Ampicillin and Sulbactam Injection Side Effects

Please note - some side effects for Ampicillin and Sulbactam Injection may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Ampicillin and Sulbactam Injection Side Effects - for the Professional

Ampicillin and Sulbactam Injection

Adult Patients

Ampicillin and Sulbactam for Injection is generally well tolerated. The following adverse reactions have been reported.

Pain at IM injection site–16%

Pain at IV injection site–3%

Thrombophlebitis–3%

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 and Sulbactam for Injection demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving Ampicillin and Sulbactam for Injection.

Adverse Laboratory Changes

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH.

Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils, and platelets.

Decreased serum albumin and total proteins.

Increased BUN and creatinine.

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 and Sulbactam for Injection.

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 and Sulbactam for Injection, 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 and Sulbactam for Injection, as with other beta-lactam antibiotics.

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