Sildenafil; Worried about conjugal life? Come to restart again

Sildenafil is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. Its effectiveness for treating sexual dysfunction in women has not been demonstrated.Common side effects include headaches and heartburn, as well as flushed skin. Caution is advised in those who have cardiovascular disease. Rare but serious side effects include prolonged erections, which can lead to damage to the penis, and sudden-onset hearing loss. Sildenafil should not be taken by people who take nitrates such as nitroglycerin (glycerin trinitrate), as this may result in a severe and potentially fatal drop in blood pressure.

Sildenafil acts by inhibiting cGMP-specific phosphodiesterase type 5 (phosphodiesterase 5, PDE₅), an enzyme that promotes degradation of cGMP, which regulates blood flow in the penis. Sildenafil relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body.

Sildenafil under the name Viagra is used to treat erectile dysfunction (impotence) in men.

Another brand of sildenafil is Revatio, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Important information

Sildenafil (Viagra Connect, Pfizer) is to be formally reclassified from a prescription only medicine (POM) to a pharmacy medicine (P), the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

Sildenafil will be available through pharmacy outlets, following a discussion with the pharmacist, for adult men with erectile dysfunction. The drug will be sold at a maximum daily dose of 50mg and a maximum pack size of eight tablets.

The decision to reclassify the drug was made following an assessment of the safety of sildenafil, advice from the Commission on Human Medicines and a public consultation earlier this year. The drug will not be sold to those with severe cardiovascular disorders, liver failure, severe kidney failure or individuals taking certain interacting medicines.

“This decision is good news for men’s health,” said Mick Foy, MHRA group manager in vigilance and risk management of medicines.

“The move to make Viagra Connect more widely accessible will encourage men to seek help within the healthcare system and increase awareness of erectile dysfunction,” he added.

President of the Royal Pharmaceutical Society, Ash Soni, welcomed the MHRA’s decision to switch sildenafil to a P medicine.

“Discussing health problems with patients and advising on the benefits and risks of treatment options is an integral part of the role of a pharmacist,” he said.

“The switch will increase access to a medicine that has been proven safe and effective through over 15 years of use by many millions of men, and provides a genuine and safe source of supply of one of the world’s most counterfeited medicines,” he added.

Pfizer is currently working on plans to launch the drug in the UK in the spring of 2018. According to Pfizer, in the interim the company will be implementing an extensive training and education programme within pharmacies.

“We understand some men may avoid seeking support and treatment for this condition so we believe giving them the option to talk to a pharmacist and buy Viagra Connect could be a real step forward in encouraging more men into the healthcare system,” said Berkeley Phillips, UK medical director at Pfizer Ltd.

“As erectile dysfunction may be a sign of an underlying condition such as diabetes, high blood pressure, or heart disease, there could also be a wider benefit to public health in the long term,” he added.

Before taking this medicine

You should not use sildenafil if you are allergic to it,

if you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).

Do not take sildenafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (“poppers”). Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure sildenafil is safe for you, tell your doctor if you have ever had:

heart disease or heart rhythm problems, coronary artery disease;
a heart attack, stroke, or congestive heart failure;
high or low blood pressure;
liver or kidney disease;
a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
a bleeding disorder such as hemophilia;
a stomach ulcer;
retinitis pigmentosa (an inherited condition of the eye);
a physical deformity of the penis (such as Peyronie’s disease); or
if you have been told you should not have sexual intercourse for health reasons.

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Sildenafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking sildenafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoked or were over 50 years old. It is not clear whether sildenafil is the actual cause of vision loss.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give sildenafil to anyone under 18 years old without medical advice.

Before taking sildenafil

Take sildenafil exactly as it was prescribed for you Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Revatio is usually taken three times each day, about 4 to 6 hours apart.

Viagra is usually taken only when needed, 30 minutes to 1 hour before sexual activity. You may take it up to 4 hours before sexual activity. Do not take Viagra more than once per day.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Viagra can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor’s instructions.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.

Store at room temperature away from moisture and heat.

If I miss a dose

Since Viagra is used as needed, you are not likely to miss a dose.

If you miss a dose of Revatio, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Sildenafil Side Effects

Applies to sildenafil: oral powder for suspension, oral tablet

Other dosage forms:

intravenous solution

Along with its needed effects, sildenafil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sildenafil:

Less common

Bladder pain
burning feeling in the chest or stomach
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
cloudy or bloody urine
dizziness
increased frequency of urination
indigestion
pain on urination
stomach upset
tenderness in the stomach area

Rare

Abnormal vision
anxiety
behavior change similar to drunkenness
bleeding of the eye
blurred vision
bone pain
breast enlargement
chest pain
chills
cold sweats
confusion
convulsions (seizures)
cool and pale skin
deafness or hearing loss
decrease in amount of urine or the frequency of urination
decreased vision
difficulty in concentrating
dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position
double vision
drowsiness
dry eyes
dry mouth
dryness, redness, scaling, or peeling of the skin
excessive hunger
eye pain
fainting or faintness
fast, irregular, or pounding heartbeat
feeling of something in the eye
fever or chills
headache (severe or continuing)
increase in the size of the pupil
increased sweating
increased thirst
lower back or side pain
migraine headache
nausea (severe or continuing)
nervousness
nightmares
numbness of the hands
painful, swollen joints
prolonged, painful erection of penis
redness, burning, or swelling of the eyes
redness, itching, or tearing of the eyes
restless sleep
seeing shades of colors differently than before
sensitivity to light
shakiness
skin lesions with swelling
skin paleness
skin rash, hives, or itching
skin ulcers
slurred speech
sore throat
sudden weakness
swelling of the face, hands, feet, or lower legs
trouble breathing
twitching of the muscles
unusual feeling of burning or stinging of the skin
unusual tiredness or weakness
vision changes
vision loss, temporary

