Revatio

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Contraindications

Hypersensitivity

Soluble guanylate cyclase (sGC) stimulators (eg, riociguat); concomitant use can cause hypotension

Coadministration with nitrates

• Coadministration with nitrates (either regularly and/or intermittently) and nitric oxide donors
• Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates
• A suitable time interval following PDE5 dosing for the safe administration of nitrates or nitric oxide donors has not been determined

Cautions

Elicits vasodilatory properties, resulting in mild and transient decreases in blood pressure

Use with caution in patients with anatomic deformation of penis (eg, angulation, cavernosal fibrosis, or Peyronie disease), conditions potentially predisposing to priapism (eg, sickle cell anemia, multiple myeloma, or leukemia), cardiovascular disease, bleeding disorders, active peptic ulcer disease, liver disease, renal impairment, multidrug antihypertensive regimens, retinitis pigmentosa, concomitant use of CYP3A4 inhibitors

Pulmonary vasodilators may significantly worsen cardiovascular status of patients with pulmonary veno-occlusive disease

Patient taking alpha blocker should be stabilized before starting phosphodiesterase (PDE)-5 inhibitor, which should be initiated at lowest dose; if patient is already taking optimized dose of PDE-5 inhibitor, alpha blocker should be initated at lowest dose to avoid hypotension

Not to be taken with other PDE-5 inhibitors

Sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness

Viagra: Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in 1 or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION); use with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION; patients with a ”crowded” optic disc may also be at an increased risk of NAION; advise patients to seek immediate medical attention in the event of a sudden loss of vision

Viagra: Potential for cardiac risk with sexual activity in patients with preexisting cardiovascular disease; therefore, treatment for erectile dysfunction generally should not be instituted in men for whom sexual activity is inadvisable because of their underlying cardiovascular status

May cause dose-related impairment of color discrimination; use caution in patients with retinitis pigmentosa

Evaluate underlying causes of erectile dysfunction or BPH before initiating therapy

Revatio: In small, prematurely terminated study of patients with PAH secondary to sickle-cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil than by those randomized to placebo; effectiveness of sildenafil in PAH secondary to sickle-cell anemia has not been established; the clinical relevance to men treated for erectile dysfunction with sildenafil is not known

Revatio: Not for use in children with PAH; increased mortality with increasing doses (hazard ratio 3.5) was observed in randomized, double-blind, placebo-controlled clinical trial of 234 children (1-17 years) with PAH who had mild-to-moderate symptoms at baseline

Revatio: Epistaxis occurred in 13% of patients with PAH secondary to connective tissue disease (eg, scleroderma); this effect was not seen in idiopathic PAH; incidence was also higher in those receiving concomitant PO vitamin K antagonist therapy (9%) than in those not receiving such therapy (2%)

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of the following:

• medicines called alpha blockers. These include Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl) or Uroxatral (alfuzosin HCl). Alpha blockers are sometimes prescribed for prostate problems or high blood pressure. If sildenafil is taken with certain alpha blockers, your blood pressure could suddenly drop and you could get dizzy or faint.
• other medicines to treat high blood pressure (hypertension)
• medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• medicines or treatments for Erectile dysfunction.

Do not take Revatio if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.

• Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.
• Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates.

This is not a complete list of Revatio drug interactions. Ask your doctor or pharmacist for more information.

It is not known if Revatio or its metabolites are excreted in human breast milk. Because many drugs pass into human milk, caution should be used when Revatio is administered to a nursing woman.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Revatio is usually taken three times each day, about 4 to 6 hours apart.

Viagra is usually taken only when needed, 30 minutes to 1 hour before sexual activity. You may take it up to 4 hours before sexual activity. Do not take Viagra more than once per day.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Viagra can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.

Store at room temperature away from moisture and heat.

