spiramycin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 4711 8025-81-8

Description:

MoleculeDescription

Synonyms:

  • spiramycin
  • espiramicin
  • foromacidin
  • provamycin
  • rovamicina
  • rovamycin
  • rovamycine
  • selectomycin
  • sequamycin
  • spiramycins
  • stomamycin
A macrolide antibiotic produced by Streptomyces ambofaciens. The drug is effective against gram-positive aerobic pathogens, N. gonorrhoeae, and staphylococci. It is used to treat infections caused by bacteria and Toxoplasma gondii.
  • Molecular weight: 2627.30
  • Formula: C134H228N6O44
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 201.45
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
3 g O

ADMET properties:

PropertyValueReference
BA (Bioavailability) 35 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 5.40 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 12.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.26 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 2, 2018 PMDA Sanofi KK

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cholestasis 122.20 45.36 38 1209 29396 63458379
Hepatocellular injury 112.17 45.36 35 1212 27346 63460429
Rash maculo-papular 64.34 45.36 24 1223 31872 63455903
Talipes 53.94 45.36 11 1236 1529 63486246
Premature rupture of membranes 50.70 45.36 13 1234 4980 63482795
Dysmorphism 49.56 45.36 11 1236 2285 63485490

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Toxic epidermal necrolysis 143.08 49.84 47 1330 21599 34933955
Hepatocellular injury 114.34 49.84 40 1337 22171 34933383
Cholestasis 95.93 49.84 37 1340 26911 34928643
Rash maculo-papular 86.99 49.84 35 1342 28416 34927138
Hypertransaminasaemia 79.63 49.84 22 1355 5584 34949970
Acute generalised exanthematous pustulosis 71.10 49.84 21 1356 6755 34948799
Drug reaction with eosinophilia and systemic symptoms 62.62 49.84 29 1348 32983 34922571
Rhabdomyolysis 60.54 49.84 36 1341 68127 34887427

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Cholestasis 211.06 39.52 75 2551 52034 79689728
Hepatocellular injury 206.09 39.52 72 2554 47521 79694241
Rash maculo-papular 144.38 39.52 58 2568 56020 79685742
Toxic epidermal necrolysis 135.46 39.52 52 2574 44529 79697233
Drug reaction with eosinophilia and systemic symptoms 85.93 39.52 42 2584 64202 79677560
Hypertransaminasaemia 79.35 39.52 25 2601 11899 79729863
Acute generalised exanthematous pustulosis 77.95 39.52 27 2599 17227 79724535
Eosinophilia 73.96 39.52 34 2592 45311 79696451
Rhabdomyolysis 57.39 39.52 38 2588 103093 79638669
Septic shock 53.67 39.52 39 2587 122762 79619000
Lung disorder 48.02 39.52 31 2595 80526 79661236
Premature rupture of membranes 46.64 39.52 13 2613 4056 79737706
Respiratory distress 43.77 39.52 26 2600 58313 79683449
Hepatic cytolysis 40.03 39.52 19 2607 27132 79714630

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01FA02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
Macrolides
ATC J01RA04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
COMBINATIONS OF ANTIBACTERIALS
Combinations of antibacterials
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:36047 antibacterial drugs
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D003049 Coccidiostats

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Prophylaxis of congenital toxoplasmosis indication 73893000 DOID:13336




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D05908 KEGG_DRUG
N0000168428 NUI
CHEBI:85260 CHEBI
CHEMBL453514 ChEMBL_ID
478 INN_ID
DB06145 DRUGBANK_ID
71ODY0V87H UNII
9991 RXNORM
002766 NDDF
302007 SNOMEDCT_US
387163002 SNOMEDCT_US
C0037962 UMLSCUI
D015572 MESH_DESCRIPTOR_UI
6440717 PUBCHEM_CID

Pharmaceutical products:

None