Is Viagra A Safe Medication?

The most daunting question that can arise before taking a medication for a long-term illness can be, ‘Is it safe to use?’.  While asking this question about safety, we should first define ‘safe medication’. What does it mean when we say is this medication safe to use?

Safety of a drug can be seen in many different aspects. They can be following as;

  • How effective is it?
  • Side effects at the normal dose
  • Therapeutic index
  • What are its contraindications (drugs with which it cannot be used)?
  • Health conditions in which it cannot be taken?
  • Factors that can decrease its efficacy
  • Long term use with minimum side effects
  • The source from which drug is being taken or used
  • Laws that govern its manufacture and sale
  • Misuse/Abuse of the drug

 

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Viagra is the brand name of drug Sildenafil. It is manufactured by Pfizer Company. Viagra is also available in its generic form Sildenafil for the treatment of erectile dysfunction. It has been around for more than 15 years so a lot has been established on its safety and efficacy. It comes in three doses of 25mg, 50mg and 100mg and can be bought at Assured Pharmacy.

Viagra is a Phosphodiesterase 5 inhibitor. It relaxes the smooth muscles of blood vessels thereby causing them to dilate and increasing blood flow to certain parts of the body including the penis. When it increases blood flow to the penis erection takes place. But it only works if the individual is sexually aroused. At recommended doses, it has no effect in absence of sexual stimulation. Sildenafil doesn’t only treat E.D. it is also used to treat pulmonary hypertension. It is basically a vasodilator and can cause a slight drop in blood pressure. But Viagra specifically is marketed and used for the treatment of erectile dysfunction only. And different doses decide different outcomes for the drug.

For men with impotence, a question may arise about the safety of Viagra. Unfortunately, there is no straightforward answer to this question. The same drug sometimes has different effects on different individuals. There are many factors that control the effect of a drug in a human body. A safety profile of the drug is checked and approved by a number of regulatory authorities that work at international and national levels. We know that Viagra has been around for more than a decade and has quite an established drug profile.

Let’s see the safety of the drug in long-term and acute patients to reach a final conclusion.

 

Effectiveness of drug

Viagra is the most effective drug for erectile dysfunction among the class of drugs used for treating the condition. Viagra has an established efficacy and safety profile and remains an important treatment option for men with erectile dysfunction. Viagra has been studied in several clinical trials involving more than 23,000 men with E.D.Manager (businessman, coach, leadership) plan to increase company performance.

It comes in three doses of 25mg, 50mg, 100mg. A dose of 50mg is known to be most effective with fewer side effects. Most men find a dose of 50mg effective for them however if an individual thinks that this dose might not be working for them the dose can be safely increased to 100mg. According to a study 50mg and 100mg dose of Viagra appeared to be the most effective for treatment of E.D. It performed 50percent better than a placebo effect. Smaller doses of Viagra less than 50mg were less effective.2

The dose can be increased or decreased based on tolerance and efficacy of the drug. If a patient is on some contraindicated drugs (nitrates etc.) or has health conditions like an ailing heart then a dose of minimum 25mg is prescribed by a doctor or recommended by a pharmacist. If tolerance is built against a 50mg dose then the dose can be safely increased to 100mg but never more than 100mg. At higher than 100mg dose side effects can become more apparent one of them being a fatal drop in blood pressure.  There are certain factors that control the efficacy of the drug like;

  • Taking it on an empty stomach
  • Taking it an hour before intercourse
  • Being sexually stimulated
  • Do not take it with alcohol
  • Smoking has also known to reduce the efficacy of a drug
  • Depression and anxiety may also restrict the effect of a drug

There are many other factors that dictate erectile dysfunction, we have many articles on our blogs regarding the condition feel free to have a read!

Although Sildenafil is effective in 88% of men that take it, unfortunately, this tiny blue pill may not have same efficacy for the rest of 22%. There are other erectile dysfunction treatments like Tadalafil, Vardenafil etc. that are also present on our website and can be bought online after a pharmacist’s recommendation.

 

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Product Description

How does Viagra and Sildenafil work?

Viagra (Sildenafil) helps men to get and maintain an erection when sexually stimulated and/or excited. The medicine relaxes the blood vessels in the penis which results in more blood flowing to the penis when you are sexually excited.

How do I take it?

You should take Viagra (Sildenafil) approximately 1 hour before planning to have intercourse. Within a window of between 30 minutes and 4 hours after you take the medicine, it will be easier to keep and maintain an erection when you are sexually excited. If you take this medicine after a meal with a high fat content it may take a little longer to start working. This medicine will only work when you are sexually excited. You won’t get an erection just by taking Viagra (Sildenafil).

