Zocef/Zocef Kids/Zocef Hospi

Zocef/Zocef Kids/Zocef Hospi

cefuroxime

Manufacturer:

Alkem Lab

Distributor:

Alkem Lab
Concise Prescribing Info
Contents
Zocef/Zocef Kids Cefuroxime axetil. Zocef Hospi Cefuroxime Na
Indications/Uses
Zocef/Zocef Kids Bronchitis (& other lower resp-tract infections eg, pneumonia, acute bronchitis, & acute exacerbations of chronic bronchitis), gonorrhea, otitis media, pharyngitis, sinusitis, skin infections (including soft-tissue infections eg, furunculosis, pyoderma & impetigo). Zocef Susceptible infections including bone & joint infections, meningitis, peritonitis, & UTI. Surgical infection prophylaxis. Zocef Kids URTI eg, ENT infections (tonsillitis); GUT infections eg, pyelonephritis, cystitis & urethritis; acute uncomplicated gonococcal urethritis, & cervicitis; treatment of early Lyme disease & subsequent prevention of late Lyme disease in adults & childn >12 yr. Zocef Hospi Community acquired pneumonia, acute exacerbations of chronic bronchitis, complicated UTI including pyelonephritis, soft-tissue infections cellulitis, erysipelas & wound infections), intra-abdominal infections. Prophylaxis against infection in GI (including oesophageal), orthopaedic, CV, & gynaecological surgery (including caesarean section).
Dosage/Direction for Use
Zocef FC tab Adult Uncomplicated UTI 125 mg bid. Resp tract infection 250-500 mg bid. Childn >3 mth 125 mg bid or 10 mg/kg bid. Max: 250 mg daily. Childn >2 yr w/ otitis media 250 mg bid or 15 mg/kg bid. Max: 500 mg daily. Zocef powd for oral susp Adult Uncomplicated UTI 250 mg bid. Resp tract infection 250-500 mg bid. Childn >3 mth 250 mg bid or 10 mg/kg bid. Max: 250 mg daily. Childn >2 yr w/ otitis media 250 mg bid or 15 mg/kg bid. Max: 500 mg daily. Zocef Kids Usual course of therapy: 7 days (range 5-10 days). Adult Most infections, UTI, mild to moderate lower resp tract infections (eg, bronchitis), pyelonephritis 250 mg bid. More severe lower resp tract infections or if pneumonia is suspected 500 mg bid. Uncomplicated gonorrhoea Single dose of 1 g. Lyme disease in adult & childn >12 yr 500 mg bid for 14 days (range 10-21 days). Childn 12 yr to infants 3 mth Most infections 10 mg/kg bid. Max: 250 mg daily. Otitis media or more severe infections 15 mg/kg bid. Max: 500 mg daily. Lyme disease 15 mg/kg bid for 14 days (range 10-21 days). Max: 500 mg daily. Renal impairment CrCl ≥30 mL/min 125-500 mg standard dose bid, 10-29 mL/min Standard individual dose every 24 hr, <10 mL/min Standard individual dose every 48 hr, during haemodialysis Single additional standard individual dose at the end of each dialysis. Zocef Hospi Adult & childn ≥40 kg Community acquired pneumonia & acute exacerbations of chronic bronchitis, soft tissue infections eg, cellulitis, erysipelas & wound infections, intra-abdominal infections 750 mg IV/IM every 8 hr. Complicated UTI including pyelonephritis 1.5 g IV/IM every 8 hr. Severe infections 750 mg IV every 6 hr or 1.5 g IV every 8 hr. Surgical prophylaxis for GI, gynecological surgery (including caesarean section) & orthopaedic operations 1.5 g upon induction of anaesth. May be supplemented w/ two 750-mg IM doses after 8 & 16 hr. Surgical prophylaxis for CV & oesophageal operations 1.5 g upon induction of anaesth followed by 750 mg IM every 8 hr for further 24 hr. Childn <40 kg & infant & toddler >3 wk Community acquired pneumonia, complicated UTI including pyelonephritis, soft-tissue infections eg, cellulitis, erysipelas & wound infections, intra-abdominal infections 30-100 mg/kg IV daily in 3 or 4 divided doses. A dose of 60 mg/kg daily is appropriate for most infections. Infant from birth to 3 wk Community acquired pneumonia, complicated UTI including pyelonephritis, soft-tissue infections eg, cellulitis, erysipelas & wound infections, intra-abdominal infections 30-100 mg/kg IV daily in 2 or 3 divided doses. Renal impairment CrCl >20 mL/min/1.73 m2 750 mg-1.5 g standard dose tid, 10-20 mL/min/1.73 m2 750 mg bid, <10 mL/min/1.73 m2 750 mg once daily. Patient on haemodialysis 750 mg IV/IM at the end of each dialysis; can be incorporated into peritoneal dialysis fluid (usually 250 mg for every 2 L of dialysis fluid) in addition to parenteral use. Patient in renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units 750 mg bid.
Administration
FC tab: May be taken with or without food. Powd for oral susp: Should be taken with food.
Contraindications
