Brand Name
Meropenem
View Brand InformationFDA approval date: October 14, 2011
Classification: Penem Antibacterial
Form: Injection
What is Meropenem?
Meropenem for injection is a penem antibacterial indicated for the treatment of: 1. Complicated skin and skin structure infections .
Approved To Treat
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Brand Information
Meropenem (Meropenem)
1INDICATIONS AND USAGE
1.1 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only)
Meropenem for Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis andpenicillin-susceptible isolates of Streptococcus pneumoniae, in pediatric patients 3 months of age and older. Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
Meropenem for Injection is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis andpenicillin-susceptible isolates of Streptococcus pneumoniae, in pediatric patients 3 months of age and older. Meropenem for injection has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
1.2 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection and other antibacterial drugs, Meropenem for Injection should only be used to treat or prevent 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.
2DOSAGE FORMS AND STRENGTHS
Meropenem for Injection, USP 2 g/vial: 2 grams of meropenem as a white to slight yellow crystalline powder in a single-dose vial for reconstitution.
3CONTRAINDICATIONS
Meropenem for 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 (β)-lactams.
4ADVERSE REACTIONS
The following are discussed in greater detail in other sections of labeling:
- Hypersensitivity Reactions
- Severe Cutaneous Adverse Reactions
- Rhabdomyolysi
- Seizure Potential
- Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid
- Clostridioides difficile – Associated Diarrhea
- Development of Drug-Resistant Bacteria
- Overgrowth of Nonsusceptible Organisms
- Thrombocytopenia
- Potential for Neuromotor Impairment
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Pediatric Patients with Bacterial Meningitis
Meropenem for injection was studied in 321 pediatric patients (3 months to less than 17 years of age) with bacterial meningitis at a dosage of 40 mg/kg every 8 hours. The most common adverse reactions and their rates of occurrence were as follows:
In these studies, the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem for injection and those who received comparator agents (either cefotaxime or ceftriaxone). In the meropenem for injection-treated group, 12/15 patients with seizures had late onset seizures (seizures that occurred on day 3 or later) versus 7/20 patients in the comparator arm.
The meropenem for injection group had a statistically higher number of patients than the comparator with transient elevation of liver enzymes.
Adverse Reactions from Studies of Meropenem for Injection in Other Serious Bacterial Infections (not bacterial meningitis)
The following adverse reactions occurred in studies of 2,904 immunocompetent adult patients who received meropenem for injection (500 mg or 1 gram every 8 hours) for the treatment of other serious bacterial infections (not bacterial meningitis). This meropenem for injection product is indicated only for the treatment of bacterial meningitis caused by certain organisms in pediatric patients 3 months of age and older
Deaths in 5 patients were assessed as possibly related to meropenem for injection; 36 (1.2%) patients had meropenem for injection discontinued because of adverse events.
Local Adverse Reactions
Local adverse reactions that were reported with meropenem for injection were as follows: Inflammation at the injection site (2.4%), injection site reaction (0.9%), phlebitis/thrombophlebitis (0.8%), pain at the injection site (0.4%), and edema at the injection site (0.2%).
Local adverse reactions that were reported with meropenem for injection were as follows: Inflammation at the injection site (2.4%), injection site reaction (0.9%), phlebitis/thrombophlebitis (0.8%), pain at the injection site (0.4%), and edema at the injection site (0.2%).
Systemic Adverse Reactions
Systemic adverse reactions that occurred in greater than 1% of the meropenem for injection-treated patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%). Additional systemic adverse reactions that occurred in less than or equal to 1% but greater than 0.1% of the meropenem for injection-treated patients are listed below within each body system in order of decreasing frequency:
Systemic adverse reactions that occurred in greater than 1% of the meropenem for injection-treated patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%). Additional systemic adverse reactions that occurred in less than or equal to 1% but greater than 0.1% of the meropenem for injection-treated patients are listed below within each body system in order of decreasing frequency:
Bleeding Events :gastrointestinal hemorrhage (0.5%), melena (0.3%), epistaxis (0.2%), hemoperitoneum (0.2%).
