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Ertapenem is a brand name for Ertapenem. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ertapenem for Injection and other antibacterial drugs, Ertapenem for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Do not mix or co-infuse Ertapenem for Injection with other medications. Do not use diluents containing dextrose (α–D–glucose) . 1 ) Ertapenem for Injection should be infused over 30 minutes in both the Treatment and Prophylactic regimens.
1 ) Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis. 5 ) Treatment regimen: • Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly.
2 ) • Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days. 1 ) Prophylaxis regimen for adults: • 1 gram single dose given 1 hour prior to elective colorectal surgery.
1 Instructions for Use in All Patients For Intravenous or Intramuscular Use DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE). Ertapenem for Injection may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days.
When administered intravenously, Ertapenem for Injection should be infused over a period of 30 minutes. Intramuscular administration of Ertapenem for Injection may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.
3) ]. 3 months to 12 years of age The dose of Ertapenem for Injection in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day). Table 1 presents treatment guidelines for Ertapenem for Injection. V. V. 1) ] .
1 g 15 mg/kg twice daily 7 to 14 days adult patients with diabetic foot infections received up to 28 days of treatment (parenteral or parenteral plus oral switch therapy) Community acquired pneumonia 1 g 15 mg/kg twice daily 10 to 14 days duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated.
3 Prophylactic Regimen in Adults Table 2 presents prophylaxis guidelines for Ertapenem for Injection. 4 Patients with Renal Impairment Ertapenem for Injection may be used for the treatment of infections in adult patients with renal impairment.
6 ADVERSE REACTIONS The following are described in greater detail in the Warnings and Precautions section. 7) ] Adults: The most common adverse reactions (≥5%) in patients treated with Ertapenem for Injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication.
1 ) In the prophylaxis indication the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials. 1 ) Pediatrics: Adverse reactions in this population were comparable to adults.
The most common adverse reactions (≥5%) in pediatric patients treated with Ertapenem for Injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc.
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adults Receiving Ertapenem for Injection as a Treatment Regimen Clinical trials enrolled 1954 patients treated with Ertapenem for Injection; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Clinical Studies (14) ] .
Most adverse experiences reported in these clinical trials were described as mild to moderate in severity. 7% of patients. Table 3 shows the incidence of adverse experiences reported in ≥2% of patients in these trials. 1%). 6% (8/307) of patients receiving comparator drug.
These deaths occurred in patients with significant co-morbidity and/or severe baseline infections. Deaths were considered unrelated to study drugs by investigators. 2) ] . 1% within each body system are listed below Body as a Whole: abdominal distention, pain, chills, septicemia, septic shock, dehydration, gout, malaise, asthenia/fatigue, necrosis, candidiasis, weight loss, facial edema, injection site induration, injection site pain, extravasation, phlebitis/thrombophlebitis, flank pain, syncope Cardiovascular System: heart failure, hematoma, chest pain, hypertension, tachycardia, cardiac arrest, bradycardia, arrhythmia, atrial fibrillation, heart murmur, ventricular tachycardia, asystole, subdural hemorrhage Digestive System: acid regurgitation, oral candidiasis, dyspepsia, gastrointestinal hemorrhage, anorexia, flatulence, C.
5 WARNINGS AND PRECAUTIONS • Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. 1 ) • Seizures and other central nervous system adverse experiences have been reported during treatment.
2 ) • Co-administration of Ertapenem for Injection with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. 3 ) • Clostridium difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs.
4 ) • Caution should be taken when administering Ertapenem for Injection intramuscularly to avoid inadvertent injection into a blood vessel. 1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-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 beta-lactam.
Before initiating therapy with Ertapenem for Injection, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to Ertapenem for Injection occurs, discontinue the drug immediately.
Serious anaphylactic reactions require immediate emergency treatment as clinically indicated. 1) ] . 1) ] . , brain lesions or history of seizures) and/or compromised renal function. Close adherence to the recommended dosage regimen is urged, especially in patients with known factors that predispose to convulsive activity.
Anticonvulsant therapy should be continued in patients with known seizure disorders. If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anticonvulsant therapy if not already instituted, and the dosage of Ertapenem for Injection re-examined to determine whether it should be decreased or discontinued.
