Vial for I.V. Compatibility of meropenem for injection with other drugs has not been established. The required dose should be administered after completion of the haemodialysis cycle. In fertility studies, intravenous meropenem was administered to male rats beginning 11 weeks before mating and throughout mating and to female rats from 2 weeks before mating through Gestation Day 7 at doses of 240, 500, and 1000 mg/kg/day. Meropenem binds to PBPs 2, 3 and 4 of (, Severe cutaneous adverse reactions have been reported in patients receiving meropenem. Meropenem is also used to treat bacterial meningitis (infection of brain or spinal cord). Intravenous infusions over 2 minutes, 3 minutes and 5 minutes of a 1 g dose of meropenem were compared in a three way crossover trial. The selection of meropenem to treat an individual patient should take into account the appropriateness of using a carbapenem antibacterial agent based on factors such as severity of the infection, the prevalence of resistance to other suitable antibacterial agents and the risk of selecting for carbapenem-resistant bacteria. In a peri-postnatal study in rats described in the published literature Urinary concentrations of meropenem in excess of 10 mcg/mL are maintained for up to 5 hours after a 500 mg dose. penicillins or cephalosporins). Consideration should be given to official guidance on the appropriate use of antibacterial agents. Common Brand Name(s): Merrem. oC (68 https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=b0075b72-c3cc-f844-e053-2a95a90a417f, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. 10 reduction in cell counts within 12 hours to 24 hours) are typically 1 to 2 times the bacteriostatic concentrations of meropenem, with the exception of 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 3.2 times the MRHD based on body surface area comparison (see Adverse Reactions (6.1), Pharmacokinetic studies with meropenem in patients with renal impairment have shown that the plasma clearance of meropenem correlates with creatinine clearance. Listeria monocytogenes, against which lethal activity is not observed. Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). Renal function - increase dose interval in renal failure. The medicinal product is supplied in pack sizes of 10 vials. Indication : • Wide spectrum antibiotic used to treat both Gram-positive and Gram-negative infections including pseudomonas spp. Each vial contains meropenem equivalent to 500 mg of meropenem activity. The reconstituted solutions for intravenous injection or infusion should be used immediately. If administration of meropenem is necessary, consider supplemental anti-convulsant therapy Repeated evaluation of the patient is essential. Warnings and Precautions (5.8), (, Known hypersensitivity to product components or anaphylactic reactions to β-lactams. One trial of 47 patients with a mean age of 2 years (range, 4 days to 20 years) examined meropenem 20 mg/kg/dose (or up to 40 mg/kg/dose for CNS or critical infections) IV every 8 hours for a … this version. (8.6), Isolates may be reported as R without prior testing. dosing Table below.). Table 4: Volume of Sterile Water for Injection for Reconstitution of Injection Vials. Sequelae were the most common reason patients were assessed as clinically not cured. The plasma protein binding of meropenem is approximately 2%. Alternatively, an injection vial may be re-constituted, then the resulting solution added to an intravenous container and further diluted with an appropriate infusion fluid. A pharmacokinetic study with meropenem in elderly patients has shown a reduction in the plasma clearance of meropenem that correlates with age-associated reduction in creatinine clearance - There is no experience in pediatric patients with renal impairment. PubMed, 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. The concomitant use of meropenem and valproic acid/sodium valproate/valpromide is not recommended (see section 4.5). For pediatric patients (with normal renal function) less than 3 months of age, with complicated intra-abdominal infections, the meropenem for injection dose is based on gestational age (GA) and postnatal age (PNA). In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with meropenem. The dose for adults and adolescents should be adjusted when creatinine clearance is less than 51 ml/min, as shown below. Solutions of intravenous meropenem for injection should not be frozen. urticaria toxic epidermal necrolysis, Stevens Johnson syndrome, erythema, multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome), blood creatinine increased, blood urea increased, General disorders and administration site conditions, thrombophlebitis pain at the injection site. There was no evidence of mutagenic potential found in any of these tests. Meropenem for injection should be administered by intravenous infusion over approximately 15 minutes to 30 minutes. If continued treatment with MEROPENEM RANBAXY for Injection is necessary, the unit dose (based on the type and severity of infection) is recommended at the completion of the haemodialysis procedure to … There is one metabolite of meropenem that is microbiologically inactive. 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 to determine whether it should be decreased or discontinued. The following are discussed in greater detail in other sections of labeling: Because clinical trials are conducted under widely varying conditions, adverse reactions 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. Abdominal pain. The half-life is approximately one hour. If superinfection does occur during therapy, appropriate measures should be taken. Intentional overdosing of meropenem is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. 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. <10 one-half unit dose every 24 hours Meropenem is cleared by haemodialysis. Concomitant use with valproic acid/sodium valproate/valpromide. -- = Susceptibility testing not recommended as the species is a poor target for therapy with the drug. Additional considerations for dosing are needed when treating patients with renal insufficiency (see further below). Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. 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, nervousness, paresthesia, hallucinations, somnolence, anxiety, depression, asthenia Table 5: Meropenem Concentrations in Selected Tissues (Highest Concentrations Reported). Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding- protein (PBP) targets. Table 3: Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-abdominal Infections and Normal Renal Function, Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.. Table 11 shows the degree of hearing loss between the meropenem-treated patients and the comparator-treated patients. Page 1 of 3 King Edward Memorial Hospital & Perth Children’s Hospital Neonatology Meropenem - Neonatal NEONATAL MEROPENEM This document should be read in conjunction with this DISCLAIMER Restricted: Requires Microbiologist review within 24 hours of initiation Presentation Vial: 500mg Classification Bactericidal carbapenem antibiotic. Currently there is no additional information available to further interpret this observation. In patients with renal impairment, thrombocytopenia has been observed but no clinical bleeding reported Meropenem to be used for bolus intravenous injection should be constituted with sterile water for injection. Adverse Reactions (6.1)]. 12 & 16, Chuangye Rd., Xinshi Dist, Tainan City, 74144, Taiwan, 500 mg per vial The patients in the intermittent bolus group (n = 5) were given a 1500 mg meropenem first dose (in 10 mL of water-for-injection infused by central line over 5 min) and then 1000 mg (in 10 mL of water-for-injection infused by central line over 3 min) every 8 h. The dose for both groups on day 1 was 3500 mg and 3000 mg/day thereafter. Date of first authorisation/renewal of the authorisation. Drug Interactions (7.2)]. The dosage is based on your medical condition and response to treatment. Any unused product or waste material should be disposed of in accordance with local requirements. (, Co-administration of meropenem with probenecid inhibits renal excretion of meropenem and is therefore not recommended. It is given by injection into a vein.. Common side effects include nausea, diarrhea, constipation, headache, rash, and pain at the site of injection. Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. C. difficile. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of meropenem (see section 4.8). Meropenem is a broad spectrum carbapenem antibiotic that has potent activity against an array of important gram‐positive and gram‐negative bacteria, such as pseudomonus aeruginosa, enterobacteriaceae, and anaerobes.It is commonly used for treatment of serious infections, including intra‐abdominal infections and meningitis in both adult and pediatric patients. Meropenem - Injection. Animal studies indicate that meropenem is well tolerated by the kidney. Dosage adjustment is necessary in patients with creatinine clearance 50 mL/min or less The measured renal clearance and the effect of probenecid show that meropenem undergoes both filtration and tubular secretion. [see [see When meropenem for injection is indicated in patients with these risk factors, caution is advised. Meropenem Injection is used for complicated skin and soft tissue infection, complicated infections occurring within the stomach cavity, inflammation of the brain and spinal cord membranes (bacterial meningitis), or infection during or following childbirth (intra or post-partum infections). Drug Interactions (7.2)]. If you are a consumer or patient please visit The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meropenem and any potential adverse effects on the breast-fed child from meropenem or from the underlying maternal conditions. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of 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. Severe pneumonia including hospital and ventilator-associated pneumonia. A dose of up to 2 g three times daily in adults and adolescents and a dose of up to 40 mg/kg three times daily in children may be particularly appropriate when treating some types of infections, such as infections due to less susceptible bacterial species (e.g. Staphylococcus aureus (methicillin-susceptible isolates only), Preparation of solution: Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection.Shake to dissolve and to obtain solution which is clear and colorless or pale yellow. There is no dose adjustment necessary (see section 4.2). Do not use flexible container in series connections. ), More about getting RSS News & Updates from DailyMed, Complicated skin and skin structure infections, 30 mL in 1 VIAL; Type 0: Not a Combination Product, 20 mL in 1 VIAL; Type 0: Not a Combination Product, 2 Dosage and Administration (2.2), [see C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. They are for use only for organisms that do not have specific breakpoints. [see 30 mg/kg and an equivalent dose of the drug-loaded nanoparticle dispersion; single intraperitoneal injection Application In septic rat model of Klebsiella pneumoniae, treatment with free meropenem exhibited 30% mortality, which was not statistically significant, as … Meropenem 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 (β)-lactams. This medicine is given by drip or by direct injection into a vein, under the supervision of a healthcare professional. 1 gram Injection Vial (NDC 72572-416-01) and packaged in cartons of 10 vials (NDC 72572-416-10). [see Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae. Adult patients with complicated skin and skin structure infections including complicated cellulitis, complex abscesses, perirectal abscesses, and skin infections requiring intravenous antimicrobials, hospitalization, and surgical intervention were enrolled in a randomized, multi-center, international, double-blind trial. A five minute intravenous bolus injection of meropenem in normal volunteers results in peak plasma levels of approximately 52 microgram/mL for the 500 mg dose and 112 microgram/mL for the 1 g dose. Injection vials (500 mg and 1 gram) may be directly re-constituted with a compatible infusion fluid. The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. No information is available on the effects of meropenem on the breast-fed child or on milk production. Diminished renal function and central nervous system lesions may increase the risk of seizures. (See [see They do not treat viral infections (e.g., the common cold). The following (, Renal Impairment: Dose adjustment is necessary, if creatinine clearance is 50 mL/min or less. Effects were seen in acute toxicity studies in rodent at doses exceeding 1000 mg/kg. Higher doses (40 mg/kg/dose IV every 8 hours) have been used in patients with severe infections. The study included 510 patients randomized to meropenem and 527 patients randomized to imipenem-cilastatin. - Intravenous bolus injection (5 mL to 20 mL) is to be given over approximately 3 minutes to 5 minutes. Clinical Pharmacology (12.3),  12 & 16 Chuangye Rd., Tainan City 74144, Taiwan, R.O.C. When meropenem for injection is indicated in patients with these risk factors, caution is advised. Dosage should be reduced in adult patients with renal impairment. 5Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. Use of meropenem 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
2020 meropenem injection dose