Zegen

Cefuroxime (tab: axetil, inj: sodium).

Tablet: Each tablet contains: Cefuroxime (as axetil) 250 mg.
Each film-coated tablet contains: Cefuroxime (as axetil) 500 mg.
Powder for Injection: Each vial contains: Cefuroxime (as sodium) 750 mg.
When reconstituted for intramuscular use, cefuroxime is an opaque off-white suspension. Cefuroxime solution for intravenous use is clear and yellowish.

Pharmacology: Pharmacodynamics: Tablet: Cefuroxime, a semi-synthetic second generation cephalosporin which exerts its bactericidal activity by interfering with the bacterial cell wall synthesis. It binds to specific penicillin-binding proteins responsible for the synthesis of peptidoglycan, a heteropolymeric structure that gives the cell wall its mechanical stability. The final stage of the peptidoglycan synthesis involves the completion of the cross-linking of the terminal glycine residue of the pentaglycine bridge to the fourth residue of the pentapeptide. The transpeptidase that catalyzes this step is inhibited by cephalosporins. As a result, the bacterial cell wall is weakened, the cell swells and then ruptures.
Powder for Injection: Cefuroxime, a semi-synthetic second generation cephalosporin, has antibacterial activity similar to penicillins, carbacephems and cephamycins. Cefuroxime exerts its bactericidal activity by interfering with the synthesis of the bacterial cell wall. It binds to specific penicillin-binding proteins responsible for the synthesis of peptidoglycan, a heteropolymeric structure that gives the cell wall its mechanical stability. The final stage of the peptidoglycan synthesis involves the completion of the cross-linking of the terminal glycine residue of the pentaglycine bridge to the fourth residue of the pentapeptide. The transpeptidase that catalyzes this step is inhibited by cephalosporins. Thus, inhibition of the transpeptidase interrupts peptidoglycan synthesis, causing formation of defective cell walls and osmotically unstable spheroplasts and lysis of the bacteria.
Pharmacokinetics: Tablet: The bioavailability of cefuroxime axetil after oral administration is variable and depends on the formulation used. The tablet/capsule formulations should not, therefore, be substituted with powder for oral suspension formulations on a mg/mg basis.
The bioavailability of cefuroxime axetil is significantly increased from 37% to 52% by coadministration with food.
Average peak serum cefuroxime concentrations of 4.1, 7, or 13.6 mcg/mL are attained approximately 2 to 3 hours after oral administration in adults of a single 250 mg, 500 mg or 1 g dose, respectively. Average serum concentrations after 6 hours are 0.7, 2.2, or 3.4 mcg/mL, respectively. The area under the curve (AUC) of the drug averaged 12.9, 27.4, or 50 mcg-hr/mL, respectively.
Cefuroxime's apparent volume of distribution in healthy adults ranges from 9.3 to 15.8 L per 1.73 m². Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid, and aqueous humor, but only achieves therapeutic concentrations in the cerebrospinal fluid when the meninges are inflamed. Cefuroxime is 33-50% protein-bound.
Cefuroxime readily crosses the placenta and can also be detected in human milk.
In adults, the serum or plasma half-life (t_1/2) after oral administration of cefuroxime axetil ranges from 1.2 to 1.6 hours and about 50% of an administered dose is recovered in the urine within 12 hours.
Following oral administration or cefuroxime axetil, the drug undergoes rapid hydrolysis by nonspecific esterases in the intestinal mucosa and blood to yield the active parent drug cefuroxime, which is released into the systemic circulation.
The axetil moiety of the drug is metabolized to acetaldehyde and acetic acid. Cefuroxime itself is not metabolized and its serum level is much closer to the minimum inhibitory concentration (MIC) of important pathogens than cefuroxime axetil.
Cefuroxime is excreted unchanged primarily in the urine by both glomerular filtration and tubular secretion.
In patients with renal impairment, the serum t_1/2 of the drug is prolonged and generally ranges from 1.9-16.1 hours depending on the degree of renal impairment.
Cefuroxime is removed by hemodialysis and by peritoneal dialysis.
500 mg: Bioequivalence Study: Cefuroxime axetil 500 mg film-coated tablet (Supplier: PT. Darya Varia Laboratoria Tbk, Indonesia).
In a randomized, crossover, two-period, two-sequence design bioequivalence in-house study involving 24 healthy adult male volunteers, the bioequivalence of cefuroxime axetil (Zegen) 500 mg was compared to the reference product (innovator) of cefuroxime axetil 500 mg film-coated tablet. Volunteers were randomly allocated one tablet (fasted) to each treatment sequence and crossed over to the alternate treatment after a one-week washout period.
The following are important pharmacokinetic parameters of cefuroxime axetil in adult volunteers who received cefuroxime axetil (Zegen) and the reference product (innovator) of cefuroxime axetil 500 mg film-coated tablets (as a single oral dose): (See Table 1.)