4 CONTRAINDICATIONS • Ertapenem for Injection is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams.
• Due to the use of lidocaine HCl as a diluent, Ertapenem for Injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. • Known hypersensitivity to product components or anaphylactic reactions to β-lactams.
( 4 ) • Due to the use of lidocaine HCl as a diluent, Ertapenem for Injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. ( 4 )
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73 m 2 , no dosage adjustment is necessary. 73 m 2 ) should receive 500 mg daily. A supplementary dose of 150 mg is recommended if ertapenem is administered within 6 hours prior to hemodialysis. There are no data in pediatric patients with renal impairment.
5 Patients on Hemodialysis When adult patients on hemodialysis are given the recommended daily dose of 500 mg of Ertapenem for Injection within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the hemodialysis session.
If Ertapenem for Injection is given at least 6 hours prior to hemodialysis, no supplementary dose is needed. There are no data in patients undergoing peritoneal dialysis or hemofiltration. There are no data in pediatric patients on hemodialysis.
When only the serum creatinine is available, the following formula Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976 may be used to estimate creatinine clearance.
The serum creatinine should represent a steady state of renal function. 3) ] . 7 Preparation and Reconstitution for Administration Vials Adults and pediatric patients 13 years of age and older Preparation for intravenous administration: DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS.
DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE). ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION. 9% Sodium Chloride Injection or Bacteriostatic Water for Injection, using a syringe equipped with a 21-gauge or smaller diameter needle.
9% Sodium Chloride Injection. • Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:
ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION. 2 mL of 1% lidocaine HCl injection Refer to the prescribing information for lidocaine HCl. ( without epinephrine ). Shake vial thoroughly to form solution. • Immediately withdraw the contents of the vial and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh).
M. solution should be used within 1 hour after preparation.
NOTE:
THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY. Pediatric patients 3 months to 12 years of age Preparation for intravenous administration: DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).
ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION. 9% Sodium Chloride Injection or Bacteriostatic Water for Injection, using a syringe equipped with a 21-gauge or smaller diameter needle. 9% Sodium Chloride Injection to a final concentration of 20 mg/mL or less.
• Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:
ERTAPENEM FOR INJECTION MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION. 2 mL of 1% lidocaine HCl injection ( without epinephrine ). Shake vial thoroughly to form solution. • Immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh).
M. solution should be used within 1 hour after preparation.
NOTE:
THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY . Storage When prepared with the diluent, Ertapenem for Injection maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration.
Solutions of Ertapenem for Injection should not be frozen . Before administering, see accompanying package circular for Ertapenem for Injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit.
Solutions of Ertapenem for Injection range from colorless to pale yellow. Variations of color within this range do not affect the potency of the product.
2) ] , tremor, depression, hypesthesia, spasm, paresthesia, aggressive behavior, vertigo Respiratory System: cough, pharyngitis, rales/rhonchi, respiratory distress, pleural effusion, hypoxemia, bronchoconstriction, pharyngeal discomfort, epistaxis, pleuritic pain, asthma, hemoptysis, hiccups, voice disturbance Skin & Skin Appendage: erythema, sweating, dermatitis, desquamation, flushing, urticaria Special Senses: taste perversion Urogenital System: renal impairment, oliguria/anuria, vaginal pruritus, hematuria, urinary retention, bladder dysfunction, vaginal candidiasis, vulvovaginitis.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with Ertapenem for Injection, the adverse experience profile was generally similar to that seen in previous clinical trials.
Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of Ertapenem for Injection 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall adverse experience profile was generally comparable to that observed for Ertapenem for Injection in previous clinical trials.
Table 4 shows the incidence of adverse experiences other than those previously described above for Ertapenem for Injection that were reported regardless of causality in ≥2% of patients in this trial. 5% within each body system are listed below: Gastrointestinal Disorders: C.
difficile infection or colitis, dry mouth, hematochezia General Disorders and Administration Site Condition: crepitations Infections and Infestations: cellulitis, abdominal abscess, fungal rash, pelvic abscess Injury, Poisoning and Procedural Complications: incision site complication, incision site hemorrhage, intestinal stoma complication, anastomotic leak, seroma, wound dehiscence, wound secretion Musculoskeletal and Connective Tissue Disorders: muscle spasms Nervous System Disorders: cerebrovascular accident Renal and Urinary Disorders: dysuria, pollakiuria Respiratory, Thoracic and Mediastinal Disorders: crackles lung, lung infiltration, pulmonary congestion, pulmonary embolism, wheezing.
