Ticlopidine use in specific populations: Difference between revisions
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==Use In Specific Populations== | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TICLOPIDINE HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=707127cb-cdcd-81b0-274d-3c11fefa6824 | publisher = | date = | accessdate = }}</ref> | ===Pregnancy=== | ||
Teratogenic Effects: <u>'''Pregnancy: Category B'''</u>. | |||
[[Teratology]] studies have been conducted in mice (doses up to 200 mg/kg/day), rats (doses up to 400 mg/kg/day) and rabbits (doses up to 200 mg/kg/day). Doses of 400 mg/kg in rats, 200 mg/kg/day in mice and 100 mg/kg in rabbits produced maternal toxicity, as well as fetal toxicity, but there was no evidence of a teratogenic potential of ticlopidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, this drug should be used during pregnancy only if clearly needed. | |||
===Nursing Mothers=== | |||
Studies in rats have shown ticlopidine is excreted in the milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ticlopidine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. | |||
===Pediatric Use=== | |||
Safety and effectiveness in pediatric patients have not been established. | |||
===Geriatric Use=== | |||
Clearance of ticlopidine is somewhat lower in elderly patients and trough levels are increased. The major clinical trials with ticlopidine in stroke patients were conducted in an elderly population with an average age of 64 years. Of the total number of patients in the therapeutic trials, 45% of patients were over 65 years old and 12% were over 75 years old. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TICLOPIDINE HYDROCHLORIDE TABLET, FILM COATED [APOTEX CORP.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=707127cb-cdcd-81b0-274d-3c11fefa6824 | publisher = | date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Revision as of 17:01, 6 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
Use In Specific Populations
Pregnancy
Teratogenic Effects: Pregnancy: Category B. Teratology studies have been conducted in mice (doses up to 200 mg/kg/day), rats (doses up to 400 mg/kg/day) and rabbits (doses up to 200 mg/kg/day). Doses of 400 mg/kg in rats, 200 mg/kg/day in mice and 100 mg/kg in rabbits produced maternal toxicity, as well as fetal toxicity, but there was no evidence of a teratogenic potential of ticlopidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of a human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Studies in rats have shown ticlopidine is excreted in the milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ticlopidine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clearance of ticlopidine is somewhat lower in elderly patients and trough levels are increased. The major clinical trials with ticlopidine in stroke patients were conducted in an elderly population with an average age of 64 years. Of the total number of patients in the therapeutic trials, 45% of patients were over 65 years old and 12% were over 75 years old. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.[1]
References
Adapted from the FDA Package Insert.