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(cefuroxime) for Injection
Tq reduce the development of drug-resistant bacteria and maintain the effectiveness of ZINACEF (cefuroxime) and other antibacterial drugs, ZINACEF (cefuroxime) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Cefuroxime is a semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following chemical structure:
The empirical formula is C16H15N4O8S, representing a molecular weight of 446.4.
ZINACEF (cefuroxime) contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity.
ZINACEF (cefuroxime) in sterile crystalline form is supplied in vials equivalent to 750 mg, 1.5 g, or 7.5 g of cefuroxime as cefuroxime sodium and in ADD-Vantage® vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of ZINACEF (cefuroxime) range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5.
ZINACEF (cefuroxime) is available as a frozen, iso-osmotic, sterile, nonpyrogenic solution with 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Approximately 1.4 g of Dextrose Hydrous, USP has been added to the 750-mg dose to adjust the osmolality. Sodium Citrate Hydrous, USP has been added as a buffer (300 mg and 600 mg to the 750-mg and 1.5-g doses, respectively). ZINACEF (cefuroxime) contains approximately 111 mg (4.8 mEq) and 222 mg (9.7 mEq) of sodium in the 750-mg and 1.5-g doses, respectively. The pH has been adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. Solutions of premixed ZINACEF (cefuroxime) range in color from light yellow to amber. The solution is intended for intravenous (IV) use after thawing to room temperature. The osmolality of the solution is approximately 300 mOsmol/kg, and the pH of thawed solutions ranges from 5 to 7.5.
The plastic container for the frozen solution is fabricated from a specially designed multilayer plastic, PL 2040. Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue, culture toxicity studies.
What are the precautions when taking cefuroxime (Zinacef)?
Before using cefuroxime, tell your doctor or pharmacist if you are allergic to it; or to other cephalosporins; or to penicillins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, stomach/intestinal diseases (e.g., colitis).
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.
Tell your doctor if you are pregnant before using this medication.
This medication passes into breast milk and...
Last reviewed on RxList: 8/17/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Zinacef Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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