Primaxin IM

Drug Description

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PRIMAXIN® I.M.
(imipenem and cilastatin) for Injectable Suspension

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

DRUG 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 [5R-[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:

Imipenem Structural Formula Illustration

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:

Cilastatin Sodium Structural Formula Illustration

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.

Brand Name: Primaxin IM
Generic Name: Imipenem and Cilastatin

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Important Safety Information Prescribing Information

ENABLEX is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder:

· having a strong need to go to the bathroom right away (also called "urgency")
· leaks or wetting accidents (also called "urinary incontinence")
· having to go to the bathroom too often (also called "urinary frequency")

IMPORTANT SAFETY INFORMATION

You should not take once-daily ENABLEX if you have certain types of stomach problems, glaucoma, or have trouble emptying your bladder. Side effects of ENBLEX include blurred vision, and more commonly dry mouth, constipation, indigestion, and abdominal pain. Use caution when doing certain activities until you know how ENBALEX affects you.