Meropenem And Sodium Chloride
Generic Name: meropenem and sodium chloride
Brand Names:
Meropenem And Sodium Chloride
11 DESCRIPTION Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4 R ,5 S ,6 S )-3- [[(3 S ,5 S )-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1 R )-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 is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. Meropenem is (4 R ,5 S ,6 S )-3- [[(3 S ,5 S )-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1 R )-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 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). ( 1.1 ) Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). ( 1.2 ) Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only).
Dosage
2 DOSAGE AND ADMINISTRATION Use this formulation of meropenem only in patients who require the entire 500 mg or 1 gram dose and not any fraction thereof. ( 2.1 ) 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 ( 2.1 ). 1 gram every 8 hours by intravenous infusion over 15 to 30 minutes for intra-abdominal infections for adult patients. ( 2.1 ) 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.
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 Neuromotor Impairment [see Warnings an...
Interactions
7 DRUG INTERACTIONS Co-administration of Meropenem for Injection with probenecid inhibits renal excretion of meropenem and is therefore not recommended. ( 7.1 ) 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. ( 5.5 , 7.2 ) 7.1 Probenecid Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Coadministration 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 beta-lactams. ( 5.1 ) 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. ( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Meropenem for Injection and Sodium Chloride Injection and initiate appropriate therapy. ( 5.3 ) Seizures and other adverse CNS experiences have been reported during treatment. 4 CONTRAINDICATIONS 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.
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 macaques administered intravenous meropenem during organogenesis at doses up to 3.2 and 2.3 times the maximum recommended human dose based on body surface area comparison, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Meropenem for Injection USP and Sodium Chloride Injection USP in the DUPLEX® Container is a flexible dual chamber single-dose container supplied in two concentrations. The diluent chamber contains approximately 50 mL of 0.9% Sodium Chloride Injection USP. After reconstitution, the delivered doses are equivalent to 500 Anhydrous basis. mg and 1 gram meropenem.
Frequently Asked Questions
What is Meropenem And Sodium Chloride used for?▼
1 INDICATIONS AND USAGE 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). ( 1.1 ) Complicated intra-abdominal infections (adult patients and pediatric patients 3 months of age and older requiring the full adult dose only). ( 1.2 ) Bacterial meningitis (pediatric patients 3 months of age and older requiring the full adult dose only).
What are the side effects of Meropenem And Sodium Chloride?▼
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 Neuromotor Impairment [see Warnings an...
Can I take Meropenem And Sodium Chloride 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 macaques administered intravenous meropenem during organogenesis at doses up to 3.2 and 2.3 times the maximum recommended human dose based on body surface area comparison, respectively.
What are the important warnings for Meropenem And Sodium Chloride?▼
5 WARNINGS AND PRECAUTIONS Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactams. ( 5.1 ) 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. ( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Meropenem for Injection and Sodium Chloride Injection and initiate appropriate therapy. ( 5.3 ) Seizures and other adverse CNS experiences have been reported during treatment. 4 CONTRAINDICATIONS 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.
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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.