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The study concluded that cefuroxime axetil (Zegen) 500 mg film-coated tablet by PT. Darya Varia Laboratoria Tbk, Indonesia is bioequivalent with the reference product (innovator) of cefuroxime axetil 500 mg film-coated tablet.
Powder for Injection: In neonates, a single IM administration of cefuroxime 25 mg/kg resulted in cefuroxime serum concentrations averaging 45 μg/mL, 35 μg/mL and 10.5 μg/mL 30 minutes, 3 hours, and 12 hours after injection, respectively.
Cefuroxime's serum half-life is inversely proportional to age in neonates and children. After IM or IV administration, cefuroxime's serum half-life has been reported to be 5.1 to 5.8 hours in neonates 3 days or younger, 2 to 4.2 hours in neonates 6 to 14 days, and 1 to 1.5 hours in neonates 3 to 4 weeks old.
In healthy adults with normal renal function, a single intramuscular (IM) injection of cefuroxime sodium 500-mg, 750-mg, or 1-g dose results in peak serum concentrations of 20.8 to 25.7, 26 to 34.9, and 32 to 40 μg/mL, respectively, attained within 15 to 60 minutes. A single 500- or 750-mg dose given as intravenous (IV) infusion for 30 minutes results in peak serum cefuroxime concentrations averaging 37.8 and 51.1 μg/mL, respectively.
Mean peak serum cefuroxime concentrations and areas under the concentration-time curve (AUC) attained after IM injection is almost similar to those attained after oral administration. Cefuroxime's AUC is proportional to the administered dose and is also similar after IM or IV administration.
Cefuroxime is widely distributed into body tissues and fluids including the kidneys, heart, gallbladder, liver, prostatic adenoma tissue, uterine and ovarian tissue, aqueous humor, saliva, sputum, bronchial secretions, bone, bile, adipose tissue, wound exudates, peritoneal fluid, ascitic fluid, synovial fluid, pericardial fluid, and pleural fluid after IM or IV administration. Therapeutic concentrations of cefuroxime may be attained in cerebrospinal fluid after IV administration in patients with inflamed meninges; however, only low concentrations are attained if the meninges are uninflamed.
Cefuroxime has a protein binding of 33% to 50%.
Cefuroxime readily crosses the placenta. It is also found in amniotic fluid at concentrations averaging 17 to 18.6 μg/mL after a single 750-mg IM dose. Cefuroxime is distributed in breast milk.
Microbiology: Antimicrobial Spectrum of Activity: The in vivo bactericidal activity or cefuroxime axetil is due to the parent compound cefuroxime.
Cefuroxime has demonstrated activity against most strains of the following microorganisms both in vitro and in clinical infections: See Table 2.

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Cefuroxime has also demonstrated in vitro activity against most strains of the following microorganisms; however, clinical significance is unknown: See Table 3.

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Listeria monocytogenes and certain strains of enterococci, e.g., Enterococcus faecalis (formerly Streptococcus faecalis), are resistant to cefuroxime. Methicillin-resistant staphylococci are resistant to cefuroxime.
Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Legionella spp., and most strains of Serratia spp. and Proteus vulgaris are resistant to most first- and second-generation cephalosporins. Some strains of Morganella morganii, Enterobacter cloacae, and Citrobacter spp. have been shown by in vitro tests to be resistant to cefuroxime and other cephalosporins.
Most strains of Clostridium difficile and Bacteroides fragilis are resistant to cefuroxime.

