spiramycin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

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 117.59 40.60 38 1589 36261 90590559
Hepatocellular injury 92.45 40.60 30 1597 28928 90597892
Rash maculo-papular 74.89 40.60 28 1599 40905 90585915
Hepatic cytolysis 52.36 40.60 20 1607 30896 90595924
Premature rupture of membranes 50.46 40.60 13 1614 5545 90621275
Talipes 48.10 40.60 10 1617 1670 90625150
Hyperbilirubinaemia 46.72 40.60 15 1612 13921 90612899
Dysmorphism 43.87 40.60 10 1617 2558 90624262
Acute kidney injury 43.69 40.60 40 1587 320347 90306473

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 137.66 42.43 49 1745 26701 42592840
Cholestasis 110.10 42.43 44 1750 32835 42586706
Hepatocellular injury 105.41 42.43 39 1755 23639 42595902
Rash maculo-papular 104.50 42.43 44 1750 37459 42582082
Acute generalised exanthematous pustulosis 77.19 42.43 24 1770 8571 42610970
Hypertransaminasaemia 67.33 42.43 22 1772 9205 42610336
Drug reaction with eosinophilia and systemic symptoms 65.57 42.43 33 1761 42042 42577499
Eosinophilia 60.81 42.43 29 1765 32870 42586671
Rhabdomyolysis 53.79 42.43 36 1758 77983 42541558
Craniosynostosis 46.80 42.43 9 1785 427 42619114
Lung disorder 45.23 42.43 27 1767 47896 42571645

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 227.83 39.54 82 3247 64436 110521534
Hepatocellular injury 184.84 39.54 66 3263 50576 110535394
Rash maculo-papular 177.52 39.54 71 3258 74151 110511819
Toxic epidermal necrolysis 159.36 39.54 61 3268 56666 110529304
Drug reaction with eosinophilia and systemic symptoms 97.18 39.54 48 3281 82047 110503923
Eosinophilia 93.61 39.54 42 3287 57894 110528076
Hepatic cytolysis 92.44 39.54 41 3288 55012 110530958
Acute generalised exanthematous pustulosis 89.50 39.54 31 3298 21633 110564337
Hypertransaminasaemia 64.15 39.54 25 3304 24230 110561740
Dermatitis exfoliative generalised 58.38 39.54 19 3310 10953 110575017
Respiratory distress 57.78 39.54 32 3297 68842 110517128
Rhabdomyolysis 55.10 39.54 38 3291 120363 110465607
Acute kidney injury 52.72 39.54 79 3250 635351 109950619
Septic shock 52.38 39.54 41 3288 157487 110428483
Premature rupture of membranes 46.11 39.54 13 3316 4624 110581346
Hyperbilirubinaemia 45.60 39.54 21 3308 30650 110555320
Interstitial lung disease 41.48 39.54 34 3295 139300 110446670

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
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000981 Antiprotozoal Agents
MeSH PA D003049 Coccidiostats
CHEBI has role CHEBI:33282 antibacterial agent

Related Drugs by ATC class:

J01FA Macrolides 13 drugs
azithromycinclarithromycindirithromycinerythromycinflurithromycinjosamycinmiocamycinmydecamycinoleandomycinrokitamycinroxithromycintelithromycin show all 13 →
J01RA Combinations of antibacterials 18 drugs
amikacinazithromycincefepimecefiximecefuroximeciprofloxacinfluconazolelevofloxacinmetronidazolenitazoxanidenorfloxacinnystatin show all 18 →

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
CHEMBL6195749 ChEMBL_ID
13312 IUPHAR_LIGAND_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
5289394 PUBCHEM_CID

Pharmaceutical products:

None