BIAPENEM

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C15H18N4O4S
Molecular Weight	350.393
Optical Activity	UNSPECIFIED
Defined Stereocenters	4 / 5
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

C[C@@H](O)[C@@H]1[C@H]2[C@@H](C)C(SC3CN4C=NC=[N+]4C3)=C(N2C1=O)C([O-])=O

InChI

InChIKey=MRMBZHPJVKCOMA-YJFSRANCSA-N

InChI=1S/C15H18N4O4S/c1-7-11-10(8(2)20)14(21)19(11)12(15(22)23)13(7)24-9-3-17-5-16-6-18(17)4-9/h5-11,20H,3-4H2,1-2H3/t7-,8-,10-,11-/m1/s1

HIDE SMILES / InChI

Molecular Formula	C15H18N4O4S
Molecular Weight	350.393
Charge	0
Count

Stereochemistry	EPIMERIC
Additional Stereochemistry	No
Defined Stereocenters	4 / 5
E/Z Centers	0
Optical Activity	UNSPECIFIED

Description
Sources: http://www.ncbi.nlm.nih.gov/pubmed/12381221

Biapenem (INN) is a carbapenem antibiotic. It has in vitro activity against anaerobes. Approved in Japan in 2001. Biapenem is a carbopenems antibiotic which suppresses bacterial growth by inhibiting the enzymes responsible for bacterial cell wall synthesis, and shows broad-spectrum antibacterial activity both against gram-positive bacteria and gram-negative bacteria. Biapenem is stable to dehaloperoxidase-I (DHP-I) and can not be administered together with DHP-I inhibitor. This product is applicable to the treatment of a variety of infections caused by sensitive bacteria: septicemia, pneumonia, lung abscess, secondary infections resulting from chronic respiratory disease, cystitis, pyelonephritis, peritonitis, appendagitis, etc. Biapenem is generally well tolerated. The most common adverse events in clinical trials were skin eruptions/rashes, nausea and diarrhoea.

Approval Year

Conditions

Condition	Modality	Targets	Highest Phase	Product
Variety of infections 1 Sources: https://clinicaltrials.gov/ct2/show/NCT01702649	Curative		Approved 8583	Unknown Approved Use Unknown

C_max

Value	Dose	Analyte	Population
8.8 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	150 mg single, intravenous dose: 150 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
17.3 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
32.4 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
15.6 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	300 mg 2 times / day multiple, intravenous dose: 300 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
14.7 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	300 mg 2 times / day multiple, intravenous dose: 300 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
32.6 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=3 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	600 mg 2 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
35.3 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=3 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	600 mg 2 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
20.2 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
17.4 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
14.2 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
40.2 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
33.8 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
33.2 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
25.6 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
24 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
12.8 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
24.8 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
19 μg/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
5.43 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	250 mg single, intravenous dose: 250 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
5.71 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	250 mg 3 times / day multiple, intravenous dose: 250 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
16.3 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	500 mg single, intravenous dose: 500 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
16.6 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	500 mg 3 times / day multiple, intravenous dose: 500 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
22.6 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	750 mg single, intravenous dose: 750 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
20.8 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	750 mg 3 times / day multiple, intravenous dose: 750 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
39.8 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
38.2 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1000 mg 3 times / day multiple, intravenous dose: 1000 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
52.3 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1250 mg single, intravenous dose: 1250 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
44.8 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1250 mg 3 times / day multiple, intravenous dose: 1250 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN

AUC

Value	Dose	Analyte	Population
14.7 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	150 mg single, intravenous dose: 150 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
29.2 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
55.4 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
26.2 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	300 mg 2 times / day multiple, intravenous dose: 300 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
23.4 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	300 mg 2 times / day multiple, intravenous dose: 300 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
56.7 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=3 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	600 mg 2 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
57.1 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=3 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	600 mg 2 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
44.6 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
34.5 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
26.6 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
91.9 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
70.1 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
66.1 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
68 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
61.1 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
46.6 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
52.7 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
120 μg × h/mL OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
17.5 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	250 mg single, intravenous dose: 250 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
18.4 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	250 mg 3 times / day multiple, intravenous dose: 250 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
52.4 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	500 mg single, intravenous dose: 500 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
49.4 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	500 mg 3 times / day multiple, intravenous dose: 500 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
68.3 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	750 mg single, intravenous dose: 750 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
70 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	750 mg 3 times / day multiple, intravenous dose: 750 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
123 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
115 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1000 mg 3 times / day multiple, intravenous dose: 1000 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
148 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1250 mg single, intravenous dose: 1250 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
146 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1250 mg 3 times / day multiple, intravenous dose: 1250 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN

T_1/2

Value	Dose	Analyte	Population
0.97 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	150 mg single, intravenous dose: 150 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
1.03 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
1.04 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=24	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
0.96 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	300 mg 2 times / day multiple, intravenous dose: 300 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
0.85 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	300 mg 2 times / day multiple, intravenous dose: 300 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.03 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=3 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	600 mg 2 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.01 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=3 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=25	600 mg 2 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.75 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.82 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.51 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=7 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=26	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.59 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.45 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
2.19 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W103_1.pdf#page=8	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
2.28 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.82 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.95 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=2 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
3.33 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
3.92 h OTHER GOV'T https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_Q101_1.pdf#page=3 \| https://www.pmda.go.jp/drugs/2001/P200100035/53039600_21300AMZ00761_W104_1.pdf#page=1 \| https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=27	300 mg single, intravenous dose: 300 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.1 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	250 mg single, intravenous dose: 250 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.06 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	250 mg 3 times / day multiple, intravenous dose: 250 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.3 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	500 mg single, intravenous dose: 500 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.13 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	500 mg 3 times / day multiple, intravenous dose: 500 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.03 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	750 mg single, intravenous dose: 750 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	750 mg 3 times / day multiple, intravenous dose: 750 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.21 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.42 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1000 mg 3 times / day multiple, intravenous dose: 1000 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.31 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1250 mg single, intravenous dose: 1250 mg route of administration: Intravenous experiment type: SINGLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.63 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/33685898/	1250 mg 3 times / day multiple, intravenous dose: 1250 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	BIAPENEM plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN

F_unbound

Value	Dose	Co-administered	Analyte	Population
93.4% OTHER GOV'T https://www.info.pmda.go.jp/go/interview/2/780009_6139401D1020_2_1F.pdf#page=29			BIAPENEM plasma	Homo sapiens

Doses

Dose	Population	Adverse events
300 mg 3 times / day multiple, intravenous Recommended Dose: 300 mg, 3 times / day Route: intravenous Route: multiple Dose: 300 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/24725621/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/24725621/	Other AEs: Liver disorder, Nausea... Other AEs: Liver disorder (12%) Nausea (4%) Sources: https://pubmed.ncbi.nlm.nih.gov/24725621/
500 mg 3 times / day multiple, intravenous Studied dose Dose: 500 mg, 3 times / day Route: intravenous Route: multiple Dose: 500 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/	Disc. AE: Trombocytopenia, Drug fever... AEs leading to discontinuation/dose reduction: Trombocytopenia (1.7%) Drug fever (1.7%) Oedema (1.7%) Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/

AEs

AE	Significance	Dose	Population
Liver disorder	12%	300 mg 3 times / day multiple, intravenous Recommended Dose: 300 mg, 3 times / day Route: intravenous Route: multiple Dose: 300 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/24725621/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/24725621/
Nausea	4%	300 mg 3 times / day multiple, intravenous Recommended Dose: 300 mg, 3 times / day Route: intravenous Route: multiple Dose: 300 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/24725621/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/24725621/
Drug fever	1.7% Disc. AE	500 mg 3 times / day multiple, intravenous Studied dose Dose: 500 mg, 3 times / day Route: intravenous Route: multiple Dose: 500 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/
Oedema	1.7% Disc. AE	500 mg 3 times / day multiple, intravenous Studied dose Dose: 500 mg, 3 times / day Route: intravenous Route: multiple Dose: 500 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/
Trombocytopenia	1.7% Disc. AE	500 mg 3 times / day multiple, intravenous Studied dose Dose: 500 mg, 3 times / day Route: intravenous Route: multiple Dose: 500 mg, 3 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/8953683/

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inducer 1087			inhibitor 2217

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
OAT3 747 OAT1 725 CYP19A1 429 OCT2 779	OAT3 391 OAT1 395 OCT2 434 P-gp 2052

