Cefuroxime Injection

What is Cefuroxime Injection?

• Cefuroxime (Zinacef; Kefurox) is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic used to treat certain infections caused by bacteria including pneumonia and other lower respiratory tract infections; meningitis; gonorrhea; and skin, blood, bone, joint, and urinary tract infections.
• It is also be used before, during, and sometimes for a brief period after surgery in order to prevent the patient from getting an infection.

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What are the uses of this medicine?

Cefuroxime (Zinacef; Kefurox) is used for the treatment of fallowing infections:

• Lower Respiratory Tract Infections, including pneumonia
• Urinary Tract Infections
• Skin and Skin­-Structure Infections
• Septicemia
• Meningitis
• Gonorrhea

As Prophylix:

• The preoperative prophylactic administration of Cefuroxime for Injection, USP may prevent the growth of susceptible disease-causing bacteria and thereby may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures (e.g., vaginal hysterectomy).
• Cefuroxime for Injection, USP should usually be given one-half to 1 hour before the operation.

How does this medicine work?

• Cefuroxime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis.
• Cefuroxime has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.

Cefuroxime has been shown to be active against most isolates of the following bacteria: Gram-negative bacteria:

• Enterobacter spp.
• Escherichia coli
• Klebsiella spp.
• Haemophilus influenzae
• Neisseria meningitidis
• Neisseria gonorrhoeae

Gram-positive bacteria:

• Staphylococcus aureus
• Streptococcus pneumoniae
• Streptococcus pyogenes

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known allergy to the cephalosporin group of antibiotics.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking.

Be sure to mention any of the following:

• amikacin
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• chloramphenicol
• gentamicin
• kanamycin
• neomycin (Neo-Fradin)
• probenecid (Probalan)
• streptomycin
• tobramycin
• oral contraceptives

Is this medicine FDA approved?

• Cefuroxime was patented in 1971, and approved for medical use in 1977.
• In 2020, it was the 325th most commonly prescribed medication in the United States, with more than 800 thousand prescriptions.

How should this medicine be used?

Recommended 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 life-threatening infections or infections due to less susceptible organisms, 1.5 grams every 6 hours may be required.
• In bacterial meningitis, the dosage should not exceed 3 grams every 8 hours.
• The recommended dosage for uncomplicated gonococcal infection is 1.5 grams given intramuscularly as a single dose at 2 different sites together with 1 gram of oral probenecid.
• For preventive use for clean-contaminated or potentially contaminated surgical procedures, a 1.5-gram dose administered intravenously just before surgery (approximately one-half to 1 hour before the initial incision) is recommended. Thereafter, give 750 mg intravenously or intramuscularly every 8 hours when the procedure is prolonged.
• For preventive use during open heart surgery, a 1.5 gram dose administered intravenously at the induction of anesthesia and every 12 hours thereafter for a total of 6 grams is recommended.

Pediatric Patients Above 3 Months of Age:

• Administration of 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours has been successful for most infections susceptible to cefuroxime.
• The higher dosage of 100 mg/kg/day (not to exceed the maximum adult dosage) should be used for the more severe or serious infections.
• In bone and joint infections, 150 mg/kg/day (not to exceed the maximum adult dosage) is recommended in equally divided doses every 8 hours.
• In cases of bacterial meningitis, a larger dosage of Cefuroxime for Injection is recommended, 200 to 240 mg/kg/day intravenously in divided doses every 6 to 8 hours.

Administration:

• Cefuroxime injection comes as a powder to be mixed with liquid to be injected intravenously or intramuscularly.
• Cefuroxime injection is also available as a premixed product to be injected intravenously.
• It is usually given every six or eight hours for five to ten days.
• You may receive cefuroxime injection in a hospital or you may administer the medication at home.
• If you will be receiving cefuroxime injection at home, your healthcare provider will show you how to use the medication.
• Use cefuroxime injection until you finish the prescription, even if you feel better.
• If you stop using cefuroxime injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium.

This medicine is available in fallowing brand namesː

• Zinacef; Kefurox

What side effects can this medication cause?

The most common side effects of this medicine include:

• Cefuroxime for Injection is generally well-tolerated.
• The most common adverse effects have been local reactions following IV administration.

Local Reactions:

• Thrombophlebitis

Gastrointestinal:

• diarrhea, nausea, pseudomembranous colitis

Hypersensitivity Reactions: rash, Pruritus, urticaria, and positive Coombs'test, rare cases of anaphylaxis, drug fever, erythema multiforme, interstitial nephritis, toxic epidermal necrolysis, and Stevens-Johnson syndrome have occurred.

Blood:

• A decrease in hemoglobin and hematocrit, transient eosinophilia.
• Less common reactions seen were transient neutropenia and leukopenia.

Hepatic:

• Transient rise in SGOT and SGPT, alkaline phosphatase, LDH, and bilirubin levels has been noted.

Kidney:

• Elevations in serum creatinine and/or blood urea nitrogen and a decreased creatinine clearance have been observed.

What special precautions should I follow?

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefuroxime for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• The total daily dose of Cefuroxime for Injection should be reduced in patients with transient or persistent renal insufficiency.
• Broad-spectrum antibiotics should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
• Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporins.
• As with other therapeutic regimens used in the treatment of meningitis, mild-to-moderate hearing loss has been reported in a few pediatric patients treated with cefuroxime.
• Cephalosporins may be associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
• Prescribing Cefuroxime for Injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Patients should be counseled that antibacterial drugs, including Cefuroxime for Injection, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefuroxime for Injection or other antibacterial drugs in the future.
• Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
• A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution or with CLINITEST® tablets) but not with enzyme-based tests for glycosuria.
• A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution or with CLINITEST® tablets) but not with enzyme-based tests for glycosuria.
• cefuroxime injection also decreases the effectiveness of some oral contraceptives ('birth control pills). You will need to use another form of birth control while taking this medication. Talk to your doctor about other ways to prevent pregnancy while you are taking this medication.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• convulsions

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below 3 months of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CEFUROXIME SODIUM

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured by:

• HIKMA FARMACÊUTICA (PORTUGAL), S.A.
• Terrugem SNT PORTUGAL

Distributed by:

• Hikma Pharmaceuticals USA Inc.
• Berkeley Heights, NJ

What should I know about storage and disposal of this medication?

• Cefuroxime for Injection, USP in the dry state should be stored at 20° to 25°C (68° to 77°F) and protected from light.

• Dailymed label info on Cefuroxime Injection
• FDA Cefuroxime Injection

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