Meropenem adverse reactions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Adverse Reactions
Adult Patients:
During clinical investigations, 2904 immunocompetent adult patients were treated for infections outside the CNS with MERREM I.V. (500 mg or 1000 mg q 8 hours). Deaths in 5 patients were assessed as possibly related to meropenem; 36 (1.2%) patients had meropenem discontinued because of adverse events. Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with MERREM I.V.
The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with MERREM I.V.
Local Adverse Reactions
Local adverse reactions that were reported irrespective of the relationship to therapy with MERREM I.V. were as follows:
Inflammation at the injection site 2.4%
Injection site reaction 0.9%
Phlebitis/thrombophlebitis 0.8%
Pain at the injection site 0.4%
Edema at the injection site 0.2%
Systemic Adverse Reactions
Systemic adverse clinical reactions that were reported irrespective of the relationship to MERREM I.V. occurring in greater than 1.0% of the patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%).
Additional adverse systemic clinical reactions that were reported irrespective of relationship to therapy with MERREM I.V. and occurring in less than or equal to 1.0% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency:
Bleeding events were seen as follows: gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%), summing to 1.2%.
Body as a Whole: pain, abdominal pain, chest pain, fever, back pain, abdominal enlargement, chills, pelvic pain.
Cardiovascular: heart failure, heart arrest, tachycardia, hypertension, myocardial infarction, pulmonary embolus, bradycardia, hypotension, syncope
Digestive System: oral moniliasis, anorexia, cholestatic jaundice/jaundice, flatulence, ileus, hepatic failure, dyspepsia, intestinal obstruction
Hemic/Lymphatic: anemia, hypochromic anemia, hypervolemia
Metabolic/Nutritional: peripheral edema, hypoxia
Nervous System: insomnia, agitation/delirium, confusion, dizziness, seizure (see PRECAUTIONS), nervousness, paresthesia, hallucinations, somnolence, anxiety, depression, asthenia
Respiratory: respiratory disorder, dyspnea, pleural effusion, asthma, cough increased, lung edema
Skin and Appendages: urticaria, sweating, skin ulcer
Urogenital System: dysuria, kidney failure, vaginal moniliasis, urinary incontinence
Adverse Laboratory Changes
Adverse laboratory changes that were reported irrespective of relationship to MERREM I.V. and occurring in greater than 0.2% of the patients were as follows:
Hepatic: increased SGPT (ALT), SGOT (AST), alkaline phosphatase, LDH, and bilirubin Hematologic: increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased WBC, shortened prothrombin time and shortened partial thromboplastin time, leukocytosis, hypokalemia
Renal: increased creatinine and increased BUN
NOTE: For patients with varying degrees of renal impairment, the incidence of heart failure, kidney failure, seizure and shock reported irrespective of relationship to MERREM I.V., increased in patients with moderately severe renal impairment (creatinine clearance >10 to 26 mL/min).
Urinalysis: presence of red blood cells
Complicated Skin and Skin Structure Infection In a study of complicated skin and skin structure infection, the type of clinical adverse reactions were similar to those listed above. The patients with the most common adverse events with an incidence of >5% were: headache (7.8%), nausea (7.8%), constipation (7.0%), diarrhea (7.0%), anemia (5.5%), and pain (5.1%). Adverse events with an incidence of >1%, and not listed above, include: pharyngitis, accidental injury, gastrointestinal disorder, hypoglycemia, peripheral vascular disorder, and pneumonia.
Pediatric Patients
Clinical Adverse Reactions MERREM I.V. was studied in 515 pediatric patients (> 3 months to < 13 years of age) with serious bacterial infections (excluding meningitis. See next section.) at dosages of 10 to 20 mg/kg every 8 hours. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably or definitely related to MERREM I.V. and their rates of occurrence as follows:
Diarrhea 3.5% Rash 1.6% Nausea and Vomiting 0.8%
MERREM I.V. was studied in 321 pediatric patients (> 3 months to < 17 years of age) with meningitis at a dosage of 40 mg/kg every 8 hours. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably, or definitely related to MERREM I.V. and their rates of occurrence as follows:
Diarrhea 4.7% Rash (mostly diaper area moniliasis) 3.1% Oral Moniliasis 1.9% Glossitis 1.0%
In the meningitis studies the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem and those who received comparator agents (either cefotaxime or ceftriaxone). In the MERREM I.V. treated group, 12/15 patients with seizures had late onset seizures (defined as occurring on day 3 or later) versus 7/20 in the comparator arm.
Adverse Laboratory Changes:
Laboratory abnormalities seen in the pediatric-aged patients in both the pediatric and the meningitis studies are similar to those reported in adult patients.
There is no experience in pediatric patients with renal impairment.
Post-marketing Experience:
Worldwide post-marketing adverse events not otherwise listed in the product label and reported as possibly, probably, or definitely drug related are listed within each body system in order of decreasing severity. Hematologic - agranulocytosis, neutropenia, and leukopenia. Skin – toxic epidermal necrolysis, Stevens-Johnson Syndrome, angioedema, and erythema multiform.[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.