VARDENAFIL (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Levitra

? Not commercially available in Canada.

Category

• Impotence therapy agent(systemic)

Description

Vardenafil (var-DEN-a-fil) 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 usedto treat men who have erectile dysfunction (also called sexual impotence).Erectile dysfunction is a condition where the penis does not harden and expandwhen a man is sexually excited, or when he cannot keep an erection. Vardenafilmay help a man get and keep an erection when he is sexually excited. Vardenafilhelps to increase the blood flow to the penis and may help men with erectiledysfunction get and keep an erection satisfactory for sexual activity. Oncea man has completed sexual activity, blood flow to his penis decreases, andhis erection goes away. Vardenafil does not help to cure erectile dysfunction.

This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):

Oral
• Tablets (U.S.)

Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to vardenafil. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Vardenafil is not indicated for use in women. Vardenafilhas not been studied in pregnant women. However, vardenafil has not been shownto cause birth defects or other problems in animal studies.

Breast-feeding?It is not known whether vardenafil passes intobreast milk. Vardenafil is not indicated for use in women.

Older adults?Elderly people are especially sensitive to theeffects 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 youngeradults. The dose may be increased by a doctor as needed and tolerated.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingvardenafil, it is especially important that your doctor and pharmacist knowif you are taking any of the following:

• Medicine for irregular heart beats, such as
• Amiodarone (e.g., Cordarone) or
• Procainamide (e.g., Procan SR, Promine, Pronestyl, Pronestyl-SR)or
• Quinidine (e.g., Cardioquin, Quinaglute Dura-tabs, Quinidex Extentabs,Quin-Release) or
• Sotalol (e.g., Betapace, Sotacor)?These medicines should notbe used together with vardenafil

• Alpha blockers (medicine for high blood pressure) such as
• Alfuzosin (e.g., Uroxatral) or
• Doxazosin (e.g., Cardura) or
• Prazosin (e.g., Minipress) or
• Tamsulosin (e.g., Flomax) or
• Terazosin (e.g., Hytrin)?These medicines should be used withcaution because together with vardenafil they can cause low blood pressure.Your doctor may want to adjust your dose of vardenafil.

• Erythromycin (medicine used to treat infection)?This medicinemay cause there to be more vardenafil in your body; your doctor may want toadjust your dose of vardenafil.

• Ketoconazole (e.g., Nizoral)?These medicines may cause thereto be more vardenafil in your body; your doctor may want to adjust your doseof vardenafil.

• Indinavir (e.g., Crixivan) or
• Ritonavir (e.g., Norvir, Kaletra)?These medicines may causethere to be more vardenafil in your body; your doctor may want to adjust yourdose of vardenafil.

• Nitrates, such as nitroglycerin (e.g., Nitrostat or Transderm-Nitro)?Vardenafilincreases the chance of very low blood pressure and using these medicinestogether is not recommended

Other medical problems?The presenceof other medical problems may affect the use of vardenafil. Make sure youtell your doctor if you have any other medical problems, especially:

• 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 eyeproblem 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 studiedin patients with these medical conditions and should not be used.
• Abnormal penis, including curved penis and birth defects of the penis?Chanceof problems occurring may be increased and should be used with caution inthese patients

• 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
• Leukemia
• Sickle-cell anemia?Vardenafil should be used with caution inthese patients.

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

• Liver disease, moderate?This condition may cause there to bemore vardenafil in your body; your doctor may want to start these patientson a lower dose.

• Heart blood flow problems?These conditions may cause you tobe more sensitive to vardenafil.

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

• QT prolongation (rare heart condition)?Vardenafil may causethis 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 timeyou 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 yourhealth care professional.

Dosing?The dose of vardenafil will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of vardenafil. If your dose is different,do not change it unless your doctor tells you to do so.

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

Storage?To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Vardenafil has not been studied with other medicines used fortreatment 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 healthcareproviders that you take vardenafil. If you need emergency medical carefor a heart problem, it is important that your healthcare provider knows whenyou last took vardenafil.

If you experience a prolonged or painful erection for4 hours or more, contact your doctor immediately. This condition mayrequire prompt medical treatment to prevent serious and permanent damage toyour penis.

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

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

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

Side Effects of This Medicine

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

Check with your doctorimmediately 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; difficultor labored breathing; difficulty swallowing; dizziness; dizziness, faintness, orlightheadedness 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 theeyelids 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

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome.

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; abdominal pain; acid orsour stomach; back pain; belching; bloody nose; body aches or pain; burning, crawling, itching, numbness,prickling, "pins and needles" , or tingling feelings; burning feeling in chest or stomach; changes in colorvision; changes in vision; congestion; cough; diarrhea; difficulty in moving; difficulty seeing at night; difficulty swallowing; dim vision; dry mouth; dryness or soreness of throat; eye pain; excessive muscle tone; 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; increasedsensitivity of eyes to sunlight; indigestion; itching skin; joint pain; lack or loss of strength; loss of appetite; muscle aches and pains; runny nose; trouble sleeping; muscle cramping; muscle stiffness; muscle tension or tightness; neck pain; pain; pain or burning in throat; 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; unableto sleep; voice changes; watery eyes

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.