DRUGS AND SUPPLEMENTS

Vardenafil

March 21, 2017

Vardenafil Hydrochloride Oral disintegrating tablet

What is this medicine?

VARDENAFIL (var den a fil) is used to treat erection problems in men.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • bleeding disorders

  • eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa

  • anatomical deformation of the penis, Peyronie’s disease, or history of priapism (painful and prolonged erection)

  • heart disease, angina, a history of heart attack, irregular heart beats, or other heart problems

  • high or low blood pressure

  • history of blood diseases, like sickle cell anemia or leukemia

  • history of stomach bleeding

  • kidney disease

  • liver disease

  • stroke

  • an unusual or allergic reaction to vardenafil, sorbitol, fructose, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Place the tablet on the tongue and allow it to dissolve, then swallow. The tablet will dissolve rapidly. Do not crew, crush, or split the tablet. Take the tablet as soon as it is removed from its blister packaging. This medicine should be taken without liquid. You may take this medicine with or without meals. Follow the directions on the prescription label. The dose is taken 1 hour before sexual activity. You should not take this dose more than once per day. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • bepridil

  • certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

  • cisapride

  • droperidol

  • grepafloxacin

  • medicines for irregular heartbeat like dronedarone, dofetilide

  • methscopolamine nitrate

  • nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

  • nitroprusside

  • other medicines for erectile dysfunction like avanafil, sildenafil, tadalafil

  • pimozide

  • thioridazine

  • ziprasidone

This medicine may also interact with the following medications:

  • antiviral medicines for HIV or AIDS

  • certain antibiotics like erythromycin and clarithromycin

  • certain drugs for high blood pressure

  • medicines for prostate problems

  • other medicines that prolong the QT interval (cause an abnormal heart rhythm)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Stop using this medicine and call your health care provider right away if you have a loss of sight in one or both eyes.

Contact your doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medicine, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking this medicine. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

Using this medicine does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • changes in hearing

  • changes in vision

  • chest pain

  • fast, irregular heartbeat

  • prolonged or painful erection

  • seizures

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • back pain

  • dizziness

  • flushing

  • headache

  • indigestion

  • muscle aches

  • nausea

  • stuffy or runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep in the original blister package until time of use. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Vardenafil Hydrochloride Oral tablet

What is this medicine?

VARDENAFIL (var den a fil) is used to treat erection problems in men.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • bleeding disorders

  • eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa

  • anatomical deformation of the penis, Peyronie’s disease, or history of priapism (painful and prolonged erection)

  • heart disease, angina, a history of heart attack, irregular heart beats, or other heart problems

  • high or low blood pressure

  • history of blood diseases, like sickle cell anemia or leukemia

  • history of stomach bleeding

  • kidney disease

  • liver disease

  • stroke

  • an unusual or allergic reaction to vardenafil, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You may take this medicine with or without meals. The dose is usually taken 1 hour before sexual activity. You should not take this dose more than once per day. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • bepridil

  • certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

  • cisapride

  • droperidol

  • grepafloxacin

  • medicines for irregular heartbeat like dronedarone, dofetilide

  • methscopolamine nitrate

  • nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin

  • nitroprusside

  • other medicines for erectile dysfunction like avanafil, sildenafil, tadalafil

  • pimozide

  • riociguat

  • thioridazine

  • ziprasidone

This medicine may also interact with the following medications:

  • antiviral medicines for HIV or AIDS

  • certain antibiotics like erythromycin and clarithromycin

  • certain drugs for high blood pressure

  • medicines for prostate problems

  • other medicines that prolong the QT interval (cause an abnormal heart rhythm)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible. Stop using this medicine and call your health care provider right away if you have a loss of sight in one or both eyes.

Contact your doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medicine, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking this medicine. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

Using this medicine does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible.

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • changes in hearing

  • changes in vision

  • chest pain

  • fast, irregular heartbeat

  • prolonged or painful erection

  • seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • back pain

  • dizziness

  • flushing

  • headache

  • indigestion

  • muscle aches

  • nausea

  • stuffy or runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Updated:  

March 21, 2017

Sources:  

U.S. FDA-approved Package Insert