Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C8H11N3O3S |
Molecular Weight | 229.256 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
NC1=NC(=O)N(C=C1)[C@@H]2CS[C@H](CO)O2
InChI
InChIKey=JTEGQNOMFQHVDC-NKWVEPMBSA-N
InChI=1S/C8H11N3O3S/c9-5-1-2-11(8(13)10-5)6-4-15-7(3-12)14-6/h1-2,6-7,12H,3-4H2,(H2,9,10,13)/t6-,7+/m0/s1
Molecular Formula | C8H11N3O3S |
Molecular Weight | 229.256 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
DescriptionSources: https://pharmaffiliates.com/%C2%B1-trans-lamivudine/lamivudine-impurity-b-impurity/62787 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf | https://newdrugapprovals.org/2016/03/18/lamivudine/http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdfCurator's Comment: Description was created based on several sources, including:
http://www.drugbank.ca/drugs/DB00709
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2df7349c-f5d7-47b5-d29b-1b6b31985591
Sources: https://pharmaffiliates.com/%C2%B1-trans-lamivudine/lamivudine-impurity-b-impurity/62787 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf | https://newdrugapprovals.org/2016/03/18/lamivudine/http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020564s035,020596s034lbl.pdf
Curator's Comment: Description was created based on several sources, including:
http://www.drugbank.ca/drugs/DB00709
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2df7349c-f5d7-47b5-d29b-1b6b31985591
Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1) and hepatitis B (HBV). Intracellularly, lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC-TP). The principal mode of action of 3TC-TP is inhibition of HIV-1 reverse transcriptase (RT) via DNA chain termination after incorporation of the nucleotide analogue. The most common reported adverse reactions in adults are headache, nausea, malaise and fatigue. No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine.
CNS Activity
Sources: http://www.ncbi.nlm.nih.gov/pubmed/22514580
Curator's Comment: Known to be CNS penetrant in rat, guinea pig. Human data not available.
http://www.ncbi.nlm.nih.gov/pubmed/9593963
http://www.ncbi.nlm.nih.gov/pubmed/18042828
http://www.ncbi.nlm.nih.gov/pubmed/12766261
Originator
Sources: https://www.ncbi.nlm.nih.gov/pubmed/1929298http://www.thepharmaletter.com/article/lamivudine-positive-effects-in-hepatitis-b
Curator's Comment: http://www.google.com/patents/US20030004175?hl=ru&cl=en
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL247 |
2.0 nM [IC50] | ||
Target ID: CHEMBL2362994 |
3.3 µM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | EPIVIR Approved UseEPIVIR is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Launch Date1.10108161E12 |
|||
Primary | EPIVIR Approved UseEPIVIR-HBV is a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation Launch Date1.10108161E12 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
3.3 μg/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/29150845 |
300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered: |
LAMIVUDINE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
1.4 μg/mL |
150 mg 2 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
LAMIVUDINE unknown | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
12.4 μg × h/mL EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/29150845 |
300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered: |
LAMIVUDINE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
5.53 μg × h/mL |
150 mg 2 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
LAMIVUDINE unknown | Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
13.9 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/29150845 |
300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered: |
LAMIVUDINE blood | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
Doses
Dose | Population | Adverse events |
---|---|---|
100 mg 1 times / day multiple, oral Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: |
unhealthy, 14.6 n = 12 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 14.6 Sex: M+F Population Size: 12 Sources: |
Other AEs: Malaise and fatigue, Ear, nose and throat infection... Other AEs: Malaise and fatigue (25%) Sources: Ear, nose and throat infection (17%) Cough (8%) Headache (17%) Nausea and vomiting (8%) Ear, nose and throat infection (8%) |
10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Other AEs: Coughing, Diarrhea... Other AEs: Coughing (6 patients) Sources: Diarrhea (9 patients) Abdominal discomfort (2 patients) Nausea and vomiting (1 patient) Malaise and fatigue (6 patients) Headache (6 patients) Disorder sleep (4 patients) Cognitive disorders (2 patients) Oral ulceration (2 patients) Oral lesion (2 patients) Muscle pain (3 patients) Arthralgia (1 patient) Temperature regulation disorder (2 patients) |
4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Other AEs: Malaise and fatigue, Cough... Other AEs: Malaise and fatigue (27%) Sources: Cough (27%) Temperature regulation disorder NOS (27%) Nausea and vomiting (9%) Ear, nose and throat infection (18%) Ear disorder (9%) Pharyngitis (18%) |
