CIMEX Cefuroxime Axetil 500mg Film-Coated Tablet 50's
RXDRUG-DRP-1908-01
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
FC tablet: Treatment of the following infections cause by sensitive bacteria: Lower respiratory tract infections eg, acute bronchitis, acute exacerbation of acute bronchitis and pneumonia; upper respiratory tract infection eg, ear, nose, throat infections eg, otitis media, sinusitis, tonsillitis or pharyngitis; peritonitis; uncomplicated genitourinary tract infections eg, pyelonephritis, cystitis and urethritis; gonorrhea eg, acute uncomplicated gonorrhea, urethritis and cervicitis; skin infections eg, furunculosis, pyodema and impetigo; bone and joint infections; urinary tract infection; meningitis.
Treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children >12 years.
Oral suspension: Treatment of susceptible infections including those bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis, otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft tissue infections) and urinary tract infection. Prophylaxis for surgical infection.
Treatment of early Lyme disease and subsequent prevention of late Lyme disease in adults and children >12 years.
Oral suspension: Treatment of susceptible infections including those bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis, otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft tissue infections) and urinary tract infection. Prophylaxis for surgical infection.
Dosage/Direction for Use
FC tablet: Adults: Pharyngitis/Tonsillitis, Acute Sinusitis: 250-500 mg twice a day.
Acute Exacerbation of Chronic Bronchitis/Acute Bronchitis, Skin Infections: 250-500 mg twice daily.
Uncomplicated Gonorrhea: Single dose of 1 g is recommended.
Uncomplicated Urinary Tract Infection: 125 or 250-500 mg twice daily.
Oral suspension 125 mg/5 mL: Adults: 5-20 mL (1-4 tsp) twice daily.
Children >2 years: 10 mL (2 tsp) or 15 mg/kg body weight twice daily. Maximum Dose: 20 mL daily; >3 months: 5 mL (1 tsp) or 10 mg/kg body weight twice daily. Maximum Dose: 10 mL (2 tsp) daily.
Oral suspension 250 mg/5 mL: Adults: 5-10 mL (1-2 tsp) twice daily.
Children >2 years: 5 mL (1 tsp) or 15 mg/kg body weight twice daily. Maximum Dose: 10 mL (2 tsp) daily; >3 months: 2.5 mL (½ tsp) or 10 mg/kg body weight twice daily. Maximum Dose: 5 mL (1 tsp) daily.
Acute Exacerbation of Chronic Bronchitis/Acute Bronchitis, Skin Infections: 250-500 mg twice daily.
Uncomplicated Gonorrhea: Single dose of 1 g is recommended.
Uncomplicated Urinary Tract Infection: 125 or 250-500 mg twice daily.
Oral suspension 125 mg/5 mL: Adults: 5-20 mL (1-4 tsp) twice daily.
Children >2 years: 10 mL (2 tsp) or 15 mg/kg body weight twice daily. Maximum Dose: 20 mL daily; >3 months: 5 mL (1 tsp) or 10 mg/kg body weight twice daily. Maximum Dose: 10 mL (2 tsp) daily.
Oral suspension 250 mg/5 mL: Adults: 5-10 mL (1-2 tsp) twice daily.
Children >2 years: 5 mL (1 tsp) or 15 mg/kg body weight twice daily. Maximum Dose: 10 mL (2 tsp) daily; >3 months: 2.5 mL (½ tsp) or 10 mg/kg body weight twice daily. Maximum Dose: 5 mL (1 tsp) daily.
Overdosage
FC tablet: Can cause cerebral irritation leading to convulsion. Serum levels can be reduced by haemodialysis and peritoneal dialysis.
Administration
FC tab: May be taken with or without food. Powd for oral susp: Should be taken with food.
Contraindications
Hypersensitivity to cephalosporins or with cefuroxime itself.
Special Precautions
FC tablet: Cefuroxime axetil may be given safely to patients who are hypersensitive to penicillins. Special care is indicated in patients who have experienced anaphylactoid reactions with penicillin. Prolonged use of cefuroxime may result in overgrowth of susceptible organism. There is no evidence of embryogenic and teratogenic effect due to cefuroxime axetil. Should be administered with caution in pregnancy especially during the early period. Cefuroxime is excreted in milk. A Jarisch Herxheimer reaction has been reported following administration of cefuroxime in Lyme disease. Pseudomembranous colitis has been reported with cefuroxime. A false positive reaction for glucose in the urine may occur with copper reductive tests (Benedict's test). It is recommended that either the glucose oxidase or hexokinase methods be used to determine blood/plasma glucose level. Should be given with caution to patients receiving concurrent treatment with potent diuretics.
Oral suspension: Care is also necessary in patients with history of allergy.
Cefuroxime should be given in cautions to patients with renal impairment; a dosage reduction may be necessary. Renal hematological status should be monitored especially during prolonged and high-dose therapy.
Oral suspension: Care is also necessary in patients with history of allergy.
Cefuroxime should be given in cautions to patients with renal impairment; a dosage reduction may be necessary. Renal hematological status should be monitored especially during prolonged and high-dose therapy.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 3200 mg/kg/day (23 times the recommended maximum human dose based on mg/m3) and have revealed no evidence of harm to the fetus due to cefuroxime axetil. 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.
As safety in human pregnancy has not been established, cefuroxime should not be administered to pregnant women or women of childbearing potential unless therapeutic benefit is considered to exceed the possible risk.
