Cefuroxime Sodium

Generic Name: cefuroxime sodium

Over-the-Counter (OTC)

Brand Names:

Cefuroxime Sodium

DESCRIPTION Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-[(carbamoyloxy)methyl]-7-[[(Z)-(furan-2-yl) (methoxyimino)acetyl] amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, and it has the following chemical structure: The empirical formula is C 16 H 15 N 4 NaO 8 S, representing a molecular weight of 446.37.

Overview

DESCRIPTION Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-[(carbamoyloxy)methyl]-7-[[(Z)-(furan-2-yl) (methoxyimino)acetyl] amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, and it has the following chemical structure: The empirical formula is C 16 H 15 N 4 NaO 8 S, representing a molecular weight of 446.37.

Uses

INDICATIONS AND USAGE Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes , and Escherichia coli . Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes , Escherichia coli, Klebsiella spp., and Enterobacter spp.

Dosage

DOSAGE AND ADMINISTRATION Dosage Adults The usual adult dosage range for Cefuroxime for Injection is 750 mg to 1.5 grams every 8 hours, usually for 5 to 10 days. In uncomplicated urinary tract infections, skin and skin-structure infections, disseminated gonococcal infections, and uncomplicated pneumonia, a 750-mg dose every 8 hours is recommended. In severe or complicated infections, a 1.5-gram dose every 8 hours is recommended. In bone and joint infections, a 1.5-gram dose every 8 hours is recommended. In clinical trials, surgical intervention was performed when indicated as an adjunct to therapy with Cefuroxime for Injection. A course of oral antibiotics was administered when appropriate following the completion of parenteral administration of Cefuroxime for Injection.

Side Effects

ADVERSE REACTIONS Cefuroxime for Injection is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely. Local Reactions Thrombophlebitis has occurred with IV administration in 1 in 60 patients. Gastrointestinal Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). The onset of pseudomembranous colitis may occur during or after antibacterial treatment (see WARNINGS ). Hypersensitivity Reactions Hypersensitivity reactions have been reported in fewer than 1% of the patients treated with Cefuroxime for Injection and include rash (1 in 125).

Warnings

WARNINGS BEFORE THERAPY WITH CEFUROXIME FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFUROXIME FOR INJECTION OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES. CONTRAINDICATIONS Cefuroxime for Injection is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Pregnancy

Pregnancy Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 6,400 mg/kg/day (6.3 times the recommended maximum human dose based on mg/m 2 ) and rabbits at doses up to 400 mg/kg/day (2.1 times the recommended maximum human dose based on mg/m 2 ) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime. There are, however, no adequate and well-controlled studies in pregnant women.

Storage

Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Frequently Asked Questions

What is Cefuroxime Sodium used for?

INDICATIONS AND USAGE Cefuroxime for Injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections , including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase- producing strains), Streptococcus pyogenes , and Escherichia coli . Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes , Escherichia coli, Klebsiella spp., and Enterobacter spp.

What are the side effects of Cefuroxime Sodium?

ADVERSE REACTIONS Cefuroxime for Injection is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely. Local Reactions Thrombophlebitis has occurred with IV administration in 1 in 60 patients. Gastrointestinal Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). The onset of pseudomembranous colitis may occur during or after antibacterial treatment (see WARNINGS ). Hypersensitivity Reactions Hypersensitivity reactions have been reported in fewer than 1% of the patients treated with Cefuroxime for Injection and include rash (1 in 125).

Can I take Cefuroxime Sodium during pregnancy?

Pregnancy Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 6,400 mg/kg/day (6.3 times the recommended maximum human dose based on mg/m 2 ) and rabbits at doses up to 400 mg/kg/day (2.1 times the recommended maximum human dose based on mg/m 2 ) and have revealed no evidence of impaired fertility or harm to the fetus due to cefuroxime. There are, however, no adequate and well-controlled studies in pregnant women.

What are the important warnings for Cefuroxime Sodium?

WARNINGS BEFORE THERAPY WITH CEFUROXIME FOR INJECTION IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF ALLERGY, PARTICULARLY TO DRUGS. IF AN ALLERGIC REACTION TO CEFUROXIME FOR INJECTION OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE EPINEPHRINE AND OTHER EMERGENCY MEASURES. CONTRAINDICATIONS Cefuroxime for Injection is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.