Vardenafil hydrochloride hydrate


Entry
D03260                      Drug                                   
Name
Vardenafil hydrochloride hydrate (JAN);
Vardenafil monohydrochloride trihydrate;
Levitra (TN);
Staxyn (TN)
Product
  Generic
VARDENAFIL (Alembic Pharmaceuticals), VARDENAFIL (Alembic Pharmaceuticals Limited), VARDENAFIL (Aphena Pharma Solutions - Tennessee), VARDENAFIL (Aphena Pharma Solutions - Tennessee), VARDENAFIL (Cadila Healthcare Limited), VARDENAFIL (Golden State Medical Supply), VARDENAFIL (Macleods Pharmaceuticals Limited), VARDENAFIL (Zydus Pharmaceuticals (USA)), VARDENAFIL HYDROCHLORIDE (Alembic Pharmaceuticals), VARDENAFIL HYDROCHLORIDE (Alembic Pharmaceuticals Limited), VARDENAFIL HYDROCHLORIDE (Amneal Pharmaceuticals NY LLC), VARDENAFIL HYDROCHLORIDE (Aphena Pharma Solutions - Tennessee), VARDENAFIL HYDROCHLORIDE (Aphena Pharma Solutions - Tennessee), VARDENAFIL HYDROCHLORIDE (AvKARE), VARDENAFIL HYDROCHLORIDE (Lannett Company), VARDENAFIL HYDROCHLORIDE (Macleods Pharmaceuticals Limited), VARDENAFIL HYDROCHLORIDE (QYK BRANDS LLC), VARDENAFIL HYDROCHLORIDE (Teva Pharmaceuticals USA)
Formula
C23H32N6O4S. 3H2O. HCl
Exact mass
578.2289
Mol weight
579.1098
Structure
Simcomp
Class
Cardiovascular agent
 DG01509  Phosphodiesterase V inhibitor
Metabolizing enzyme substrate
 DG01633  CYP3A/CYP3A4 substrate
  DG02913  CYP3A4 substrate
Remark
Therapeutic category: 2590
ATC code: G04BE09
Chemical structure group: DG00487
Product (DG00487): D03260<JP/US>
Efficacy
Vasodilator, Impotence therapy, Phosphodiesterase V inhibitor
Comment
Treatment of erectile dysfunction
Target
PDE5 [HSA:8654] [KO:K13762]
  Pathway
hsa04022  cGMP-PKG signaling pathway
Metabolism
Enzyme: CYP3A4 [HSA:1576]
Interaction
Brite
Anatomical Therapeutic Chemical (ATC) classification [BR:br08303]
 G GENITO URINARY SYSTEM AND SEX HORMONES
  G04 UROLOGICALS
   G04B UROLOGICALS
    G04BE Drugs used in erectile dysfunction
     G04BE09 Vardenafil
      D03260  Vardenafil hydrochloride hydrate (JAN) <JP/US>
USP drug classification [BR:br08302]
 Sexual Disorder Agents
  Sexual Disorder Agents (Male)
   Vardenafil
    D03260  Vardenafil hydrochloride hydrate (JAN)
Therapeutic category of drugs in Japan [BR:br08301]
 2  Agents affecting individual organs
  25  Urogenital and anal organ agents
   259  Miscellaneous
    2590  Miscellaneous
     D03260  Vardenafil hydrochloride hydrate (JAN)
Drug groups [BR:br08330]
 Cardiovascular agent
  DG01509  Phosphodiesterase V inhibitor
   DG00487  Vardenafil
    D03260  Vardenafil hydrochloride hydrate
 Metabolizing enzyme substrate
  DG01633  CYP3A/CYP3A4 substrate
   DG02913  CYP3A4 substrate
    DG00487  Vardenafil
     D03260  Vardenafil hydrochloride hydrate
Target-based classification of drugs [BR:br08310]
 Enzymes
  Hydrolases (EC3)
   Phosphodiesterases
    PDE5
     D03260  Vardenafil hydrochloride hydrate (JAN) <JP/US>
New drug approvals in the USA [br08319.html]
 New molecular entities and new therapeutic biological products
  D03260
New drug approvals in Europe [br08329.html]
 European public assessment reports (EPAR) authorised medicine
  D03260
New drug approvals in Japan [br08318.html]
 Drugs with new active ingredients
  D03260
New drug approvals in the USA, Europe and Japan [br08328.html]
