Label: MEROPENEM injection
- NDC Code(s): 51810-502-01, 51810-502-02, 51810-503-01, 51810-503-02
- Packager: Qilu Antibiotics Pharmaceutical Co., Ltd.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 14, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use MEROPENEM FOR INJECTION safely and effectively. See full prescribing information for MEROPENEM FOR INJECTION - MEROPENEM for ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only) Meropenen for injection is indicated for the treatment of complicated ...
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2 DOSAGE AND ADMINISTRATION2.1 Adult Patients - The recommended dose of meropenen for injection is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal ...
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3 DOSAGE FORMS AND STRENGTHSSingle dose clear glass vials of Meropenen for Injection, USP containing 500 mg or 1 gram (as the trihydrate blended with anhydrous sodium carbonate for re-constitution) of sterile meropenem ...
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4 CONTRAINDICATIONSMeropenen 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 ...
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5 WARNINGS AND PRECAUTIONS5.1 Hypersensitivity Reactions - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. These reactions are more ...
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6 ADVERSE REACTIONSThe 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 ...
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7 DRUG INTERACTIONS7.1 Probenecid - Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem. Co-administration of probenecid with meropenem is not ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEIn mice and rats, large intravenous doses of meropenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities. Intentional overdosing of meropenem is ...
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11 DESCRIPTIONMeropenem for Injection, USP (meropenem for injection) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3 ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Meropenem is an antibacterial drug [see Microbiology (12.4)]. 12.2 Pharmacodynamics - The percentage of time of a dosing interval that unbound plasma concentration of ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis: Carcinogenesis studies have not been performed. Mutagenesis: Genetic toxicity studies were performed with ...
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14 CLINICAL STUDIES14.1 Complicated Skin and Skin Structure Infections - Adult patients with complicated skin and skin structure infections including complicated cellulitis, complex abscesses, perirectal abscesses ...
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15 REFERENCES1. Cockcroft DW, MH Gault, 1976, Prediction of creatinine clearance from serum creatinine, Nephron, 16:31–41. 2. Kawamura S, AW Russell, SJ Freeman, and RA Siddall, 1992, Reproductive and ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGMeropenem for Injection, USP is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry ...
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17 PATIENT COUNSELING INFORMATION•Counsel patients that antibacterial drugs including meropenem for injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold) ...
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SPL UNCLASSIFIED SECTIONManufactured by: Qilu Antibiotics Pharmaceutical Co., Ltd. Jinan, 250105, China
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PRINCIPAL DISPLAY PANEL - 1 g Vial LabelNDC 51810-503-01 - Meropenem for Injection, USP - 1 g/vial meropenem equivalent - For Intravenous Use only - Contents are Sterile Single-Dose Vial - Rx Only
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PRINCIPAL DISPLAY PANEL - 1 g Vial CartonDC 51810-503-02 - Meropenem for Injection, USP - 1 g/vial meropenem equivalent - For Intravenous Use only - 10 × 1 g Single-Dose Vials - Rx Only
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PRINCIPAL DISPLAY PANEL - 500 mg Vial LabelNDC 51810-502-01 - Meropenem for Injection, USP - 500 mg/vial meropenem equivalent - For Intravenous Use only - Contents are Sterile Single-Dose Vial - Rx Only
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PRINCIPAL DISPLAY PANEL - 500 mg Vial CartonDC 51810-502-02 - Meropenem for Injection, USP - 500 mg/vial meropenem equivalent - For Intravenous Use only - 10 × 500 mg Single-Dose Vials - Rx Only
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INGREDIENTS AND APPEARANCEProduct Information