Vardenafil (INN) is a PDE5 inhibitor used in the treatment of erectile dysfunction. It can assist men with this disorder in achieving and maintaining an erection during sexual activity. It is commonly marketed under the trade name Levitra (Bayer AG).

History
Vardenafil was co-marketed by Bayer Pharmaceuticals and GSK under the trade name Levitra. As of 2005, the co-promotion rights of GSK on Levitra have been “transferred back” to Bayer in many markets outside of the United States. In Italy, Bayer markets the product as Levitra and GSK markets the product as Vivanza. Due to European Union trade rules, parallel imports may result in the Vivanza branded packs being seen alongside Levitra packs in pharmacies in other EU member states.
Important Safety and Dosing Information

LEVITRA is a prescription medicine that is used to treat erectile dysfunction (ED). Men taking nitrate drugs, often used to control chest pain (also known as angina), should not take LEVITRA. Such combinations could cause blood pressure to drop to an unsafe level.

As with all ED drugs, there is a rare risk of an erection lasting longer than four hours. To avoid long-term injury, seek immediate medical attention. LEVITRA does not protect against sexually transmitted diseases. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicine, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes, or a sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience any of these symptoms, stop taking PDE5 inhibitors, including LEVITRA, and call a doctor right away.

Discuss your medical conditions, including heart problems, and medications, including alpha blockers prescribed for prostate problems or high blood pressure, with your doctor to ensure LEVITRA is right for you and that you are healthy enough for sexual activity. LEVITRA is not recommended for men with uncontrolled high blood pressure.

The starting dose of LEVITRA is 10 mg taken no more than once per day. Your doctor will decide the dose that is right for you. In patients taking alpha blockers, your doctor may start you on a lower dose of LEVITRA. In patients taking certain medications such as ritonavir, indinavir, saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin and clarithromycin, lower doses of LEVITRA are recommended, and time between doses of LEVITRA may need to be extended.

In clinical trials, the most commonly reported side effects were headache, flushing, and stuffy or runny nose. LEVITRA is available in 2.5-mg, 5-mg, 10-mg, and 20-mg tablets.

LEVITRA MECHANISM

Levitra is an oral medicine for the treatment of erectile dysfunction. Vardenafil is the main ingredient of Levitra and monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 (PDE5). It is an inhibitor for corporal smooth muscle relaxation, resulting in increased blood flow in the penis in reaction to sexual stimulation.

PDE5 is an inhibitor that increases the blood flow to the penis and helps man attain erection and keep the erection strong and long enough to finish a successful sexual intercourse. The active ingredient in LEVITRA works during arousal when two large chambers in a man’s penis fill up with blood.

Levitra label says it takes 60 minutes before sexual activity, but medical studies have proved that it can work within 16 minutes of its oral administration. Levitra works properly at the very first time taken.

Levitra gives same result in a full stomach; the quality of erection will be strong and satisfactory without being affected by food or drink.

Levitra works quicker and better than Viagra and Cialis, as it can start working withing 16 minutes and it gives full and strong erection even though you have high blood pressure or diabetes type 1 and 2 or high cholesterol.

Before taking Levitra
Do not take Levitra if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (”poppers”). Taking this medication with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.

A small number of patients have had a sudden loss of eyesight after taking Levitra. This type of vision loss is caused by decreased blood flow to the optic nerve of the eye. It is not clear whether Levitra is the actual cause of such vision loss. Sudden vision loss with Levitra use has occurred most often in people with heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.

Before taking this medication, tell your doctor if you have:

*heart disease or heart rhythm problems;
*a recent history (in the past 6 months) of a heart attack, angina (chest pain), or congestive heart failure;
*a history of stroke or blood clots;
*a personal or family history of “Long QT syndrome”;
*high or low blood pressure;
*liver disease;
*kidney disease (or if you are on dialysis);
*a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
*a bleeding disorder such as hemophilia;
*a stomach ulcer;
*retinitis pigmentosa (an inherited condition of the eye);
*a physical deformity of the penis (such as Peyronie’s disease); or
*if you have been told you should not have sexual intercourse for health reasons.

If you have any of these conditions, you may not be able to use Levitra or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category B: Although Levitra is not for use in women, this medication is not expected to be harmful to an unborn baby. Do not use this medication without telling your doctor if you are pregnant or plan to become pregnant during treatment. Although Levitra is not for use in women, it is not known if this medication passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. You may need a lower dose of this medication if you are older than 65. Follow your doctor’s instructions.
How should I take Levitra?

Take Levitra exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor.
Take each dose with a full glass of water.

Levitra can be taken with or without food.

Levitra is usually taken only when needed, up to 60 minutes before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor’s instructions.
Do not take Levitra 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 this medication at room temperature away from moisture and heat.

Levitra side effects
If you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw during sexual activity, stop and call your doctor right away. You could be having a serious side effect of Levitra. Stop using Levitra and get emergency medical help if you have sudden vision loss. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Levitra and call your doctor at once if you have any of these serious side effects:

*chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
*irregular heartbeat;
*swelling in your hands, ankles, or feet;
*shortness of breath;
*vision changes;
*feeling light-headed, fainting; or
* penis erection that is painful or lasts 4 hours or longer.

Continue taking this medication and talk with your doctor if you have any of these less serious side effects:

*warmth or redness in your face, neck, or chest;
*stuffy nose;
*headache;
*upset stomach; or
*back pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.