Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding- protein (PBP) targets. Reference(s) National Institutes of Health, U.S. National Library of Medicine, DailyMed Database. [see A further 28% is recovered as the microbiologically inactive metabolite. Table 4: Volume of Sterile Water for Injection for Reconstitution of Injection Vials. By continuing to browse the site you are agreeing to our policy on the use of cookies. The pH of freshly constituted solutions is between 7.3 and 8.3. These highlights do not include all the information needed to use MEROPENEM FOR INJECTION safely and effectively. Meropenem content and pH values before and after storage at 32°C for 24 hours in different buffered diluents are shown in table 1. Co-administration of probenecid with meropenem is not recommended. Alert patients receiving meropenem on an outpatient basis regarding adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Staphylococcus aureus (MRSA) or methicillin-resistant The offered meropenem injection • For pediatric patients weighing over 50 kg administer MERREM IV at a dose of 500 mg every 8 hours for cSSSI, 1 gram every 8 hours for cIAI and 2 grams every 8 hours for meningitis. Symptomatic treatments should be considered. Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species Any unused product or waste material should be disposed of in accordance with local requirements. Meropenem administered to pregnant rats during organogenesis (Gestation Day 6 to Gestation Day 17) in intravenous doses of 240, 500, and 750 mg/kg/day was associated with mild maternal weight loss at all doses, but did not produce malformations or fetal toxicity. Increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction. 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. [see 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 … Viridans group streptococci. For abdominal infections, 1 to 2 grams should be administered intravenously every 8 hours. Continue typing to refine. Table 11: Hearing Loss at Post-Therapy in the Evaluable Population Treated with Meropenem. View Labeling Archives, Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Use under close clinical supervision after discussion with Starship ID service. No specific medicinal product interaction studies other than probenecid were conducted. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Adverse Reactions (6.1), The NOAEL value was considered to be 1000 mg/kg/day (approximately 3.2 times the MRHD based on body surface area comparisons). After a single intravenous dose of meropenem, the highest mean concentrations of meropenem were found in tissues and fluids at 1 hour (0.5 hours to 1.5 hours) after the start of infusion, except where indicated in the tissues and fluids listed in Table 5 below. 5Non-species related breakpoints have been determined using PK/PD data and are independent of MIC distributions of specific species. eosinophilia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis, haemolytic anaemia. Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibiotics may also be hypersensitive to meropenem. Warnings and Precautions (5.3), [see [see This medication is given by injection into a vein as directed by your doctor, usually every 8 hours. The background risk of major birth defects and miscarriage for the indicated population is unknown. Pharmacokinetic/Pharmacodynamic (PK/PD) relationship. 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 Meropenem for injection, like all β-lactam antibiotics, has the potential to cause seizures. As with all beta-lactam antibiotics, serious and occasionally fatal hypersensitivity reactions have been reported (see sections 4.3 and 4.8). Intravenous powder for solution: 500 mg/vial and 1 gram/vial. Detailed Meropenem dosage information for adults and children. MERREM IV injection vials re-constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of MERREM IV) may be stored for up to 3 hours at up to 25°C (77°F) or for 13 hours at up to 5°C (41°F). 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 … Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. Indications and Usage (1.3), Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against For 4 g (2 g meropenem and 2 g vaborbactam) dose, use an infusion bag with a volume of 250, 500, or 1,000 mL. Sodium content is 45.1 mg (1.96 mEq). A solution for bolus injection is prepared by dissolving the drug product meropenem in sterile water for injection to a final concentration of 50 mg/ml. Renal function - increase dose interval in renal failure. However, when driving or operating machines, it should be taken into account that headache, paraesthesiae and convulsions have been reported for meropenem. Vomiting and pseudomembranous colitis – consider alternate antibiotic. 5S∙3H Patients who are hypersensitive to penicillins may also be hypersensitive to meropenem. Business and Technology Centre, Bessemer Drive, Stevenage, SG1 2DX. The owner is comfortable giving SQ injections at home. Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies. Clinical Studies (14.1)]. Until it is reasonably well established that meropenem for injection is well tolerated, patients should not operate machinery or motorized vehicles. After rapid administration (5 minutes or less) the pharmacokinetics are biexponential but this is much less evident after 30 minutes infusion. There is one metabolite of meropenem that is microbiologically inactive. Bacterial resistance to meropenem may result from: (1) decreased permeability of the outer membrane of Gram-negative bacteria (due to diminished production of porins) (2) reduced affinity of the target PBPs (3) increased expression of efflux pump components, and (4) production of beta-lactamases that can hydrolyse carbapenems. Diminished renal function and central nervous system lesions may increase the risk of seizures. If a severe allergic reaction occurs, the medicinal product should be discontinued and appropriate measures taken. 2 g x 3 daily was taken into consideration for severe infections and in setting the I/R breakpoint. Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) (see section 4.8). Pediatric Patients 3 Months of Age and Older, Table 2: Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal Renal Function. - Intravenous infusion is to be given over approximately 15 minutes to 30 minutes. For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: †Resistance rate ≥ 50% in one or more EU countries. Use in Specific Populations (8.6)]. Discard unused portion. Une dose est généralement administrée toutes les 8 heures. 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. o to 77 [see Hepatic function – at the beginning of treatment, and weekly thereafter. Additional systemic adverse events that were reported with meropenem and occurring in less than or equal to 1.0% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency: Bleeding events were seen as follows: gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%). Adverse Reactions (6.1), There are limited safety data available to support the administration of a 2 g dose in adults as an intravenous bolus injection. (, Known hypersensitivity to product components or anaphylactic reactions to β-lactams. 25N Meropenem for Injection Page 6 of 36 Meropenem for Injection, like all β-lactam antibiotics, has the potential to cause seizures. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. However, bacteria may exhibit resistance to more than one class of antibacterials agents when the mechanism involved include impermeability and/or an efflux pump(s). [see Dosage and Administration (2.2), Dosage and Administration (2.3), Dosage should be reduced in adult patients with renal impairment. There was no evidence of mutagenic potential found in any of these tests. The pharmacokinetics of meropenem, in pediatric patients 2 years of age or older, are similar to those in adults. Meropenem 1 g: Each vial contains meropenem trihydrate equivalent to 1 g anhydrous meropenem. Pediatric Patients Less Than 3 Months of Age. Pediatric Patients (Neonates and Infants less than 3 months of Age): Meropenem was studied in 200 neonates and infants less than 3 months of age. 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. (8.6),  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. The medicinal product is supplied in pack sizes of 10 vials. Meropenem administered intravenously to pregnant Cynomolgus monkeys during organogenesis from Day 20 to 50 after mating at doses of 120, 240, and 360 mg/kg/day did not produce maternal or fetal toxicity at the NOAEL dose of 360 mg/kg/day (approximately 2.3 times the MRHD based on body surface area comparison). Table 11 shows the degree of hearing loss between the meropenem-treated patients and the comparator-treated patients. If you have any questions, ask your doctor or pharmacist. Know Meropenem 500 MG Injection uses, side-effects, composition, substitutes, drug interactions, precautions, dosage, warnings only on Pronunciation: MER-oh-PEN-em. C. difficile, and surgical evaluation should be instituted as clinically indicated. Do not use flexible container in series connections. Meropenem is not licensed for children <3 months of age. A 5-minute intravenous bolus injection of MERREM IV in healthy volunteers results in mean peak plasma concentrations of approximately 45 mcg/mL (range 18-65) for the 500 mg dose and 112 mcg/mL (range 83-140) for the 1 gram dose. The intravenous formulation was well tolerated in animal studies. No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (MRHD) based on body surface area comparison, respectively. Meronem (1 gm) 1gm - 1 Vial Injection (Meropenem) drug information. Consider administration of antibacterial drugs other than carbapenems to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. Dosage and Administration (2.2), Clinical Pharmacology (12.3)]. (, Co-administration of meropenem with probenecid inhibits renal excretion of meropenem and is therefore not recommended. Meropenem should not be used in breast-feeding women unless the potential benefit for the mother justifies the potential risk to the baby. ), or very severe infections. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.

meropenem injection dose

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