Ampicillin sulbactam adverse reactions: Difference between revisions
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==Adverse Reactions== | ==Adverse Reactions== | ||
===Adult Patients=== | ===Adult Patients=== | ||
Ampicillin/sulbactam is generally well tolerated. The following adverse reactions have been reported: | Ampicillin/sulbactam is generally well tolerated. The following adverse reactions have been reported: | ||
=====Local Adverse Reactions===== | =====Local Adverse Reactions===== | ||
* Pain at IM injection site – 16% | * Pain at IM injection site – 16% | ||
* Pain at IV injection site – 3% | * Pain at IV injection site – 3% | ||
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=====Systemic Adverse Reactions===== | =====Systemic Adverse Reactions===== | ||
The most frequently reported adverse reactions were [[diarrhea]] in 3% of the patients and rash in less than 2% of the patients. | The most frequently reported adverse reactions were [[diarrhea]] in 3% of the patients and rash in less than 2% of the patients. | ||
Additional systemic reactions reported in less than 1% of the patients were: [[itching]], [[nausea]], [[vomiting]], [[candidiasis]], [[fatigue]], [[malaise]], [[headache]], [[chest pain]], [[flatulence]], [[abdominal distension]], [[glossitis]], [[urine retention]], [[dysuria]], [[edema]], facial swelling, [[erythema]], [[chills]], tightness in throat, substernal pain, [[epistaxis]] and mucosal bleeding. | Additional systemic reactions reported in less than 1% of the patients were: [[itching]], [[nausea]], [[vomiting]], [[candidiasis]], [[fatigue]], [[malaise]], [[headache]], [[chest pain]], [[flatulence]], [[abdominal distension]], [[glossitis]], [[urine retention]], [[dysuria]], [[edema]], facial swelling, [[erythema]], [[chills]], tightness in throat, substernal pain, [[epistaxis]] and mucosal bleeding. | ||
===Pediatric Patients=== | ===Pediatric Patients=== | ||
Available safety data for pediatric patients treated with ampicillin/sulbactam demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving ampicillin/sulbactam. | Available safety data for pediatric patients treated with ampicillin/sulbactam demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving ampicillin/sulbactam. | ||
=====Adverse Laboratory Changes===== | =====Adverse Laboratory Changes===== | ||
* Hepatic: Increased [[AST]], [[ALT]], [[alkaline phosphatase]], and [[LDH]]. | * Hepatic: Increased [[AST]], [[ALT]], [[alkaline phosphatase]], and [[LDH]]. | ||
* Hematologic: Decreased [[hemoglobin]], [[hematocrit]], [[RBC]], [[WBC]], [[neutrophil]]s, [[lymphocyte]]s, [[platelet]]s and increased [[lymphocyte]]s, [[monocyte]]s,[[basophil]]s, [[eosinophil]]s, and [[platelet]]s. | * Hematologic: Decreased [[hemoglobin]], [[hematocrit]], [[RBC]], [[WBC]], [[neutrophil]]s, [[lymphocyte]]s, [[platelet]]s and increased [[lymphocyte]]s, [[monocyte]]s,[[basophil]]s, [[eosinophil]]s, and [[platelet]]s. | ||
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* Urinalysis: Presence of RBCs and [[hyaline cast]]s in urine. | * Urinalysis: Presence of RBCs and [[hyaline cast]]s in urine. | ||
'''''The following adverse reactions have been reported with ampicillin-class antibiotics and can also occur with ampicillin/sulbactam.''''' | |||
=====Gastrointestinal===== | =====Gastrointestinal===== | ||
[[Gastritis]], [[stomatitis]], black “hairy” tongue and [[enterocolitis]]. Onset of [[pseudomembranous colitis]] symptoms may occur during or after antibiotic treatment. | [[Gastritis]], [[stomatitis]], black “hairy” tongue and [[enterocolitis]]. Onset of [[pseudomembranous colitis]] symptoms may occur during or after antibiotic treatment. | ||
=====Hypersensitivity Reactions===== | =====Hypersensitivity Reactions===== | ||
[[Urticaria]], [[erythema multiforme]], and an occasional case of [[exfoliative dermatitis]] have been reported. These reactions may be controlled with [[antihistamines]] and, if necessary, systemic [[corticosteroid]]s. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal [[hypersensitivity]] ([[anaphylaxis|anaphylactic]]) reactions can occur with a | |||
[[Urticaria]], [[erythema multiforme]], and an occasional case of [[exfoliative dermatitis]] have been reported. These reactions may be controlled with [[antihistamines]] and, if necessary, systemic [[corticosteroid]]s. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal [[hypersensitivity]] ([[anaphylaxis|anaphylactic]]) reactions can occur with a penicillin. | |||
=====Hematologic===== | =====Hematologic===== | ||
In addition to the adverse laboratory changes listed above for ampicillin/sulbactam, [[agranulocytosis]] has been reported during therapy with penicillins. All of these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment with ampicillin/sulbactam, as with other beta-lactam antibiotics.<ref>{{Cite web | last = | first = |title =http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf | publisher = |date = |accessdate = }}</ref> | In addition to the adverse laboratory changes listed above for ampicillin/sulbactam, [[agranulocytosis]] has been reported during therapy with penicillins. All of these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment with ampicillin/sulbactam, as with other beta-lactam antibiotics.<ref>{{Cite web | last = | first = |title =http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf | publisher = |date = |accessdate = }}</ref> | ||
Latest revision as of 01:00, 6 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Adverse Reactions
Adult Patients
Ampicillin/sulbactam is generally well tolerated. The following adverse reactions have been reported:
Local Adverse Reactions
- Pain at IM injection site – 16%
- Pain at IV injection site – 3%
- Thrombophlebitis – 3%
Systemic Adverse Reactions
The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients. Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding.
Pediatric Patients
Available safety data for pediatric patients treated with ampicillin/sulbactam demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving ampicillin/sulbactam.
Adverse Laboratory Changes
- Hepatic: Increased AST, ALT, alkaline phosphatase, and LDH.
- Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes,basophils, eosinophils, and platelets.
- Blood Chemistry: Decreased serum albumin and total proteins.
- Renal: Increased BUN and creatinine.
- Urinalysis: Presence of RBCs and hyaline casts in urine.
The following adverse reactions have been reported with ampicillin-class antibiotics and can also occur with ampicillin/sulbactam.
Gastrointestinal
Gastritis, stomatitis, black “hairy” tongue and enterocolitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions
Urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with a penicillin.
Hematologic
In addition to the adverse laboratory changes listed above for ampicillin/sulbactam, agranulocytosis has been reported during therapy with penicillins. All of these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment with ampicillin/sulbactam, as with other beta-lactam antibiotics.[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050608s040lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.