|
|
Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Enoxaparin#Nonclinical Toxicology]] |
| {{Enoxaparin}}
| |
| {{CMG}}; {{AE}} {{SS}}
| |
| | |
| ==Nonclinical Toxicology==
| |
| | |
| ===Carcinogenesis, Mutagenesis, Impairment of Fertility===
| |
| | |
| No long-term studies in animals have been performed to evaluate the carcinogenic potential of enoxaparin. Enoxaparin was not mutagenic in in vitro tests, including the Ames test, mouse lymphoma cell forward mutation test, and human lymphocyte chromosomal aberration test, and the in vivo rat bone marrow chromosomal aberration test. Enoxaparin was found to have no effect on fertility or reproductive performance of male and female rats at SC doses up to 20 mg/kg/day or 141 mg/m2/day. The maximum human dose in clinical trials was 2.0 mg/kg/day or 78 mg/m2/day (for an average body weight of 70 kg, height of 170 cm, and body surface area of 1.8 m2).
| |
| | |
| ===Animal Toxicology and/or Pharmacology===
| |
| | |
| A single SC dose of 46.4 mg/kg enoxaparin was lethal to rats. The symptoms of acute toxicity were [[ataxia]], decreased motility, [[dyspnea]], [[cyanosis]], and [[coma]].
| |
| | |
| ===Reproductive and Developmental Toxicology===
| |
| | |
| Teratology studies have been conducted in pregnant rats and rabbits at SC doses of enoxaparin up to 30 mg/kg/day corresponding to 211 mg/m2/day and 410 mg/m2/day in rats and rabbits respectively. There was no evidence of teratogenic effects or fetotoxicity due to enoxaparin.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LOVENOX (ENOXAPARIN SODIUM) INJECTION [SANOFI-AVENTIS U.S. LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5017a927-2a24-4f27-89f9-27c805bf7d59 | publisher = | date = | accessdate = 6 February 2014 }}</ref>
| |
| | |
| ==References==
| |
| | |
| {{Reflist|2}}
| |
| | |
| [[Category:Antiplatelet drugs]]
| |
| [[Category:Cardiovascular Drugs]]
| |
| [[Category:Drugs]]
| |
| {{WikiDoc Help Menu}}
| |
| {{WikiDoc Sources}}
| |