Cefuroxime

Before taking cefuroxime,

• tell your doctor and pharmacist if you are allergic to cefuroxime; other cephalosporin antibiotics such as cefaclor , cefadroxil , , cefazolin (Ancef, Kefzol), cefdinir , cefditoren (Spectracef), cefepime (Maxipime), cefixime, , cefotaxime (Claforan), cefotetan, cefoxitin (Mefoxin), cefpodoxime , cefprozil , ceftaroline (Teflaro), ceftazidime ( Fortaz, Tazicef, in Avycaz), ceftibuten (Cedax), ceftriaxone (Rocephin), and cephalexin (Keflex); penicillin antibiotics; or any other medications. Also tell your doctor if you are allergic to any of the ingredients in cefuroxime tablets or suspension. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven), cimetidine, diuretics ('water pills'), famotidine (Pepcid), nizatidine (Axid), omeprazole (Prilosec, in Zegerid), pantoprazole(Protonix), probenecid (Probalan) and ranitidine (Zantac). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids that contain magnesium or aluminum, take them at least 1 hour before or 2 hours after cefuroxime.
• tell your doctor if you have or have ever had gastrointestinal disease (GI; affecting the stomach or intestines), especially colitis (condition that causes swelling in the lining of the colon [large intestine]), or kidney or liver disease.
• you should know that cefuroxime 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.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking cefuroxime, call your doctor.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that cefuroxime suspension is sweetened with aspartame that forms phenylalanine.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to cefuroxime.

If you are diabetic and test your urine for sugar, use Clinistix or TesTape (not Clinitest) to test your urine while taking this medication. If you test your blood for sugar, check with your doctor or pharmacist to recommend the best product to use while taking this medication.

Do not let anyone else take your medication. Your prescription is probably not refillable.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Ceftin^®

Cefuroxime is part of the drug class:

• Second generation cephalosporins

Before taking cefuroxime, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to cefuroxime or to any of its ingredients
• have or have had kidney disease
• have liver problems
• have gastrointestinal disease, especially colitis
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Oral:

• Store cefuroxime tablets and suspension at room temperature. The suspension may be stored in the refrigerator, if preferred.
• Keep this and all medicines out of the reach of children.

Injectable:

• Store cefuroxime for intravenous injection in the refrigerator or freezer.
• Keep this and all medicines out of the reach of children.

Acute bacterial maxillary sinusitis (tablets and oral suspension only): Treatment of mild to moderate acute bacterial maxillary sinusitis in adults and pediatric patients ≥3 months caused by Streptococcus pneumoniae, Haemophilus influenzae (non-beta-lactamase-producing strains only).

Limitations of use: Effectiveness for sinus infections caused by beta-lactamase–producing H. influenzae or M. catarrhalis in patients with acute bacterial maxillary sinusitis has not been established. Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefuroxime is no longer recommended as monotherapy for initial empiric treatment (Chow 2012).

Acute bacterial exacerbations of chronic bronchitis (tablets only): Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis s in adults and adolescents ≥13 years caused by S. pneumoniae, H. influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).

Acute otitis media (tablets and oral suspension only): Treatment of pediatric patients ≥3 months with acute bacterial otitis media caused by S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.

Bone and joint infections (injection only): Treatment of bone and joint infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).

Lower respiratory tract infections (injection only): Treatment of lower respiratory tract infections, including pneumonia, caused by S. pneumoniae, H. influenzae (including ampicillin-resistant strains), Klebsiella spp., S. aureus (penicillinase- and non-penicillinase-producing strains), S. pyogenes, and Escherichia coli.

Lyme disease (early) (tablets only): Treatment of adults and adolescents ≥13 years with early Lyme disease caused by Borrelia burgdorferi.

Pharyngitis/tonsillitis (tablets and oral suspension only): Treatment of mild to moderate pharyngitis/tonsillitis caused by S. pyogenes in adults and pediatric patients ≥3 months

Limitations of use: The efficacy in the prevention of rheumatic fever has not been established in clinical trials. Efficacy in the treatment of penicillin-resistant strains of S. pyogenes has not been demonstrated.

