Reteplase use in specific populations: Difference between revisions
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Revision as of 14:56, 4 March 2014
| Reteplase |
|---|
| Retavase® FDA Package Insert |
| Indications and Usage |
| Dosage and Administration |
| Contraindications |
| Warnings and Precautions |
| Adverse Reactions |
| Drug Interactions |
| Use in Specific Populations |
| Description |
| Clinical Pharmacology |
| Nonclinical Toxicology |
| How Supplied/Storage and Handling |
| Labels and Packages |
| Clinical Trials on Reteplase |
| ClinicalTrials.gov |
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
Pregnancy Category C
Reteplase has been shown to have an abortifacient effect in rabbits when given in doses 3 times the human dose (0.86 units/kg). Reproduction studies performed in rats at doses up to 15 times the human dose (4.31 units/kg) revealed no evidence of fetal anomalies; however, Reteplase administered to pregnant rabbits resulted in hemorrhaging in the genital tract, leading to abortions in mid-gestation. There are no adequate and well-controlled studies in pregnant women. The most common complication of thrombolytic therapy is bleeding and certain conditions, including pregnancy, can increase this risk. Reteplase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether Retavase® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retavase® is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of Retavase® in pediatric patients have not been established.[1]
References
Adapted from the FDA Package Insert.