150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Other AEs: Headache, Malaise and fatigue... Other AEs: Headache (35%) Sources: Malaise and fatigue (27%) Chills & fever (10%) Nausea (33%) Diarrhea (18%) Nausea and vomiting (13%) Decreased appetite (10%) Abdominal pain (9%) Abdominal cramps (6%) Dyspepsia (5%) Neuropathy (12%) Insomnia disorder (11%) Dizziness (10%) Depressive disorders (9%) Nasal disorders NEC (20%) Cough (18%) Skin rash (9%) Musculoskeletal pain (12%) Myalgia (8%) Arthralgia (5%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Ear, nose and throat infection | 17% | 100 mg 1 times / day multiple, oral Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: |
unhealthy, 14.6 n = 12 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 14.6 Sex: M+F Population Size: 12 Sources: |
Headache | 17% | 100 mg 1 times / day multiple, oral Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: |
unhealthy, 14.6 n = 12 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 14.6 Sex: M+F Population Size: 12 Sources: |
Malaise and fatigue | 25% | 100 mg 1 times / day multiple, oral Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: |
unhealthy, 14.6 n = 12 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 14.6 Sex: M+F Population Size: 12 Sources: |
Cough | 8% | 100 mg 1 times / day multiple, oral Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: |
unhealthy, 14.6 n = 12 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 14.6 Sex: M+F Population Size: 12 Sources: |
Ear, nose and throat infection | 8% | 100 mg 1 times / day multiple, oral Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: |
unhealthy, 14.6 n = 12 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 14.6 Sex: M+F Population Size: 12 Sources: |
Nausea and vomiting | 8% | 100 mg 1 times / day multiple, oral Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: |
unhealthy, 14.6 n = 12 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 14.6 Sex: M+F Population Size: 12 Sources: |
Arthralgia | 1 patient | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Nausea and vomiting | 1 patient | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Abdominal discomfort | 2 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Cognitive disorders | 2 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Oral lesion | 2 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Oral ulceration | 2 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Temperature regulation disorder | 2 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Muscle pain | 3 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Disorder sleep | 4 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Coughing | 6 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Headache | 6 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Malaise and fatigue | 6 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Diarrhea | 9 patients | 10 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 10 mg/kg, 2 times / day Route: oral Route: multiple Dose: 10 mg/kg, 2 times / day Sources: |
unhealthy, 37 years (range: 23-63 years) n = 14 Health Status: unhealthy Condition: HIV infection Age Group: 37 years (range: 23-63 years) Population Size: 14 Sources: |
Ear, nose and throat infection | 18% | 4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Pharyngitis | 18% | 4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Cough | 27% | 4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Malaise and fatigue | 27% | 4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Temperature regulation disorder NOS | 27% | 4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Ear disorder | 9% | 4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Nausea and vomiting | 9% | 4 mg/kg 2 times / day multiple, oral Highest studied dose Dose: 4 mg/kg, 2 times / day Route: oral Route: multiple Dose: 4 mg/kg, 2 times / day Sources: |
unhealthy, 7.6 n = 11 Health Status: unhealthy Condition: Chronic hepatitis B Age Group: 7.6 Sex: M+F Population Size: 11 Sources: |
Chills & fever | 10% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Decreased appetite | 10% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Dizziness | 10% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Insomnia disorder | 11% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Musculoskeletal pain | 12% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Neuropathy | 12% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Nausea and vomiting | 13% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Cough | 18% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Diarrhea | 18% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Nasal disorders NEC | 20% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Malaise and fatigue | 27% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Nausea | 33% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Headache | 35% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Arthralgia | 5% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Dyspepsia | 5% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Abdominal cramps | 6% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Myalgia | 8% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Abdominal pain | 9% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Depressive disorders | 9% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Skin rash | 9% | 150 mg 1 times / day multiple, oral Recommended Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Co-administed with:: zidovudine(200 mg; 3/day) Sources: |
unhealthy n = 251 Health Status: unhealthy Condition: HIV-1 infection Population Size: 251 Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
no | ||||
no | ||||
no | ||||
