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Vardenafil Hydrochloride

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(CAS: 224785-90-4)

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Manufacturer: Schering

If you need trial data of vardenafil hcl, please visit drug.com for detail.

Vardenafil HCl is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).

Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, mono-hydrochloride and has the following structural formula:

Structure:

Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with "BAYER" cross debossed on one side and "2.5", "5", "10", and "20" on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.

What is vardenafil?

¢Vardenafil relaxes muscles within the penis. This allows increased blood flow into the penis which is necessary to achieve and maintain an erection.

¢Vardenafil is used to treat erectile dysfunction (impotence)

¢Vardenafil may also be used for purposes other than those listed in this medication guide

Cardiovascular effects:

General: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.

Left Ventricular Outflow Obstruction: Patients with left ventricular outflow obstruction, e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.

Blood Pressure Effects: LEVITRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 7 mmHg systolic and 8 mmHg diastolic) . While this normally would be expected to be of little consequence in most patients, prior to prescribing LEVITRA, physicians should carefully consider whether their patients with underlying cardiovascular

What are the possible side effects of vardenafil?

¢If you experience any of the following serious side effects, stop taking vardenafil and seek emergency medical attention or contact your doctor immediately:
, an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
, chest pain or an irregular heartbeats;
, swelling of the ankles or legs;
, shortness of breath;
, prolonged or severe dizziness;
, fainting;
, a prolonged (lasting longer than 4 hours) or painful erection;
, dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw); or
, back pain.

¢ Other, less serious side effects may be more likely to occur. Continue to take vardenafil and talk to your doctor if you experience
, flushing;
, mild dizziness;
, headache;
, nasal congestion;
, stomach upset;
, sensitivity of the eyes to light; or
, temporary blue tint in vision or other vision abnormalities.

¢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.

What other drugs will affect vardenafil?

¢Do not take vardenafil if you are taking any of the following medicines:
, a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
, a recreational drug such as amyl nitrate or nitrite ("poppers"); or
, an alpha blocker such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), tamsulosin (Flomax), and others.

? Taking vardenafil with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack
? Before taking vardenafil, tell your doctor if you are taking any of the following medications:
, any other drug used to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others);
, the antibiotic drug erythromycin (E-Mycin, Eryc, Ery-Tab, others);
, an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
, a medication used to treat irregular heartbeats such as quinidine (Quinaglute, Quinidex, Quin-Release), procainamide (Procan SR, Procanbid, Pronestyl), amiodarone (Cordarone, Pacerone), or sotalol (Betapace, Sorine); or
, the HIV medications indinavir (Crixivan) or ritonavir (Norvir).

? You may not be able to take vardenafil, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

? Drugs other than those listed here may also interact with vardenafil or affect your condition. Talk to your doctor or pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.