Tablet: For the treatment of the following infections caused by susceptible microorganisms: Upper respiratory tract infections including ear, nose and throat infections such as acute sinusitis, acute otitis media, and tonsillopharyngitis.
Lower respiratory tract infections including: Acute bacterial exacerbations of chronic bronchitis; Secondary bacterial infections of acute bronchitis.
Uncomplicated skin and skin structure infections including furunculosis, pyoderma and impetigo.
Uncomplicated urinary tract infections including pyelonephritis.
Uncomplicated gonorrhea.
Early Lyme disease (erythema migrans).
Step down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral cefuroxime.
Powder for Injection: For the treatment of the following infections caused by susceptible microorganisms: Upper respiratory tract infections including ear, nose and throat infections, such as otitis media, sinusitis, tonsillitis, and pharyngitis.
Lower respiratory tract infections including pneumonia, acute bronchitis and acute exacerbations of chronic bronchitis.
Genitourinary tract infections including pyelonephritis and gonorrhea.
Skin and soft tissue infections including furunculosis, pyoderma and impetigo.
Septicemia.
Meningitis.
Bone and joint infections.
For surgical prophylaxis (e.g., biliary, gastroduodenal, cardiovascular or orthopedic surgery).

Tablet: In general, most infections in adults and adolescents (13 years and older) will respond to 250 mg every 12 hours. However, for more severe infections, 500 mg every 12 hours may be recommended. (See Table 4.)

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Powder for Injection: Cefuroxime sodium may be given intravenously (IV) or by deep intramuscular (IM) injection into a large muscle mass (such as the gluteus or lateral part of the thigh). Before IM injection, aspiration is necessary to avoid inadvertent injection into a blood vessel.
For the treatment of septicemia and other severe, life-threatening infections or in immunocompromised patients, especially when shock is present, IV administration is recommended rather than IM.
Treatment of chronic urinary tract infection requires monitoring of bacteriological and clinical response even after therapy has been completed. Persistent infections may require several weeks of treatment. Doses smaller than recommended should not be used to prevent development of antimicrobial resistance.
In staphylococcal and other infections, surgical drainage should be carried out when indicated.
Usual Adult Dose: 750 mg to 1.5 g every 6 to 8 hours for 2 to 10 days depending on the type and severity of infection. (See Table 5.)

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Usual Pediatric Dose: 50 to 150 mg/kg body weight per day given IV in 3 to 4 divided doses 2 to 10 days depending on the type and severity of infection.
When clinically appropriate, patients may shift to oral antibiotic therapy as recommended by a physician. (See Table 6.)

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For patients with impaired renal function: Dosage should be determined based on the degree of renal impairment and the susceptibility of the causative organism.
For patients with creatinine clearances greater than 20 mL/minute, dose modification may not be necessary. However, in patients with creatinine clearance of 20 mL/minute or less, doses and/or frequency of administration of cefuroxime must be adjusted based on the degree of renal impairment, severity of infection, and susceptibility of the causative organism as deemed necessary by the doctor.
The frequency of administration of parenteral cefuroxime should be modified as shown as follows: See Table 7.

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Continue treatment for a minimum of 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained.

Limited information is available on the acute toxicity of cefuroxime in humans. Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. If acute overdosage occurs, cefuroxime may be removed by hemodialysis or peritoneal dialysis.

Known hypersensitivity to cefuroxime, cephalosporins, penicillins, or any component of the product.