Pediatric Patients Receiving Ertapenem for Injection as a Treatment Regimen Clinical trials enrolled 384 patients treated with Ertapenem for Injection; in some of the clinical trials, parenteral therapy was followed by a switch to an appropriate oral antimicrobial [see Clinical Studies (14) ] .
The overall adverse experience profile in pediatric patients is comparable to that in adult patients. Table 5 shows the incidence of adverse experiences reported in ≥2% of pediatric patients in clinical trials. 1%). V. V. daily or ticarcillin/clavulanate 50 mg/kg for patients <60 kg or ticarcillin/clavulanate 3 g for patients >60 kg, 4 or 6 times a day.
V. V. V. V. in a single daily dose. 5% within each body system are listed below: Gastrointestinal Disorders: nausea General Disorders and Administration Site Condition: hypothermia, chest pain, upper abdominal pain; infusion site pruritus, induration, phlebitis, swelling, and warmth Infections and Infestations: candidiasis, oral candidiasis, viral pharyngitis, herpes simplex, ear infection, abdominal abscess Metabolism and Nutrition Disorders: decreased appetite Musculoskeletal and Connective Tissue Disorders: arthralgia Nervous System Disorders: dizziness, somnolence Psychiatric Disorders: insomnia Reproductive System and Breast Disorders: genital rash Respiratory, Thoracic and Mediastinal Disorders: wheezing, nasopharyngitis, pleural effusion, rhinitis, rhinorrhea Skin and Subcutaneous Tissue Disorders: dermatitis, pruritus, rash erythematous, skin lesion Vascular Disorders: phlebitis.
2 Post-Marketing Experience The following additional adverse reactions have been identified during the post-approval use of Ertapenem for Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
3 Adverse Laboratory Changes in Clinical Trials Adults Receiving Ertapenem for Injection as Treatment Regimen Laboratory adverse experiences that were reported during therapy in ≥2% of adult patients treated with Ertapenem for Injection in clinical trials are presented in Table 6 .
8%). 3% of patients. 1% of patients treated with Ertapenem for Injection in clinical trials include: increases in serum creatinine, serum glucose, BUN, total, direct and indirect serum bilirubin, serum sodium and potassium, PT and PTT; decreases in serum potassium, serum albumin, WBC, platelet count, and segmented neutrophils.
In a clinical trial for the treatment of diabetic foot infections in which 289 adult diabetic patients were treated with Ertapenem for Injection, the laboratory adverse experience profile was generally similar to that seen in previous clinical trials.
Prophylaxis of Surgical Site Infection following Elective Colorectal Surgery In a clinical trial in adults for the prophylaxis of surgical site infection following elective colorectal surgery in which 476 patients received a 1 g dose of Ertapenem for Injection 1 hour prior to surgery and were then followed for safety 14 days post surgery, the overall laboratory adverse experience profile was generally comparable to that observed for Ertapenem for Injection in previous clinical trials.
Pediatric Patients Receiving Ertapenem for Injection as a Treatment Regimen Laboratory adverse experiences that were reported during therapy in ≥2% of pediatric patients treated with Ertapenem for Injection in clinical trials are presented in Table 7 .
1%). 5% of patients treated with Ertapenem for Injection in clinical trials include: alkaline phosphatase increased, eosinophil count increased, platelet count increased, white blood cell count decreased and urine protein present.
3 Interaction with Valproic Acid Case reports in the literature have shown that co-administration of carbapenems, including ertapenem, 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 ertapenem and valproic acid/divalproex sodium is generally not recommended. Anti-bacterials other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium.
2) ] . 4 Clostridium difficile -Associated Diarrhea (CDAD) CDAD has been reported with use of nearly all antibacterial agents, including ertapenem, 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 Clostridium difficile .
Clostridium difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of Clostridium 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 Clostridium difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of Clostridium difficile , and surgical evaluation should be instituted as clinically indicated.
7) ] . 6 Development of Drug-Resistant Bacteria As with other antibiotics, prolonged use of Ertapenem for Injection may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Prescribing Ertapenem for Injection 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.
7 Laboratory Tests While Ertapenem for Injection possesses toxicity similar to the beta-lactam group of antibiotics, periodic assessment of organ system function, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.