Spectinomycin adverse reactions: Difference between revisions
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==Adverse Reactions== | ==Adverse Reactions== | ||
The following reactions were observed during the single dose clinical trials: soreness at the injection site, urticaria, dizziness, nausea, chills, fever and insomnia. | The following reactions were observed during the single dose clinical trials: [[soreness]] at the injection site, [[urticaria]], [[dizziness]], [[nausea]], [[chills]], [[fever]], and [[insomnia]]. | ||
During multiple dose subchronic tolerance studies in normal human volunteers, the following were noted: a decrease in hemoglobin, hematocrit and creatinine clearance; elevation of alkaline phosphatase, BUN and SGPT. In single and multiple dose studies in normal volunteers, a reduction in urine output was noted. Extensive renal function studies demonstrated no consistent changes indicative of renal toxicity. | During multiple dose subchronic tolerance studies in normal human volunteers, the following were noted: a decrease in [[hemoglobin]], [[hematocrit]] and [[creatinine clearance]]; elevation of [[alkaline phosphatase]], [[BUN]] and [[SGPT]]. In single and multiple dose studies in normal volunteers, a reduction in urine output was noted. Extensive renal function studies demonstrated no consistent changes indicative of renal toxicity. | ||
A few cases of anaphylaxis or anaphylactoid reactions have been reported. If serious allergic reactions occur, the usual agents (epinephrine, corticosteroids, and/or | A few cases of [[anaphylaxis]] or anaphylactoid reactions have been reported. If serious allergic reactions occur, the usual agents ([[epinephrine]], [[corticosteroids]], and/or [[antihistamine]]s) should be available for emergency use. In cases of severe anaphylaxis, airway support and oxygen may also be required.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TROBICIN (SPECTINOMYCIN) [PHARMACIA AND UPJOHN, CO.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=becf7b7a-508c-44ff-add0-558a60fd0067 | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
Latest revision as of 00:55, 31 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Adverse Reactions
The following reactions were observed during the single dose clinical trials: soreness at the injection site, urticaria, dizziness, nausea, chills, fever, and insomnia.
During multiple dose subchronic tolerance studies in normal human volunteers, the following were noted: a decrease in hemoglobin, hematocrit and creatinine clearance; elevation of alkaline phosphatase, BUN and SGPT. In single and multiple dose studies in normal volunteers, a reduction in urine output was noted. Extensive renal function studies demonstrated no consistent changes indicative of renal toxicity.
A few cases of anaphylaxis or anaphylactoid reactions have been reported. If serious allergic reactions occur, the usual agents (epinephrine, corticosteroids, and/or antihistamines) should be available for emergency use. In cases of severe anaphylaxis, airway support and oxygen may also be required.[1]
References
Adapted from the FDA Package Insert.