Tablet: Careful inquiry should be made prior to cefuroxime therapy to determine whether the patient has had previous hypersensitivity reactions to cefuroxime, other cephalosporins, penicillins, or other drugs. Use with caution in penicillin-sensitive patients since cross-sensitivity among beta-lactam antibiotics has been clearly documented and may occur in patients with a history of allergy to penicillin. In case of an allergic reaction to cefuroxime, the drug should be discontinued.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, intravenous fluids, corticosteroids, pressor amines, and airway management, as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) and colitis have been reported with the use of nearly all antibacterial agents, including cefuroxime, 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.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
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.
Cefuroxime should not be used in patients with a history of cephalosporin-associated hemolytic anemia since the recurrence of hemolysis is much more severe.
If a patient develops anemia anytime during, or within 2 to 3 weeks subsequent to the administration of cefuroxime, the diagnosis of cephalosporin-associated anemia should be considered and the drug discontinued until the etiology is determined.
Periodic monitoring for signs and symptoms of hemolytic anemia, including measurement of hematological parameters of drug-induced antibody testing is recommended in patients treated with cefuroxime.
As with other broad-spectrum antibacterial agents, cefuroxime should be used with caution in patients with a history of gastrointestinal disease, particularly colitis.
Cephalosporins, including cefuroxime, have been associated with the development of seizures, particularly in patients with renal impairment, in whom dosage of the drug was not reduced. If seizures due to cefuroxime develop, the drug should be discontinued and treatment with an anticonvulsant be given as clinically indicated.
Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
The patient's renal function should be carefully monitored when cefuroxime is given concurrently with aminoglycosides and/or diuretics because adverse renal effects may occur [see Interactions].
The Jarisch-Herxheimer reaction, a transient immunological reaction lasting 1 to 2 days, has been observed following cefuroxime treatment of Lyme disease. Patients should be reassured that this is a common and usually a self-limiting consequence of antibiotic treatment of Lyme disease.
Cefuroxime has been used safely in a few patients with porphyria although data are insufficient and experimental evidence of porphyrinogenicity are conflicting.
Prescribing cefuroxime 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 antibiotic resistance.
As with other antibacterial agents, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.
Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of cefuroxime has not been evaluated in long-term animal studies.
No evidence of mutagenicity was observed with cefuroxime in various in vitro and in vivo test systems, including the mouse lymphoma assay, micronucleus test, and bacterial mutation tests. Cefuroxime produced positive results in the in vitro chromosome aberration assay.
There are no adequate and controlled studies using cefuroxime in pregnant women. Cefuroxime axetil has not been studied for use during labor and delivery. Since cefuroxime is distributed into milk, cefuroxime axetil should be used with caution in breastfeeding women.
Effects on Ability to Drive and Use Machines: Since cefuroxime may cause dizziness, patients should be advised to avoid performing tasks which require complete mental alertness such as driving and operating machinery.
Renal Impairment: The safety and efficacy of oral cefuroxime axetil in patients with renal impairment have not been established. Since cefuroxime is renally eliminated, its half-life will be prolonged in patients with reduced renal function.
Use in Children: The safety and efficacy of cefuroxime axetil in children younger than 3 months old have not been established.
Use in the Elderly: There are no apparent differences in efficacy and safety of cefuroxime between the elderly and younger adults. However, since elderly patients have increased risk of renal impairment, dose adjustment and renal function monitoring may be necessary.
Powder for Injection: A thorough inquiry about the patient's previous hypersensitivity history should be made. Cefuroxime, like other cephalosporins, penicillins and other drugs, may cause serious hypersensitivity reactions and should be used with caution in any patient who has demonstrated some allergy to any drug. Although it has not been established, allergic reactions to antibiotics may occur more frequently in atopic individuals.
Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, intravenous fluids and intravenous antihistamines, corticosteroids, pressor amines, and airway management as clinically indicated.
Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly an antibacterial agents, including cefuroxime, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality. Careful medical history is necessary because CDAD can occur over two months after administration of antibacterial agents. If CDAD is suspected or confirmed, discontinue ongoing antibiotic use not directed against C. difficile. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
General: As with other broad-spectrum antibiotics, cefuroxime should be given with caution in individuals with a history of colitis. The safety and efficacy of cefuroxime have not been established in patients with gastrointestinal malabsorption.
Cephalosporins may be associated with a fall in prothrombin activity. Patients who are at risk are those with kidney or liver impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous Vitamin K administered as indicated.
Prescribing cefuroxime 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 antibiotic resistance.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to date to evaluate the carcinogenic potential of cefuroxime.
No evidence of mutagenicity was observed with cefuroxime in various in vitro and in vivo test systems, including the mouse lymphoma assay, micronucleus test, bacterial mutation tests. Cefuroxime produced positive results in the in vitro chromosome aberration assay.
Reproduction studies in mice and rabbits using cefuroxime sodium in dosages up to 14 and 9 times the usual human dosage, respectively, based on mg/m² have not revealed evidence of impaired fertility.
Use in Children: Cefuroxime's serum half-life is inversely proportional to age when given in children and neonates.

Pregnancy: (Pregnancy Category B) Since there are no adequate and well controlled studies to date using cefuroxime in pregnant women, cefuroxime sodium should only be used during pregnancy when clearly needed and when the benefits justify the potential risks.
Lactation: Cefuroxime is distributed into human milk and should be used with caution in breastfeeding women.

