterner sex representatives) that sildenafil citrate’s effect was not a success, because it hadn’t influenced the blood flow to the heart muscle the way it was intended to. But it had greatly influenced the blood flow to the pelvic organs instead. To be more precise, it provided the blood flow improvement to the male genitalia in all the patients, who had participated in the clinical studies. Their stone-like erection became the living proof to this unexpected side effect of the newly synthesized medicine.

Then the clinical studies were brought into another direction. Since 1993 the newly discovered sildenafil’s effect on the human body was researched on the group of about 3 000 male patients aged from 19 to 87. It took 5 years for Pfizer’s pharmacists to prove the high efficiency of the medicine in men’s impotence (or erectile dysfunction) treatment and its health safety as well.

Viagra®

The luck turned to the Pfizer’s scientists on March, 27 1998, when the U.S. Department of Food and Drug Administration gave its approval for the sildenafil citrate as a treatment for erectile dysfunction. It was introduced into the pharmaceutical market under the trade name VIAGRA®​, that comes from the English “vigor”, meaning “power” or “energy”.

“How you call a boat so it will float”, they say in English-speaking countries, and it also turned to be true.

Success on the Market

During the first week on the market 247 000 patients were prescribed to Viagra and used it. 50 000 more got prescription one week after. Up to nowadays for more than 35 million of male patients all over the World sildenafil is still the symbol and the promise for the real men’s health and sexual power. All of them should thank at least three genii, Robert Francis Furchgott, Louis J. Ignarro and Ferid Murad. These guys made a healthy, happy and full sex life of an average American true.

Sometimes big fail turns into big success.

Nitric oxide is the key biochemical that increases blood flow in the penile muscles, which cause erection, and it is metabolized by c-GMP-specific phosphodiesterase. During sexual activity, nitric oxide is produced and degraded simultaneously.

Sildenafil citrate increases the activity of nitric oxide by inhibiting the degrading enzyme and thereby promotes increased blood flow in the penis and also the erection. Though rarely prescribed, sildenafil citrate is also beneficial in the treatment of pulmonary arterial hypertension (PAH) and altitude sickness (Revatio).

The intestinal absorption of sildenafil citrate is rapid, within one hour. The absorption is delayed, if used after food intake. The plasma half-life of sildenafil citrate is 3-4 hours, and then the drug may lose its potency/therapeutic activity in the body.

Primarily, sildenafil citrate is excreted in faeces and also in urine. Sildenafil citrate is a prescription drug that is sold as 25mg, 50mg and 100mg film (enteric) coated tablets. Sildenafil citrate is mostly (brand name VIAGRA) available in blue colour, in round or diamond-shaped tablets.

Every medicine is associated with certain side effects, which may be mild to moderate or even severe, depending on the drug and its dosage. The adverse events that are associated with sildenafil citrate therapy are mostly mild to moderate, except some rare serious adverse events.

Some of the common adverse events of sildenafil citrate are diarrhoea, urticaria-like skin rashes, vision changes, dizziness, digestion disorders with acidic imbalance, water imbalance with edema, chills, fever, flu-like reaction with nasal congestion or discharge, sinusitis, bronchitis, allergic skin reactions, thrombosis in vasculatures, abnormal low pressure, vomiting or nausea, and behavioural problems with alterations in sleep patterns.

The adverse events may differ from one person to another. The serious adverse events that are associated with Viagra are sudden hearing or vision loss, increase in myocardial infarction risks, especially in patients with medical or familial history, increased stroke risks and aneurysm problems. These serious events are experienced by less than 10% of the persons taking sildenafil citrate. Some of the post-marketing complications are being evaluated in clinical trials by Pfizer and the results are statistically less significant.

Contraindications

Sildenafil citrate is contraindicated in patients with medical or familial history of stroke, hepatic/liver problems, drug allergy to any of the phosphodiesterase drugs (PDE5 inhibitors), abnormal low pressure, kidney damage or decreased functions, hereditary macular degenerative disorders and patients with medical advice to refrain from sexual activities due to cardiac problems.

Sildenafil is also contraindicated in patients with unexplained hearing loss or visual disturbances, pregnant women and lactating mothers. This is not a complete list of contraindications and some of the other pre-existing medical problems can also worsen upon Viagra intake. However, the patient can consult the Physician to prevent these problems. Sildenafil is also contraindicated in women and children.