Dosage

The standard recommended dose for Viagra (Sildenafil) is 50mg and this will be suitable for most people.  If this dose is not effective, you can try 100mg and if 50mg gives you side effects you can also reduce the dose to 25mg tablets.

You must not take more than 100mg daily of Sildenafil/ Viagra. Clinical trials have been conducted in patients taking up to 200mg sildenafil and it was found that ‘doses of 200mg did not result in increased efficacy but did increase the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision).’

In addition, in patients taking more than 100mg daily, there have been reports of rhabdomyolysis (a breakdown in skeletal muscle tissue the byproducts of which can lead to kidney failure), visual perception changes, vertebral artery dissection (a tear in the artery supplying blood to the brain), heart attacks and aggressive behaviour.

If the 100mg strength doesn’t work for you, there may be alternatives you can try and we recommend that you call us for a free consultation with our pharmacist or doctor to discuss any underlying conditions you may have. We recommend that all men taking medicine for erectile dysfunction have regular tests for blood pressure, cholesterol, diabetes and hormone imbalances. For instance, it may be that by fixing a hormone imbalance such as testosterone, your Viagra medication will be even more effective.

In addition, drug manufacturers do not advise patients to split tablets in half to get the correct dosage as they cannot guarantee that the active ingredient will be distributed evenly throughout the tablet.  For instance, if you cut a 100mg tablet in two, you may find that you get 80mg in one half of the tablet and 20mg in the other half leading to either an overdose (increased risk of side effects) or a suboptimal dose (the medication may not work).

It is important that you choose the correct dose for you. If you wish to talk to our pharmacist or doctor about this, please contact us in the pharmacy on 01625 460621 or email [email protected]

Side Effects

Viagra (Sildenafil) is normally well tolerated, however, side effects can include:

  • Headache
  • Dizziness
  • Nausea

Side effects normally subside after a few hours, however, if you experience a prolonged or painful erection (longer than 4 hours), then you must contact your doctor immediately.

Drug interactions

There are a number of medicines which interact with Sildenafil/ Viagra. For an exhaustive list please see the patient information leaflet (see section below) or call us in the pharmacy to discuss your specific situation. The main drug interactions are listed here:

Recreational drugs such as ‘poppers’ or amyl nitrate
Alpha blockers used for urinary retention or blood pressure problems (eg Flomax or Cardura)
Anti- arrhythmic drugs such as disopyramide
Antibiotics such as erythromycin
Antifungals such as itraconazole
Antivirals such as drugs used to treat HIV
Bosentan
Cobicistat
Calcium channel blockers to treat blood pressure and angina such as amlodipine
Dapoxetine (Priligy – used to treat premature ejaculation)
Grapefruit juice**
Nicorandil
Nitrates
Riociguat
Cimetidine (to treat stomach ulcers)

Please do not take Sildenafil/Viagra if you have taken any of the above drugs within the last 60 days without first consulting with either us in the Pharmacy ([email protected] / 01625 460621) or via email with our doctor [email protected]

**We advise not to take Sildenafil/Viagra with grapefruit juice as the blood concentration of Sildenafil will possibly be increased resulting in side effects.

Patient Information Leaflets

Please click here for the patient information leaflet for Viagra.

For Actavis Sildenafil please see the following leaflets: 100mg, 50mg, 25mg.

Storing Medicines Safely

Please keep your medicine out of the reach of children and store at room temperature.  Unwanted medicine can be disposed of by returning it to any local pharmacy or indeed to us here for us to dispose of it for you.

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Side effects

Another common question that may arise about a drug is about its side effects. Side effects are a huge factor that defines the safety of any medication. Viagra is generally considered a safe medication but following are some of its side effects: 3.

  • Very Common side effects:
    • Flushing, warmth or tingly feeling
    • Headache dizziness
  • Common Side effects:
    • Abnormal vision. This can manifest itself as blurred vision or changes in the colour of vision. This colour change is called Cyanopsia or blue vision. It is a vision where everything is tinted with blue.
    • Stuffy / blocked nose or nasal congestion
    • Feeling sick
    • Dizziness
    • Dyspepsia or indigestion
  • Uncommon or some rare side effects:
    • It is a condition characterized by prolonged erections. It can be a very painful condition.
    • Nosebleeds
    • Severe fatigue
    • Palpitations or fast heartbeat
    • Blindness
    • Rash

Common side effects may subside on its own after some time and are nothing to worry about. However, if you experience symptoms like a painful erection, strong chest pains, fits, loss of vision, or an allergic reaction immediately call medical attention and visit a hospital.

In a minority of people, Viagra can also cause allergic reactions. An allergic reaction to Viagra is characterized by wheezing, swelling of face mouth or throat and breathing problems. A medical attention should immediately be sought if any abnormal symptom is experienced.

