Valacyclovir warnings and precautions: Difference between revisions
Jump to navigation
Jump to search
(Created page with "__NOTOC__ {{Valacyclovir}} {{CMG}} ==Warnings And Precautions== ==Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS)== TTP/HUS, in some cases resulting...") |
Gerald Chi (talk | contribs) mNo edit summary |
||
| (3 intermediate revisions by one other user not shown) | |||
| Line 1: | Line 1: | ||
__NOTOC__ | __NOTOC__ | ||
{{Valacyclovir}} | {{Valacyclovir}} | ||
{{CMG}} | {{CMG}}; {{AE}} {{SS}} | ||
==Warnings And Precautions== | ==Warnings And Precautions== | ||
==Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS)== | ====Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS)==== | ||
TTP/HUS, in some cases resulting in death, has occurred in patients with advanced | TTP/HUS, in some cases resulting in death, has occurred in patients with advanced [[HIV]]─1 disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of VALTREX at doses of 8 grams per day. Treatment with VALTREX should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur. | ||
==Acute Renal Failure== | ====Acute Renal Failure==== | ||
Cases of acute renal failure have been reported in: | Cases of acute [[renal failure]] have been reported in: | ||
*Elderly patients with or without reduced renal function. Caution should be exercised when administering VALTREX to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4), Use in Specific Populations (8.5)]. | *Elderly patients with or without reduced renal function. Caution should be exercised when administering VALTREX to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4), Use in Specific Populations (8.5)]. | ||
| Line 20: | Line 20: | ||
In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4), Adverse Reactions (6.3)]. | In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4), Adverse Reactions (6.3)]. | ||
===Central Nervous System Effects=== | ====Central Nervous System Effects==== | ||
Central nervous system adverse reactions, including [[agitation]], [[hallucinations]], [[confusion]], [[delirium]], [[seizures]], and [[encephalopathy]], have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher-than-recommended doses of VALTREX for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. VALTREX should be discontinued if central nervous system adverse reactions occur [see Adverse Reactions (6.3), Use in Specific Populations (8.5, 8.6)].<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf | publisher = |date = | accessdate = }}</ref> | |||
==References== | ==References== | ||
Latest revision as of 23:22, 2 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Warnings And Precautions
Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS)
TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV─1 disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of VALTREX at doses of 8 grams per day. Treatment with VALTREX should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur.
Acute Renal Failure
Cases of acute renal failure have been reported in:
- Elderly patients with or without reduced renal function. Caution should be exercised when administering VALTREX to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4), Use in Specific Populations (8.5)].
- Patients with underlying renal disease who received higher-than-recommended doses of VALTREX for their level of renal function. Dosage reduction is recommended when administering VALTREX to patients with renal impairment [see Dosage and Administration (2.4), Use in Specific Populations (8.6)].
- Patients receiving other nephrotoxic drugs. Caution should be exercised when administering VALTREX to patients receiving potentially nephrotoxic drugs.
- Patients without adequate hydration. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Adequate hydration should be maintained for all patients.
In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4), Adverse Reactions (6.3)].
Central Nervous System Effects
Central nervous system adverse reactions, including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher-than-recommended doses of VALTREX for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. VALTREX should be discontinued if central nervous system adverse reactions occur [see Adverse Reactions (6.3), Use in Specific Populations (8.5, 8.6)].[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020487s014lbl.pdf" (PDF). External link in
|title=(help)
Adapted from the FDA Package Insert.