Levitra

Name: Levitra

Levitra Interactions

Many medicines interact with Levitra and should be avoided if possible, including::

  • Dronedarone (Multaq)
  • Fluconazole (Diflucan)
  • Nelfinavir (Viracept)
  • Nitroglycerin (Nitro-BID, Nitro-Dur, others)
  • Posaconazole (Noxafil)
  • Isosorbide Mononitrate (Imdur, Ismo, Monoket)

If any of these medications are required, you and your doctor will need to weigh the potential risks and benefits of taking them while also taking Levitra.

Your doctor may change the dosage of one or both medicines, as well as how often you take them.

Levitra and Alcohol

When taking Levitra, you should not drink alcohol excessively. Too much alcohol can increase the risk of side effects such as headache, dizziness, and low blood pressure.

Levitra and Grapefruit

While you are using Levitra, do not eat grapefruit or drink grapefruit juice. Doing so affects the way the drug is metabolized and can increase the risk of side effects.

Levitra and Other Interactions

Don"t take Levitra if you use street drugs containing nitrates, commonly known as "poppers."

Always tell your doctor about any prescription, non-prescription, over-the-counter (OTC), illegal and recreational drugs you are taking, as well as herbal remedies and nutritional and dietary supplements.

Levitra Dosage

If you are using the disintegrating tablet form of Levitra, the recommended single dose is 10-milligrams (mg) no more than once a day, an hour before you expect to have sex.

If you are using the oral tablet, take a 10-mg single dose once a day an hour before sex. Men age 65 years and older can take a 5-mg dose once a day, an hour before sex.

The recommended dose of Levitra will be different for different men, however. Talk to your doctor about the correct dosage for you.

Levitra Overdose

No more than one dose of Levitra every 24 hours should be taken. Call your doctor immediately if you think you've overdosed on Levitra.

Levitra Overview

Levitra is a prescription medication used to treat erectile dysfunction (impotence) in adult men. Levitra belongs to a group of drugs called phosphodiesterase (PDE) inhibitors, which work by relaxing muscles and increasing blood flow to the penis during sexual stimulation.

This medication comes in tablet and that is taken one hour before sexual activity, with or without food.

Common side effects of Levitra include facial flushing, headache, stuffy nose, and upset stomach.

Levitra Drug Class

Levitra is part of the drug class:

  • Drugs used in erectile dysfunction

Levitra Dosage

Take Levitra exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

For most patients, the recommended starting dose of Levitra is 10 mg, taken by mouth approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. 

A starting dose of 5 mg Levitra should be considered in patients 65 years of age or older.

What is the most important information I should know about vardenafil?

Taking vardenafil with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take vardenafil if you also take riociguat (Adempas) or a nitrate drug such as nitroglycerin.

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

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

How should I take vardenafil?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Vardenafil can be taken with or without food.

Vardenafil is usually taken only when needed, about 60 minutes before sexual activity. The medicine can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

To take the orally disintegrating tablet (Staxyn):

  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

  • Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

  • Swallow several times as the tablet dissolves. Do not take Staxyn with liquid.

Do not take vardenafil more than once a day. Allow 24 hours to pass between doses.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since vardenafil is used as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).1

Before Using Levitra

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
  • Amisulpride
  • Amyl Nitrite
  • Bepridil
  • Cisapride
  • Dronedarone
  • Erythrityl Tetranitrate
  • Fluconazole
  • Isosorbide Dinitrate
  • Isosorbide Mononitrate
  • Mesoridazine
  • Nelfinavir
  • Nitroglycerin
  • Pentaerythritol Tetranitrate
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Propatyl Nitrate
  • Riociguat
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

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
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azimilide
  • Azithromycin
  • Bretylium
  • Buserelin
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Conivaptan
  • Crizotinib
  • Dabrafenib
  • Darunavir
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Efavirenz
  • Erythromycin
  • Escitalopram
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Foscarnet
  • Gatifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Lopinavir
  • Lumacaftor
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Moricizine
  • Moxifloxacin
  • Nafarelin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Panobinostat
  • Pasireotide
  • Pazopanib
  • Pimavanserin
  • Pitolisant
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Ribociclib
  • Salmeterol
  • Saquinavir
  • Sematilide
  • Sevoflurane
  • Simeprevir
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tedisamil
  • Telaprevir
  • Telithromycin
  • Tetrabenazine
  • Toremifene
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vemurafenib
  • Vinflunine
  • Voriconazole
  • Zuclopenthixol

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:

  • Abnormally shaped penis, including a curved penis and birth defects or
  • Crowded optic disc (an eye disorder) or
  • Leukemia (cancer of the blood) or
  • Multiple myeloma (cancer of the blood) or
  • Non-arteritic anterior ischemic optic neuropathy (NAION; serious eye condition), history of or
  • Peyronie disease or
  • Sickle-cell anemia (blood disorder)—Use with caution. May make side effects become worse.
  • Fructose intolerance—The Staxyn® disintegrating tablet contains sorbitol, which can make this condition worse.
  • Hypotension (low blood pressure) or
  • QT prolongation (rare heart condition), or history of—Use with caution. May make these conditions worse.
  • Kidney disease, severe or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Phenylketonuria (PKU)—The Staxyn® disintegrating tablet contains aspartame, which can make this condition worse.

Uses of Levitra

  • It is used to treat erectile dysfunction (ED).
  • It may be given to you for other reasons. Talk with the doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Levitra or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Levitra (vardenafil tablets). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

How Supplied/Storage and Handling

Levitra (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “2.5”, “5”, “10”, and “20” on the other side equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively.

Package

Strength

NDC Code

Bottles of 30

2.5 mg

0173-0828-13

5 mg

0173-0829-13

10 mg

0173-0830-13

20 mg

0173-0831-13

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Levitra side effects

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

Stop using Levitra 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.

Stop using Levitra 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 Levitra 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.

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