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MEROPENEM FOR is a brand name for Meropenem, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Meropenem for Injection USP and Sodium Chloride Injection USP is indicated for treatment of the following infections when caused by susceptible strains of the designated micro-organisms: • Lower Respiratory Tract Community-acquired pneumonia caused by Staphylococcus aureus (methicillin- susceptible strains only),…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. If a dose of Meropenem for Injection USP and Sodium Chloride Injection USP is required that does not equal 500 mg or 1 gram, this product is not recommended for use and an alternative formulation of meropenem should be considered.
Adults The usual dose is 500 mg to 1 g by intravenous infusion every 8 hours, depending on the type and severity of infection, the known or suspected susceptibility of the pathogens and the condition of the patient (see Table 1). Doses up to 2 g every 8 hours have been used.
Meropenem for Injection should be given by intravenous infusion over approximately 15 to 30 minutes. When treating infections known or suspected to be caused by Pseudomonas aeruginosa, a dose of at least 1 g every 8 hours in adults (maximum approved dose is 6 g daily given in 3 divided doses) is recommended.
This dose is based on pharmacokinetic/pharmacodynamic modeling and probability of target attainment simulation for susceptible strains of Pseudomonas aeruginosa (MIC ≤ 2 mcg / mL). 2 Recommended Dose and Dosage Adjustment The recommended dose to be given for adults is as in Table 1.
Table 1:
Recommended Dose in Adults Type of Infection Dose Dosing Interval Complicated urinary tract 500 mg Every 8 hours Uncomplicated skin and skin structure 500 mg Every 8 hours Complicated skin and skin structure 500 mg Every 8 hours Gynecologic and Pelvic Inflammatory Disease 500 mg Every 8 hours Lower respiratory Community-acquired pneumonia Nosocomial pneumonia 500 mg 1 g Every 8 hours Every 8 hours Complicated intra-abdominal 1 g Every 8 hours Meningitis 2 g Every 8 hours Septicemia 1 g Every 8 hours Impaired Renal Function Dosage should be reduced in patients with creatinine clearance less than 51 mL / min (Table 2).
Table 2:
Dosage in Patients with Creatinine Clearance Less than 51 mL / min Creatinine Clearance (mL / min) Dose (dependent on type of infection) Dosing Interval 26 - 50 Recommended dose (500 mg to 2000 mg) Every 12 hours 10 - 25 One-half recommended dose Every 12 hours < 10 One-half recommended dose Every 24 hours Meropenem is removed by hemodialysis and hemofiltration; if continued treatment with Meropenem for Injection is necessary, the dose, based on the infection type and severity, should be administered at the completion of the hemodialysis procedure to reinstitute effective treatment.
In the event of an overdose, Meropenem for Injection should be discontinued and general supportive treatment given until renal elimination takes place. Meropenem for Injection and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.
The intravenous LD50 of meropenem in mice and rats is more than 2500 mg / kg and is approximately 2000 mg / kg in dogs. For management of a suspected drug overdose, contact your regional poison control centre. 9% sodium chloride solution.
9% sodium chloride solution in the diluent chamber. 6 mEq). The osmolality of the reconstituted solution of Meropenem for Injection USP and Sodium Chloride Injection USP is approximately 356 mOsmol / kg for the 500 mg dose and approximately 417 mOsmol / kg for the 1 gram dose.
The Duplex® Container is a flexible dual chamber container. After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is hyperosmotic and is intended for single intravenous use.
The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The Duplex® Container is not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).
Meropenem for Injection USP and Sodium Chloride Injection USP is supplied in 24-unit cases. Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Intravenous Powder for solution / 500 mg or 1 g / meropenem Drug chamber: Sodium carbonate Diluent chamber1: Sodium chloride, water for injection Meropenem for Injection USP and Sodium Chloride Injection USP Product Monograph Page 12 of 79 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
). 1 Dosing Considerations Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. If a dose of Meropenem for Injection USP and Sodium Chloride Injection USP is required that does not equal 500 mg or 1 gram, this product is not recommended for use and an alternative formulation of meropenem should be considered.
Adults The usual dose is 500 mg to 1 g by intravenous infusion every 8 hours, depending on the type and severity of infection, the known or suspected susceptibility of the pathogens and the condition of the patient (see Table 1). Doses up to 2 g every 8 hours have been used.