Sources: https://www.pmda.go.jp/drugs/2020/P20200109001/340278000_30200AMX00001_I100_1.pdf#page=6 Page: 6.0 |
no | |||
Sources: https://www.pmda.go.jp/drugs/2020/P20200109001/340278000_30200AMX00001_I100_1.pdf#page=6 Page: 6.0 |
no | |||
Sources: https://www.pmda.go.jp/drugs/2020/P20200109001/340278000_30200AMX00001_I100_1.pdf#page=6 Page: 6.0 |
no | |||
weak to no | ||||
weak to no | ||||
weak to no | ||||
Sources: https://www.pmda.go.jp/drugs/2020/P20200109001/340278000_30200AMX00001_I100_1.pdf#page=6 Page: 6.0 |
yes | |||
Sources: https://www.pmda.go.jp/drugs/2020/P20200109001/340278000_30200AMX00001_I100_1.pdf#page=6 Page: 6.0 |
yes |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
not signifiicant | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf#page=19 Page: 19.0 |
yes | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf#page=19 Page: 19.0 |
yes | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf#page=19 Page: 19.0 |
yes | |||
yes | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf#page=19 Page: 19.0 |
yes | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020564s039,020596s038lbl.pdf#page=19 Page: 19.0 |
yes |
PubMed
Title | Date | PubMed |
---|---|---|
Disappearance of hepatitis B virus core deletion mutants and successful combined kidney/liver transplantation in a patient treated with lamivudine. | 1999 |
|
Anti-HIV-1 activities of 1,3-dioxolane guanine and 2,6-diaminopurine dioxolane. | 1999 Apr-May |
|
Abacavir and mycophenolic acid, an inhibitor of inosine monophosphate dehydrogenase, have profound and synergistic anti-HIV activity. | 1999 Aug 15 |
|
Susceptibility of lamivudine-resistant hepatitis B virus to other reverse transcriptase inhibitors. | 1999 Jun |
|
Liver transplantation for chronic hepatitis B infection with the use of combination lamivudine and low-dose hepatitis B immune globulin. | 1999 Nov |
|
Mechanism of action and in vitro activity of 1',3'-dioxolanylpurine nucleoside analogues against sensitive and drug-resistant human immunodeficiency virus type 1 variants. | 1999 Oct |
|
Inhibition of human immunodeficiency virus type 1 replication in acutely and chronically infected cells by EM2487, a novel substance produced by a Streptomyces species. | 1999 Oct |
|
A novel genotype encoding a single amino acid insertion and five other substitutions between residues 64 and 74 of the HIV-1 reverse transcriptase confers high-level cross-resistance to nucleoside reverse transcriptase inhibitors. Abacavir CNA2007 International Study Group. | 1999 Oct 1 |
|
Pretherapy alanine transaminase level as a determinant for hepatitis B e antigen seroconversion during lamivudine therapy in patients with chronic hepatitis B. Asian Hepatitis Lamivudine Trial Group. | 1999 Sep |
|
Antiviral combination therapy for lamivudine-resistant hepatitis B reinfection after liver transplantation. | 2000 |
|
Additional interferon alpha for lamivudine resistant hepatitis B infection after liver transplantation: a preliminary report. | 2000 Apr 27 |
|
Beneficial effects of lamivudine in hepatitis B virus-related decompensated cirrhosis. | 2000 Aug |
|
Prevalence and characteristics of multinucleoside-resistant human immunodeficiency virus type 1 among European patients receiving combinations of nucleoside analogues. | 2000 Aug |
|
A randomized, comparative study of lamivudine plus stavudine, with indinavir or nelfinavir, in treatment-experienced HIV-infected patients. | 2000 Jan 28 |
|
Synthesis and anti-HIV evaluation of new 2',3'-dideoxy-3'-thiacytidine prodrugs. | 2000 Jul |
|
Drug resistance and drug combination features of the human immunodeficiency virus inhibitor, BCH-10652 [(+/-)-2'-deoxy-3'-oxa-4'-thiocytidine, dOTC]. | 2000 Jul |
|
Lamivudine after hepatitis B immune globulin is effective in preventing hepatitis B recurrence after liver transplantation. | 2000 Jul |
|
Combination low-dose hepatitis B immune globulin and lamivudine therapy provides effective prophylaxis against posttransplantation hepatitis B. | 2000 Jul |
|
Management of hepatitis B in China. | 2000 Jul |
|
3-year suppression of HIV viremia with indinavir, zidovudine, and lamivudine. | 2000 Jul 4 |
|
Presence of 2',5'-Bis-O-(tert-butyldimethylsilyl)-3'-spiro-5"-(4"-amino-1",2"-oxath iole-2",2"-dioxide) (TSAO)-resistant virus strains in TSAO-inexperienced HIV patients. | 2000 Jun 10 |
|
Steatosis-lactic acidosis syndrome associated with stavudine and lamivudine therapy. | 2000 Jun 16 |
|
Synthesis and antiviral evaluation of some beta-L-2', 3'-dideoxy-5-chloropyrimidine nucleosides and pronucleotides. | 2000 Mar |
|
Selection and characterization of human immunodeficiency virus type 1 variants resistant to the (+) and (-) enantiomers of 2'-deoxy-3'-oxa-4'-thio-5-fluorocytidine. | 2000 May |
|
Selection of resistance-conferring mutations in HIV-1 by the nucleoside reverse transcriptase inhibitors (+/-)dOTC and (+/-)dOTFC. | 2000 Nov |
|
An efficacy and cost-effectiveness analysis of combination hepatitis B immune globulin and lamivudine to prevent recurrent hepatitis B after orthotopic liver transplantation compared with hepatitis B immune globulin monotherapy. | 2000 Nov |
|
Clinical improvement in patients with decompensated liver disease caused by hepatitis B after treatment with lamivudine. | 2000 Nov |
|
Leucocytoclastic vasculitis and indinavir. | 2000 Nov |
|
Successful orthotopic liver transplantation for lamivudine-associated YMDD mutant hepatitis B virus. | 2000 Nov |
