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Secnidazole

P01A - Agents against amoebiasis and other protozoal diseases ATC P01AB07 Small molecule approved 2017 Oral Natural product

JFDA label: Secnezole 500mg tablet

Mechanism of Action

Inhibitor of DNA — DNA inhibitor

TargetActionGene / class
DNA efficacy INHIBITOR

Indications

Approved

  • Bacterial vaginosis

Antimicrobial Spectrum

Expected / intrinsic spectrum (EUCAST breakpoints & labels) — not local resistance. Source: openfda-label.

Protozoa

OrganismActivityMIC
Trichomonas cells Active
Trichomonas vaginalis Active

Contraindications

Source: Lexicomp

  • Hypersensitivity to secnidazole, other nitroimidazole derivatives, or any component of the formulation Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Nervous system disorders (1)

Common Headache

Renal and urinary disorders (1)

Common Vulvovaginal candidiasis

Gastrointestinal disorders (2)

Common diarrhea · Nausea

Other (1)

Not Known Nonapproved dosing regimens are included in the reported incidences

Dosing

Source: Lexicomp

Bacterial vaginosis: Oral: 2 g single dose
Refer to adult dosing.

Warnings & Precautions

Source: Lexicomp

Carcinogenic

Carcinogenicity has been observed in mice and rats with nitroimidazole agents that are structurally similar to secnidazole in animal studies; it is unknown whether secnidazole is associated with carcinogenicity in humans. Avoid chronic use. Disease-related concerns:

Candidiasis

Vulvovaginal candidiasis may occur; antifungal treatment may be necessary if patient is symptomatic.

Pregnancy & Lactation

Pregnancy

Adverse events were not observed in animal reproduction studies. Information related to the use of secnidazole in pregnancy is limited (Camargo 2015).

Lactation

It is not known if secnidazole is present in breast milk. Due to the potential for adverse events, the manufacturer recommends breastfeeding be avoided during therapy and for 96 hours after the last dose.

Chemistry & Properties

2D structure
FormulaC7H11N3O3
Molecular weight185.18 g/mol
IUPAC name1-(2-methyl-5-nitroimidazol-1-yl)propan-2-ol
CAS3366-95-8
PubChem CID71815
InChIKeyKPQZUUQMTUIKBP-UHFFFAOYSA-N
logP0.48 (XLogP 0.2)
Polar surface area81.19 Ų
H-bond acceptors / donors5 / 1
Drug-likeness (QED)0.55
Lipinski violations0
SMILESCc1ncc([N+](=O)[O-])n1CC(C)O

Biology & Pharmacokinetics

Pharmacokinetics predicted

Bioavailability10.0%
Half-life2.182 h
Volume of distribution0.916 L/kg
Protein binding8.3%
BBB penetrantYes

Enzyme interactions

EnzymeRoleDetail
CYP2C19Substrate
CYP2C9Substrate
CYP3A4Substrate

Transporters

BCRP (Inhibitor)BCRP (Inhibitor)BSEP (Inhibitor)MDR1 (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)BCRP (Substrate)MDR1 (Substrate)OAT1 (Substrate)OAT3 (Substrate)OATP1B1 (Substrate)OATP1B3 (Substrate)OCT2 (Substrate)P-gp (Substrate)

Drug–drug interactions (92, DDInter)

Interacting drugSeverityManagement
Typhoid vaccine (live) major
Vibrio cholerae CVD 103-HgR strain live antigen (live) major
Adalimumab moderate
Amiodarone moderate
Atorvastatin moderate
Auranofin moderate
Aurothioglucose moderate
Benznidazole moderate
Bifidobacterium longum infantis moderate
Bortezomib moderate
Brentuximab vedotin moderate
Cabazitaxel moderate
Carboplatin moderate
Carfilzomib moderate
Cerivastatin moderate
Certolizumab pegol moderate
Chloramphenicol moderate
Chloroquine moderate
Cisplatin moderate
Colchicine moderate
Crizotinib moderate
Dapsone moderate
Didanosine moderate
Diiodohydroxyquinoline moderate
Dinutuximab moderate
Disulfiram moderate
Docetaxel moderate
Elotuzumab moderate
Enfortumab vedotin moderate
Eribulin moderate
Etanercept moderate
Ethambutol moderate
Ethionamide moderate
Etoposide moderate
Etravirine moderate
Fludarabine moderate
Fluvastatin moderate
Golimumab moderate
Hydralazine moderate
Hydroxychloroquine moderate

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Registered Products (2)

BrandForm / strengthPackAgentCitizen (JOD)
Secnezole Tablet 500 mg 4 tab pack varies THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN 3.610
Secnezole Tablet 500 mg 12 tab pack varies THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN 8.820