Drug interactions

Some of the drugs may interact with sildenafil citrate and cause increase in its activity, or the cross-reacting medicine or a decrease in activity in either of these medicines may cause other side effects.

Some of the medicines that are known to interact with sildenafil citrate are Rifampicin, organic nitrites, mononitrates, alpha-blocker medicines, diuretics, all anti-hypertensive drugs and vasodilating medicines.

Sildenafil citrate adversely affects the absorption, distribution and elimination of many other drugs but specifically anti-hypertensive drugs.

Sildenafil citrate is metabolized by Cytochrome P-450 (CYP) system that also metabolizes many of the drugs and other xenobiotics. The drugs that are metabolized by CYP gene get reacted and may result in a drug-interaction or cross-reaction, which may lead to adverse events or accumulation of the drug in the body.

Hence, it is better to avoid taking these drugs, concomitantly.

In the year 2000, the sales of sildenafil citrate reached more than 92 percent in the global ED market. Nowadays, it remains the key drug of choice for physicians for the treatment of patients with erectile dysfunction.

But the entry of Cialis and Levitra as well as generic sildenafil citrate (non approved status in US as of writing), considerably decreased the global share stock of Pfizer to about 50%.

To counter this, in 2007, the pharmacy chains in England announced and pushed-up over-the-counter sales of Viagra. Any eligible males in the age group of between 30 and 65 years could purchase VIAGRA (sildenafil citrate) tablets over-the-counter.

After consultation with a pharmacist with blood pressure check-ups and glucose/cholesterol profiling, they could buy up to four tablets, without prescription. This move increased the over-the-counter purchase of sildenafil citrate across Europe and in other western countries.

In the third world countries such as India and China, sildenafil citrate is the most abused, recreational drug often used to increase the sexual drive and for better performance.

Some athletes used the drug in sports events for better physical performance and to enhance blood circulation to the muscles to decrease oxygen demand and fatigue. But these benefits are not scientifically proved by the researchers and some of them speculate that this may be a placebo reaction.

VIAGRA vs LEVITRA

Levitra (Vardenafil) is a PDE-5 inhibitor drug prescribed for erectile dysfunction and other problems in male impotence. The plasma half-life of Levitra is 3-4 hours, and thereafter the drug activity will be decreased in blood.

LEVITRA received the Food and Drug Administration’s approval in 2003.

The significant features in LEVITRA are as following:

• Levitra can be used with alcohol and meal without causing severe side effects or decreasing effects
• The drug effects can remain up to 12 hours which is twice more than in VIAGRA
• Levitra is reported to prolong duration of sexual intercouse (not approved for the premature ejacuation)
• Levitra starts to act in 20 minutes after intake
• LEVITRA has a more tolerable safety profile with less side effects compared to VIAGRA
• Vardenafil, an active ingredient in LEVITRA, has an FDA-approved orally disintegrating formulation (brand name: STAXYN).

VIAGRA VS CIALIS

CIALIS is a brand name for tadalafil, a PDE-5 inhibitor, that is prescribed for male sexual dysfunction.

The significant features in CIALIS are as following:

• Unlike of sildenafil citrate, the plasma half-life of Cialis is about 17.5 hours, therefore CIALIS effects can remain up to 36 hours (this is why CIALIS is often called the Weekend Pill).
• Additionally, low dosaged CIALIS (2.5 mg and 5 mg) can be used on a daily basis for the male to be ready to a spontaneous sexual activity.

The question has been live since appearence of VIAGRA on the market.

First-of-all, af of writing there have been NO USFDA APPROVED GENERIC FORMULATIONS OF SILDENAFIL CITRATE on the market. And these won’t appear legally untill March 2012 when Pfizer loses its exclusive right for promoting and selling VIAGRA in the US due to patent expiration. After that VIAGRA goes generic.

Secondly, Brand VIAGRA is available by prescription only in three dosages: 25 mg, 50mg and 100 mg. And only your doctor should examine your health and decide which of the erectile dysfunction drugs is appropriate for you or not.

You should remember, that most of the generic VIAGRA tablets, primarily available online, without prescription and under other trade names, are illegal and might harm your health.

As of now, no regulatory approval and medical sale clearance are given to generic sildenafil citrate, and using it can pose severe or even life-threatening complications. There are no clinical trials, post-marketing survey, pre/para-clinical research, and medical publications with scientific backings of generic sildenafil efficacy.

The cheaper generic options are not always a good option in medicines. Though costlier, the brand Viagra by Pfizer is the best option for erectile dysfunction.