Septicemia (injection only): Treatment of septicemia caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pneumoniae, E. coli, H. influenzae (including ampicillin-resistant strains), and Klebsiella spp.

Skin and skin structure infection (impetigo) (oral suspension only): Treatment of pediatric patients 3 months to 12 years of age with skin or skin structure infections (impetigo) caused by S. aureus (including beta-lactamase-producing strains) or S. pyogenes.

Skin and skin structure infection (injection; tablets [uncomplicated infections only]): Treatment of adults and pediatric patients >3 months with skin and skin-structure infections (including impetigo) caused by S. aureus (penicillinase- and non-penicillinase-producing strains), S. pyogenes, E. coli, Klebsiella spp., and Enterobacter spp.

Surgical (perioperative) prophylaxis (injection only): Prophylaxis of infection in patients undergoing surgical procedures (eg, vaginal hysterectomy) that are classified as clean-contaminated or potentially contaminated procedures.

Urinary tract infections (tablets and injection only): Treatment of adults and pediatric patients >3 months with urinary tract infections caused by E. coli and Klebsiella spp.

Oral:

Manufacturer’s labeling:

Adults:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl 10 to <30 mL/minute: Administer recommended dose based on indication every 24 hours

CrCl <10 mL/minute: Administer recommended dose based on indication every 48 hours

ESRD requiring intermittent hemodialysis (IHD): Additional recommended dose based on indication should be given at the end of each dialysis session.

Pediatric: There are no dosage adjustments provided in the manufacturer’s labeling; however, the following adjustments have been reported in the literature (Aronoff 2007): Note: Renally adjusted dose recommendations are based on doses of 30 mg/kg/day divided every 12 hours:

CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl 10 to 29 mL/minute/1.73 m2: 15 mg/kg/dose every 12 hours.

CrCl <10 mL/minute/1.73 m2: 15 mg/kg/dose every 24 hours.

Hemodialysis: Dialyzable: 15 mg/kg/dose every 24 hours

Peritoneal dialysis: 15 mg/kg/dose every 24 hours

IV:

Manufacturer’s labeling:

Adults:

CrCl >20 mL/minute: No dosage adjustment necessary.

CrCl 10 to 20 mL/minute: Administer recommended dose based on indication every 12 hours

CrCl <10 mL/minute: Administer recommended dose based on indication every 24 hours

Hemodialysis: Administer additional recommended dose based on indication at the end of dialysis

Infants >3 months, Children, and Adolescents: Administer recommended dose based on indication but decrease frequency similar to the adult recommendations.

Alternate dosing (Aronoff 2007):

Peritoneal dialysis:

Adults: Administer full dose every 24 hours

Children: 25 to 50 mg/kg dose every 24 hours

Continuous renal replacement therapy (CRRT):

Adults: 1 g every 12 hours

Children: 25 to 50 mg/kg every 8 hours

Applies to cefuroxime: injectable powder for injection, intravenous solution, oral powder for reconstitution, oral tablet

General

Cefuroxime was generally well tolerated. The side effects most commonly reported with the parenteral formulation have included neutropenia, eosinophilia, transient liver enzyme/bilirubin elevations, and injection site reactions. The side effects most commonly reported with the oral formulations have included Candida overgrowth, eosinophilia, headache, dizziness, gastrointestinal disturbances, and transient liver enzyme elevations.[Ref]

Side effects may be more likely and more severe in patients with liver disease and/or renal dysfunction.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea/loose stools, nausea/vomiting, abdominal pain, nausea
Uncommon (0.1% to 1%): Abdominal cramps, flatulence, indigestion, mouth ulcers, swollen tongue, dyspepsia, gastrointestinal (GI) infection, ptyalism/excess salivation, GI disturbance, vomiting
Frequency not reported: Abdominal discomfort, dry mouth, Clostridium difficile-associated diarrhea
Postmarketing reports: GI disturbances (including diarrhea, nausea, vomiting, abdominal pain), pseudomembranous colitis

