Theoroxime

Theoroxime

cefuroxime

Manufacturer:

Theon Pharma

Distributor:

Orange Biotec
Full Prescribing Info
Contents
Cefuroxime (FC tab: axetil; powd for inj: sodium).
Description
Theoroxime-500: Each FC tab contains 500 mg Cefuroxime (as Axetil).
Theoroxime-750: Each vial contains: Sterile Cefuroxime Sodium USP eq. to Cefuroxime 750 mg.
Theoroxime-1.5: Each vial contains: Sterile Cefuroxime Sodium USP eq. to Cefuroxime 1500 mg.
Action
Pharmacology: Pharmacokinetics: Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid, and aqueous humour, but only achieves therapeutic concentrations in the CSF when the meninges are inflamed. It crosses the placenta and has been detected in breast milk. It is excreted unchanged, by glomerular titration and renal tubular secretion, and high concentrations are achieved in the urine. Following injection most of a dose of cefuroxime is excreted within 24 hours, the majority within 6 hours. Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxirne. Small amounts of cefuroxime are excreted in bile. Plasma concentrations are reduced by dialysis.
Indications/Uses
FC tab: Treatment of susceptible infections such as bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis, otitis media, peritonitid, pharyngitis, sinusitis, skin and soft tissue infections, urinary tract infection and for surgical infection prophylaxis.
Powd for Inj: Used in the treatment of susceptible infections. These have included bone and joint infections, bronchitis, gonorrhoea, meningitis, otitis media, peritonitis, pharyngitis, sinusitis, skin infections, and urinary tract infections.
Dosage/Direction for Use
Powd for Inj: Cefuroxime Sodium may be given by deep intramuscular injection, by slow intravenous injection over 3 to 5 minutes, or by intravenous infusion.
For adult: 750 mg every 8 hours. Severe infection 1.5g IV every 6 to 8 hours for 5 to 10 days.
Infant and children: 30-60 mg/kg/day, dose may be increased to 100 mg/kg/day in 3-4 divided doses.
Neonates: Same total daily dose as children but in 2-3 divided doses.
Or as prescribed by the physician.
Contraindications
Should not be given to patients who are sensitive to it or to other cephalosporins.
Special Precautions
It should not be given to patient who are hypertensive to it or to other cephalosporin. About 10% of penicillin-sensitive patients may also be allergic to cephalosporins although the true incidence is uncertain; Great care should be taken if it is to be given to such patients. Care is also necessary in patients with a history of allergy. It should be given with caution to patients with renal impairment; a dosage of reduction may be necessary. Renal and haematological status should be monitored especially drug prolonged and high dose therapy.
Adverse Reactions
Gastrointestinal disturbances, including diarrhoea, nausea, and vomiting have occured in some patients receiving cefuroxime. There have been rare reports of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Drug Interactions
Probenecid reduces the renal clearance of cefuroxime.
Caution For Usage
Direction for Reconstitution: For 750 mg: IM Use: Dissolve the content in 3 mL of Sterile Water for Injection.
IV Use: Dissolve the content in 8.3 mL of Sterile Water for Injection.
For 1.5 g: IV Use: Dissolve the content in 16 mL Sterile Water for Injection.
Storage
Store at temperatures not exceeding 30°C.
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
Theoroxime-500 FC tab 500 mg
Packing/Price
10's;30's
Form
Theoroxime-1.5 powd for inj 1.5 g
Packing/Price
10 × 1's;1's
Form
Theoroxime-750 powd for inj 750 mg
Packing/Price
10 × 1's;1's
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