Meropenem

What it is used for

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

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. 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.

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, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.

Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only) Meropenem for Injection, USP is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae. Meropenem for Injection, USP has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.

Usage 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. 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.

Side effects, and when to stop

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 ) ]

Who should not take it

Meropenem for injection (I.V.) 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.