ANTIBIOTIK MEROPENEM PDF

Carbapeneme Meropenem ist ein Antibiotikum aus der Gruppe der Carbapeneme zur Behandlung bakterieller Infektionskrankheiten. Die bakteriziden Eigenschaften beruhen auf der Hemmung der Zellwandsynthese. Meropenem unterliegt einer aktiven Sekretion an der Niere. Es ist in der Schweiz seit dem Jahr zugelassen. Wirkungen hat bakterizide Eigenschaften gegen grampositive und gramnegative Erreger.

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Compatibility Compatibility of Meropenem with other drugs has not been established. Meropenem should not be mixed with or physically added to solutions containing other drugs. Stability and Storage Freshly prepared solutions of Meropenem should be used. However, re-constituted solutions of Meropenem maintain satisfactory potency under the conditions described below. Solutions of intravenous Meropenem should not be frozen.

Dosage Forms and Strengths Single dose clear glass vials of Meropenem for Injection, USP containing mg or 1 gram as the trihydrate blended with anhydrous sodium carbonate for re-constitution of sterile Meropenem powder. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. If an allergic reaction to Meropenem for injection occurs, discontinue the drug immediately. If signs and symptoms suggestive of these reactions appear, Meropenem should be withdrawn immediately and an alternative treatment should be considered.

Seizure Potential Seizures and other adverse CNS experiences have been reported during treatment with Meropenem for injection. These experiences have occurred most commonly in patients with CNS disorders e. During clinical investigations, immunocompetent adult patients were treated for non-CNS infections with the overall seizure rate being 0.

All Meropenem-treated patients with seizures had pre-existing contributing factors. Among these are included prior history of seizures or CNS abnormality and concomitant medications with seizure potential. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.

Continue anti-convulsant therapy in patients with known seizure disorders. If focal tremors, myoclonus, or seizures occur, evaluate neurologically, placed on anti-convulsant therapy if not already instituted, and re-examine the dosage of Meropenem for injection to determine whether it should be decreased or discontinued.

Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid The concomitant use of Meropenem and valproic acid or divalproex sodium is generally not recommended. 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.

Consider administration of antibacterial drugs other than carbapenems to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. If administration of Meropenem for injection is necessary, consider supplemental anti-convulsant therapy [see Drug Interactions 7.

Clostridium difficile—associated Diarrhea Clostridium difficile-associated diarrhea CDAD has been reported with use of nearly all antibacterial agents, including Meropenem for injection, 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. Hypertoxin producing isolates of C. 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. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C.

Development of Drug-Resistant Bacteria Prescribing Meropenem 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. Overgrowth of Nonsusceptible Organisms As with other broad-spectrum antibacterial drugs, 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. Thrombocytopenia In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported [see Dosage and Administration 2.

Until it is reasonably well established that Meropenem for injection is well tolerated, advise patients not to operate machinery or motorized vehicles [see Adverse Reactions 6.

Adult Patients: During clinical investigations, immunocompetent adult patients were treated for non-CNS infections with Meropenem for injection mg or 1 gram every 8 hours.

Deaths in 5 patients were assessed as possibly related to Meropenem; 36 1. 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 Meropenem for injection.

The following adverse reaction frequencies were derived from the clinical trials in the patients treated with Meropenem for injection. Local Adverse Reactions Local adverse events that were reported with Meropenem for injection were as follows: Inflammation at the injection site 2. The types of systemic and local 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 Meropenem for injection and their rates of occurrence as follows: Diarrhea 3.

The types of systemic and local adverse events seen in these patients are similar to the adults, with the most common adverse reactions reported as possibly, probably, or definitely related to Meropenem for injection and their rates of occurrence as follows: Diarrhea 4. The Meropenem group had a statistically higher number of patients with transient elevation of liver enzymes. Pediatric Patients Neonates and Infants less than 3 months of Age : Meropenem for injection was studied in neonates and infants less than 3 months of age.

Post-marketing Experience The following adverse reactions have been identified during post-approval use of Meropenem 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.

Worldwide post-marketing adverse reactions not otherwise listed in the Adverse Reactions from Clinical Trials section of this prescribing information and reported as possibly, probably, or definitely drug related are listed within each body system in order of decreasing severity. Blood and Lymphatic System Disorders: agranulocytosis, neutropenia, and leukopenia; a positive direct or indirect Coombs test, and hemolytic anemia.

Immune System Disorders: angioedema Skin and Subcutaneous Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms DRESS , erythema multiforme and acute generalized exanthematous pustulosis.

Drug Interactions Probenecid Probenecid competes with Meropenem for active tubular secretion, resulting in increased plasma concentrations of Meropenem. Co-administration of probenecid with Meropenem is not recommended. 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.