Cephalosporin-class:
-Frequency not reported: Vomiting, abdominal pain, colitis[Ref]

The onset of pseudomembranous colitis symptoms has been reported during or after antibacterial therapy.[Ref]

Hepatic

Common (1% to 10%): Transient increase in AST, transient increase in ALT, transient increase in liver enzyme levels
Uncommon (0.1% to 1%): Transient increase in bilirubin
Postmarketing reports: Hepatic dysfunction, hepatitis, cholestasis, jaundice (mainly cholestatic)

Cephalosporin-class:
-Frequency not reported: Hepatic dysfunction (including cholestasis)[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Sleepiness, somnolence, hyperactivity
Postmarketing reports: Seizures, encephalopathy[Ref]

Cephalosporin-class antibiotics (including this drug) have been associated with seizures, especially in patients with renal dysfunction when the dose was not reduced.[Ref]

Hypersensitivity

Delayed hypersensitivity reaction to this drug has been reported in 2.9% of patients with history of delayed hypersensitivity to penicillin (but not a cephalosporin).

Rare cases of severe hypersensitivity reactions (including erythema multiforme, toxic epidermal necrolysis [exanthematic necrolysis], drug fever, serum sickness-like reaction, anaphylaxis, Stevens-Johnson syndrome) have been reported.[Ref]

Common (1% to 10%): Delayed hypersensitivity reaction
Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, pruritus, urticaria)
Rare (0.01% to 0.1%): Severe hypersensitivity reactions
Frequency not reported: Serum sickness
Postmarketing reports: Anaphylaxis, serum sickness-like reaction[Ref]

Hematologic

Profound leukopenia has sometimes been profound with oral therapy.[Ref]

Common (1% to 10%): Eosinophilia, decreased hemoglobin and hematocrit, neutropenia, decreased hemoglobin concentration
Uncommon (0.1% to 1%): Positive Coombs test, leukopenia, thrombocytopenia
Frequency not reported: Autoimmune granulocytopenia, increased coagulation time
Postmarketing reports: Hemolytic anemia, pancytopenia, increased prothrombin time

Cephalosporin-class:
-Frequency not reported: Aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, pancytopenia, agranulocytosis[Ref]

Renal

Acute renal failure has been reported. Renal function improved after this drug was stopped, and deteriorated upon rechallenge.[Ref]

Frequency not reported: Increased BUN, increased creatinine, decreased CrCl, acute renal failure
Postmarketing reports: Renal dysfunction, interstitial nephritis (including reversible fever, azotemia, pyuria, eosinophilia)

Cephalosporin-class:
-Frequency not reported: Toxic nephropathy[Ref]

Genitourinary

Common (1% to 10%): Vaginitis
Uncommon (0.1% to 1%): Vulvar itch, dysuria, vaginal candidiasis, vaginal discharge, vaginal itch, urethral pain/bleeding, kidney pain, urinary tract infection, vaginal irritation

Cephalosporin-class:
-Frequency not reported: Vaginitis (including vaginal candidiasis)[Ref]

Dermatologic

A case of occupational contact dermatitis due to cephalosporin allergy has been reported in a nurse who prepared cephalosporin solutions for administration to patients. The dermatitis resolved after the nurse stopped preparing the solutions.[Ref]

Common (1% to 10%): Diaper/nappy rash
Uncommon (0.1% to 1%): Rash, urticaria/hives, pruritus, erythema
Rare (0.01% to 0.1%): Erythema multiforme, toxic epidermal necrolysis (exanthematic necrolysis), Stevens-Johnson syndrome
Frequency not reported: Acute generalized exanthematous pustulosis
Postmarketing reports: Angioedema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, cutaneous vasculitis[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Cephalosporin-class:
-Frequency not reported: Urine glucose false positive[Ref]