• Tell all of your health care providers that you take this medicine. 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 Revatio 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.
• Do not take this medicine with other drugs used to treat a change in sex ability.
• Talk with your doctor before you drink alcohol.
• Very bad and sometimes deadly side effects like a heartbeat that does not feel normal, heart attack, stroke, and very bad high blood pressure have happened with Revatio. Talk with the doctor.
• A very bad eye problem has rarely happened with this medicine. This may lead to a change in eyesight and sometimes loss of eyesight, which may not come back. Talk with the doctor.
• If you are 65 or older, use Revatio with care. You could have more side effects.
• This medicine is not approved for use in children. A higher rate of death has been seen in children as the dose of this medicine gets higher. However, your child's doctor may decide the benefits of taking Revatio may outweigh the risks. If your child has been given this medicine, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving Revatio to your child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Revatio (sildenafil tablets (PAH)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Take Revatio at the same time of day.
• To gain the most benefit, do not miss doses.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Loose stools (diarrhea).
• Flushing.
• Headache.
• Belly pain or heartburn.
• Upset stomach.
• Stuffy nose.
• Runny nose.
• Muscle pain.
• Redness.
• Nosebleed.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Nitrates

Concomitant use of Revatio with nitrates in any form is contraindicated [see Contraindications (4)].

Ritonavir and other Potent CYP3A Inhibitors

Concomitant use of Revatio with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].

Other drugs that reduce blood pressure

Alpha blockers. In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, were observed. Mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were also observed. There were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.

Amlodipine. When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.

Monitor blood pressure when co-administering blood pressure lowering drugs with Revatio [see Warnings and Precautions (5.2)].

In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

Revatio® (re-VAH-tee-oh)
(sildenafil) tablets

Revatio® (re-VAH-tee-oh)
(sildenafil)
oral suspension

Read this Patient Information before you start taking Revatio and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Revatio, ask your doctor or pharmacist.

What is the most important information I should know about Revatio?

Never take Revatio with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level.

Nitrate medicines include:

• Medicines that treat chest pain (angina)
• Nitroglycerin in any form including tablets, patches, sprays, and ointments
• Isosorbide mononitrate or dinitrate
• Street drugs called "poppers" (amyl nitrate or nitrite)

Guanylate cyclase stimulators include:

• Riociguat (Adempas)

Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.

What is Revatio?

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.

• Revatio is not for use in children
• Adding Revatio to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.

Revatio contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take Revatio with VIAGRA or other PDE-5 inhibitors.

Who should not take Revatio?

Do not take Revatio if you:

• take nitrate medicines. See "What is the most important information I should know about Revatio?"
• take guanylate cyclase stimulator medicines. See "What is the most important information I should know about Revatio?"
• are allergic to sildenafil or any other ingredient in Revatio. See "What are the ingredients in Revatio?" at the end of this leaflet.

What should I tell my doctor before taking Revatio?

Tell your doctor about all of your medical conditions, including if you

• have heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attack
• have a disease called pulmonary veno-occlusive disease (PVOD)
• have high or low blood pressure or blood circulation problems
• have an eye problem called retinitis pigmentosa
• have or had loss of sight in one or both eyes
• have any problem with the shape of your penis or Peyronie's disease
• have any blood cell problems such sickle cell anemia
• have a stomach ulcer or any bleeding problems
• are pregnant or planning to become pregnant. It is not known if Revatio could harm your unborn baby.
• are breastfeeding. It is not known if Revatio passes into your breast milk or if it could harm your baby.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Revatio and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Revatio.

Especially tell your doctor if you take

• Nitrate medicines. See "What is the most important information I should know about Revatio?"
• Riociguat (Adempas). See "What is the most important information I should know about Revatio?"
• Ritonavir (Norvir®) or other medicines used to treat HIV infection
• Ketoconazole (Nizoral®)
• Itraconazole (Sporanox)
• High blood pressure medicine

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How should I take Revatio?

• Take Revatio exactly as your doctor tells you.

Revatio may be prescribed to you as

• Revatio tablets or Revatio oral suspension
• Take Revatio tablet or oral suspension 3 times a day about 4 to 6 hours apart
• Take Revatio tablets or oral suspension at the same times every day.
• Revatio oral suspension will be mixed for you by your pharmacist. Do not mix Revatio oral suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.
• Do not take more than one dose of Revatio at a time.
• Do not change your dose or stop taking Revatio on your own. Talk to your doctor first.
• If you take too much Revatio, call your doctor or go to the nearest hospital emergency room.

What are the possible side effects of Revatio?

• 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.

The most common side effects with Revatio include:

Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.

Tell your doctor if you have any side effect that bothers you or doesn't go away.

These are not all the possible side effects of Revatio. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Revatio?

• Store Revatio tablets at controlled room temperature, between 20°C –25°C (68°F to 77°F).
• Store Revatio constituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F).
• Do not freeze Revatio oral suspension.
• Throw away Revatio oral suspension after 60 days.
• Keep Revatio and all medicines away from children.