|
Efficacy of long-term lamivudine monotherapy in patients with hepatitis B e antigen-negative chronic hepatitis B. | 2000 Oct |
|
Lamivudine without HBIg for prevention of graft reinfection by hepatitis B: long-term follow-up. | 2000 Sep 15 |
|
Amino acid deletion at codon 67 and Thr-to-Gly change at codon 69 of human immunodeficiency virus type 1 reverse transcriptase confer novel drug resistance profiles. | 2001 Apr |
|
Successful lamivudine therapy for post-chemotherapeutic fulminant hepatitis B in a hepatitis B virus carrier with non-Hodgkin's lymphoma: case report and review of the literature. | 2001 Aug |
|
Cross-resistance testing of antihepadnaviral compounds using novel recombinant baculoviruses which encode drug-resistant strains of hepatitis B virus. | 2001 Jun |
|
Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. | 2001 Jun 29 |
|
Efavirenz-induced acute eosinophilic hepatitis. | 2001 May |
|
4'-Ethynyl nucleoside analogs: potent inhibitors of multidrug-resistant human immunodeficiency virus variants in vitro. | 2001 May |
|
Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1 and lamivudine-resistant hepatitis B virus: an open-label pilot study. | 2001 Sep 1 |
Patents
Substance Class |
Chemical
Created
by
admin
on
Edited
Sat Dec 17 18:06:57 UTC 2022
by
admin
on
Sat Dec 17 18:06:57 UTC 2022
|
Record UNII |
2T8Q726O95
|
Record Status |
Validated (UNII)
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Record Version |
|
-
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Classification Tree | Code System | Code | ||
---|---|---|---|---|
|
NDF-RT |
N0000175462
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-VATC |
QJ05AR04
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ATC |
J05AR05
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-VATC |
QJ05AR02
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
NCI_THESAURUS |
C97452
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
EMA ASSESSMENT REPORTS |
LAMIVUDINE TEVA PHARMA B.V. (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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WHO-VATC |
QJ05AR05
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
|
EMA ASSESSMENT REPORTS |
KIVEXA (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-VATC |
QJ05AR11
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ATC |
J05AR02
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ATC |
J05AR11
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ESSENTIAL MEDICINES LIST |
6.4.2.3 (LAM/NEV/ZID)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ESSENTIAL MEDICINES LIST |
6.4.2.1
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ATC |
J05AR16
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
NDF-RT |
N0000175459
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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|
NDF-RT |
N0000175656
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
|
NDF-RT |
N0000175459
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
EMA ASSESSMENT REPORTS |
ZEFFIX (AUTHORIZED: HEPTATIS B, CHRONIC)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ATC |
J05AR24
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ATC |
J05AR12
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ATC |
J05AR07
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
NDF-RT |
N0000009947
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
EMA ASSESSMENT REPORTS |
EPIVIR (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ESSENTIAL MEDICINES LIST |
6.4.2.3 (LAM/NEV/STA)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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LIVERTOX |
NBK548553
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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WHO-ATC |
J05AR01
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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WHO-ATC |
J05AR13
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
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WHO-ATC |
J05AR04
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
EMA ASSESSMENT REPORTS |
TRIUMEQ (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
|
WHO-VATC |
QJ05AR01
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
EMA ASSESSMENT REPORTS |
LAMIVUDINE/ZIDOVUDINE TEVA (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
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NDF-RT |
N0000175459
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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WHO-ATC |
J05AF05
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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|
WHO-VATC |
QJ05AR07
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
|
EMA ASSESSMENT REPORTS |
COMBIVIR (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
EMA ASSESSMENT REPORTS |
TRIZIVIR (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
WHO-ESSENTIAL MEDICINES LIST |
6.4.2.3 (LAM/ZID)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
||
|
EMA ASSESSMENT REPORTS |
LAMIVUDINE TEVA (AUTHORIZED: HEPATITIS B, CHRONIC)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
|
EMA ASSESSMENT REPORTS |
DUTREBIS (AUTHORIZED: HIV INFECTIONS)
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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||
|
WHO-VATC |
QJ05AF05