Hypersensitivity to cefuroxime or to cephalosporins. Zocef powd for oral susp/Zocef Hospi History of severe hypersensitivity to any other type of β-lactam antibacterial agent (penicillins, monobactams & carbapenems).
Special Precautions
Pregnancy & lactation. Zocef FC tab: Consider Clostridium difficile associated diarrhea in all patients who present w/ diarrhea following antibiotic use & discontinue if suspected or confirmed. Institute appropriate fluid & electrolyte management, protein supplementation, antibiotic treatment of C. difficile & surgical evaluation as clinically indicated. Prolonged administration may result in overgrowth of non-susceptible microorganisms. Superinfection. Patients receiving potent diuretics; individuals w/ history of colitis. Monitor prothrombin time in patients at risk including patients w/ renal or hepatic impairment or poor nutritional state, receiving protracted course of antimicrobial therapy & previously stabilized on anticoagulant therapy, & administer exogenous vit K as indicated. Renal failure. Powd for oral susp: Not to be given to patients who are hypersensitive to other cephalosporins. Penicillin-sensitive patients may also be allergic to cephalosporins; patients w/ history of allergy; renal impairment. Monitor renal & hematological status especially in drug-prolonged & high-dose therapy. Zocef Kids/Zocef Hospi Patients who have experienced allergic reaction to penicillins or other β-lactams. May result in overgrowth of Candida. Prolonged use may result in overgrowth of other non-susceptible organisms (eg, enterococci & Clostridium difficile). Consider pseudomembranous colitis diagnosis in patients w/ diarrhoea during or after antibiotic use, & discontinue treatment immediately if prolonged or significant diarrhoea occurs or patient experiences abdominal cramps & investigate further. False -ve result in ferricyanide test, use either glucose oxidase or hexokinase methods to determine blood/plasma glucose levels. Zocef Kids Jarisch-Herxheimer reaction following treatment of Lyme disease. Warn patients to be cautious when driving or operating machinery as treatment may cause dizziness. Zocef Hospi Patients receiving potent diuretics eg, furosemide or aminoglycosides. Do not give medicinal products that inhibit peristalsis. Not suitable for infections caused by gm -ve non-fermenting bacteria. +ve Coombs test may interfere w/ cross matching of blood. Slight interference w/ Cu reduction methods (Benedict's, Fehling's, Clinitest). Not formulated for intracameral use. Patients on controlled Na diet.
Adverse Reactions
Zocef/Zocef Kids Diarrhea, nausea & vomiting; erythema multiforme, SJS & TEN. Zocef FC tab: Loose stools, dyspepsia, flatulence; anaphylactic/anaphylactoid reactions, skin rashes, urticaria, drug fever, pruritus, angioedema & facial edema; transient elevations in BUN or creatinine, acute renal failure; somnolence; genital pruritus, vaginitis, candidiasis, muscle cramps, muscle stiffness, muscle spasm of neck, dysuria, chest pain, chills, shortness of breath, mouth ulcers, swollen tongue; mild to moderate hearing loss in childn treated for meningitis. Zocef FC tab/Zocef Kids Abdominal pain; headache, dizziness; transient elevations in/increases of hepatic enzyme levels, ALT (SGPT), AST (SGOT), LDH. Zocef Kids Overgrowth of Candida. Zocef Kids/Zocef Hospi Eosinophilia. Zocef Hospi Neutropenia, decreased Hb conc; transient rise in liver enzymes or bilirubin, particularly in patients w/ pre-existing liver disease; inj site reactions including pain & thrombophlebitis.
Drug Interactions
Zocef/Zocef Hospi Increased AUC/elevated peak serum level & reduced renal clearance/prolonged excretion w/ probenecid. Zocef FC tab/Zocef Kids May lower bioavailability w/ drugs that reduce gastric acidity. Zocef FC tab/Zocef Kids/Zocef Hospi May affect gut flora, leading to lower estrogen reabsorption & reduced efficacy of combined oral estrogen/progesterone contraceptives. Zocef Hospi Impairment of renal function w/ loop/strong-acting diuretics (eg, furosemide) or potential nephrotoxic drugs/prep (eg, aminoglycosides). Increased INR w/ oral anticoagulants.
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
Zocef Hospi powd for inj 750 mg
Packing/Price
(vial + 10 mL amp diluent) 1's
Form
Zocef Kids powd for oral susp 250 mg/5 mL
Packing/Price
(w/ measuring cup) 60 mL x 1's
Form
Zocef powd for oral susp 250 mg/5 mL
Packing/Price
30 mL x 1's;60 mL x 1's
Form
Zocef FC tab 500 mg
Packing/Price
10's
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