Propranolol nonclinical toxicology: Difference between revisions
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In dietary administration studies in which mice and rats were treated with propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. On a body surface area basis, this dose in the mouse and rat is, respectively, about equal to and about twice the maximum recommended human oral daily dose (MRHD) of 640 mg propranolol hydrochloride. In a study in which both male and female rats were exposed to propranolol hydrochloride in their diets at concentrations of up to 0.05% (about 50 mg/kg body weight and less than the MRHD), from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. | In dietary administration studies in which mice and rats were treated with propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. On a body surface area basis, this dose in the mouse and rat is, respectively, about equal to and about twice the maximum recommended human oral daily dose (MRHD) of 640 mg propranolol hydrochloride. In a study in which both male and female rats were exposed to propranolol hydrochloride in their diets at concentrations of up to 0.05% (about 50 mg/kg body weight and less than the MRHD), from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. | ||
Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of propranolol in bacteria (S. typhimurium strain TA 1538<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INDERAL LA (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AKRIMAX PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fce692df-1e68-465e-8dda-0cb01320608c | publisher = | date = |accessdate = }}</ref> | Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of propranolol in bacteria (S. typhimurium strain TA 1538<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = INDERAL LA (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AKRIMAX PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=fce692df-1e68-465e-8dda-0cb01320608c | publisher = | date = |accessdate = }}</ref> | ||
==References== | ==References== | ||
{{Reflist}} | {{Reflist}} | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Cardiovascular Drugs]] | |||
[[Category:Beta blockers]] | |||
Revision as of 22:19, 9 February 2014
| Propranolol |
|---|
| Inderal LA® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Overdosage |
| Description |
| Clinical Pharmacology |
| Nonclinical Toxicology |
| How Supplied/Storage and Handling |
| Labels and Packages |
| Clinical Trials on Propranolol |
| ClinicalTrials.gov |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Nonclinical Toxicology
- Carcinogenesis
- Mutagenesis
- Impairment of Fertility
In dietary administration studies in which mice and rats were treated with propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis. On a body surface area basis, this dose in the mouse and rat is, respectively, about equal to and about twice the maximum recommended human oral daily dose (MRHD) of 640 mg propranolol hydrochloride. In a study in which both male and female rats were exposed to propranolol hydrochloride in their diets at concentrations of up to 0.05% (about 50 mg/kg body weight and less than the MRHD), from 60 days prior to mating and throughout pregnancy and lactation for two generations, there were no effects on fertility. Based on differing results from Ames Tests performed by different laboratories, there is equivocal evidence for a genotoxic effect of propranolol in bacteria (S. typhimurium strain TA 1538[1]
References
Adapted from the FDA Package Insert.