Tablet: The following adverse events have been reported with the use of cefuroxime, although in many instances the causal relationship to the drug has not been established: Dermatologic/Hypersensitivity Reaction: Rash (e.g., morbilliform), hives, erythema, pruritus, urticaria, drug fever, anaphylaxis (very rarely), angioedema, serum sickness-like reaction, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthemic necrolysis), shortness of breath and severe bronchospasm.
Gastrointestinal (GI): Diarrhea or loose stools, nausea, vomiting, abdominal pain/cramps, gagging, epigastric burning, epigastric pain/dyspepsia, flatulence, indigestion, GI bleeding, mouth ulcers, swollen tongue, dislike of taste, stomach cramps, anorexia, thirst, GI infection, ptyalism, pseudomembranous colitis.
Genitourinary: Urethral pain or bleeding, kidney pain, urinary tract infection, dysuria, acute renal failure/dysfunction, interstitial nephritis, transient increases in blood urea nitrogen (BUN) and serum creatinine concentrations; decreased creatinine clearance; bilateral renal cortical necrosis, vaginitis, vaginal candidiasis, vulvovaginal pruritus, vaginal discharge or irritation, menstrual irregularities.
Hematologic: Eosinophilia, neutropenia, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, thrombocytosis, lymphocytosis; increased prothrombin time; increased erythrocyte sedimentation rate, decreased hemoglobin and/or hematocrit, positive Coombs' test.
Hepatic: Transient elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase, alkaline phosphatase, lactate dehydrogenase (LDH), and bilirubin; jaundice, hepatic impairment including hepatitis and cholestasis, decreased serum albumin and/or total protein.
Musculoskeletal: Muscle spasm of the neck, muscle cramps or stiffness, arthralgia/joint pain or swelling.
Nervous System: Headache, dizziness, somnolence/sleepiness, irritable behavior, seizures, myoclonic jerks, generalized hyperexcitability/hyperactivity.
Respiratory: Pleural effusion, pulmonary infiltrate, dyspnea or respiratory distress, upper respiratory infection, rhinitis, sinusitis, cough.
Cardiovascular: Chest pain or tightness, tachycardia.
Other Adverse Effects: Jarisch-Herxheimer reaction in patients treated for Lyme disease, candidiasis/candida overgrowth, mild to severe hearing loss, increased or decreased serum glucose concentration, lockjaw-type reaction, viral illness.
Powder for Injection: Dermatologic and Hypersensitivity Reactions: Rash (e.g., morbilliform), fever, pruritus, erythema, urticaria, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, serum sickness-like reactions, angioedema, and anaphylaxis.
Gastrointestinal Effects: Nausea, vomiting, diarrhea or loose stools, strong, persistent, bitter taste; gagging, burning epigastric pain, gastrointestinal bleeding; flatulence; gastrointestinal infection; ptyalism; indigestion; mouth ulcers; swollen tongue; anorexia; thirst; dyspepsia, and stomach cramps.
Hematologic Effects: Decreased hematocrit and hemoglobin concentration; transient eosinophilia and neutropenia; pancytopenia; thrombocytopenia; leucopenia; thrombocytosis; lymphocytosis; hemolytic anemia, and increased prothrombin time.
Central Nervous System Effects: Headache, dizziness, somnolence or sleepiness; hyperactivity, irritable behavior, seizures, myoclonic jerks, and generalized hyperexcitability.
Hepatic Effects: Jaundice; transient increases in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, lactate dehydrogenase (LDH), and bilirubin concentrations.
Renal and Genitourinary Effects: Acute renal failure and interstitial nephritis have been reported rarely in patients receiving cefuroxime.
Bilateral renal cortical necrosis that appeared to be a hypersensitivity reaction has occurred in one patient receiving oral cefuroxime. Urinary tract infection, kidney pain, urethral pain or bleeding, dysuria; vaginitis, vaginal candidiasis; vulvovaginal pruritus, and vaginal discharge or irritation have also been reported with oral cefuroxime.
Other Effects: Jarisch-Herxheimer reaction has occurred in patients receiving oral cefuroxime for the treatment of Lyme disease. Mild to severe hearing loss has been reported in a few pediatric patients receiving cefuroxime. Muscle spasm of the neck, muscle cramps or stiffness, chest pain or tightness, shortness of breath, upper respiratory infection, sinusitis, fever, cough, lockjaw-type reaction, viral illness, tachycardia, chills, sinusitis, fever, cough, joint swelling, and arthralgia have been reported in less than 1% of patients receiving oral cefuroxime. Diaper rash has been reported in 3.4% of pediatric patients receiving oral cefuroxime.

