Meropenem 1 g/1
Meropenem · INJECTION, POWDER, FOR SOLUTION · WG Critical Care, LLC
Meropenem is a injection, powder, for solution containing meropenem at 1 g/1, taken intravenous. Manufactured by WG Critical Care, LLC.
Key Facts
- Brand Name
- Meropenem
- Generic Name
- Meropenem
- NDC Code (Product)
44567-146- Manufacturer
- WG Critical Care, LLC
- Strength
- 1 g/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA210773
- Marketing Start
- 06/30/2021
Recall History
Pfizer Inc.
Lack of assurance of sterility: loss of container integrity.
Sentara Infusion Services
Lack of sterility assurance
Walgreens Infusion Services
Lack of sterility assurance.
AstraZeneca Pharmaceuticals LP
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Baptist Health Medical Towers Pharmacy and Infusion Services
Lack of Sterility Assurance
Franck's Lab Inc dba Trinity Care Solutions
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Walgreens Infusion Services
Lack of Assurance of Sterility
Hospira Inc.
Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Sentara Enterprises
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Meropenem for Injection, USP is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1 ) Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2 ) Bacterial meningitis (pediatric patients 3 months of age and older only). ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection, USP and other antibacterial drugs, Meropenem for Injection, USP should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only) Meropenem for 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, Prote…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. When treating infections caused by Pseudomonas aeruginosa , a dose of 1 gram every 8 hours is recommended. ( 2.1 ) 1 gram every 8 hours by intravenous infusion over 15 minutes to 30 minutes for intra-abdominal infections for adult patients. ( 2.1 ) 1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL) over 3 minutes to 5 minutes for adult patients. ( 2.1 ) Dosage should be reduced in adult patients with renal impairment. ( 2.2 ) Recommended Meropenem for Injection, USP Dosage Schedule for Adult Patients with Renal Impairment Creatinine Clearance (mL/min) Dose (dependent on type of infection) Dosing Interval Greater than 50 Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal) Every 8 hours 26 to 50 Recommended dose Every 12 hours 10 to 25 One-half recommended dose Every 12 hours Less than 10 One-half recommended dose Every 24 hours Pediatric patients 3 months of age and older Recommended Meropenem for Injection, USP Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal …
Contraindications
4 CONTRAINDICATIONS Meropenem for Injection, USP 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. Known hypersensitivity to product components or anaphylactic reactions to β-lactams. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Co-administration of Meropenem for Injection, USP with probenecid inhibits renal excretion of meropenem and is therefore not recommended. ( 7.1 ) The concomitant use of Meropenem for Injection, USP and valproic acid or divalproex sodium is generally not recommended. Antibacterial drugs other than carbapenems should be considered to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium. ( 5.4 , 7.2 ) 7.1 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. 7.2 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. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggest that carbapenems may inhibit t…
Adverse Reactions
6 ADVERSE REACTIONS The following are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions (5.2) ] Seizure Potential [see Warnings and Precautions (5.3) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.4) ] Clostridium difficile – associated Diarrhea [see Warnings and Precautions (5.5) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6) ] Overgrowth of Nonsusceptible Organisms [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.9) ] Most common adverse reactions (2% or less) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at safety@xellia.com or 1-833-295-6953, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Adverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reactions rate…
Frequently Asked Questions
What is Meropenem used for?
Meropenem contains Meropenem. It is a injection, powder, for solution taken intravenous. Consult your doctor for specific uses.
Is Meropenem a controlled substance?
Meropenem is not classified as a controlled substance by the DEA.
What is the generic name for Meropenem?
The generic name for Meropenem is Meropenem. There are 3 other brand versions of Meropenem.
What is the NDC code for Meropenem 1 g/1?
The NDC (National Drug Code) for Meropenem 1 g/1 is 44567-146, listed by WG Critical Care, LLC.