Sildenafil, Oral/Injection (Pulmonary Hypertension)

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KEY POINTS

• This medicine is taken by mouth or given via injection to treat pulmonary hypertension. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Do not start or stop taking any other medicine without your healthcare provider’s advice.

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What are other names for this medicine?

Type of medicine: PDE-5 inhibitor; antihypertensive

Generic and brand names: sildenafil, oral; sildenafil, injection; Revatio

What is this medicine used for?

This medicine is taken by mouth or given by injection to treat pulmonary hypertension (high blood pressure in the lungs) in adults.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A heart attack, coronary artery disease, or chest pain
• A stroke or transient ischemic attack (TIA)
• Arrhythmias (irregular heartbeat)
• Bleeding problems such as hemophilia or conditions causing thickened blood or slower blood flow, such as leukemia; multiple myeloma (tumors of the bone marrow); polycythemia; sickle cell disease; or thrombocythemia
• Diabetes
• High cholesterol
• High or low blood pressure or blood circulation problems
• Kidney problems
• Liver problems
• Problems with dehydration
• Pulmonary veno-occlusive disease (PVOD), which is narrowing of blood vessels in your lungs
• Retinitis pigmentosa or any eye disorder that caused loss of vision
• Ulcers

Do not take this medicine if you are taking riociguat or nitrate products (such as nitroglycerin, isosorbide dinitrate, or isosorbide mononitrate).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

This medicine comes as a tablet and a liquid. Check the label on the medicine for directions about your specific dose. Take your dosage of this medicine exactly as your healthcare provider prescribes. Take the medicine at the same times every day, about 4 to 6 hours apart. Do not take more than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food.

If you have the liquid form of this medicine, shake the bottle well for at least 10 seconds before taking a dose. Use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct. Do not mix the liquid with any other product. Ask your pharmacist about anything you do not understand.

The injection form of this medicine will be given by a healthcare provider.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: chest pain, nausea, irregular heartbeat, lightheadedness fainting.

What should I watch out for?

This medicine may affect your vision. You may have trouble telling the difference between blue and green. Talk with your healthcare provider about this. If you have a sudden loss of vision in one or both eyes, contact your healthcare provider or get medical help right away.

This medicine may cause sudden decrease or loss of hearing, ringing in the ears, or dizziness. If this happens, contact your healthcare provider or get medical care right away.

This medicine may lower your blood pressure and cause you to feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves. Do not drive or operate machinery unless you are fully alert.

Rarely, this medicine may cause a painful erection of the penis that does not return to normal within 4 hours. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

Adults over the age of 65 or people who are underweight may be at greater risk for side effects.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. If you need emergency medical care for a heart problem, it is very important you inform the healthcare provider when you last took this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Erection that is painful or lasts longer than 4 hours; dizziness; fainting; change in vision or abnormal vision (eyes sensitive to light, blurred vision, change in color vision); loss of hearing or ringing in the ears; chest pain; fast or pounding heartbeat; worsening shortness of breath; nosebleeds; numbness or tingling in the hands or feet; unexplained swelling in hands, ankles, or feet; seizures.

Other: Headache, nausea, flushing, diarrhea, runny or stuffy nose, back pain, muscle aches, trouble sleeping, heartburn.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Alprostadil (Caverject, Edex, Muse)
• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as haloperidol (Haldol) and pimozide (Orap)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), and sotalol (Betapace, Sorine)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), ceritinib (Zykadia), dabrafenib (Tafinlar), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), and mitotane (Lysodren)
• Cimetidine (Tagamet)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Heart or blood pressure medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), chlorothiazide (Diuril), chlorthalidone, diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), eplerenone (Inspra), furosemide (Lasix), hydralazine, hydrochlorothiazide (Microzide), lisinopril (Prinivil, Zestril), losartan (Cozaar), methyldopa, nicardipine (Cardene), quinidine, valsartan (Diovan), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Lumacaftor/ivacaftor (Orkambi)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as aprepitant (Emend) and netupitant/palonosetron (Akynzeo)
• Nefazodone
• Nitrate medicines such as isosorbide (Dilatrate, Isordil, Monoket) and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)
• Other medicines to treat pulmonary hypertension such as riociguat (Adempas) and tadalafil (Adcirca)
• Propranolol (Hemangeol, Inderal, InnoPran)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Vasodilators such as hydralazine, isoxsuprine, minoxidil, and nesiritide (Natrecor)
• Warfarin (Coumadin)

Do not drink alcohol unless your healthcare provider approves.

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the tablets at room temperature. Store the liquid form of this medicine at room temperature or in the refrigerator. Do not freeze.

Keep the medicine container tightly closed. Protect it from heat, high humidity, and bright light.

If you have the liquid, discard any unused medicine after 60 days.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.