General information about Revatio

Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use Revatio for a condition for which it was not prescribed. Do not give Revatio to other people, even if they have the same symptoms you have. It could harm them.

This patient leaflet summarizes the most important information about Revatio. If you would like more information about Revatio talk with your doctor. You can ask your doctor or pharmacist for information about Revatio that is written for health professionals.

For more information go to www.Revatio.com or call 1-800-879-3477.

What are the ingredients in Revatio?

Revatio tablets

Active ingredients: sildenafil citrate

Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin

Revatio for oral suspension

Active ingredients: sildenafil citrate

Inactive ingredients: sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide , sodium benzoate, colloidal silicon dioxide anhydrous, and grape flavor

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

This Patient Information has been approved by the U.S. Food and Drug Administration

LAB-0335-10.0
April 2015

Instructions for Use

Revatio® (re-VAH-tee-oh)
(sildenafil) oral suspension

Read this Instructions for Use for Revatio oral suspension before you start taking and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Important information:

• Your pharmacist should tell you how to measure Revatio oral suspension by using the oral syringe provided in the pack.
• Revatio oral suspension should only be given using the oral syringe supplied with each pack.
• Revatio for oral suspension should not be mixed with any other medicine or flavoring.

Supplies you will need to take Revatio oral suspension:

• Bottle of Revatio oral suspension with syringe adaptor fitted in neck of bottle
• Oral syringe (as supplied by pharmacist). (See Figure A)

Figure A

1. Shake the bottle of Revatio oral suspension for 10 seconds before each use. (See Figure B)
2. Remove the cap. Open the bottle by pushing downward on the cap and twisting it in the direction of the arrow (counter-clockwise). (See Figure B)
   

   Figure B

3. Insert the tip of the oral syringe into the adaptor while the bottle is upright, on a flat surface. Fully push down (depress) the plunger of the syringe. (See Figure C)
   

   Figure C

4. Turn the bottle upside down while holding the oral syringe in place. Slowly pull back the plunger of the oral syringe until the bottom of the plunger is even with the graduation markings on the syringe for the prescribed dose for you. Take your dose of Revatio oral suspension exactly as prescribed by your doctor. If air bubbles can be seen, slowly push the oral suspension in the syringe back into the bottle. Repeat steps 3 and 4. (See Figure D)
   

   Figure D

5. Turn the bottle back upright with the oral syringe still in place. Remove the oral syringe from the bottle by pulling straight up on the barrel of the oral dosing syringe. (See Figure E)
   

   Figure E

6. Put the tip of the oral syringe into your mouth. Point the tip of the oral syringe towards the inside of the cheek. Slowly push down the plunger of the oral syringe. (See Figure F)
   

   Figure F

7. Replace the cap on the bottle, leaving the bottle adaptor in place. Wash the oral syringe as instructed below.
8. The syringe should be washed after each dose. Pull the plunger out of the barrel and rinse both parts with water. (See Figure G)
   

   Figure G

9. Dry all parts with a clean paper towel. Push the plunger back into the barrel. Store the syringe with Revatio oral suspension in a clean safe place.

Administer Revatio oral suspension using the oral syringe supplied with each pack. Refer to the patient instructions for use for more detailed instructions for use. Discard any unused suspension after the expiration date written on the bottle.

How should I store Revatio?

• Store Revatio constituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to46°F).
• Do not freeze Revatio oral suspension
• Throw away (discard) Revatio oral suspension after 60 days.
• Keep Revatio and all medicines away from children.

This Instruction for Use has been approved by the U.S. Food and Drug Administration.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

LAB-0575-3.0
January 2014

Jan/2014

NDC 0069-0336-21

Revatio®
(sildenafil) for
oral suspension

10 mg/mL

For Oral Use Only
Shake Well Before Each Use

112 mL following Constitution

Grape Flavored

Pfizer

Rx only

If you miss a dose of Revatio, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take Revatio with similar medications such as avanafil (Stendra), tadalafil (Cialis) or vardenafil (Levitra).

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antibiotic such as clarithromycin, erythromycin, or telithromycin;

• antifungal medicine such as ketoconazole or itraconazole;

• medicine to treat HIV/AIDS, such as atazanavir, indinavir, ritonavir, or saquinavir; or

• drugs to treat high blood pressure or a prostate disorder.

This list is not complete. Other drugs may interact with sildenafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.