Revatio (Sildenafil Oral)

Generic name: Sildenafil
Drug class: Agents for pulmonary hypertension

Usage of Revatio (Sildenafil Oral)

Sildenafil is used to treat men who have erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, sildenafil helps to maintain an erection after the penis is stroked. Without physical action to the penis, such as that occurring during sexual intercourse, sildenafil will not work to cause an erection.

Sildenafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. Sildenafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

This medicine is available only with your doctor's prescription.

Revatio (Sildenafil Oral) side effects

Along with its needed effects, a medicine 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:

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

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

seizures

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

Incidence not known

Blindness

Some side effects 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

rectal bleeding

redness or irritation of the tongue

redness, soreness, swelling, or bleeding of the gums

ringing or buzzing in the ears

sensation of motion, usually whirling, either of one's self or of one's surroundings

sexual problems in men (continuing), including failure to experience a sexual orgasm

sleepiness

sores in the mouth and on the lips

tense muscles

trembling and shaking

vomiting

waking to urinate at night

worsening of asthma

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Revatio (Sildenafil Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sildenafil in children younger than 1 year of age. Safety and efficacy have not been established.

Sildenafil should never be used in children for erectile dysfunction. In general, sildenafil should not be used for pulmonary arterial hypertension in children, especially for chronic use.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sildenafil in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving sildenafil.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amprenavir

Amyl Nitrite

Atazanavir

Boceprevir

Cobicistat

Darunavir

Erythrityl Tetranitrate

Fosamprenavir

Indinavir

Isosorbide Dinitrate

Isosorbide Mononitrate

Levoketoconazole

Lopinavir

Molsidomine

Nelfinavir

Nirmatrelvir

Nitroglycerin

Nitroprusside

Pentaerythritol Tetranitrate

Propatyl Nitrate

Riociguat

Ritonavir

Saquinavir

Telaprevir

Tipranavir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adagrasib

Belzutifan

Bosentan

Cannabis

Carbamazepine

Cenobamate

Ceritinib

Clarithromycin

Conivaptan

Dabrafenib

Dihydrocodeine

Duvelisib

Efavirenz

Enzalutamide

Etravirine

Fedratinib

Fexinidazole

Fluconazole

Fosnetupitant

Fosphenytoin

Idelalisib

Itraconazole

Ivosidenib

Ketoconazole

Larotrectinib

Lefamulin

Lenacapavir

Lorlatinib

Lumacaftor

Mavacamten

Mitotane

Modafinil

Nafcillin

Nefazodone

Netupitant

Olutasidenib

Omaveloxolone

Pacritinib

Phenobarbital

Phenytoin

Pirtobrutinib

Posaconazole

Primidone

Rifabutin

Rifampin

Rifapentine

Ritlecitinib

Simeprevir

St John's Wort

Telithromycin

Tocilizumab

Trofinetide

Vericiguat

Voriconazole

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfuzosin

Bunazosin

Ciprofloxacin

Delavirdine

Doxazosin

Erythromycin

Moxisylyte

Nebivolol

Prazosin

Silodosin

Tamsulosin

Terazosin

Trimazosin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Pomelo Juice

Relate drugs

How to use Revatio (Sildenafil Oral)

Use sildenafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects is increased.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully before you start using sildenafil and each time you get a refill of your medicine. Ask your doctor if you have any questions.

You may take this medicine with or without food.

To use the oral liquid:

Shake the bottle well for at least 10 seconds before each use.

Remove the cap by pushing it down and twisting it counter-clockwise. Push the plunger of the syringe, then insert the tip into the bottle while holding the bottle upright on a flat surface.

Slowly pull back the plunger until the required dose. If you see air bubbles in the syringe, repeat the steps. Remove the syringe from the bottle. Do not press on the plunger of the syringe.

Place the tip of the syringe into you or your child's mouth and point it towards the cheek.

This medicine usually begins to work for erectile dysfunction within 30 minutes after taking it. It continues to work for up to 4 hours, although its action is usually less after 2 hours.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For treatment of erectile dysfunction:

For oral dosage form (tablets):

Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed.

Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed.

Children—Use is not recommended.

For treatment of pulmonary arterial hypertension:

For oral dosage forms (suspension or tablets):

Adults—20 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 80 mg 3 times a day.

Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. Your doctor may adjust your dose as needed and tolerated. However the dose is usually not more than 40 mg 3 times a day.

Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day.

Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day.

Children younger than 1 year of age—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store mixed oral liquid in the refrigerator. Throw away any unused mixed Revatio® oral liquid after 60 days.

Warnings

It is important that you tell all of your doctors that you take sildenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil.

Do not use this medicine if you are also using a nitrate medicine, often used to treat angina or high blood pressure. Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® ointment, Nitrolingual® spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite). Do not use this medicine if you also use riociguat (Adempas®).

If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If you take sildenafil for pulmonary arterial hypertension, do not take Viagra® or other PDE5 inhibitors, including tadalafil (Cialis®) or vardenafil (Levitra®). Viagra® also contains sildenafil. If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher.

Sildenafil should not be used with any other medicine or device that causes erections.

It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

If you experience a sudden loss of vision in one or both eyes, contact your doctor immediately.

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness.

This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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