If administration of Meropenem for injection is necessary, then supplemental anti-convulsant therapy should be considered [see Warnings and Precautions 5.

No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous Meropenem during organogenesis at doses up to 2. In rats administered intravenous Meropenem in late pregnancy and during the lactation period, there were no adverse effects on offspring at doses equivalent to approximately 3.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. There were no adverse effects in the dams and no adverse effects in the first generation offspring including developmental, behavioral, and functional assessments and reproductive parameters except that female offspring exhibited lowered body weights which continued during gestation and nursing of the second generation offspring.

Second generation offspring showed no Meropenem-related effects. Lactation Risk Summary Meropenem has been reported to be excreted in human milk. No information is available on the effects of Meropenem on the breast-fed child or on milk production. Pediatric Use The safety and effectiveness of Meropenem for injection have been established for pediatric patients 3 months of age and older with complicated skin and skin structure infections and bacterial meningitis, and for pediatric patients of all ages with complicated intra-abdominal infections.

Skin and Skin Structure Infections Use of Meropenem for injection in pediatric patients 3 months of age and older with complicated skin and skin structure infections is supported by evidence from an adequate and well-controlled study in adults and additional data from pediatric pharmacokinetics studies [see Indications and Usage 1.

Intra-abdominal Infections Use of Meropenem for injection in pediatric patients 3 months of age and older with intra-abdominal infections is supported by evidence from adequate and well-controlled studies in adults with additional data from pediatric pharmacokinetics studies and controlled clinical trials in pediatric patients.

Use of Meropenem for injection in pediatric patients less than 3 months of age with intra-abdominal infections is supported by evidence from adequate and well-controlled studies in adults with additional data from a pediatric pharmacokinetic and safety study [see Indications and Usage 1. Bacterial Meningitis Use of Meropenem for injection in pediatric patients 3 months of age and older with bacterial meningitis is supported by evidence from adequate and well-controlled studies in the pediatric population [see Indications and Usage 1.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects; spontaneous reports and other reported clinical experience have not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Meropenem is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with renal impairment.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. A pharmacokinetic study with Meropenem for injection in elderly patients has shown a reduction in the plasma clearance of Meropenem that correlates with age-associated reduction in creatinine clearance [see Clinical Pharmacology Intentional overdosing of Meropenem for injection is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function.

The largest dose of Meropenem administered in clinical trials has been 2 grams given intravenously every 8 hours. At this dosage, no adverse pharmacological effects or increased safety risks have been observed. Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction.

Consider symptomatic treatments. In individuals with normal renal function, rapid renal elimination takes place. Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.

Meropenem Description Meropenem for Injection, USP is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. Its structural formula is: Meropenem for Injection, USP is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.

When re-constituted as instructed, each mg Meropenem for Injection, USP vial will deliver mg Meropenem and Meropenem - Clinical Pharmacology Meropenem is an antibacterial drug [see Microbiology Pharmacodynamics The percentage of time of a dosing interval that unbound plasma concentration of Meropenem exceeds the Meropenem minimum inhibitory concentration MIC against the infecting organism has been shown to best correlate with efficacy in animal and in vitro models of infection.

No accumulation of Meropenem in plasma was observed with regimens using mg administered every 8 hours or 1 gram administered every 6 hours in healthy volunteers with normal renal function. After a single intravenous dose of Meropenem for injection, the highest mean concentrations of Meropenem were found in tissues and fluids at 1 hour 0.

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Meropeném (pó para solução injetável)

Medical uses[ edit ] The spectrum of action includes many Gram-positive and Gram-negative bacteria including Pseudomonas and anaerobic bacteria. The overall spectrum is similar to that of imipenem, although meropenem is more active against Enterobacteriaceae and less active against Gram-positive bacteria. This condition frequently occurs in patients with hematological malignancies and cancer patients receiving anticancer drugs that suppress bone marrow formation. It is approved for complicated skin and skin structure infections, complicated intra-abdominal infections and bacterial meningitis. In the FDA granted approval for the combination of meropenem and vaborbactam to treat adults with complicated urinary tract infections. Dosing must be adjusted for altered kidney function and for haemofiltration. Several cases of severe hypokalemia have been reported.

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Sign Up Log In Cancel. Abbreviations Haemophilus influenzae 1, 2 and Moraxella catarrhalis 2. Seizures Seizures have infrequently been reported during treatment with carbapenems, including meropenem see section 4. Monte Carlo dosing simulations and subcutaneous tissue distribution. The better outcomes associated with high-dose colistin may come at the cost of worsening renal function [ 35 ]. Int J Antimicrob Agents ; For serious infections caused by resistant Gram-negative pathogens, high total daily doses of colistin appear to be important to maximize treatment efficacy [ ]. Impact of various conditions on the efficacy of dual carbapenem therapy against KPC-producing Klebsiella pneumoniae.

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