Source: FDA, National Drug Code (US) Revision Year: 2021
MERREM IV (meropenem for injection) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It 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 C17H25N3O5Sā3H2O with a molecular weight of 437.52.
Its structural formula is:
MERREM IV is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether.
When re-constituted as instructed, each 1 gram MERREM IV vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg MERREM IV vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [see Dosage and Administration (2.4)].
| Dosage Forms and Strengths |
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Single dose clear glass vials of MERREM IV containing 500 mg or 1 gram (as the trihydrate blended with anhydrous sodium carbonate for re-constitution) of sterile meropenem powder. |
| How Supplied |
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MERREM IV is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. 500 mg Injection Vial (NDC 0069-0313-01) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017 |
| Drug | Countries | |
|---|---|---|
| MERREM | Mexico, New Zealand, United States |
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