Pronunciation:

sil-DEN-a-fil

Brand Names:

• Revatio

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Vasodilator

Pharmacologic—

Phosphodiesterase Type 5 Inhibitor

Uses of This Medicine:

Sildenafil injection is used 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 belongs to 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 the supply of blood to the lungs and reduce the workload of the heart.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sildenafil injection 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 injection.

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.

Other 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 receiving 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

Other interactions—

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

Other medical problems—

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

• Abnormal penis, including a curved penis or birth defects of the penis—Chance of problems occurring may be increased 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 cause side effects to become worse.

• 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 for a serious side effect in the eye called NAION.

• Bleeding disorders, history of or
• Stomach ulcer, or history of or—Chance of problems occurring may be increased. 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 as problems with prolonged erection of the penis may occur.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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 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 or 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.