Meropenem for Injection should be given by intravenous infusion over approximately 15 to 30 minutes. When treating infections known or suspected to be caused by Pseudomonas aeruginosa, a dose of at least 1 g every 8 hours in adults (maximum approved dose is 6 g daily given in 3 divided doses) is recommended.
This dose is based on pharmacokinetic/pharmacodynamic modeling and probability of target attainment simulation for susceptible strains of Pseudomonas aeruginosa (MIC ≤ 2 mcg / mL). 2 Recommended Dose and Dosage Adjustment The recommended dose to be given for adults is as in Table 1.
Table 1:
Recommended Dose in Adults Type of Infection Dose Dosing Interval Complicated urinary tract 500 mg Every 8 hours Uncomplicated skin and skin structure 500 mg Every 8 hours Complicated skin and skin structure 500 mg Every 8 hours Gynecologic and Pelvic Inflammatory Disease 500 mg Every 8 hours Lower respiratory Community-acquired pneumonia Nosocomial pneumonia 500 mg 1 g Every 8 hours Every 8 hours Complicated intra-abdominal 1 g Every 8 hours Meningitis 2 g Every 8 hours Septicemia 1 g Every 8 hours Impaired Renal Function Dosage should be reduced in patients with creatinine clearance less than 51 mL / min (Table 2).
Meropenem for Injection is contraindicated: • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• in patients who have demonstrated anaphylactic reactions to β-lactam antibiotics. • where the administration of sodium chloride could be clinically detrimental (see 7 WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There are no data on appropriate doses in patients requiring peritoneal dialysis. Meropenem for Injection USP and Sodium Chloride Injection USP Product Monograph Page 7 of 79 Hepatic Impairment (Adults) No dosage adjustment is necessary in patients with hepatic dysfunction as long as renal function is normal.
4 Geriatrics). Pediatrics (≥ 3 months of age) Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. Meropenem is not to be used in pediatric patients aged less than three months.
For infants and children over 3 months of age and weighing up to 50 kg, the recommended dose of Meropenem for Injection is 10 to 40 mg / kg every 8 hours, depending on the type and severity of infection, the known or suspected susceptibility of the pathogens and the condition of the patient (see Table 3).
Children weighing over 50 kg require the adult dosage. Meropenem for Injection should be given as an intravenous infusion over approximately 15 to 30 minutes. When treating infections known or suspected to be caused by Pseudomonas aeruginosa, a dose of at least 20 mg / kg every 8 hours in children (maximum approved dose is 120 mg / kg daily given in 3 divided doses) is recommended.
This dose is based on pharmacokinetic/pharmacodynamic modeling and probability of target attainment simulation for susceptible strains of Pseudomonas aeruginosa (MIC ≤ 2 mcg / mL).
Table 3:
Dosage in Pediatric Patients Type of Infection Dose (mg / kg) Dosing Interval Complicated urinary tract 10 Every 8 hours Uncomplicated skin and skin structure 10 - 20 Every 8 hours Community acquired pneumonia 10 - 20 Every 8 hours Complicated intra-abdominal 20 Every 8 hours Meningitis 40 Every 8 hours There are no data on appropriate doses for children with renal impairment.
4 Administration), the delivered doses are equivalent to 500 mg and 1 gram meropenem anhydrous (added as meropenem trihydrate). Compatibility Compatibility of Meropenem for Injection USP and Sodium Chloride Injection USP with other drugs has not been established.
Meropenem for Injection USP and Sodium Chloride Injection USP should not be mixed with or physically added to solutions containing other drugs. Stability and Storage Freshly prepared solutions of Meropenem for Injection USP and Sodium Chloride Injection USP should be used.
Following reconstitution (activation) in the DUPLEX® Container, the product maintains satisfactory potency for 1 hour at up to 25°C (77°F) or for 15 hours at up to 5°C (41°F). Solutions of intravenous Meropenem for Injection USP and Sodium Chloride Injection USP should not be frozen.
4 Administration Important Administration Instructions • Do not use in series connections. Such use would result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the Meropenem for Injection USP and Sodium Chloride Injection USP Product Monograph Page 8 of 79 secondary container is complete.
If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. • Do not introduce additives into the DUPLEX® […]
General As with other broad-spectrum antibiotics, prolonged use of Meropenem for Injection may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient is essential. If superinfection does occur during therapy, appropriate measures should be taken.