There are certain ways through which we can try and avoid side effects. They can be avoided by

  • Avoiding overdose
  • Avoiding its use as a recreational drug
  • Mixing it with other recreational drugs like ecstasy or alcohol etc.

Therapeutic window

Therapeutic window or Therapeutic index can be defined as the ratio of the amount of therapeutic agent that causes the therapeutic effect to the amount that causes toxicity 4. This index is usually studied so that we may know the amount or dose of the drug at which it gives its maximum therapeutic effect and the dose above which its toxic effects start appearing. If a drug has high TI (Therapeutic index) it means its safety is more with lesser side effects.

During a clinical trial, the TI of a drug is unknown however understanding it is of utmost importance because it helps in a successful drug development.

Viagra’s therapeutic window is wide, that is it is generally a safe drug, however, the manufacturer recommends that the dose should never exceed beyond 100mg as side effects become more pronounced after this dose 5. 100mg is considered maximum effective dose of Viagra, if efficacy is not achieved at this dose then treatment change may be desired.

Contraindications

The word ‘contraindication’ means indications or conditions in which the drug administration is inadvisable 6. Usually, there are certain health conditions in which drug cannot be given as such or its dose is usually modified. Sometimes drug also cannot be given with other medication because it interferes with its efficacy either reducing its effect or potentiating its effect to a toxic level.

  • Drugs with which Viagra cannot be given:

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    • Nitrates – Viagra cannot be taken with Nitrates. Nitrates can be in form of Glyceryl Trinitrate. Isosorbide mononitrate, Isosorbide dinitrate, Amyl nitrate etc. Nitrates are usually given in heart patients can cause a fatal drop in blood pressure if co-administered with Viagra 7.
    • Alpha blockers – Alpha blockers are usually prescribed for high blood pressure or an enlarged prostate gland (prostate gland hyperplasia), they include drugs like Doxazosin, Alfuzosin, Indoramin, and Tamsulosin. If this is taken along with Viagra then it causes a sudden drop in blood pressure which can be fatal.
    • Enzyme inhibitors – CYP3A4 is an enzyme found in the liver. It is responsible for converting Viagra into its inactive form and then clearing it out of body helping in its excretion. There are some drugs that inhibit this enzyme in the liver and therefore increase the level of Viagra up to three-fold in blood 8.  The doctor may recommend a starting dose of just 25mg for the patient or may end the treatment altogether. These drugs include; Antibiotics like Clarithromycin, antifungals erythromycin, ketoconazole, itraconazole. HIV drugs are also present in this list Indinavir, ritonavir. Calcium channel blocker verapamil
    • Enzyme inducer – Some drugs may potentiate the effect of CYP3A4 enzymes and therefore cause a decrease in the effect of Viagra. When these liver enzymes are induced they will increase the clearance and excretion of this drug, as a result, its effective dose doesn’t reach the blood and no effect is seen. Some of these enzyme inducers are; Phenobarbital, carbamazepine, rifampicin, phenytoin,
  • Health conditions in which it cannot be used:
    • Dose adjustment due to hepatic impairment or renal impairment – Liver and kidneys are two vital organs of the body that are responsible for excretion and clearance of drugs and its metabolites. If any of these two are compromised then it will affect the drug efficacy and toxicity. If a drug or its metabolites don’t get excreted from the body it may increase its amount in blood up to two or three folds. So in patients with a renal or hepatic impairment dose needs to be adjusted to the minimum so that it doesn’t increase to a toxic level. Usually, a starting dose of 25mg is given for patients with such impairments.
    • Geriatrics – Geriatrics is the study of elderly patients. This study is important because in the elderly population many body systems have slowed down due to ageing etc. The effect of drugs is therefore also affected in such population. Usually, renal and hepatic functions are affected most that will, in turn, affect the drug efficacy and its excretion etc. Usually in men above 65 years of age 25 mg of starting dose of Viagra is given.
    • Effects on Eye – Viagra has known side effects on the eye. It is contraindicated in a patient with a prior visual impairment because Viagra is known to worsen the condition. It is also known to cause a condition called Cyanopsia, it’s a condition where vision is discoloured and everything seems to be tinted with a blue hue. Viagra is totally contraindicated in individuals that have a hereditary disease called as Retinitis pigmentosa, it is a condition where the cells of retina gradually die. Viagra can worsen and aggravate the condition, therefore, will not be prescribed to such patients. Similarly, there is another eye condition called as Non-arteritic anterior ischemic optic neuropathy (NAION) where the use of Viagra and all other similar drugs from the same class of PDE 5 inhibitors are completely contraindicated. This condition is characterized by a loss of blood flow to the optic nerve. Underlying factors are usually diabetes and high blood pressure. Sildenafil or Viagra can further worsen the condition causing permanent blindness.
    • Heart Disease – Patients with heart disease are also never prescribed Viagra because it interferes with the nitrates that are prescribed for the heart disease. Nitrates and Viagra together can cause a fatal drop in blood pressure, therefore, causing death. Patients with unstable angina where physical activity is not allowed are also not prescribed Viagra because getting involved in a sexual activity can be dangerous for the patient and can cause a heart attack.
  • Other conditions with contraindications:
    Some of the other conditions where Viagra is contraindicated are as follows;
  1. Peptic ulcers or bleeding disorders
  2. Sickle cell anaemia
  3. Leukaemia
  4. Peyronie’s disease
  5. Haemophilia

