Pronunciation:

var-DEN-a-fil

Brand Names:

• Levitra
• Staxyn

Dosage Forms:

• Tablet
• Tablet, Disintegrating

Classifications:

Therapeutic—

Erectile Dysfunction Agent

Pharmacologic—

Phosphodiesterase Type 5 Inhibitor

Uses of This Medicine:

Vardenafil is used to treat men with erectile dysfunction (sexual impotence). It belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, avanafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, avanafil will not work to cause an erection.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Vardenafil is not indicated for use in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vardenafil in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amyl Nitrite
• Bepridil
• Cisapride
• Dronedarone
• Erythrityl Tetranitrate
• Fluconazole
• Isosorbide
• Isosorbide Dinitrate
• Isosorbide Mononitrate
• Ketoconazole
• Lefamulin
• Levoketoconazole
• Mesoridazine
• Nitroglycerin
• Pentaerythritol Tetranitrate
• Pimozide
• Piperaquine
• Posaconazole
• Propatyl Nitrate
• Riociguat
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Adagrasib
• Ajmaline
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Avacopan
• Azithromycin
• Bedaquiline
• Boceprevir
• Bretylium
• Bunazosin
• Buprenorphine
• Buserelin
• Carbamazepine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dapiprazole
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desflurane
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxazosin
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fosnetupitant
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Givinostat
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Isoflurane
• Itraconazole
• Ivabradine
• Ivosidenib
• Josamycin
• Lapatinib
• Larotrectinib
• Lenacapavir
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lonafarnib
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lumefantrine
• Macimorelin
• Mavorixafor
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mibefradil
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Moxisylyte
• Nafarelin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nirmatrelvir
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olutasidenib
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenoxybenzamine
• Phentolamine
• Pimavanserin
• Pipamperone
• Pirtobrutinib
• Pitolisant
• Ponesimod
• Prajmaline
• Prazosin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Revumenib
• Ribociclib
• Rilpivirine
• Risperidone
• Ritlecitinib
• Ritonavir
• Saquinavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Silodosin
• Simeprevir
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sparteine
• Sulpiride
• Sultopride
• Sunitinib
• Suzetrigine
• Tacrolimus
• Tamoxifen
• Tamsulosin
• Tazemetostat
• Tedisamil
• Telaprevir
• Telavancin
• Telithromycin
• Terazosin
• Tetrabenazine
• Tolazoline
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimazosin
• Trimipramine
• Triptorelin
• Trofinetide
• Troleandomycin
• Tucatinib
• Urapidil
• Vandetanib
• Vemurafenib
• Venlafaxine
• Vericiguat
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apalutamide
• Mavacamten

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormally shaped penis, including a curved penis and birth defects or
• Age greater than 50 years or
• Coronary artery disease or
• Crowded disc or low cup to disc ratio in the eye (an eye disorder) or
• Diabetes or
• Hyperlipidemia (high fats in the blood) or
• Hypertension (high blood pressure) or
• Leukemia (cancer of the blood) or
• Multiple myeloma (cancer of the blood) or
• Non-arteritic anterior ischemic optic neuropathy (NAION; serious eye condition), history of or
• Peyronie disease or
• Sickle-cell anemia (blood disorder) or
• Smoking—May increase the chance for a serious side effect in the eye called NAION.

• Angina (severe chest pain), unstable or
• Blood vessel problems (eg, aortic stenosis, idiopathic subaortic stenosis) or
• Heart attack (within the last 6 months) or
• Heart failure or
• Heart rhythm problems or
• Hypertension (high blood pressure), uncontrolled or
• Hypotension (low blood pressure) or
• Liver disease, severe or
• Retinal disorders (eye problem) or
• Retinitis pigmentosa (an inherited eye disorder) or
• Stroke, history of—Should not be used in patients with these conditions.

• Bleeding disorders or
• Stomach ulcers—Chance of problems occurring may be increased. It is not known if the medicine is safe for use in these patients.

• Fructose intolerance—The Staxyn® disintegrating tablet contains sorbitol, which can make this condition worse.

• Hypotension (low blood pressure) or
• QT prolongation (rare heart condition), or history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The Staxyn® disintegrating tablet contains aspartame, which can make this condition worse.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If you use too much, the chance of having unwanted effects is increased.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medicine with or without food.

This medicine usually begins to work within 60 minutes after taking it and stimulation of the penis is required. If you have any questions about the use of vardenafil, talk to your doctor.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack until you are ready to take the tablet. Peel back the foil and take the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue and allow it to melt. Take the tablet without liquid. Do not break, crush, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of erectile dysfunction:
  • For oral dosage form (disintegrating tablets):
    • Adults—10 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity.
    • Children—Use is not recommended.
  • For oral dosage form (tablets):
    • Adults 65 years and older—5 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg once per day.
    • Adults up to 65 years—10 mg as a single dose, no more than once per day, approximately 1 hour before sexual activity. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg once per day.
    • Children—Use is not recommended.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that you tell all of your doctors that you take vardenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took vardenafil.

Do not use this medicine if you are also using a nitrate medicine for angina or high blood pressure. Some examples of nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® ointment, Nitrolingual® spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs called "poppers" also contain nitrates such as amyl nitrate and butyl nitrate. Do not use this medicine if you also use riociguat (Adempas®).

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor right away. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

If you have a sudden loss of vision in one or both eyes, contact your doctor right away.

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing with dizziness or ringing in the ears.

If you already use medicine for high blood pressure (hypertension), vardenafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness.

This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Arm, back, or jaw pain

blindness

blurred vision

chest pain, discomfort, or tightness

chest tightness or heaviness

chills

cold sweats

confusion

decreased vision

difficult or labored breathing

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

eye pain

fainting

fast, irregular, pounding, or racing heartbeat or pulse

headache

hives, itching, or skin rash

nausea

nervousness

pain or discomfort in the arms, jaw, back, or neck

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

slow or fast heartbeat

sweating

tearing

unusual tiredness or weakness

vomiting

Incidence not known

Hearing loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest

sneezing

stuffy nose

Less common

Abnormal ejaculation

abnormal vision

acid or sour stomach

back pain

belching

bloody nose

body aches or pain

burning feeling in the chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in color vision

changes in vision

congestion

cough

diarrhea

difficulty seeing at night

difficulty with moving

difficulty with swallowing

dim vision

dry mouth

dryness or soreness of the throat

excessive muscle tone

eye pain

face swelling

fast heartbeat

feeling of constant movement of self or surroundings

fever

general feeling of discomfort or illness

heartburn

hoarseness

increased redness of the eye

increased sensitivity of the eyes to sunlight

indigestion

joint pain

lack or loss of strength

loss of appetite

muscle aches and pains

muscle cramping

muscle stiffness

muscle tension or tightness

neck pain

pain or burning in the throat

runny nose

sensation of spinning

shivering

sleepiness or unusual drowsiness

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

stomach discomfort, upset, or pain

swollen joints

tender, swollen glands in the neck

tenderness in the stomach area

trouble with sleeping

trouble with swallowing

voice changes

watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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