Revatio (Intravenous)

Sildenafil injection is used to treat the symptoms of pulmonary arterial hypertension. This is a type of high blood pressure that happens 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 is part of a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. It works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase blood flow to the lungs and lessen the workload on the heart.

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

It is very important that your doctor check your progress while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not take Viagra® or other PDE5 inhibitors, such as 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.

Do not use this medicine if you are also using a nitrate medicine for chest pain (angina). Some examples of nitrate medicines are: isosorbide, nitroglycerin, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® ointment, Nitrolingual® spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs or "poppers" also contain nitrates, including amyl nitrate, butyl nitrate, or nitrite. Do not use this medicine if you also use riociguat (Adempas®).

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.

Sildenafil injection could make your blood pressure go too low. Tell your doctor right away 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.

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

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 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.

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. 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 inform your healthcare 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 effects of sildenafil injection in children younger than 1 year of age. Safety and effectiveness have not been established.

Geriatric

Appropriate studies performed to date have not shown any specific problems in elderly patients that would limit the usefulness of sildenafil injection. 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 receiving sildenafil injection.

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. 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 receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on 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 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 necessary for your treatment. 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

Some medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may increase 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 about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Abnormal penis, including a curved penis or birth defects of the penis—The chance of problems may increase and this medicine should be used with caution in these patients.

• Angina (chest pain) or
• Arrhythmia (irregular heartbeat) or
• Heart attack or
• Heart disease or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Priapism, history of or
• Retinitis pigmentosa (an inherited eye disorder) or
• Stroke—Use with caution. May worsen side effects.

• 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 risk for a serious eye side effect called NAION.

• Bleeding disorders, history of or
• Stomach ulcer, or history of—The chance of problems may increase. It is not known if the medicine is safe for use in these patients.

• 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 due to the risk of prolonged erection of the penis.

• Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—May worsen this condition.

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

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody nose
• Chest tightness
• Difficult or labored breathing
• Fever
• Rapid weight gain
• Tingling of the hands or feet
• Unusual weight gain or loss

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings

Incidence not known

• Blindness
• Blurred vision
• Decreased hearing
• Decreased vision
• Loss of hearing
• Seizures

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, are bothersome, or if you have any questions about them:

More common

• Acid or sour stomach
• Belching
• Diarrhea
• Difficulty with moving
• Feeling of warmth
• Flushing or redness of the skin
• Headache
• Heartburn
• Indigestion
• Joint pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Nausea
• Pain in the arms or legs
• Redness of the face, neck, arms, and occasionally, upper chest
• Sleeplessness
• Stomach discomfort, upset, or pain
• Swollen joints
• Trouble sleeping
• Unable to sleep
• Unusually warm skin

Less common

• Burning feeling in the chest or stomach
• Cough
• Pain or tenderness around the eyes and cheekbones
• Runny nose
• Sneezing
• Stuffy or runny nose
• Tenderness in the stomach area

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

Available Dosage Forms:

• Solution

Therapeutic Class: Vasodilator

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

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