Factors that can decrease Viagra’s efficacy

There are certain factors that can affect the therapeutic effect of Viagra and may decrease its efficacy, some of these factors are:

  1. Taking Viagra after a fatty meal or with a full stomach
  2. Taking it more than an hour before sex
  3. Drinking grapefruit with it
  4. Taking it with alcohol

Laws that govern the manufacture and sale of Viagra

Medicines and healthcare products regulatory agency (MHRA) is the chief regulatory authority under the department of health in the UK that makes sure that the medicines and related products are safe to use and are effective  Recently in UK Viagra has been made an OTC drug (over the counter) from PO drug (prescription only). This has been done in the UK only. MHRA says that this move has been made to decrease the buying of Viagra from the black market and darknet.LogoSancoInternet_UK_B-336

Erectile dysfunction can be a debilitating condition, men often find it hard to go to pharmacy or GP themselves to buy the medicine given the stigma attached to the condition. So instead they turn to unregulated websites that sell Viagra which can be illegal and counterfeit. Last year in the UK alone £17 million worth of illegal and counterfeit Viagra was seized  This amounts to largest volumes of unlicensed and fake drug to be ever seized in the history. Since being unregulated there is no way to know how it has been manufactured or under what circumstances, and what is the amount of active ingredient in it. According to a source most of fake Viagra was known to be manufactured in India under extremely unhygienic conditions and subsequent lab testing showed that it contained some toxic substances. Usually, Viagra bought on the black market is very cheap around the price of £2

This step of MHRA in order to make Viagra available over the counter will help men to buy it from authorized and regulated online sites and online pharmacies and this will help to save them from buying illegal and counterfeit drug which may not have any effect altogether.

Recently Pfizer is trying to revolutionize the selling of Viagra in the USA by creating a website where men will be able to buy it online directly from Pfizer itself. It will change the traditional concept of selling of medication where a medication is bought in bulk then sold in pharmacies. But we should keep one thought in mind that all of these efforts are being made to decrease the selling of Viagra on the black market and to encourage people to buy it from regulated and authorized sources. Assured Pharmacy is a GPhC registered and regulated pharmacy and medication for erectile dysfunction can be bought online.

Misuse and abuse of Viagra

Viagra is sometimes also abused for recreational purposes especially among young generation and men under 40. It is usually mixed with another recreational banned drug ecstasy and the substance is called as ‘sextasy’. It has highly dangerous consequences when abused with other banned drug or alcohol. The side effects can be debilitating and fatal at times. It also causes certain chemical changes in the brain that can further predispose a patient to neurological diseases.

It is also seen that most of the black market costumers of Viagra are men who don’t need it for any medical purposes and are only after pleasure. But unfortunately, this kind of pleasure never lasts long and further puts the person in a state of dismay and darkness.

Conclusion

Is Viagra a safe medication? Viagra is generally a safe drug with minimal side effects if taken in the right doses and not abused. Even if you are buying it over the counter have a frank chat with the pharmacist about your overall health condition and your previous usage of Viagra, if any. This will help him adjust the right dose for you.

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REFERENCES

  1. http://www.medicaldaily.com/viagra-and-other-erectile-dysfunction-drugs-vary-effectiveness-side-effects-328360
  2. https://www.ncbi.nlm.nih.gov/pubmed/19817982
  3. http://www.netdoctor.co.uk/medicines/sexual-health/a7733/viagra-sildenafil/
  4. https://en.wikipedia.org/wiki/Therapeutic_index
  5. http://www.pdr.net/drug-summary/Viagra-sildenafil, Maximum Dose
  6. https://www.merriam-webster.com/dictionary/contraindication
  7. http://www.netdoctor.co.uk/medicines/sexual-health, contraindications of Viagra
  8. https://www.rxlist.com/viagra-drug.htm#indications_dosage
  9. https://en.wikipedia.org/wiki/Medicines_and_Healthcare_products_Regulatory_Agency
  10. https://www.theguardian.com/business/2017/nov/28/viagra-will-be-available-over-the-counter-in-uk-says-medicines-regulator

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected]