Overview

A phosphodiesterase type-5 inhibitor; vasodilator agent and urological agent that is used in the treatment of erectile dysfunction and primary pulmonary hypertension.

Description

A phosphodiesterase type-5 inhibitor; vasodilator agent and urological agent that is used in the treatment of erectile dysfunction and primary pulmonary hypertension.

Usage

This medication can be taken with or without food. For optimal absorption, the medication is recommended to be taken on an empty stomach 1 hour before you eat or 2 hours after you eat. Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. 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. VIAGRA is a prescription medicine used to treat erectile dysfunction (ED). You will not get an erection just by taking this medicine. VIAGRA helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated). REVATIO is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs. REVATIO improves the ability to exercise and can slow down worsening changes in your physical condition. Doctors often prescribe this medication for off label use for erectile dysfunction for many reasons including cost of medication. VIAGRA® contains the same medicine as REVATIO, which is sildenafil citrate. Do not take REVATIO with VIAGRA or other PDE-5 inhibitors as Cialis/Adcirca (Tadalafil), Levitra/Staxyn (Vardenafil), Stendra/Vivus (Avanafil). Special patient instructions comes with sildenafil. Read the directions carefully before you start using sildenafil and each time you get a refill of your medicine.

Side Effects

**The most common side effects:** * headache * flushing * upset stomach * abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision * stuffy or runny nose * back pain * muscle pain * nausea * dizziness * rash **Rarely reported side effects include:** * low blood pressure. Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. * more shortness of breath than usual. Tell your doctor if you get more short of breath after you start REVATIO. More shortness of breath than usual may be due to your underlying medical condition. * decreased eyesight or loss of sight in one or both eyes (NAION). If you notice a sudden decrease or loss of eyesight, talk to your doctor right away. * sudden decrease or loss of hearing. If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including REVATIO, or to other diseases or medicines, to other factors, or to a combination of factors. * heart attack, stroke, irregular heartbeats, and death. Most of these happened in men who already had heart problems. * erections that last several hours. If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis. In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking VIAGRA. Most, but not all, of these men had heart problems before taking VIAGRA. It is not known if VIAGRA caused these problems. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Sildenafil. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088. You may also report side effects at [https://www.fda.gov/medwatch](http://).

Precautions

If you have an allergy to sildenafil or any other part of this drug; If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had; If you have a health problem called pulmonary veno-occlusive disease (PVOD). Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. ; Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.; To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.; Talk with your doctor before you drink alcohol.; Rarely, certain side effects like abnormal heartbeat, heart attack, stroke, bleeding in the lungs, and very bad high blood pressure have happened with this drug. Sometimes, this has been deadly. Most of the time, these problems happened in people who had heart problems before taking this drug. It is not known if this drug caused these problems. If you have questions, talk with the doctor.; A very bad eye problem has rarely happened with this drug. This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.; If you have sickle cell disease, talk with your doctor.; If you are 65 or older, use this drug with care. You could have more side effects.; This drug is not approved for use in children. A higher rate of death has been seen in children as the dose of this drug gets higher. However, your child's doctor may decide the benefits of taking this drug may outweigh the risks. If your child has been given this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.; Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: riociguat. Sildenafil can cause a serious drop in your blood pressure when used with nitrates. A serious drop in blood pressure can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use sildenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl nitrate, amyl nitrite, or butyl nitrite. If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may adjust your medications to minimize your risk of low blood pressure. Other medications can affect the removal of sildenafil from your body, which may affect how sildenafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as ritonavir, saquinavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), cobicistat, mifepristone, rifampin, among others. Do not take this medication with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil).

Storage

Store in a cool and dry place away from direct light. Ideal room temperature is 20°C -25°C (68°F to 77°F). Do not store in a bathroom. Keep all drugs in a safe place and out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

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