Drug as perpetrator

Target	Modality	Activity
OAT3 749	inhibitor 4027 Sources: https://pubmed.ncbi.nlm.nih.gov/33753216/	mild [IC50 >500 uM]
CYP19A1 430	inhibitor 4027 Sources: https://pubchem.ncbi.nlm.nih.gov/compound/71339#section=BioAssay-Results Page: 37.0	no
CYP3A4 2633	inducer 1966 Sources: https://pubchem.ncbi.nlm.nih.gov/compound/71339#section=BioAssay-Results Page: 42.0	no
OAT1 730	inhibitor 4027 Sources: https://pubmed.ncbi.nlm.nih.gov/33753216/	no
OCT2 782	inhibitor 4027 Sources: https://pubmed.ncbi.nlm.nih.gov/33753216/	no

Drug as victim

Target	Modality	Activity
OAT1 395	substrate 4014 Sources: https://pubmed.ncbi.nlm.nih.gov/33753216/	no
OCT2 434	substrate 4014 Sources: https://pubmed.ncbi.nlm.nih.gov/33753216/	no
P-gp 2052	substrate 4014 Sources: https://pubchem.ncbi.nlm.nih.gov/compound/71339#section=BioAssay-Results Page: 41 \| 43	no
OAT3 391	substrate 4014 Sources: https://pubmed.ncbi.nlm.nih.gov/33753216/	yes

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 2263	inhibitor 2237 Sources: https://pubchem.ncbi.nlm.nih.gov/compound/71339#section=BioAssay-Results Page: 17.0

PubMed

Title	Date	PubMed
Optimal dosing regimen of biapenem in Chinese patients with lower respiratory tract infections based on population pharmacokinetic/pharmacodynamic modelling and Monte Carlo simulation.	2016-03	26895604

Patents

Sample Use Guides

In Vivo Use Guide

For adults is 0.6 g/d, given over approximately 30-60 minutes in twice administration per day. Dosage can be adjusted according to the physical condition such as age and symptom of each individual, but should not exceed 1.2 g/d.

Route of Administration: Intravenous

In Vitro Use Guide

For the carbapenems, the rank order of activity was meropenem (MIC50, 1 microg/ml)=biapenem (1 microg/ml)>imipenem (2 microg/m)>panipenem (8 microg/ml).

Substance Class	Chemical Created by `admin` on `Mon Mar 31 18:06:34 GMT 2025` Edited by `admin` on `Mon Mar 31 18:06:34 GMT 2025`
Record UNII	YR5U3L9ZH1
Record Status	`Validated (UNII)`
Record Version

Download

Name

Type

Language

BIAPENEM

Official Name

English

OMEGACIN

Preferred Name

English

6-[[(4R,5S,6S)-2-Carboxy-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]thio]-6,7-dihydro-5H-pyrazolo[1,2-a]-S-triazol-4-ium hydroxide, inner salt

Systematic Name

English

Biapenem [WHO-DD]

Common Name

English

biapenem [INN]

Common Name

English

BIAPENEM [JAN]

Common Name

English

CL 186,815

Code

English

LJ-C10627

Code

English

BIAPENEM [MART.]

Common Name

English

6-(((4R,5S,6S)-2-CARBOXY-6-((1R)-1-HYDROXYETHYL)-4-METHYL-7-OXO-1-AZABICYCLO(3.2.0)HEPT-2-EN-3-YL)THIO)-6,7-DIHYDRO-5H-PYRAZOLO(1,2-A)(1,2,4)TRIAZOL-4-IUM INNER SALT

Systematic Name

English

L-627

Code

English

5H-PYRAZOLO(1,2-A)(1,2,4)TRIAZOL-4-IUM, 6-((2-CARBOXY-6-(1-HYDROXYETHYL)-4-METHYL-7-OXO-1-AZABICYCLO(3.2.0)HEPT-2-EN-3-YL)THIO)-6,7-DIHYDRO-, HYDROXIDE, INNER SALT, (4R-(4.ALPHA.,5.BETA.,6.BETA.(R*)))-

Systematic Name

English

BIAPENEM [MI]

Common Name

English

CL-186815

Code

English

BIAPENEM [USAN]

Common Name

English

LJC-10627

Code

English

LJ C10,627

Code

English

Classification Tree Code System Code

WHO-VATC

QJ01DH05