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| Clinical data | |
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| Trade names | Levitra, Staxyn, Vivanza |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a603035 |
| License data | |
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| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | 15% |
| Protein binding | 95% |
| Metabolism | Liver (CYP3A4) |
| Eliminationhalf-life | 4–5 hours |
| Excretion | Bile duct |
| Identifiers | |
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| CAS Number | |
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| IUPHAR/BPS | |
| DrugBank |
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| UNII | |
| KEGG | |
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| CompTox Dashboard(EPA) | |
| ECHA InfoCard | 100.112.672 |
| Chemical and physical data | |
| Formula | C23H32N6O4S |
| Molar mass | 488.61 g·mol−1 |
| 3D model (JSmol) | |
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_-_Vardenafil_-_Aristo_Pharma_-_Vardenaristo_-_4_tablets_Blister_20_mg_-_Image_002.jpg)
Vardenafil, sold under the brand nameLevitra among others, is amedication that is used for treatingerectile dysfunction.[1][2] It is aPDE5 inhibitor.[1] It is takenby mouth.[1]
Vardenafil's indications and contraindications are the same as with other PDE5 inhibitors; it is closely related in function tosildenafil citrate (Viagra) andtadalafil (Cialis). The difference between the vardenafil molecule and sildenafil citrate is anitrogen atom's position and the change of sildenafil'spiperazine ringmethyl group to anethyl group. Tadalafil is structurally different from both sildenafil and vardenafil. Vardenafil's relatively short effective time is comparable to but somewhat longer than sildenafil's. Despite the structural differences between vardenafil and sildenafil, they both show similar ocular side effects due to their similar selectivity overlap with PDE6, an enzyme found in the eye.[3]
Beyond its indications for erectile dysfunction, vardenafil may be effective in the treatment ofpremature ejaculation, where it may significantly increase the time from penetration to ejaculation.[4]
The common, adverse drug reactions (side effects) are the same as with other PDE5 inhibitors. The frequent vardenafil-specific side-effect isnausea; the infrequent side effects are abdominal pain, back pain,photosensitivity, abnormal vision, eye pain, facialedema,hypotension, palpitation,tachycardia,arthralgia,myalgia, rash, itch, andpriapism.
One possibly serious, but rare, side effect with vardenafil isheart attack. Also, in rare cases, vardenafil use may cause priapism, a very painful emergency condition that can cause impotence if left untreated.[5]
In October 2007, theU.S. Food and Drug Administration (FDA) announced that a warning about possibledeafness (sudden hearing loss) would be added to the drug labels of vardenafil, and other PDE5 inhibitors.[6]
Vardenafil should not be used by people takingnitrate medications, because combining them with vardenafil might provoke potentially life-threateninghypotension (low blood pressure).[7][8]
Further, vardenafil causes lengthening of theQT interval. Therefore, it should not be taken by people taking other medications that affect the QT interval (such asamiodarone).[9][10]
Vardenafil was co-marketed byBayer Pharmaceuticals,GlaxoSmithKline, andSchering-Plough under the brand name Levitra. As of 2005, the co-promotion rights of GSK on Levitra have been returned to Bayer in many markets outside the US. In Italy, Bayer sells vardenafil as Levitra and GSK sells it as Vivanza. Thus, because of European Union trade rules,parallel imports might result in Vivanza sold next to Levitra in the EU.
An orally disintegrating form, marketed as Staxyn and Levitra Soft, has been gaining approvals in countries such as the United States[11] and Canada.[12]
The USFood and Drug Administration (FDA) has found vardenafil and other synthetic PDE5 inhibitors in numerous products marketed as "herbal" supplements or "all natural" products for male enhancement.[13][14]
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