Aminoglycosides: The risk of nephrotoxicity may increase when aminoglycosides and cephalosporins are given concomitantly. This has not been reported with cefuroxime use to date. Monitoring of the patient's renal function is advisable when these drugs are given together.
Probenecid: Probenecid, given together with or right before administration of cefuroxime, slows down tubular secretion of cefuroxime and produces higher and more prolonged serum cefuroxime concentrations. This drug interaction is usually used beneficially in treating gonorrhea.
Tablet: Diuretics: Studies suggest that the concomitant use of potent diuretics, including furosemide and ethacrynic acid, may increase the risk of renal toxicity with cephalosporins.
Oral Antacids: These drugs may result in lower bioavailability of cefuroxime compared with that of the fasting state and tend to cancel the effect of enhanced postprandial absorption.
Oral Contraceptives: As with other antibacterial agents, cefuroxime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives.
Powder for Injection: Other Drugs: The patient's renal function should be carefully monitored when cefuroxime is given concurrently with diuretics because adverse renal effects may occur.
Interference with Laboratory Tests: 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 (e.g., Clinistix, Tes-Tape).
As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime.
The presence of cefuroxime does not interfere with the assay of serum and urine creatinine by the alkaline picrate method.
Positive direct antiglobulin (Coombs') test results have also been reported in a few patients receiving oral cefuroxime; however, it is not clear whether the mechanism of this reaction is immunologic in nature. This phenomenon can interfere with cross matching of blood.
Powder for Injection: Transient increases in blood urea nitrogen (BUN) and/or serum creatinine concentrations and decreased creatinine clearance have been reported with cefuroxime use, although causal relationship has not been established.

Powder for Injection: Directions for Reconstitution and Parenteral Administration: See Table 8.

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Compatibility, Storage and Stability: When reconstituted as directed with Sterile Water for Injection, cefuroxime suspension for IM injection maintains satisfactory potency for 24 hours at room temperature and for 48 hours under refrigeration (5°C). Discard any unused suspension after the previously-mentioned storage periods.
After reconstitution with Sterile Water for Injection, cefuroxime sodium solutions containing 90 to 100 mg cefuroxime per mL or suspensions containing 200 to 220 mg cefuroxime per mL are stable for 24 hours at room temperature and for 48 hours under refrigeration (5°C). More dilute solutions such as 750 mg or 1.5 g dissolved in 100 mL of Sterile Water for Injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection, also maintain satisfactory potency for 24 hours at room temperature or for 7 days under refrigeration (5°C).
These solutions may be further diluted to 1-30 mg cefuroxime per mL in the following intravenous solutions and will be stable for 24 hours at room temperature or for 7 days under refrigeration: 0.9% Sodium Chloride Injection; 5% Dextrose and 0.9% Sodium Chloride Injection; 1/6 M Sodium Lactate Injection; 5% Dextrose and 0.45% Sodium Chloride Injection; Ringer's Solution, USP; 5% Dextrose Injection; Lactated Ringer's Solution, USP; 10% Dextrose Injection; 5% Dextrose and 0.2% Sodium Chloride Injection; 10% Invert Sugar in Water for Injection.
The compatibility of aminoglycosides and cefuroxime sodium depends on several factors such as concentrations of the drugs, specific diluents used, resulting pH, and temperature. If these drugs are to be given concomitantly, it is advised that the drugs be administered at separate infusion sites.
Inspect parenteral drug products visually for particulate matter and discoloration before administration whenever solution and container permit. Like other cephalosporins, cefuroxime powder as well as solutions and suspensions tend to darken, depending on storage conditions, without adversely affecting product potency.

Tablet: Store in a cool, dry and dark place at temperatures not exceeding 30°C.
Powder for Injection: Store at temperatures not exceeding 30°C.

Cephalosporins

J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.

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