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Meropenem for 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 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 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. 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, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species. 1.2 Complicated Intra-abdominal Infections (Adult and Pediatric Patients) Meropenem for injection, USP is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli , Klebsiella pneumoniae , …

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. Known hypersensitivity to product components or anaphylactic reactions to β-lactams. ( 4 )

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. ( 5.1 ) Severe cutaneous adverse reactions have been reported in patients receiving meropenem for injection. ( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue meropenem for injection and initiate appropriate therapy. ( 5.3 ) Seizures and other adverse CNS experiences have been reported during treatment. ( 5.4 ) 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. ( 5.5 , 7.2 ) Clostridioides difficile- associated diarrhea (ranging from mild diarrhea to fatal colitis) has been reported. Evaluate if diarrhea occurs. ( 5.6 ) In patients with renal dysfunction, thrombocytopenia has been observed. ( 5.9 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another β-lactam. Before initiating therapy with Meropenem for injection, it is important to inquire about previous hypersensitivity reactions to …

8.1 Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with meropenem in pregnant women. No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (MRHD) based on body surface area comparison, respectively. In rats administered intravenous meropenem in late pregnancy and during the lactation period, there were no adverse effects on offspring at doses equivalent to approximately 3.2 times the MRHD based on body surface area comparison ( see …