Meropenem and Sodium Chloride 500 mg/50mL
Meropenem and Sodium Chloride · INJECTION, SOLUTION · B. Braun Medical Inc.
Meropenem and Sodium Chloride is a injection, solution containing meropenem and sodium chloride at 500 mg/50mL, taken intravenous. Manufactured by B. Braun Medical Inc..
Key Facts
- Brand Name
- Meropenem and Sodium Chloride
- Generic Name
- Meropenem and Sodium Chloride
- NDC Code (Product)
0264-3183- Manufacturer
- B. Braun Medical Inc.
- Strength
- 500 mg/50mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA202106
- Marketing Start
- 04/30/2015
Recall History
No Recall HistorySide 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 and Sodium Chloride Injection 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 requiring the full adult dose only). ( 1.1 ) Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). ( 1.2 ) Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and Sodium Chloride Injection and other antibacterial drugs, Meropenem for Injection and Sodium Chloride Injection should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 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 and Sodium Chloride Injection is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Stap…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use this formulation of meropenem only in patients who require the entire 500 mg or 1 gram dose and not any fraction thereof. ( 2.1 ) 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 to 30 minutes for intra-abdominal infections for adult patients. ( 2.1 ) Dosage should be reduced in adult patients with renal impairment. If less than a full dose (1 gram or 500 mg) is required, an alternative formulation should be used to avoid risk of overdose. ( 2.2 ) Recommended Meropenem for Injection 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 infection) Every 8 hours 26-50 Recommended dose Every 12 hours 10-25 One-half recommended dose Every 12 hours less than 10 One-half recommended dose Every 24 hours Meropenem for Injection and Sodium C…
Contraindications
4 CONTRAINDICATIONS Meropenem for Injection and Sodium Chloride Injection 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-lactams. Known hypersensitivity to product components or anaphylactic reactions to beta-lactams. ( 4 ) Contraindicated where the administration of sodium or chloride could be clinically detrimental. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Co-administration of Meropenem for Injection with probenecid inhibits renal excretion of meropenem and is therefore not recommended. ( 7.1 ) The concomitant use of Meropenem 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. ( 5.5 , 7.2 ) 7.1 Probenecid Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Coadministration 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 the hydrolysis of valproic…
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)] Rhabdomyolysis [see Warnings and Precautions (5.3) ] Seizure Potential [see Warnings and Precautions (5.4) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.5) ] Clostridioides difficile – Associated Diarrhea [see Warnings and Precautions (5.6) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.7) ] Overgrowth of Nonsusceptible Organisms [see Warnings and Precautions (5.8) ] Thrombocytopenia [see Warnings and Precautions (5.9) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.10) ] High Sodium Load [see Warnings and Precautions (5.11) ] Most common adverse reactions (greater than or equal to 2%) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-800-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Adverse Reactions from Clinical Trial…
Frequently Asked Questions
What is Meropenem and Sodium Chloride used for?
Meropenem and Sodium Chloride contains Meropenem and Sodium Chloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Meropenem and Sodium Chloride a controlled substance?
Meropenem and Sodium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Meropenem and Sodium Chloride?
The generic name for Meropenem and Sodium Chloride is Meropenem and Sodium Chloride. There are no other listed brand versions of Meropenem and Sodium Chloride.
What is the NDC code for Meropenem and Sodium Chloride 500 mg/50mL?
The NDC (National Drug Code) for Meropenem and Sodium Chloride 500 mg/50mL is 0264-3183, listed by B. Braun Medical Inc..
Other Meropenem and Sodium Chloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)