Use in Lactation: Because cefuroxime axetil is excreted in human milk, consideration should be given in discontinuing nursing temporarily during drug treatment with cefuroxime axetil.
As cefuroxime is excreted in human milk, caution is required when Cimex is administered to a nursing mother.
As safety in human pregnancy has not been established, cefuroxime should not be administered to pregnant women or women of childbearing potential unless therapeutic benefit is considered to exceed the possible risk.
Use in Lactation: Because cefuroxime axetil is excreted in human milk, consideration should be given in discontinuing nursing temporarily during drug treatment with cefuroxime axetil.
As cefuroxime is excreted in human milk, caution is required when Cimex is administered to a nursing mother.
Adverse Reactions
FC tablet: These are usually mild in nature. Gastrointestinal disturbance including diarrhea, nausea and vomiting, and headache have been reported. Eosinophilia and transient increase of hepatic enzymes (SGPT, OT and LIH) have also been reported. Jaundice and Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, serum sickness-like reactions, anaphylaxis and angioedema have been reported rarely.
Oral suspension: Gastrointestinal disturbances including diarrhea, nausea and vomiting have occurred in some patients taking cefuroxime. There have been reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal syndrome.
Oral suspension: Gastrointestinal disturbances including diarrhea, nausea and vomiting have occurred in some patients taking cefuroxime. There have been reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal syndrome.
Drug Interactions
Cefuroxime axetil is not bioequivalent and is therefore not substitutable on a mg/mg basis. Before therapy with cefuroxime axetil is instituted, careful inquiry should be made to determine whether the patients has had previous hypersensitivity reactions to cefuroxime axetil, other cephalosporins, penicillin or other drugs. If Cimex is to be given to penicillin-sensitive patients, caution should be exercised because cross-hypersensitivity among β-lactam antibiotics have been clearly documented and may occur up to 10% of patients with history of penicillin allergy. If a clinically significant allergic reaction to cefuroxime axetil occurs, discontinue the drug and institute appropriate therapy, serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, IV fluids, and IV antihistamines, corticosteroids, pressor amines and airway management as clinically indicated.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefuroxime and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea, subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth or clostridia. Studies indicate that a toxin by Clostridium difficile is 1 primary cause of antibiotic-associated colitis.
After diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given in the management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against Clostridium difficile.
Suspension: Probenecid reduces the renal clearance of cefuroxime.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefuroxime and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea, subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth or clostridia. Studies indicate that a toxin by Clostridium difficile is 1 primary cause of antibiotic-associated colitis.
After diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given in the management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug effective against Clostridium difficile.
Suspension: Probenecid reduces the renal clearance of cefuroxime.
Caution For Usage
Oral suspension: Direction for Reconstitution: 125 mg/5 mL Suspension: To make 70 mL, 50 mL and 10 mL reconstituted suspension, mix thoroughly the contents with 30 mL, 24 mL and 5 mL, respectively of water and shake well until powder is evenly suspended.
250 mg/5 mL Suspension: To make 70 mL, 50 mL and 10 mL reconstituted suspension, mix thoroughly the contents with 28 mL, 22 mL and 5 mL, respectively of water and shake well until powder is evenly suspended.
250 mg/5 mL Suspension: To make 70 mL, 50 mL and 10 mL reconstituted suspension, mix thoroughly the contents with 28 mL, 22 mL and 5 mL, respectively of water and shake well until powder is evenly suspended.
Storage
Store at temperatures not exceeding 30°C.
Protect from light.
The reconstituted suspension is stable for 7 days at temperatures not exceeding 30°C and 14 days under refrigeration (2-8°C).
Protect from light.
The reconstituted suspension is stable for 7 days at temperatures not exceeding 30°C and 14 days under refrigeration (2-8°C).
Action
FC tablet: Cefuroxime axetil is the acetyloxyethyl ester of cefuroxime. Cefuroxime axetil belongs to the 2nd generation of cephalosporins and compared to the 1st generation of cephalosporins are not only active against gram-positive but also gram-negative organism. The mechanism of action of cefuroxime axetil, similar to all cephalosporins and it acts by combining with the penicillin bound proteins (PBP) part of the bacterial cell wall resulting in the lysis of the cell wall and as a consequence causing cell death and therefore having a bactericidal action. Axetil is the prodrug of the active compound cefuroxime. When given orally, cefuroxime axetil is hydrolyzed to cefuroxime by nonspecific esterases in the intestinal mucosa. Cefuroxime is distributed throughout the extracellular fluid. The axetil part is metabolized to acetaldehyde and acetic acid.
Oral suspension: Cefuroxime is bactericidal and has similar spectrum of antimicrobial action and pattern resistance to cefamandole. It is more resistant to hydrolysis by β-lactamases than cefamandole, and therefore may be more active against β-lactamase-producing strains of Haemophilus influenzae and Neisseria gonorrheae.
Oral suspension: Cefuroxime is bactericidal and has similar spectrum of antimicrobial action and pattern resistance to cefamandole. It is more resistant to hydrolysis by β-lactamases than cefamandole, and therefore may be more active against β-lactamase-producing strains of Haemophilus influenzae and Neisseria gonorrheae.
MedsGo Class
Cephalosporins
Features
Brand
Cimex
Full Details
Dosage Strength
500 mg
Drug Ingredients
- Cefuroxime
Drug Packaging
Film-Coated Tablet 50's
Generic Name
Cefuroxime Axetil
Dosage Form
Film-Coated Tablet
Registration Number
DRP-1908-01
Drug Classification
Prescription Drug (RX)
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