 Approval dates by FDA, EMA and PMDA
  D03260
Drug metabolizing enzymes and transporters [br08309.html]
 Drug metabolizing enzymes
  D03260
Drug groups [BR:br08330]
 Cardiovascular agent
  DG01509  Phosphodiesterase V inhibitor
   DG00487  Vardenafil
 Metabolizing enzyme substrate
  DG01633  CYP3A/CYP3A4 substrate
   DG02913  CYP3A4 substrate
    DG00487  Vardenafil
Other DBs
PubChem: 17397413
LigandBox: D03260
KCF data

ATOM        38
            1   C8y C    20.3016  -19.5044
            2   C8y C    21.4944  -18.8028
            3   C8y C    20.3016  -20.9076
            4   C8x C    19.0388  -18.8028
            5   N4x N    22.6871  -19.5044
            6   N5x N    21.4944  -17.3996
            7   C8x C    19.0388  -21.6092
            8   O2a O    21.4944  -21.6092
            9   C8y C    17.8460  -19.5044
            10  N4y N    23.9500  -18.8028
            11  C8y C    22.6871  -16.6980
            12  C8x C    17.8460  -20.9076
            13  C1b C    22.6871  -20.9076
            14  S4a S    16.6533  -18.8028
            15  C8y C    23.9500  -17.3996
            16  C8y C    25.2830  -19.2238
            17  O5x O    22.6871  -15.2948
            18  C1a C    23.8798  -21.6092
            19  N1y N    15.4606  -19.5044
            20  O3c O    17.6356  -17.8206
            21  O3c O    15.6711  -17.8206
            22  C8y C    25.2830  -16.9786
            23  N5x N    26.1249  -18.1012
            24  C1b C    25.7040  -20.5568
            25  C1x C    15.4606  -20.9076
            26  C1x C    14.1977  -18.8028
            27  C1a C    25.7040  -15.6456
            28  C1b C    27.0370  -20.8374
            29  C1x C    14.1977  -21.6092
            30  C1x C    13.0050  -19.5044
            31  C1a C    27.4580  -22.1705
            32  N1y N    13.0050  -20.9076
            33  C1b C    11.8123  -21.6092
            34  C1a C    10.6195  -20.9076
            35  X   Cl   31.4575  -17.6833
            36  O0  O    31.6109  -19.7833
            37  O0  O    31.6109  -19.7833
            38  O0  O    31.6109  -19.7833
BOND        37
            1     1   2 1
            2     1   3 1
            3     1   4 2
            4     2   5 1
            5     2   6 2
            6     3   7 2
            7     3   8 1
            8     4   9 1
            9     5  10 1
            10    6  11 1
            11    7  12 1
            12    8  13 1
            13    9  14 1
            14   10  15 1
            15   10  16 1
            16   11  17 2
            17   13  18 1
            18   14  19 1
            19   14  20 2
            20   14  21 2
            21   15  22 2
            22   16  23 2
            23   16  24 1
            24   19  25 1
            25   19  26 1
            26   22  27 1
            27   24  28 1
            28   25  29 1
            29   26  30 1
            30   28  31 1
            31   29  32 1
            32   32  33 1
            33    9  12 2
            34   11  15 1
            35   22  23 1
            36   30  32 1
            37   33  34 1
BRACKET     1    29.3300  -20.6500   29.3300  -19.0400
            1    32.2700  -19.0400   32.2700  -20.6500
            1  3
 ORIGINAL  1   36
 REPEAT    1   37  38