Document Detail

Oral Modified-Release Tranexamic Acid for Heavy Menstrual Bleeding (July/August).
MedLine Citation:
PMID:  22811348     Owner:  NLM     Status:  Publisher    
OBJECTIVE:To review the pharmacology, pharmacokinetics, efficacy, and safety profile of an oral modified-release (MR) formulation of tranexamic acid.DATA SOURCES:Literature was accessed through MEDLINE (1966-July 2012), Iowa Drug Information Service (1997-July 2012), and bibliographies of pertinent articles. Search terms included tranexamic acid, Lysteda, menorrhagia, menstrual blood loss, and heavy menstrual bleeding.STUDY SELECTION AND DATA EXTRACTION:All available English-language abstracts and human studies were identified for review. Data provided by the manufacturer and the Food and Drug Administration were also evaluated. Efficacy was evaluated in 2 clinical trials, change in quality of life was evaluated in 3 clinical trials, and safety was evaluated in 4 clinical trials.DATA SYNTHESIS:Tranexamic acid is a synthetic lysine analogue with antifibrinolytic activity. It interferes with the binding of plasminogen to fibrin, resulting in enhanced fibrin clot integrity. A novel MR formulation of oral tranexamic acid is approved for treatment of cyclic heavy menstrual bleeding. MR tranexamic acid is initiated at the beginning of heavy menstrual bleeding and can be taken for up to 5 days per cycle. Clinical trials show it to be safe and effective. Dosage adjustments are needed for women with renal insufficiency. Adverse effects are considered mild to moderate, with the most common being menstrual discomfort, headache, and back pain. The most significant safety concerns relate to the risk of thromboembolism.CONCLUSIONS:MR tranexamic acid offers a new first-line therapy for patients with cyclic heavy menstrual bleeding. It is reported to be safe and effective. There are no labeled equivalents to MR tranexamic acid for cyclic heavy menstrual bleeding.
Sandra L Hrometz
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-7-17
Journal Detail:
Title:  The Annals of pharmacotherapy     Volume:  -     ISSN:  1542-6270     ISO Abbreviation:  -     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-7-19     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203131     Medline TA:  Ann Pharmacother     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
< RaabeCollege of Pharmacy, Ohio Northern University, Ada, OH.
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