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Some side effects of sildenafil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Aches or pains in the muscles
bloody nose
diarrhea
difficult or labored breathing
flushing
headache
pain or tenderness around the eyes and cheekbones
redness of the skin
sneezing
stomach discomfort following meals
stuffy or runny nose
trouble sleeping
unusually warm skin

Rare

Abdominal or stomach pain
abnormal dreams
anxiety
clumsiness or unsteadiness
cough
diarrhea or stomach cramps (severe or continuing)
difficulty in swallowing
ear pain
increased amount of saliva
increased skin sensitivity
lack of coordination
loss of bladder control
mental depression
nausea
numbness or tingling of the hands, legs, or feet

Avoid that while taking sildenafil

Drinking alcohol with this medicine can cause side effects.

Grapefruit and grapefruit juice may interact with sildenafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking sildenafil.

Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor.

Call your doctor at once if you have:

ringing in your ears, or sudden hearing loss;
irregular heartbeat;
swelling in your hands, ankles, or feet;
shortness of breath;
seizure (convulsions); or
a light-headed feeling, like you might pass out.

Common sildenafil side effects may include:

flushing (warmth, redness, or tingly feeling);
headache, dizziness;
abnormal vision (blurred vision, changes in color vision)
runny or stuffy nose, nosebleeds;
sleep problems (insomnia);
muscle pain, back pain; or
upset stomach.

Sildenafil dosing information

Usual Adult Dose of Sildenafil for Erectile Dysfunction:

Initial dose: 50 mg orally once a day, as needed, 1 hour prior to sexual activity
Maintenance: 25 to 100 mg orally once a day, as needed, 1 hour prior to sexual activity

Comments: This drug may be taken anywhere from 30 minutes to 4 hours before sexual activity.

Use: Treatment of erectile dysfunction

Usual Adult Dose for Pulmonary Hypertension:

Revatio (R):
Oral:
-Initial dose: 5 or 20 mg orally three times a day, 4 to 6 hours apart
-Maximum dose: 20 mg orally three times a day

Injection:
-Initial dose: 2.5 or 10 mg IV bolus three times a day

Comments:
-No greater efficacy was achieved with oral doses higher than the maximum recommended dose.
-A 10 mg injection dose is predicted to provide pharmacological effect equivalent to the 20 mg oral dose.

Use: Treatment of PAH (WHO Group I) in adults to improve exercise ability and delay clinical worsening

Usual Geriatric Dose of Sildenafil for Erectile Dysfunction:

Initial dose: 25 mg orally once a day 1 hour prior to sexual activity

Use: Treatment of erectile dysfunction

What other drugs will affect sildenafil?

Do not take sildenafil with similar medications such as avanafil (Stendra), tadalafil (Cialis) or vardenafil (Levitra). Tell your doctor about all other medications you use for erectile dysfunction.

Tell your doctor about all your current medicines and any you start or stop using, especially:

drugs to treat high blood pressure or a prostate disorder;
an antibiotic – clarithromycin, erythromycin, or telithromycin;
antifungal medicine – ketoconazole or itraconazole; or
medicine to treat HIV/AIDS – atazanavir, indinavir, ritonavir, or saquinavir.

This list is not complete. Other drugs may interact with sildenafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Bottom Line

Sildenafil is used to treat erectile dysfunction (ED) and to reduce blood pressure in pulmonary arterial hypertension (PAH). It is taken when needed for ED and on a daily basis for PAH. A headache, stomach upsets and flushing are the main side effects.

Tips

If you are taking sildenafil (Viagra) for ED, do not take more than once a day. If you are taking sildenafil (Revatio) for PAH, take as directed (usual dosage is three times daily).
Do not consume grapefruit or grapefruit products while taking sildenafil.
Always talk to your doctor before taking ANY medication for ED. Some ED medications are not suitable for men with certain medical conditions, and your doctor can advise you on an alternative.
Call your doctor immediately if you experience dizziness or feel nauseous during sexual activity, or develop pain, numbness, tingling in your chest, arms, neck, or jaw.
Do not take sildenafil if you are also taking a nitrate drug (such as nitroglycerin or isosorbide dinitrate/mononitrate) for chest pain or heart problems. Do not take sildenafil with recreational drugs such as “poppers”. Taking these substances together can cause a sudden and dangerous drop in blood pressure.
Always buy your ED medications from a reputable supplier as there are a lot of counterfeit products on the market.
Certain lifestyle and psychological factors, such as smoking, drinking, and stress, can impact on ED. Eliminating these – for example, staying more active, losing weight if you are overweight, reducing alcohol intake, stopping smoking and reducing stress – may also help improve ED.
Never take other ED medications at the same time as taking sildenafil. Do not take Viagra while taking Revatio and vice-versa.
Seek urgent medical advice if an allergic reaction, sudden vision loss or painful erections lasting more than four hours occur.
Drinking alcohol after taking sildenafil may lower blood pressure and decrease sexual performance.