Meropenem for Injection should not be used to treat infections caused by methicillin-resistant staphylococci. When treating infections known or suspected to be caused by Pseudomonas aeruginosa, higher doses are recommended based on pharmacokinetic/pharmacodynamic modeling and probability of target attainment simulation for susceptible strains of Pseudomonas aeruginosa (MIC ≤ 2 mcg / mL) (see 4 DOSAGE AND ADMINISTRATION and 15 MICROBIOLOGY).
Caution may be required in critically ill patients with known or suspected Pseudomonas aeruginosa lower respiratory tract infections. 6 mEq) of sodium. At the usual recommended doses of 500 mg or 1000 mg every 8 hours, patients would receive between 735 mg/day and 870 mg/day (32 mEq and 38 mEq) of sodium.
Avoid use of Meropenem for Injection and Sodium Chloride Injection in patients with congestive heart failure, elderly patients and patients requiring restricted sodium intake. Driving and Operating Machinery No studies on the ability to drive and use machines have been performed.
However, when driving or operating machines, it should be taken into account that headache, paresthesia, and convulsions have been reported for Meropenem for Injection. Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including Meropenem for Injection.
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. 5 Post-Market Adverse Reactions).
Hepatic/Biliary/Pancreatic Patients with pre-existing liver disorders should have their liver function monitored during treatment with Meropenem for Injection. Meropenem for Injection USP and Sodium Chloride Injection USP Product Monograph Page 13 of 79 Immune Hypersensitivity Reactions Serious […]
Table 2:
Dosage in Patients with Creatinine Clearance Less than 51 mL / min Creatinine Clearance (mL / min) Dose (dependent on type of infection) Dosing Interval 26 - 50 Recommended dose (500 mg to 2000 mg) Every 12 hours 10 - 25 One-half recommended dose Every 12 hours < 10 One-half recommended dose Every 24 hours Meropenem is removed by hemodialysis and hemofiltration; if continued treatment with Meropenem for Injection is necessary, the dose, based on the infection type and severity, should be administered at the completion of the hemodialysis procedure to reinstitute effective treatment.
There are no data on appropriate doses in patients requiring peritoneal dialysis. Meropenem for Injection USP and Sodium Chloride Injection USP Product Monograph Page 7 of 79 Hepatic Impairment (Adults) No dosage adjustment is necessary in patients with hepatic dysfunction as long as renal function is normal.
4 Geriatrics). Pediatrics (≥ 3 months of age) Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is designed to deliver a 500 mg or 1 gram dose of meropenem. Meropenem is not to be used in pediatric patients aged less than three months.
For infants and children over 3 months of age and weighing up to 50 kg, the recommended dose of Meropenem for Injection is 10 to 40 mg / kg every 8 hours, depending on the type and severity of infection, the known or suspected susceptibility of the pathogens and the condition of the patient (see Table 3).
Children weighing over 50 kg require the adult dosage. Meropenem for Injection should be given as an intravenous infusion over approximately 15 to 30 minutes. When treating infections known or suspected to be caused by Pseudomonas aeruginosa, a dose of at least 20 mg / kg every 8 hours in children (maximum approved dose is 120 mg / kg daily given in 3 divided doses) is recommended.
This dose is based on pharmacokinetic/pharmacodynamic modeling and probability of target attainment simulation for susceptible strains of Pseudomonas aeruginosa (MIC ≤ 2 mcg / mL).
Table 3:
Dosage in Pediatric Patients Type of Infection Dose (mg / kg) Dosing Interval Complicated urinary tract 10 Every 8 hours Uncomplicated skin and skin structure 10 - 20 Every 8 hours Community acquired pneumonia 10 - 20 Every 8 hours Complicated intra-abdominal 20 Every 8 hours Meningitis 40 Every 8 hours There are no data on appropriate doses for children with renal impairment.
4 Administration), the delivered doses are equivalent to 500 mg and 1 gram meropenem anhydrous (added as meropenem trihydrate). Compatibility Compatibility of Meropenem for Injection USP and Sodium Chloride Injection USP with other drugs has not been established.
Meropenem for Injection USP and Sodium Chloride Injection USP should not be mixed with or physically added to solutions containing other drugs. Stability and Storage Freshly prepared solutions of Meropenem for Injection USP and Sodium Chloride Injection USP should be used.
Following reconstitution (activation) in the DUPLEX® Container, the product […]