Pronunciation:

var-DEN-a-fil

Brand Names:

• Levitra

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Erectile Dysfunction Agent

Pharmacologic—

Phosphodiesterase Type 5 Inhibitor

Uses of This Medicine:

Vardenafil belongs to a group of medicines that delay the enzymes (proteins in your body) called phosphodiesterases from working too quickly. The penis is one of the areas where these enzymes work. Vardenafil is used to treat men who have erectile dysfunction (also called sexual impotence). 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. Vardenafil may help a man get and keep an erection when he is sexually excited. Vardenafil helps to increase the blood flow to the penis and may help men with erectile dysfunction get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Vardenafil does not help to cure erectile dysfunction.

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.

Older adults—

Elderly people are especially sensitive to the effects of vardenafil, which may increase their chance of having side effects. Patients 65 years of age and older are started on a lower dose than younger adults. The dose may be increased by a doctor as needed and tolerated.

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.

Other medicines—

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.

• Erythrityl Tetranitrate
• Isosorbide Dinitrate
• Isosorbide Mononitrate
• Nitroglycerin
• Pentaerythritol Tetranitrate
• Ranolazine

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 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 ("crowded disc") or
• Smoking—These conditions may increase risk for a serious eye problem called NAION .

• Angina (reoccurring chest pain) or
• Arrhythmia (irregular heartbeat) or
• Heart attack (within the last 6 months) or
• Heart failure or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Liver disease (severe) or
• Kidney disease (severe) or
• Retinal disorders (rare hereditary eye problem) or
• Stroke (recent history of)—Vardenafil has not been studied in patients with these medical conditions and should not be used.

• 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 or
• Sickle-cell anemia—Vardenafil may cause this condition to become worse.

• Heart disease, underlying—Chance of low blood pressure occurring is greater; vardenafil should be used carefully in these patients.

• Liver disease, moderate—Chance of problems occurring may be increased. Lower starting doses may be used and doses increased as needed and as tolerated .

• Heart blood flow problems—These conditions may cause you to be more sensitive to vardenafil.

• NAION (serious eye condition) in one or both eyes, previously—May increase your chance of getting NAION again .

• QT prolongation (rare heart condition)—Vardenafil may cause this condition to become worse.

Proper Use of This Medicine:

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

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 health care professional.

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 oral dosage form (tablets):
  • For treatment of erectile dysfunction:
    • Adults up to 65 years of age—10 mg as a single dose no more than once a day, 1 hour before sexual activity. If needed, your doctor may change your dose.
    • Adults 65 years of age and older—5 mg as a single dose no more than once a day, 1 hour before sexual intercourse. If needed, your doctor may change your dose.

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:

Vardenafil has not been studied with other medicines used for treatment of erectile dysfunction. Using them together is not recommended.

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 is increased.

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

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.

If you experience sudden loss of vision in one or both eyes, stop using vardenafil and contact your doctor immediately

Also, 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.

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 or discomfort

chest tightness or heaviness

chills

cold sweats

confusion

decreased vision

difficult or labored breathing

difficulty swallowing

dizziness

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

eye pain

fainting

fast, irregular, pounding, or racing heartbeat or pulse

headache

hives

itching

nausea

nervousness

pain or discomfort in 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 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 pain

abnormal vision

acid or sour stomach

back pain

belching

bloody nose

body aches or pain

burning feeling in 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 in moving

difficulty seeing at night

difficulty swallowing

dim vision

dry mouth

dryness or soreness of 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 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 throat

runny nose

sensation of spinning

shivering

sleepiness or unusual drowsiness

sleeplessness

sore throat

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

stomach discomfort, upset, or pain

swollen joints

tender, swollen glands in neck

tenderness in stomach area

trouble in swallowing

trouble sleeping

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.