Vardenafil

Vardenafil is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Vardenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It works by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Vardenafil does not cure erectile dysfunction or increase sexual desire. Vardenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

For most individuals, the recommended dose of vardenafil regular tablets is 10 mg per day taken 60 minutes before intercourse. If there is no response or side effects, the dose may be increased to 20 mg or, if there are side effects, it may be reduced to 5 mg.

Individuals 65 years of age or older should begin therapy with 5 mg.

Individuals who are taking medications that increase the blood levels of vardenafil should start treatment with 2.5 to 5 mg of vardenafil. (See drug interactions.)

Orally disintegrating tablets (ODT) are not interchangeable with regular vardenafil tablets because they are better absorbed and produce higher blood levels than regular tablets. The recommended dosing when using ODT is one tablet 60 minutes before intercourse. Only one tablet should be used per day. It should be placed on the tongue until it disintegrates and should not be swallowed with water.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. Vardenafil is only for use in men. Additionally, there are no studies of vardenafil use in pregnant women. No evidence of potential for harm to unborn babies in animal studies have been observed.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using vardenafil and get emergency medical help if you have sudden vision loss.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of vardenafil.

Stop using vardenafil and call your doctor at once if you have:

• vision changes;

• ringing in your ears, or sudden hearing loss;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• irregular heartbeat;

• swelling in your hands, ankles, or feet;

• shortness of breath;

• a light-headed feeling, like you might pass out;

• penis erection that is painful or lasts 4 hours or longer; or

• seizure (convulsions).

Common side effects may include:

• flushing (warmth, redness, or tingly feeling);

• stuffy nose;

• headache, dizziness;

• upset stomach; or

• back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 vardenafil 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 vardenafil 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.

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.

• Vardenafil HCl
• Vardenafil Hydrochloride

Coadministration with nitrates (either regularly and/or intermittently), nitric oxide donors, or guanylate cyclase stimulators (eg, riociguat).

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to vardenafil or any component of the formulation; concomitant use with indinavir, ritonavir, ketoconazole or itraconazole (Levitra, Staxyn) and erythromycin or clarithromycin (Staxyn); prior episode of non-arteritic anterior ischemic optic neuropathy (NAION).

Commonly reported side effects of vardenafil include: headache and flushing. Other side effects include: dyspepsia and rhinitis. See below for a comprehensive list of adverse effects.

Applies to vardenafil: oral tablet, oral tablet disintegrating

Along with its needed effects, vardenafil 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 while taking vardenafil:

• 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 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
• tightness in the chest
• unusual tiredness or weakness
• vomiting

• Hearing loss

Some side effects of vardenafil 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:

• Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest
• sneezing
• stuffy nose

• 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
• 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

65 years or older:
-Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity

Comments: Sexual stimulation is required for a response to treatment.

Use: Erectile dysfunction