Other

Common (1% to 10%): Transient increase in LDH, transient increase in alkaline phosphatase, Candida overgrowth, dislike of taste
Uncommon (0.1% to 1%): Chest pain/tightness, chills, thirst, viral illness, candidiasis, fever
Rare (0.01% to 0.1%): Drug fever
Frequency not reported: Clostridium difficile overgrowth, disulfiram reaction[Ref]

Respiratory

Uncommon (0.1% to 1%): Shortness of breath, sinusitis, cough, upper respiratory infection[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle cramps, muscle stiffness, muscle spasm of the neck, lockjaw-type reaction, joint swelling, arthralgia[Ref]

Cardiovascular

A 90-year-old man, with no history of coronary artery disease, diabetes mellitus, hypertension, or hyperlipidemia, was administered 750 mg cefuroxime axetil IM for urinary tract infection. About 10 minutes after the injection, the patient developed chest pain and pruritic skin rashes. Kounis syndrome type I variant was diagnosed secondary to the drug. Five days after stopping the drug, the patient's symptoms had resolved.[Ref]

Uncommon (0.1% to 1%): Tachycardia
Frequency not reported: Kounis syndrome type I variant[Ref]

Local

Common (1% to 10%): Injection site reactions (including pain, thrombophlebitis), thrombophlebitis with IV administration
Frequency not reported: Pain at IM injection site[Ref]

Immunologic

Common (1% to 10%): Jarisch-Herxheimer reaction[Ref]

Psychiatric

Uncommon (0.1% to 1%): Irritable behavior

Some side effects of cefuroxime may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Tablets: 250 mg orally every 12 hours for 10 days

Comments:
-Efficacy for sinus infections due to beta-lactamase-producing H influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis not established in clinical trials.

Use: For the treatment of mild to moderate acute bacterial maxillary sinusitis due to S pneumoniae or H influenzae (non-beta-lactamase-producing strains only)

Oral (tablets):
13 years or older: 250 mg orally every 12 hours for 7 to 10 days

Parenteral:
3 months or older: 50 to 100 mg/kg/day IV or IM in equally divided doses every 6 to 8 hours
-Maximum dose: 1.5 g/dose

Uses:
-Oral: For the treatment of uncomplicated urinary tract infections due to E coli or K pneumoniae
-Parenteral: For the treatment of urinary tract infections due to E coli and Klebsiella species

13 years or older:
-Tablets: 500 mg orally every 12 hours for 20 days

Use: For the treatment of early Lyme disease (erythema migrans) due to B burgdorferi

IDSA Recommendations for Children: 15 mg/kg orally twice a day
-Maximum dose: 500 mg/dose

Duration of therapy:
-Erythema migrans: 14 to 21 days
-Lyme arthritis: 28 days
-Acrodermatitis chronica atrophicans: 21 days

Comments:
-Recommended for the treatment of early localized or early disseminated Lyme disease associated with erythema migrans when specific neurologic symptoms or advanced atrioventricular heart block absent, uncomplicated Lyme arthritis in patients without clinical evidence of neurologic disease, and acrodermatitis chronica atrophicans
-Current guidelines should be consulted for additional information.

3 months to 12 years:
-Oral suspension: 15 mg/kg orally twice a day for 10 days
---Maximum dose: 1000 mg/day

Uses: For the treatment of impetigo due to S aureus (including beta-lactamase-producing strains) or S pyogenes

13 years or older:
-Tablets: 1 g orally as a single dose

Comments:
-The patient's sexual partner(s) should also be evaluated/treated.
-Due to inferior efficacy and less favorable pharmacodynamics, most oral cephalosporins (including this drug) are not recommended by the US CDC for the treatment of uncomplicated gonococcal infections.
-Current guidelines should be consulted for additional information.

Uses: For the treatment of uncomplicated endocervical and urethral gonorrhea due to N gonorrhoeae (penicillinase- and non-penicillinase-producing strains); for the treatment of uncomplicated rectal gonorrhea in females due to N gonorrhoeae (non-penicillinase-producing strains)

Data not available