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Meropenem for Injection
|NS (preferred - greater stability), D5W (must be used immediately)|
Standard Dilutions [Amt of drug] [Infusion vol] [Infusion rate]
| DUPLEX® Containers or dilution of powder for injection:
[ 0.5 grams] [50 ml ] [15-30 minutes]
[ 1 gram] [50 ml ] [15-30 minutes]
Bolus administration (see preparation below - powder for injection):
For Intravenous Bolus Administration
Table 4: Volume of Sterile Water for Injection for Reconstitution of Injection Vials
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 25ºC (77ºF) or for 15 hours at up to 5ºC (41ºF). Solutions of intravenous Meropenem for Injection USP and Sodium Chloride Injection USP should not be frozen.
Meropenem injection, powder, for solution
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.
Intravenous Bolus Administration: Meropenem injection vials re-constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) 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).
Intravenous Infusion Administration: Solutions prepared for infusion (Meropenem concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Sodium Chloride Injection 0.9% may be stored for 1 hour at up to 25°C (77°F) or 15 hours at up to 5°C (41°F).
Solutions prepared for infusion (Meropenem concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Dextrose Injection 5% should be used immediately.
| See warnings and precautions below.
Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S•3H2O with a molecular weight of 437.52.
Meropenem for injection is a white to pale yellow crystalline powder containing meropenem trihydrate and sodium carbonate. The constituted solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether.
Meropenem for Injection USP and Sodium Chloride Injection USP is supplied as a sterile, nonpyrogenic, single-use packaged combination of meropenem (drug chamber) and 50 mL of sodium chloride (diluent) in the DUPLEX® sterile container. When reconstituted as instructed, each 1 gram Meropenem for injection in the DUPLEX® Container will deliver 1 gram of meropenem and a total sodium content of 290.2 mg (12.6 mEq). Each 500 mg Meropenem for injection in the DUPLEX® Container will deliver 500 mg of meropenem and a total sodium content of 245.1 mg (10.7 mEq) [see Dosage and Administration (2.4)]. 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.
Not made with natural rubber latex, PVC or Di(2-ethylhexyl)phthalate (DEHP).
| Mechanism of Action:
The bactericidal activity of meropenem results from the inhibition of cell wall synthesis. Meropenem penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding-protein (PBP) targets. Meropenem binds to PBPs 2, 3 and 4 of Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of Staphylococcus aureus. Bactericidal concentrations (defined as a 3 log10 reduction in cell counts within 12 to 24 hours) are typically 1-2 times the bacteriostatic concentrations of meropenem, with the exception of Listeria monocytogenes, against which lethal activity is not observed.
Meropenem has significant stability to hydrolysis by beta-lactamases, both penicillinases and cephalosporinases produced by Gram-positive and Gram-negative bacteria.
Meropenem does not have in-vitro activity against methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-resistant Staphylococcus epidermidis (MRSE).
Interaction with Other Antimicrobials
Enterococcus faecalis (vancomycin-susceptible isolates only)
| INDICATIONS AND USAGE:
1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of age and older requiring the full adult dose only)
Meropenem for Injection USP and Sodium Chloride Injection USP is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.
1.2 Complicated Intra-abdominal Infections (Adult Patients and Pediatric Patients 3 Months of age and older requiring the full adult dose only)
Meropenem for Injection USP and Sodium Chloride Injection USP is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
1.3 Bacterial Meningitis (Pediatric Patients 3 Months of age and older requiring the full adult dose only)
Meropenem for Injection USP and Sodium Chloride Injection USP is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae.
Meropenem has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
For information regarding use in pediatric patients (3 months of age and older) [see Indications and Usage (1.1), (1.2) or (1.3); Dosage and Administration (2.3), and Adverse Reactions (6.1)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection USP and Sodium Chloride Injection USP and other antibacterial drugs, Meropenem for Injection USP and Sodium Chloride Injection USP should only be used to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
| WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS:
Most common adverse reactions (greater than or equal to 2%) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. Drug information (pdf)
| DOSAGE AND ADMINISTRATION:
2.1 Adult Patients
Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container should be used only in patients who require the entire 500 mg or 1 gram dose and not any fraction thereof. The recommended dose of Meropenem for Injection USP and Sodium Chloride Injection USP is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. When treating complicated skin and skin structure infections caused by P. aeruginosa, a dose of 1 gram every 8 hours is recommended.
Meropenem for Injection USP and Sodium Chloride Injection USP should be administered by intravenous infusion over approximately 15 to 30 minutes.
2.2 Use in Adult Patients with Renal Impairment
Dosage should be reduced in patients with creatinine clearance of 50 mL/min or less. (See dosing table below.)
Dosage should be reduced in renal failure if less than a full dose (1 gram or 500 mg) is required and an alternative formulation should be used to avoid risk of overdose.
When only serum creatinine is available, the following formula (Cockcroft and Gault equation)2 may be used to estimate creatinine clearance.
Males: Creatinine Clearance (mL/min) =
Females: 0.85 x above value
Table 1: Recommended Meropenem for Injection Dosage Schedule for Adult Patients With Renal Impairment
There is inadequate information regarding the use of meropenem for injection in patients on hemodialysis or peritoneal dialysis.
2.3 Use in Pediatric Patients (3 Months of age and older only)
Table 2: Recommended Meropenem for injection (I.V.) Dosage Schedule for Pediatric Patients 3 Months of Age and Older With Normal Renal Function
There is no experience in pediatric patients with renal impairment.
When treating cSSSI caused by P. aeruginosa, a dose of 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended.
2.4 Preparation and Administration of Meropenem for Injection USP and Sodium Chloride Injection USP in DUPLEX® Container
Important Administration Instructions
This reconstituted solution is for intravenous use only. Additional info - DUPLEX® Container
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.
2.6 Stability and Storage
| DOSAGE FORMS AND STRENGTHS:
Storage and Stability
Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is a flexible dual chamber container supplied in two concentrations. The diluent chamber contains approximately 50 mL of 0.9% Sodium Chloride Injection USP. After reconstitution, the delivered doses are equivalent to 5001 mg and 11 gram meropenem.
Meropenem for Injection USP and Sodium Chloride Injection USP is supplied sterile and nonpyrogenic in the DUPLEX® Container packaged 24 units per case.
Store the unactivated unit at 20–25°C (68–77°F). Excursion permitted to 15-30°C. [See USP Controlled Room Temperature.] Protect from freezing.
Use only if prepared solution is clear and free from particulate matter.
Meropenem for injection, USP (I.V.) is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) [see USP].