Meropenem

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). Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only). 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.

Meropenem is an antibacterial drug.

Use this formulation of meropenem only in patients who require the entire 500 mg or 1 gram dose and not any fraction thereof. 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. 1 gram every 8 hours by intravenous infusion over 15 to 30 minutes for intra-abdominal infections for adult patients. 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.

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. Contraindicated where the administration of sodium or chloride could be clinically detrimental.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactams. Severe cutaneous adverse reactions have been reported in patients receiving meropenem intravenous. Discontinue meropenem immediately if patients experience these signs and symptoms and consider alternative treatment. Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Meropenem for Injection and Sodium Chloride Injection and initiate appropriate therapy. Seizures and other adverse CNS experiences have been reported during treatment. Co-administration of Meropenem for Injection with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. Clostridioides difficile- associated diarrhea (ranging from mild diarrhea to fatal colitis) has been reported.

The following are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions Severe Cutaneous Adverse Reactions Rhabdomyolysis 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 High Sodium Load Most common adverse reactions (greater than or equal to 2%) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash

Co-administration of Meropenem for Injection with probenecid inhibits renal excretion of meropenem and is therefore not recommended. 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.

Store the unactivated unit at 20°C–25°C (68°F–77°F). Excursion permitted to 15°C-30°C. Protect from freezing.