Revatio (Oral)

Sildenafil is used to treat men who have erectile dysfunction (also known as sexual impotence). Sildenafil is part of a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines slow down the action of an enzyme called phosphodiesterase type-5. This enzyme affects the penis among other areas.

Erectile dysfunction is when the penis does not become hard and expand when a man is sexually excited, or when he cannot maintain an erection. When a man is sexually stimulated, his body usually responds by increasing blood flow to his penis to create an erection. By managing the enzyme, sildenafil helps to keep an erection after the penis is stimulated. Sildenafil will not cause an erection without physical stimulation, such as during sexual intercourse.

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 affects the area between the heart and the lungs. When there is high blood pressure in the lungs, the heart has to work harder to pump enough blood through the lungs. Sildenafil acts on the PDE5 enzyme in the lungs to relax the blood vessels. This increases blood flow to the lungs and lessens the heart's workload.

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

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

Do not use this medicine if you are also taking a nitrate medicine, which is 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 known as "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) should also be avoided. Do not use this medicine if you are also using riociguat (Adempas®).

If you are taking this medicine for pulmonary arterial hypertension, your doctor will want to monitor your progress during regular visits. This will help your doctor determine if the medicine is working correctly and if you should keep taking it.

If you take sildenafil for pulmonary arterial hypertension, do not take Viagra® or other PDE5 inhibitors, such as tadalafil (Cialis®) or vardenafil (Levitra®). Viagra® also contains sildenafil. Taking too much sildenafil or combining it with these medicines increases the risk of side effects.

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

It is important to inform your doctor about any heart issues you currently have or have had in the past. This medicine can lead to serious side effects in patients with heart problems.

If you have a prolonged or painful erection lasting 4 hours or more, contact your doctor immediately. This condition may require urgent medical attention to prevent serious and permanent damage to your penis.

If you suddenly lose vision in one or both eyes, contact your doctor immediately.

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

If you are already taking medicine for high blood pressure (hypertension), sildenafil could cause your blood pressure to drop too low. Call your doctor immediately if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, 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 you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must weigh the risks of taking it against the benefits it may provide. For this medicine, please consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on the effects of sildenafil in children younger than 1 year of age. Its safety and effectiveness 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 long-term use.

Geriatric

Current studies have not shown any geriatric-specific problems that would limit the usefulness of sildenafil in older adults. However, elderly patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for those taking sildenafil.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this medicine, it is crucial for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily exhaustive.

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 necessary 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 increase the 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 taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions are based on their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following may raise the 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 provide special instructions regarding food, alcohol, or tobacco.

• Grapefruit Juice
• Pomelo Juice

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Abnormal penis, including a curved penis or birth defects of the penis—There may be an increased chance of problems, and this medicine should be used with caution in these cases.

• Angina (severe chest pain), unstable or
• Arrhythmia (irregular heartbeat, within the last 6 months) or
• Blood vessel problems (e.g., aortic stenosis, idiopathic subaortic stenosis) or
• Heart attack (within the last 6 months) or
• Heart failure or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Retinal disorders (eye problems) or
• Retinitis pigmentosa (an inherited eye disorder) or
• Stroke (within the last 6 months)—This medicine should not be used in patients with these conditions.

• Age greater than 50 years or
• Coronary artery disease or
• Crowded disc or low cup to disc ratio in the eye (an eye disorder) or
• Diabetes or
• Heart disease or
• Hyperlipidemia (high fats in the blood) or
• Hypertension (high blood pressure) or
• Non-arteritic anterior ischemic optic neuropathy or NAION (serious eye condition), history of or
• Smoking—May increase the chance of a serious side effect in the eye called NAION.

• Bleeding disorders, history of or
• Stomach ulcer, or history of or—There may be an increased chance of problems occurring. It is not known if the medicine is safe for use in these patients.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

• Leukemia (blood-related cancer) or
• Multiple myeloma (blood-related cancer) or
• Sickle-cell anemia (blood disorder)—Sildenafil should be used with caution in these patients, as prolonged erection of the penis may occur.

• Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—Use with caution. This condition may worsen.

Along with its intended effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have suggestions 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.

In the U.S.

• Revatio
• Viagra

Available Dosage Forms:

• Tablet
• Powder for Suspension
• Suspension

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

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.

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