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To reduce the development of drug-resistant bacteria and maintain the effectiveness of PRIMAXIN I.M. and other antibacterial drugs, PRIMAXIN I.M. should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
For Intramuscular Injection Only
DESCRIPTION
PRIMAXIN I.M. (Imipenem and Cilastatin for Injectable Suspension) is a formulation of imipenem (a thienamycin antibiotic) and cilastatin sodium (the inhibitor of the renal dipeptidase, dehydropeptidase I). PRIMAXIN I.M. is a potent broad spectrum antibacterial agent for intramuscular administration.
Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is [5 R -[5α, 6α (R *)]]-6-(1-hydroxyethyl) -3-[[2-[(iminomethyl) amino] ethyl]thio]-7-oxo-1-azabicyclo [3.2.0] hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water, and slightly soluble in methanol. Its empirical formula is C12H17N3O4S•H2O, and its structural formula is:
Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is [ R -[ R *, S *-(Z)]]-7-[(2-amino-2-carboxyethyl)thio]-2-[[(2,2-dimethylcyclopropyl)carbonyl]amino]-2-heptenoic acid, monosodium salt. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is:
PRIMAXIN I.M. 500 contains 32 mg of sodium (1.4 mEq) and PRIMAXIN I.M. 750 contains 48 mg of sodium (2.1 mEq). Prepared PRIMAXIN I.M. suspensions are white to light tan in color. Variations of color within this range do not affect the potency of the product.
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