Zegen

Zegen

cefuroxime

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc
Concise Prescribing Info
Contents
Cefuroxime (tab: axetil, inj: Na)
Indications/Uses
Tab: Treatment of infections caused by susceptible microorganisms including upper & lower resp tract, uncomplicated skin & skin structure infections, uncomplicated UTI & gonorrhea; early Lyme disease. Powd for inj: URTI including ENT infections (eg, otitis media, sinusitis, tonsillitis & pharyngitis) & lower resp tract infections including pneumonia, acute bronchitis & acute exacerbations of chronic bronchitis); GUT infections including pyelonephritis & gonorrhea; skin & soft tissue infections including furunculosis, pyoderma & impetigo; septicemia; meningitis; bone & joint infections; surgical prophylaxis (eg, biliary, gastroduodenal, CV or orthopedic surgery).
Dosage/Direction for Use
Tab Adult & adolescent ≥13 yr Acute sinusitis, acute tonsillopharyngitis, acute bacterial exacerbations of chronic bronchitis, uncomplicated skin & skin structure infections 250 or 500 mg every 12 hr for 10 days. Acute otitis media 500 mg every 12 hr for 10 days. Uncomplicated gonorrhea 1,000 mg once as single dose. Secondary bacterial infections of acute bronchitis 250 or 500 mg every 12 hr for 5-10 days. Uncomplicated UTI 250 or 500 mg every 12 hr for 7-10 days. Early Lyme disease 500 mg every 12 hr for 20 days. Childn 7-12 yr Acute sinusitis, acute otitis media, acute tonsillopharyngitis, acute bacterial exacerbations of chronic bronchitis, uncomplicated skin & skin structure infections 250 mg every 12 hr for 10 days. Secondary bacterial infections of acute bronchitis 250 mg every 12 hr for 5-10 days. Uncomplicated UTI 250 or 500 mg every 12 hr for 7-10 days. Early Lyme disease 500 mg every 12 hr for 20 days. Powd for inj Adult 750 mg-1.5 g every 6-8 hr for 2-10 days. Uncomplicated UTI, skin & skin structure infections, disseminated gonococcal infections, uncomplicated pneumonia 750 mg IV every 8 hr. Severe infection 1.5 IV every 8 hr. Bone & joint infections 1.5 g IV every 8 hr. Bacterial meningitis 3 g IV every 8 hr. Life-threatening infections or infections due to less susceptible organisms 1.5 g IV every 6 hr. Uncomplicated gonococcal infections 1.5 g IM as single dose given at 2 different sites + 1 g PO probenecid. Surgical prophylaxis: Biliary surgery 1.5 g IV single dose, cardiac surgery 1.5 g pre-op then 1.5 g IV every 12 hr for 48 hr, vascular surgery 1.5 g pre-op then 1.5 g IV every 8 hr for 24 hr, orthopedic surgery 1.5 pre-op then 750 mg IV every 8 hr for 24 hr. Childn 50-150 mg/kg/day IV in 3-4 divided doses 2-10 days. Mild to moderate infections Childn 10-12 yr 750 mg every 6-8 hr. Total daily dose: 2,250 mg, 6-10 yr 500 mg every 6-8 hr. Total daily dose: 1,500 mg, 2-8 yr 250 mg every 6-8 hr. Total daily dose: 1,000 mg, 10-24 mth 250 mg every 6-8 hr. Total daily dose: 750 mg, 6-9 mth 125 mg. Total daily dose: 500 mg, 3-6 mth 125 mg 6-8 hr. Total daily dose: 375 mg. Severe infections Childn 10-12 yr 1,500 mg every 6-8 hr. Total daily dose: 4,500 mg, 6-10 yr 750 mg every 6-8 hr. Total daily dose 3,000 mg, 2-8 yr 500 mg every 6-8 hr. Total daily dose: 2,250 mg, 10-24 mth 500 mg every 6-8 hr. Total daily dose: 1,500 mg, 6-9 mth 375 mg every 6-8 hr. Total daily dose: 1,125 mg, 3-6 mth 250 mg every 6-8 hr. Total daily dose: 750 mg. Renal impairment CrCl >20 mL/min 750 mg-1.5 g every 8 hr, 10-20 mL/min 750 mg every 12 hr, <10 mL/min 750 mg every 24 hr.
Administration
Should be taken with food: Take immediately after meals.
Contraindications
Hypersensitivity to cefuroxime, cephalosporins or penicillins.
Special Precautions
Clostridium difficile-associated diarrhea; alters the normal flora of the colon. History of colitis. Patients w/ kidney or liver impairment, poor nutritional state, receiving protracted course of antimicrobial therapy & previously stabilized on anticoagulant therapy. Monitor prothrombin time. Pregnancy & lactation. Tab: History of cephalosporin-associated hemolytic anemia. Periodic monitoring for signs & symptoms of hemolytic anemia including measurement of hematological parameters of drug-induced Ab testing. Discontinue if seizures develop. Monitor renal function when given concurrently w/ aminoglycosides &/or diuretics. Jarisch-Herxheimer reaction following treatment of Lyme disease. Porphyria. Overgrowth of non-susceptible organisms including fungi on long-term or repeated use. May impair ability to drive or operate machinery. Renal impairment. Childn <3 mth. Elderly.
Adverse Reactions
Rash, hives, erythema, pruritus, urticaria, drug fever, angioedema, serum sickness-like reaction, erythema multiforme, SJS, TEN (exanthemic necrolysis), shortness of breath & severe bronchospasm; diarrhea, 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; urethral pain or bleeding, kidney pain, UTI, dysuria, acute renal failure/dysfunction, interstitial nephritis, transient increases in BUN & serum creatinine conc, decreased CrCl, bilateral renal cortical necrosis, vaginitis, vag candidiasis, vulvovag pruritus, vag discharge or irritation, menstrual irregularities; eosinophilia, neutropenia, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, thrombocytosis, lymphocytosis, increased prothrombin time, increased ESR, decreased Hb &/or hematocrit, +ve Coombs' test; transient elevations in AST, ALT, γ-glutamyl transferase, alkaline phosphatase, LDH, & bilirubin, jaundice, hepatic impairment; muscle spasm of the neck, muscle cramps or stiffness, arthralgia/joint pain or swelling; headache, dizziness, somnolence/sleepiness, irritable behavior, seizures, myoclonic jerks, generalized hyperexcitability/hyperactivity; pleural effusion, pulmonary infiltrate, dyspnea or resp distress, upper resp infection, rhinitis, sinusitis, cough; chest pain or tightness, tachycardia; Jarisch-Herxheimer reaction in patients treated for Lyme disease, candidiasis/candida overgrowth, mild to severe hearing loss, increased or decreased serum glucose conc, lockjaw-type reaction, viral illness.
Drug Interactions
Increased risk of nephrotoxicity w/ aminoglycosides. Increased risk of renal toxicity w/ potent diuretics including furosemide & ethacrynic acid. Slows down tubular secretion w/ probenecid. Tab: Lower bioavailability w/ oral antacids. Reduced efficacy of combined OCs. False +ve reaction for glucose in the urine. False -ve result in ferricyanide test.
MIMS Class
Cephalosporins
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Zegen powd for inj 750 mg
Packing/Price
(vial) 1's (P332.65/vial)
Form
Zegen tab 250 mg
Packing/Price
100's (P3,969.11/pack)
Form
Zegen tab 500 mg
Packing/Price
60's (P4,261.67/pack)
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