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Imipenem And Cilastatin is a brand name for Imipenem. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory…
Verbatim from this product's FDA label. Tap a section to expand.
1 ). 1 ). 2 ). 3 ). 4 ). 5 ). ) in adult patients should be based on suspected or confirmed pathogen susceptibility as shown in Table 1 below. ) represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution.
These doses should be used for patients with creatinine clearance of greater than or equal to 90 mL/min. 3 )] . Recommend that the maximum total daily dosage not exceed 4 g/day. Administer 500 mg by intravenous infusion over 20 to 30 minutes.
Administer 1,000 mg by intravenous infusion over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. 4 )] . 4 )] . 1 )] . ) as indicated in Table 3 . The serum creatinine should represent a steady state of renal function.
) for Adult Patients in Various Renal Function Groups Based on Estimated Creatinine Clearance (CLcr) * Administer doses less than or equal to 500 mg by intravenous infusion over 20 to 30 minutes. Discard unused portion of the infusion solution.
† Administer doses greater than 500 mg by intravenous infusion over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed. 6 )] . ) unless hemodialysis is instituted within 48 hours. ) for patients undergoing peritoneal dialysis.
3 )]. Both imipenem and cilastatin are cleared from the circulation during hemodialysis. ) after hemodialysis and at intervals timed from the end of that hemodialysis session. 2 )]. ) for administration to neonates because it has been associated with toxicity in neonates.
While toxicity has not been demonstrated in pediatric patients greater than three months of age, small pediatric patients in this age range may also be at risk for benzyl alcohol toxicity. Contents of the vials must be reconstituted by adding approximately 10 mL of the appropriate diluent to the vial.
) range from colorless to yellow. Variations of color within this range do not affect the potency of the product. The reconstituted suspension must not be administered by direct Intravenous Infusion. After reconstitution, shake vial well and transfer the resulting suspension to 100 mL of an appropriate infusion solution before administering by intravenous infusion.
Repeat transfer of the resulting suspension with an additional 10 mL of infusion solution to ensure complete transfer of vial contents to the infusion solution. Agitate the resulting mixture until clear. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. 1 ). 1 ). 1 ). 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.
). ). ) -treated adult patients. 2% of the patients or reported since the drug was marketed are listed within each body system in order of decreasing severity [see Table 5 ]. 2% of Adult Patients Listed within Each Body System in Order of Decreasing Severity Body System Adverse Reactions Gastrointestinal Pseudomembranous Colitis (the onset of Pseudomembranous colitis symptoms), Hemorrhagic Colitis Gastroenteritis Abdominal Pain Glossitis Tongue Papillar Hypertrophy Heartburn Pharyngeal Pain Increased Salivation CNS Encephalopathy Confusion Myoclonus Paresthesia Vertigo Headache Special Senses Hearing Loss Tinnitus Respiratory Chest Discomfort Dyspnea Hyperventilation Thoracic Spine Pain Cardiovascular Palpitations Tachycardia Skin Erythema Multiforme Angioneurotic Edema Flushing Cyanosis Hyperhidrosis Skin Texture Changes Candidiasis Pruritus Vulvae Local Administration site Infused vein infection Body as a Whole Polyarthralgia Asthenia/Weakness Renal Oliguria/Anuria Polyuria Adverse Laboratory Changes The following adverse laboratory changes were reported during clinical trials: Hepatic: Increased alanine aminotransferase (ALT or SGPT), aspartate aminotransferase (AST or SGOT), alkaline phosphatase, bilirubin, and lactate dehydrogenase (LDH) Hemic: Increased eosinophils, positive Coombs test, increased WBC, increased platelets, decreased hemoglobin and hematocrit, increased monocytes, abnormal prothrombin time, increased lymphocytes, increased basophils Electrolytes: Decreased serum sodium, increased potassium, increased chloride Renal: Increased BUN, creatinine Urinalysis: Presence of urine protein, urine red blood cells, urine white blood cells, urine casts, urine bilirubin, and urine urobilinogen.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams. 1 ). ). 2 ). ), 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. 3 ). ) and may range in severity from mild diarrhea to fatal colitis. 4 ). 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.
), careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. ) occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.
2 )]. 6 )] . However, there have been reports of CNS adverse experiences in patients who had no recognized or documented underlying CNS disorder or compromised renal function. Anticonvulsant therapy should be continued in patients with known seizure disorders.
) re-examined to determine whether it should be decreased, or the antibacterial drug discontinued. ), 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.
) is contraindicated in patients who have shown hypersensitivity to any component of this product. ) ( 4 )
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Discard unused portion of the infusion solution where applicable. 5 )] , maintains satisfactory potency for 4 hours at room temperature or for 24 hours under refrigeration (5°C). ). ) with, or physically add to, other antibacterial drugs.
) may be administered concomitantly with other antibacterial drugs, such as aminoglycosides.
2% Adverse Laboratory Changes The following adverse laboratory changes were reported in studies of 178 pediatric patients 3 months of age: increased AST (SGOT), decreased hemoglobin/hematocrit, increased platelets, increased eosinophils, increased ALT (SGPT), increased urine protein, decreased neutrophils.
The following adverse laboratory changes were reported in studies of 135 patients (neonates to 3 months of age): increased eosinophils, increased AST (SGPT), increased serum creatinine, increased/decreased platelet count, increased/decreased bilirubin, increased ALT (SGPT), increased alkaline phosphatase, increased/decreased hematocrit.
). 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. ) Body System Adverse Reactions Gastrointestinal Hepatitis (including fulminant hepatitis) Hepatic failure Jaundice Staining of the teeth and/or tongue Hematologic Pancytopenia Bone marrow depression Thrombocytopenia Neutropenia Leukopenia Hemolytic anemia CNS Tremor Psychic disturbances including hallucinations Dyskinesia Agitation Special Senses Taste perversion Skin Stevens-Johnson syndrome Toxic epidermal necrolysis Body as a whole Drug fever Renal Acute renal failure Urine discoloration Adverse Laboratory Changes Adverse laboratory changes reported since the drug was marketed were: Hematologic: agranulocytosis.
Examination of published literature and spontaneous adverse reactions reports suggested a similar spectrum of adverse reactions in adult and pediatric patients.
Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. ) and valproic acid/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.
3 )]. Close adherence to the recommended dosage and dosage schedules is urged, especially in patients with known factors that predispose to convulsive activity. ), 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 antibacterial drug 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 antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated. ) may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
) 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.