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 123.00 44.20 38 1091 25363 50578632
Hepatocellular injury 101.47 44.20 33 1096 25914 50578081
Rash maculo-papular 51.08 44.20 20 1109 26621 50577374
Premature rupture of membranes 50.17 44.20 13 1116 4567 50599428

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
Hepatocellular injury 114.74 52.17 40 1168 21203 29552116
Toxic epidermal necrolysis 101.14 52.17 35 1173 18118 29555201
Cholestasis 92.37 52.17 35 1173 23427 29549892
Hypertransaminasaemia 88.49 52.17 22 1186 3584 29569735
Rash maculo-papular 87.61 52.17 34 1174 24255 29549064
Rhabdomyolysis 63.21 52.17 36 1172 60772 29512547
Drug reaction with eosinophilia and systemic symptoms 53.50 52.17 25 1183 27967 29545352
Eosinophilia 52.52 52.17 23 1185 22138 29551181
Acute generalised exanthematous pustulosis 52.34 52.17 16 1192 5567 29567752

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 206.77 37.76 73 2286 44799 64451574
Hepatocellular injury 202.39 37.76 72 2287 45163 64451210
Rash maculo-papular 130.97 37.76 53 2306 46973 64449400
Toxic epidermal necrolysis 93.57 37.76 39 2320 37127 64459246
Hypertransaminasaemia 89.26 37.76 25 2334 7166 64489207
Eosinophilia 76.26 37.76 34 2325 38042 64458331
Drug reaction with eosinophilia and systemic symptoms 67.69 37.76 35 2324 54182 64442191
Rhabdomyolysis 57.84 37.76 38 2321 91688 64404685
Septic shock 50.76 37.76 37 2322 105400 64390973
Acute generalised exanthematous pustulosis 50.17 37.76 19 2340 14039 64482334
Lung disorder 47.90 37.76 29 2330 60671 64435702
Premature rupture of membranes 46.36 37.76 13 2346 3731 64492642
Respiratory distress 43.87 37.76 26 2333 52305 64444068
Hepatic cytolysis 39.58 37.76 16 2343 14033 64482340
Rash morbilliform 38.09 37.76 12 2347 5129 64491244

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
5289394 PUBCHEM_CID
9991 RXNORM
002766 NDDF
302007 SNOMEDCT_US
387163002 SNOMEDCT_US
D015572 MESH_DESCRIPTOR_UI
C0037962 UMLSCUI

Pharmaceutical products:

None