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
Code System | Code | Type | Description | ||
---|---|---|---|---|---|
|
6908
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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PRIMARY | |||
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68244
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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PRIMARY | RxNorm | ||
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63577
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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PRIMARY | |||
|
134678-17-4
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
2T8Q726O95
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
Lamivudine
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
LAMIVUDINE
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | Description: A white or almost white powder.Solubility: Soluble in water; sparingly soluble in methanol R; practically insoluble in acetone R. Category: Antiretroviral (Nucleoside Reverse Transcriptase Inhibitor). Storage: Lamivudine should be kept in a well-closed container, protected from light. Additional information: Lamivudine may exhibit polymorphism. Definition: Lamivudine contains not less than 97.0% and not more than 103.0% of C8H11N3O3S, calculated with reference to the dried substance. | ||
|
D019259
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
CHEMBL141
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
C1471
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
7155
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
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PRIMARY | |||
|
DD-86
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
DTXSID7023194
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
LAMIVUDINE
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
DB00709
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
760061
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
SUB08392MIG
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
M6672
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | Merck Index | ||
|
2T8Q726O95
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
60825
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
1539
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY | |||
|
1356836
Created by
admin on Sat Dec 17 18:06:58 UTC 2022 , Edited by admin on Sat Dec 17 18:06:58 UTC 2022
|
PRIMARY |
Related Record | Type | Details | ||
---|---|---|---|---|
|
INHIBITOR->TARGET ORGANISM | |||
|
SALT/SOLVATE -> PARENT | |||
|
BASIS OF STRENGTH->SUBSTANCE |
ASSAY (HPLC)
USP
|
||
|
BASIS OF STRENGTH->SUBSTANCE |
ASSAY (HPLC)
EP
|
||
|
TARGET ORGANISM->INHIBITOR | |||
|
TARGET -> INHIBITOR | |||
|
TARGET ORGANISM->INHIBITOR |
|
Related Record | Type | Details | ||
---|---|---|---|---|
|
METABOLITE -> PARENT |
URINE
|
Related Record | Type | Details | ||
---|---|---|---|---|
|
IMPURITY -> PARENT |
UNSPECIFIED
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
UNSPECIFIED
EP
|
||
|
IMPURITY -> PARENT |
UNSPECIFIED
EP
|
||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT |
UNSPECIFIED
EP
|
||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT |
UNSPECIFIED
EP
|
||
|
IMPURITY -> PARENT |
Use the chromatogram supplied with lamivudine for system suitability RS and the chromatogram obtained with solutions (4) and (3) to identify the peaks due to impurity F. The impurity peaks are eluted at the following relative retention times with reference to lamivudine (retention time about 11 to 12 minutes): impurity F (uracil) about 0.36.
|
||
|
PARENT -> IMPURITY | |||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT |
Use the chromatogram supplied with lamivudine for system suitability RS and the chromatogram obtained with solutions (4) and (3) to identify the peaks due to impurity C. The impurity peaks are eluted at the following relative retention times with reference to lamivudine (retention time about 11 to 12 minutes): impurity C (salicylic acid) about 2.6.
In the chromatogram obtained with solution (1): - the area of any peak corresponding to impurity C is not greater than that of the principal peak in the chromatogram obtained with solution (3) (0.1%).
|
||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT |
Use the chromatogram supplied with lamivudine for system suitability RS and the chromatogram obtained with solutions (4) and (3) to identify the peaks due to impurity F. The impurity peaks are eluted at the following relative retention times with reference to lamivudine (retention time about 11 to 12 minutes): impurity E (cytosine) about 0.31.
In the chromatogram obtained with solution (1):- the area of any individual peak corresponding to impurity E, when multiplied by a correction factor of 0.6, is not greater than the area of the peak in the chromatogram obtained with solution (2) (0.1%).
|
||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT | |||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
UNSPECIFIED
EP
|
Related Record | Type | Details | ||
---|---|---|---|---|
|
ACTIVE MOIETY |
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
---|---|---|---|---|---|---|
Volume of Distribution | PHARMACOKINETIC |
|
|
|||
Biological Half-life | PHARMACOKINETIC |
|
Intercellular PHARMACOKINETIC PHARMACOKINETIC PHARMACOKINETIC |
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||