Valacyclovir: Difference between revisions
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==History== | ==History== | ||
Valtrex brand of valacyclovir was approved by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 1995.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=020487 Drugs@FDA]. U S Food and Drug Administration</ref> A generic version was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2007.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=076588 Drugs@FDA]. U S Food and Drug Administration</ref> | Valtrex brand of valacyclovir was approved by the [[Food and Drug Administration]] in the [[United States of America|United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 1995.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=020487 Drugs@FDA]. U S Food and Drug Administration</ref> A generic version with a AB [[Food and Drug Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2007.<ref>[http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&SearchType=BasicSearch&Search_Button=Submit&searchTerm=076588 Drugs@FDA]. U S Food and Drug Administration</ref> | ||
==Pharmacology== | ==Pharmacology== | ||
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==Usage== | ==Usage== | ||
Valacyclovir suppressive therapy can reduce the frequency of recurrence of [[herpes labialis]] from [[herpes simplex virus]]; however, this usage is not approved by the [[United States]] [[Food and Drug Administration]].<ref name="pmid17668537">{{cite journal| author=Gilbert SC| title=Suppressive therapy versus episodic therapy with oral valacyclovir for recurrent herpes labialis: efficacy and tolerability in an open-label, crossover study. | journal=J Drugs Dermatol | year= 2007 | volume= 6 | issue= 4 | pages= 400-5 | pmid=17668537 | Valacyclovir suppressive therapy can reduce the frequency of recurrence of [[herpes labialis]] from [[herpes simplex virus]]; however, this usage is not approved by the [[United States of America|United States]] [[Food and Drug Administration]].<ref name="pmid17668537">{{cite journal| author=Gilbert SC| title=Suppressive therapy versus episodic therapy with oral valacyclovir for recurrent herpes labialis: efficacy and tolerability in an open-label, crossover study. | journal=J Drugs Dermatol | year= 2007 | volume= 6 | issue= 4 | pages= 400-5 | pmid=17668537 | ||
| url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=17668537 }} </ref><ref name="pmid12661753">{{cite journal| author=Baker D, Eisen D| title=Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies. | journal=Cutis | year= 2003 | volume= 71 | issue= 3 | pages= 239-42 | pmid=12661753 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12661753 }} </ref><ref name="pmid18541820">{{cite journal| author=Cernik C, Gallina K, Brodell RT| title=The treatment of herpes simplex infections: an evidence-based review. | journal=Arch Intern Med | year= 2008 | volume= 168 | issue= 11 | pages= 1137-44 | pmid=18541820 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18541820 | doi=10.1001/archinte.168.11.1137 }} </ref> | | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=17668537 }} </ref><ref name="pmid12661753">{{cite journal| author=Baker D, Eisen D| title=Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies. | journal=Cutis | year= 2003 | volume= 71 | issue= 3 | pages= 239-42 | pmid=12661753 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12661753 }} </ref><ref name="pmid18541820">{{cite journal| author=Cernik C, Gallina K, Brodell RT| title=The treatment of herpes simplex infections: an evidence-based review. | journal=Arch Intern Med | year= 2008 | volume= 168 | issue= 11 | pages= 1137-44 | pmid=18541820 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18541820 | doi=10.1001/archinte.168.11.1137 }} </ref> | ||
Valacyclovir suppressive therapy can reduce the frequency of recurrence of [[herpes genitalis]] from [[herpes simplex virus]] and this usage is approved by the [[United States]] [[Food and Drug Administration]].<ref name="pmid18541820">{{cite journal| author=Cernik C, Gallina K, Brodell RT| title=The treatment of herpes simplex infections: an evidence-based review. | journal=Arch Intern Med | year= 2008 | volume= 168 | issue= 11 | pages= 1137-44 | pmid=18541820 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18541820 | doi=10.1001/archinte.168.11.1137 }} </ref> | Valacyclovir suppressive therapy can reduce the frequency of recurrence of [[herpes genitalis]] from [[herpes simplex virus]] and this usage is approved by the [[United States of America|United States]] [[Food and Drug Administration]].<ref name="pmid18541820">{{cite journal| author=Cernik C, Gallina K, Brodell RT| title=The treatment of herpes simplex infections: an evidence-based review. | journal=Arch Intern Med | year= 2008 | volume= 168 | issue= 11 | pages= 1137-44 | pmid=18541820 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=18541820 | doi=10.1001/archinte.168.11.1137 }} </ref> | ||
==External links== | ==External links== | ||
Revision as of 13:34, 2 February 2023
In pharmacology and virology, valacyclovir (Valtrex) is "a prodrug of acyclovir; 53% of oral dose excreted as acyclovir in the urine; a 200-400% improvement on acyclovir; used in the management of HSV and VZV infections and the prophylaxis of HCMV infections; RN given refers to the monohydrochloride L-valine isomer."[1]
History
Valtrex brand of valacyclovir was approved by the Food and Drug Administration in the United States with a New Drug Application (NDA) in 1995.[2] A generic version with a AB Therapeutic Equivalence Code was approved with a Abbreviated New Drug Application (ANDA) in 2007.[3]
Pharmacology
Administration
Distribution
Metabolism
Excretion
Toxicity
Drug toxicity includes
Usage
Valacyclovir suppressive therapy can reduce the frequency of recurrence of herpes labialis from herpes simplex virus; however, this usage is not approved by the United States Food and Drug Administration.[4][5][6]
Valacyclovir suppressive therapy can reduce the frequency of recurrence of herpes genitalis from herpes simplex virus and this usage is approved by the United States Food and Drug Administration.[6]
External links
The most up-to-date information about Valacyclovir and other drugs can be found at the following sites.
- Valacyclovir - FDA approved drug information (drug label) from DailyMed (U.S. National Library of Medicine).
- Valacyclovir - Drug information for consumers from MedlinePlus (U.S. National Library of Medicine).
- Valacyclovir - Detailed information from DrugBank.
References
- ↑ Anonymous (2024), Valacyclovir (English). Medical Subject Headings. U.S. National Library of Medicine.
- ↑ Drugs@FDA. U S Food and Drug Administration
- ↑ Drugs@FDA. U S Food and Drug Administration
- ↑ Gilbert SC (2007). "Suppressive therapy versus episodic therapy with oral valacyclovir for recurrent herpes labialis: efficacy and tolerability in an open-label, crossover study.". J Drugs Dermatol 6 (4): 400-5. PMID 17668537.
- ↑ Baker D, Eisen D (2003). "Valacyclovir for prevention of recurrent herpes labialis: 2 double-blind, placebo-controlled studies.". Cutis 71 (3): 239-42. PMID 12661753.
- ↑ 6.0 6.1 Cernik C, Gallina K, Brodell RT (2008). "The treatment of herpes simplex infections: an evidence-based review.". Arch Intern Med 168 (11): 1137-44. DOI:10.1001/archinte.168.11.1137. PMID 18541820. Research Blogging.
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