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
Respiratory:respiratory disorder, dyspnea, pleural effusion, asthma, cough increased, lung edema
Skin and Appendages:urticaria, sweating, skin ulcer
Urogenital System:dysuria, kidney failure, vaginal moniliasis, urinary incontinence
Laboratory Abnormalities
Laboratory abnormalities that occurred in greater than 0.2% of the meropenem for injection-treated patients were as follows:
Hepatic:increased alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, lactate
dehydrogenase (LDH), and bilirubin
dehydrogenase (LDH), and bilirubin
Hematologic:increased platelets, increased eosinophils, decreased platelets, decreased hemoglobin, decreased hematocrit, decreased white blood cell (WBC), shortened prothrombin time and shortened partial thromboplastin time, leukocytosis, hypokalemia
Renal:increased creatinine and increased blood urea nitrogen (BUN)
Urinalysis:presence of red blood cells
4.2Post-marketing Experience
The following adverse reactions have been identified during post-approval use of meropenem, including meropenem for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Worldwide post-marketing adverse reactions not otherwise listed under the Clinical Trials Experience subsection
Blood and Lymphatic System Disorders: agranulocytosis, neutropenia, and leukopenia; a positive direct or indirect Coombs test, and hemolytic anemia.
Immune System Disorders:angioedema.
Skin and Subcutaneous Disorders:Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme and acute generalized exanthematous pustulosis.
Musculoskeletal Disorders:rhabdomyolysis
5OVERDOSAGE
In mice and rats, large intravenous doses of meropenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities.
Intentional overdosing of meropenem for injection is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. The largest dose of meropenem administered in clinical trials has been 2 grams given intravenously every 8 hours. At this dosage, no adverse pharmacological effects or increased safety risks have been observed.
Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. Consider symptomatic treatments. In individuals with normal renal function, rapid renal elimination takes place. Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.
6DESCRIPTION
Meropenem for Injection, USP contains meropenem a synthetic carbapenem antibacterial. 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]hept2-ene-2-carboxylic acid trihydrate. Its empirical formula is C17H25N3O5S•3H2O with a molecular weight of 437.52. Its structural formula is:
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 is a white to slight yellow crystalline powder for intravenous administration. Each vial contains meropenem equivalent to 2 grams and 416 mg of sodium bicarbonate, anhydrous. When re-constituted as instructed Meropenem for Injection, USP will deliver 2 grams of meropenem (on anhydrous basis) and approximately 180 mg of sodium as sodium carbonate (7.8 mEq)
7REFERENCES
1. Kawamura S, AW Russell, SJ Freeman, and RA Siddall, 1992, Reproductive and Developmental Toxicity of Meropenem in Rats, Chemotherapy, 40:S238-250.
8HOW SUPPLIED/STORAGE AND HANDLING
Meropenem for Injection, USP is supplied in a single-dose vial containing meropenem as awhite to slight yellow crystalline powder powder to deliver 2 grams of meropenem for intravenous administration after reconstitution. The dry powder should be stored at 20°C to 25ºC (68°F to 77ºF). Brief exposure to 15°C to 30°C (59°F to 86°F) is permitted [see USP Controlled Room Temperature].
NDC 81962-002-01 2 gram single-dose injection vial
NDC 81962-002-08 2 gram single-dose injection vial packaged in a carton of 6
The container closure is not made with natural rubber latex.
9PATIENT COUNSELING INFORMATION
Antibacterial Resistance
Patients should be counseled that antibacterial drugs including Meropenem for Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Meropenem for Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Meropenem for Injection or other antibacterial drugs in the future
Diarrhea
Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible
Risk of Breakthrough Seizures
Counsel patients to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with Meropenem for Injection. If treatment with Meropenem for Injection is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed
Potential of Neuromotor Impairment
Patients receiving Meropenem for Injection on an outpatient basis must be alerted of adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that Meropenem for Injection is well tolerated, patients should not operate machinery or motorized vehicles
Manufactured by:
Brooks Steriscience Limited
Gujarat 391243, India (IND)
Revised- 6/2025