Vardenafil HCL, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat erectile dysfunction. Take it exactly as directed.
• This medicine may cause hearing loss, vision loss, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Do NOT take this medicine if you are taking riociguat or nitrate medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: PDE-5 inhibitor; erectile dysfunction therapy

Generic and brand names: vardenafil HCL, oral; Levitra; Staxyn

What is this medicine used for?

This medicine is taken by mouth to treat erectile dysfunction (when a man is unable to get and keep his penis erect for sexual intercourse). This medicine is prescribed for men only.

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 surgery, heart attack, coronary artery disease, irregular heartbeat, or chest pain
• A stroke or transient ischemic attack (TIA)
• A deformed penis shape, including curved penis or birth defects of the penis
• Bleeding problems such as hemophilia
• 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
• Fructose intolerance. The orally disintegrating tablets contain sorbitol.
• High blood pressure or low blood pressure
• Kidney problems
• Liver problems
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Phenylketonuria (PKU). The orally disintegrating tablets contain phenylalanine.
• Priapism (erection lasting longer than 4 hours)
• Retinitis pigmentosa or any eye disorder that causes loss of vision
• Ulcers

This medicine can interact with many other medicines and cause harmful side effects. It is very important that you tell your healthcare provider about all the prescription medicines, nonprescription medicines, or supplements you take.

• Do not take this medicine if you are taking riociguat for pulmonary hypertension, or any nitrate product for the treatment of angina or chest pain.
• Tell your healthcare provider if you are using any other treatment for erectile dysfunction.
• Also, tell your healthcare provider if you are taking an alpha blocker, such as alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, or terazosin. If this medicine is taken with an alpha blocker, you may have low blood pressure or fainting.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take your dosage of this medicine exactly as your healthcare provider prescribes. Do not take more than prescribed. Do not take this medicine more than once a day.

This medicine is not for use in children. Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food.

This medicine may improve the ability to have sexual activity within 60 minutes of when you take it. There must be some sexual stimulation in order for this medicine to work. Ask your healthcare provider or pharmacist if you have any questions.

This medicine comes in regular tablets (Levitra) and orally disintegrating tablets (Staxyn). They are not the same. Do not change brands unless your healthcare provider approves.

If you are taking the orally disintegrating tablets, do not remove from the blister pack until needed. Peel the backing off the blister pack. Do not push the tablet through the packaging. With dry hands, place a tablet on your tongue and let it dissolve in your mouth before swallowing. Do not take the orally disintegrating tablet with liquid.

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: back pain, muscle pain, vision problems.

What should I watch out for?

This medicine may affect your vision. If you have a sudden loss of vision, contact your healthcare provider right away. You may also have blurred vision, problems with night vision, or trouble telling the difference between blue and green. Talk with your healthcare provider about this.

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

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert. Also, drinking alcohol may make it worse. Alcohol may increase your chances of getting a headache or dizzy, increasing your heart rate, or lowering your blood pressure. Do not drink alcohol unless your healthcare provider approves.

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.

The use of this medicine does not protect against sexually transmitted diseases.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

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; rash; chest pain; fast or pounding heartbeat; trouble breathing; loss of vision or abnormal vision (eyes sensitive to light, blurred vision, change in color vision); loss of hearing or ringing in the ears; severe nausea or vomiting.

Other: Headache, mild nausea, flushing, stuffy or runny nose, sore throat, back pain, muscle aches, pain or burning when urinating, diarrhea.

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:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), dutasteride/tamsulosin (Jalyn), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Alprostadil (Caverject, Edex, Muse)
• Anagrelide (Agrylin)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Apomorphine (Apokyn)
• 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 arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), degarelix (Firmagon), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cisapride
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Ezogabine (Potiga)
• Fingolimod (Gilenya)
• Heart or blood pressure medicines such as aliskiren (Tekturna), amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), chlorothiazide (Diuril), chlorthalidone, diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), eplerenone (Inspra), flecainide, furosemide (Lasix), hydralazine, hydrochlorothiazide (Microzide), ibutilide (Corvert), lisinopril (Prinivil, Zestril), losartan (Cozaar), methyldopa, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, valsartan (Diovan), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as arformoterol (Brovana) and formoterol (Perforomist)
• Medicines to treat pulmonary hypertension such as riociguat (Adempas), sildenafil (Revatio), and tadalafil (Adcirca)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), granisetron (Sancuso), netupitant/palonosetron (Akynzeo), ondansetron (Zofran), and promethazine
• Nitrate medicines such as amyl nitrite inhalant, isosorbide (Dilatrate, Isordil, Monoket) and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)
• Other erectile dysfunction medicines
• Pain medicines such as buprenorphine (Buprenex, Butrans) and methadone (Dolophine, Methadose)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Phenoxybenzamine (Dibenzyline)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• St. John's wort
• Tetrabenazine (Xenazine)
• Vasodilators such as isoxsuprine, minoxidil, and nesiritide (Natrecor)

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.

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

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

---

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.