Meropenem
Generic Name: meropenem
Brand Names:
Meropenem
11 DESCRIPTION Meropenem for Injection 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]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C 17 H 25 N 3 O 5 S•3H 2 O with a molecular weight of 437.52.
Overview
11 DESCRIPTION Meropenem for Injection 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]hept-2-ene-2-carboxylic acid trihydrate. Its empirical formula is C 17 H 25 N 3 O 5 S•3H 2 O with a molecular weight of 437.52.
Uses
1 INDICATIONS AND USAGE Meropenem for Injection is a penem antibacterial indicated for the treatment of bacterial meningitis in pediatric patients 3 months of age and older only. ( 1.1 ) 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.
Dosage
2 DOSAGE AND ADMINISTRATION • Pediatric patients 3 months of age and older with bacterial meningitis ( 2.1 ) Recommended Meropenem for Injection Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Bacterial Meningitis and Normal Renal Function (2.1) Type of Infection Dose (mg/kg) Up to a Maximum Dose Dosing Interval Bacterial Meningitis 40 2 grams Every 8 hours - Intravenous infusion is to be given over approximately 15 minutes to 30 minutes. - There is no experience with the use of Meropenem for Injection in pediatric patients with renal impairment.
Side Effects
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 Neuromot...
Interactions
7 DRUG INTERACTIONS • Co-administration of meropenem for injection with probenecid inhibits renal excretion of meropenem and therefore Meropenem for Injection is not recommended ( 7.1 ) • The concomitant use of Meropenem for Injection 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. ( 5.4 , 7.2 ) 7.1 Probenecid Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Co-administration of probenecid with meropenem is not recommended.
Warnings
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS 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.
Pregnancy
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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Meropenem for Injection is supplied in a single-dose vial containing meropenem as a white to light yellow powder to deliver 2 grams of meropenem for intravenous administration after reconstitution. The dry powder should be stored at 20º C to 25ºC (68º F to 77ºF). Brief exposure to 15ºC to 30ºC (59ºF to 86ºF) is permitted [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Meropenem used for?▼
1 INDICATIONS AND USAGE Meropenem for Injection is a penem antibacterial indicated for the treatment of bacterial meningitis in pediatric patients 3 months of age and older only. ( 1.1 ) 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.
What are the side effects of Meropenem?▼
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 Neuromot...
Can I take Meropenem during pregnancy?▼
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.
What are the important warnings for Meropenem?▼
5 WARNINGS AND PRECAUTIONS • 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. 4 CONTRAINDICATIONS 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.