Generic Name: vardenafil (Oral route)

var-DEN-a-fil

Commonly used brand name(s)

In the U.S.

  • Levitra
  • Staxyn

Available Dosage Forms:

  • Tablet
  • Tablet, Disintegrating

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

Uses For Staxyn

Vardenafil is used to treat men who have erectile dysfunction (also called sexual impotence). Vardenafil 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.

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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, vardenafil 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, vardenafil will not work to cause an erection.

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

Before Using Staxyn

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.

Pediatric

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

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Interactions with 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.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Erythrityl Tetranitrate
  • Fluconazole
  • Isosorbide Dinitrate
  • Isosorbide Mononitrate
  • Mesoridazine
  • Nelfinavir
  • Nitroglycerin
  • Pentaerythritol Tetranitrate
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Riociguat
  • Sparfloxacin
  • Thioridazine

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
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azimilide
  • Azithromycin
  • Bretylium
  • Carbamazepine
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Crizotinib
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Gatifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lopinavir
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Mifepristone
  • Mitotane
  • Moricizine
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Pazopanib
  • Perflutren Lipid Microsphere
  • Primidone
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Salmeterol
  • Saquinavir
  • Sematilide
  • Sevoflurane
  • Siltuximab
  • Simeprevir
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tedisamil
  • Telaprevir
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Vandetanib
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Ziprasidone

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.

  • Alfuzosin
  • Amprenavir
  • Bunazosin
  • Dapiprazole
  • Doxazosin
  • Indinavir
  • Moxisylyte
  • Phenoxybenzamine
  • Phentolamine
  • Prazosin
  • Silodosin
  • Tamsulosin
  • Terazosin
  • Tolazoline
  • Urapidil

Interactions with Food/Tobacco/Alcohol

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:

  • Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients.
  • Age greater than 50 years or
  • Coronary artery disease or
  • Diabetes or
  • Hyperlipidemia (excess of lipids in the blood) or
  • Hypertension (high blood pressure) or
  • Low cup to disc ratio (eye condition also called "crowded disc") or
  • Smoking—These conditions may increase risk for a serious eye problem called non-arteritic ischemic optic neuropathy or NAION.
  • Angina (reoccurring chest pain) or
  • Arrhythmia (irregular heartbeat) or
  • Heart attack (within the last 6 months) or
  • Heart failure, severe or
  • Hypertension (high blood pressure), uncontrolled or
  • Hypotension (low blood pressure) or
  • Kidney disease, severe or
  • Liver disease, severe or
  • Retinal disorders (eye problem) or
  • Retinitis pigmentosa (an inherited eye disorder) or
  • Stroke, recent 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.
  • Bone marrow cancer or
  • Leukemia (blood related cancer) or
  • Multiple myeloma (blood related cancer) or
  • Sickle-cell anemia (blood disorder)—Vardenafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.
  • Fructose intolerance—The orally disintegrating tablet contains sorbitol, which can make this condition worse.
  • Heart blood flow problems—These conditions may cause you to be more sensitive to vardenafil.
  • Heart disease, underlying—Chance of low blood pressure occurring is greater; vardenafil should be used carefully in these patients.
  • Kidney disease or
  • Liver disease—Chance of problems occurring may be increased. Lower starting doses may be used and doses increased as needed and as tolerated.
  • NAION (serious eye condition) in one or both eyes, history of—May increase your chance of getting NAION again.
  • Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.
  • QT prolongation (rare heart condition), or history of—Use with caution. May make this condition worse.

Proper Use of vardenafil

This section provides information on the proper use of a number of products that contain vardenafil. It may not be specific to Staxyn. Please read with care.

Use vardenafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

Special patient instructions come with vardenafil. Read the directions carefully before you start using vardenafil and each time you get a refill of your medicine.

You may take this medicine with or without food.

This medicine usually begins to work within 60 minutes after taking it. It continues to work for up to 4 hours. Stimulation is required for an erection. If you have any questions about the use and benefits of vardenafil ask 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 that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue. It should melt quickly. The tablet should be taken without liquids. 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.

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 (as needed):
    • For oral dosage form (disintegrating tablets):
      • Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 1 hour before you think sexual activity may occur.
      • Children—Use is not recommended.
    • For oral dosage form (tablets):
      • Adults 65 years of age and older—5 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may change your dose if needed.
      • Adults up to 65 years of age—10 mg as a single dose no more than once a day, 1 hour before sexual activity. Your doctor may change your dose if needed.
      • 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 Staxyn

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.

Levitra® also contains vardenafil. If you take too much vardenafil or take it together with these medicines, the chance for side effects will be higher.

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

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

It is important to tell your doctor about any heart problems you may have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

Do not use this medicine if you are also using a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates.

Do not drink excessive amounts of alcohol (e.g., 5 glasses of wine or 5 shots of whiskey) when taking vardenafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increase your heart rate, or lower your blood pressure.

If you have sudden loss of vision in one or both eyes, stop using vardenafil and contact your doctor right away.

Stop using this medicine and check with your doctor right away if you have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

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

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.

Staxyn Side Effects

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 or discomfort
  • 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 from a lying or sitting position
  • eye pain
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • hives
  • itching
  • 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
  • shortness of breath
  • skin rash
  • slow or fast heartbeat
  • sweating
  • tearing
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
  • wheezing
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
  • abdominal or stomach pain
  • 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
  • itching skin
  • 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
  • pain or burning in the throat
  • runny nose
  • sensation of spinning
  • shivering
  • sleepiness or unusual drowsiness
  • sleeplessness
  • 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
  • unable to sleep
  • 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.

See also: Side effects (in more detail)

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