Revatio Injection

(Sildenafil Citrate)

The active ingredient in Revatio is sildenafil, which is a PDE-5 inhibitor. It contains the same medicine as Viagra, which is used to treat erectile dysfunction (impotence).

It works by inhibiting the enzyme phosphodiesterase-5 (PDE-5) in the blood vessels of the lungs. This prevents the breakdown of cyclic GMP (cGMP), leading to relaxation and widening of pulmonary blood vessels. As a result, pulmonary blood pressure decreases, blood flow through the lungs improves, and the heart does not have to work as hard, which helps improve exercise capacity in patients with pulmonary arterial hypertension.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Revatio. However, the following is a synopsis of the general guidelines for the use of Revatio:

• Revatio may be taken as an oral tablet, oral suspension, or IV dose when oral use is not possible.
• It is usually given three times daily by mouth, spaced evenly throughout the day.
• The oral suspension must be shaken well before use.
• The IV dose is given by a healthcare professional as a slow injection.
• Do not take Revatio with nitrates or products sometimes known as “poppers,” as this can cause dangerous drops in blood pressure.
• If you miss a dose, take it as soon as possible unless it is almost time for your next dose. Do not double doses.

Some mild or common side effects of sildenafil seen in clinical trials include:

• Headache.
• Flushing.
• Upset stomach or diarrhea.
• Nasal congestion.
• Back pain.
• Sleep difficulty.
• Nosebleeds.

Some individuals may experience serious side effects while using Revatio. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Sudden loss of vision or blurred vision, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION).
• Sudden decrease or loss of hearing, sometimes with ringing.
• Chest pain, shortness of breath, or signs of a heart attack.
• Signs of very low blood pressure, such as fainting or lightheadedness.
• Priapism (erection lasting more than 4 hours).
• Worsening shortness of breath in individuals with pulmonary veno-occlusive disease (PVOD).
• Severe allergic reactions, including hives, swelling, or difficulty breathing.

These are not all of the possible adverse events of Revatio. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Revatio, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Heart disease, including heart failure, angina, a history of heart attack, or other heart problems.
• Erectile dysfunction or Peyronie’s disease.
• Low blood pressure or uncontrolled high blood pressure.
• Pulmonary veno-occlusive disease.
• Bleeding disorders or stomach ulcers.
• Eye problems such as retinitis pigmentosa.
• Sickle cell anemia or any other blood cell issues.
• Conditions that increase the risk of prolonged erections.
• Liver or kidney problems.
• Any allergies to medications.

Revatio should not be used in individuals who:

• Take nitrates such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate.
• Use nitric oxide donors, including amyl nitrite or amyl nitrate.
• Use riociguat, a soluble guanylate cyclase stimulator.
• Have known hypersensitivity to sildenafil or any component of the formulation.

Revatio begins working within a few hours of a dose. Symptom improvement may take days or weeks, depending on the severity of pulmonary arterial hypertension and individual response.

When Revatio is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Nitrates, because the combination can cause severe drops in blood pressure.
• Riociguat, because combined use may lead to dangerously low blood pressure.
• Alpha-blockers, due to the risk of low blood pressure.
• Certain HIV medicines, such as ritonavir, can raise sildenafil levels.
• Viagra.
• Epoprostenol.
• Azole antifungals such as ketoconazole and itraconazole, because they slow sildenafil breakdown.
• Certain antibiotics, such as clarithromycin, may increase sildenafil levels.
• Bosentan may lower sildenafil levels.

Revation comes in multiple dosage forms, such as oral tablets, oral suspension, and an IV injection.

It should be stored at room temperature, away from the reach of children or pets.

Revatio is manufactured by Pfizer Inc.

Yes, sildenafil is available as a generic.

Do not stop taking Revatio without speaking with your doctor. Stopping suddenly may worsen symptoms of pulmonary arterial hypertension. Your healthcare provider will advise the safest way to make changes if needed.

It is not known if Revatio could harm your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed, as it is not certain if this drug passes into the breast milk. They will know or recommend what is best for you.