Meropenem warnings: Difference between revisions
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__NOTOC__ | __NOTOC__ | ||
{{Meropenem}} | {{Meropenem}} | ||
{{CMG}} | {{CMG}}; {{AE}} {{SS}} | ||
==Warnings== | ==Warnings== | ||
===Hypersensitivity Reactions=== | ===Hypersensitivity Reactions=== | ||
Serious and occasionally fatal [[hypersensitivity]] (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. | Serious and occasionally fatal [[hypersensitivity]] (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. | ||
There have been reports of individuals with a history of | There have been reports of individuals with a history of penicillin [[hypersensitivity]] who have experienced severe [[hypersensitivity]] reactions when treated with another β-lactam. before initiating therapy with merrem i.v., careful inquiry should be made concerning previous [[hypersensitivity]] reactions to [[penicillins]], [[cephalosporins]], other β-lactams, and other allergens. If an allergic reaction to merrem i.v. occurs, discontinue the drug immediately. serious anaphylactic reactions require immediate emergency treatment with [[epinephrine]],[[oxygen]], [[intravenous steroids]], and airway management, including [[intubation]]. Other therapy may also be administered as indicated. | ||
===Seizure Potential=== | ===Seizure Potential=== | ||
Seizures and other CNS adverse experiences have been reported during treatment with MERREM I.V.. | Seizures and other CNS adverse experiences have been reported during treatment with MERREM I.V.. | ||
===Interaction with Valproic Acid=== | ===Interaction with Valproic Acid=== | ||
Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of [[valproic acid]] or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of MERREM I.V. is necessary, supplemental anti-convulsant therapy should be considered. | Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of [[valproic acid]] or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of MERREM I.V. is necessary, supplemental anti-convulsant therapy should be considered. | ||
===Clostridium difficile–Associated Diarrhea=== | ===Clostridium difficile–Associated Diarrhea=== | ||
[[Clostridium difficile]] associated [[diarrhea]] (CDAD) has been reported with use of nearly all antibacterial agents, including MERREM I.V., and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. | [[Clostridium difficile]] associated [[diarrhea]] (CDAD) has been reported with use of nearly all antibacterial agents, including MERREM I.V., and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. | ||
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===Development of Drug-Resistant Bacteria=== | ===Development of Drug-Resistant Bacteria=== | ||
Prescribing MERREM I.V. in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. | Prescribing MERREM I.V. in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. | ||
===Overgrowth of Nonsusceptible Organisms=== | ===Overgrowth of Nonsusceptible Organisms=== | ||
As with other broad-spectrum antibiotics, prolonged use of meropenem may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient is essential. If superinfection does occur during therapy, appropriate measures should be taken. | As with other broad-spectrum antibiotics, prolonged use of meropenem may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient is essential. If superinfection does occur during therapy, appropriate measures should be taken. | ||
===Laboratory Tests=== | ===Laboratory Tests=== | ||
While MERREM I.V. possesses the characteristic low toxicity of the beta-lactam group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy. | While MERREM I.V. possesses the characteristic low toxicity of the beta-lactam group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy. | ||
===Patients with Renal Impairment=== | ===Patients with Renal Impairment=== | ||
In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported. | In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported. | ||
===Dialysis=== | ===Dialysis=== | ||
There is inadequate information regarding the use of MERREM I.V. in patients on hemodialysis or peritoneal dialysis. | There is inadequate information regarding the use of MERREM I.V. in patients on hemodialysis or peritoneal dialysis. | ||
===Potential for Neuromotor Impairment=== | ===Potential for Neuromotor Impairment=== | ||
Patients receiving MERREM I.V. on an outpatient basis may develop adverse events such as seizures, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that MERREM I.V. is well tolerated, patients should not operate machinery or motorized vehicles.<ref>{{Cite web | last = | first = |title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf | publisher = |date = | accessdate = }}</ref> | Patients receiving MERREM I.V. on an outpatient basis may develop adverse events such as seizures, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that MERREM I.V. is well tolerated, patients should not operate machinery or motorized vehicles.<ref>{{Cite web | last = | first = |title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050706s022lbl.pdf | publisher = |date = | accessdate = }}</ref> | ||
Latest revision as of 22:41, 5 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Warnings
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.
There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another β-lactam. before initiating therapy with merrem i.v., careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other β-lactams, and other allergens. If an allergic reaction to merrem i.v. occurs, discontinue the drug immediately. serious anaphylactic reactions require immediate emergency treatment with epinephrine,oxygen, intravenous steroids, and airway management, including intubation. Other therapy may also be administered as indicated.
Seizure Potential
Seizures and other CNS adverse experiences have been reported during treatment with MERREM I.V..
Interaction with Valproic Acid
Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. The concomitant use of meropenem and valproic acid or divalproex sodium is generally not recommended. Antibacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of MERREM I.V. is necessary, supplemental anti-convulsant therapy should be considered.
Clostridium difficile–Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MERREM I.V., and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Development of Drug-Resistant Bacteria
Prescribing MERREM I.V. in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Overgrowth of Nonsusceptible Organisms
As with other broad-spectrum antibiotics, prolonged use of meropenem may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient is essential. If superinfection does occur during therapy, appropriate measures should be taken.
Laboratory Tests
While MERREM I.V. possesses the characteristic low toxicity of the beta-lactam group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.
Patients with Renal Impairment
In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported.
Dialysis
There is inadequate information regarding the use of MERREM I.V. in patients on hemodialysis or peritoneal dialysis.
Potential for Neuromotor Impairment
Patients receiving MERREM I.V. on an outpatient basis may develop adverse events such as seizures, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that MERREM I.V. is well tolerated, patients should not operate machinery or motorized vehicles.[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.