Panaxim

Panaxim

cefuroxime

Manufacturer:

Panpharma Healthcare

Distributor:

Metro Drug
Full Prescribing Info
Contents
Cefuroxime sodium.
Description
Each gram of cefuroxime contains sodium 51.1 mg (38.62 mg/750-mg vial).
Action
Pharmacology: Cefuroxime sodium is a β-lactam antibiotic from the 2nd generation cephalosporin group.
Pharmacokinetics: Cefuroxime is widely distributed to most body fluids and tissues, including cerebrospinal fluid. Among 2nd generation cephalosporins, cefuroxime is the only agent to achieve therapeutic levels in the cerebrospinal fluid. The t½ of cefuroxime is about 1.1-1.4 hrs. Cefuroxime is only minimally metabolized, with >95% of the dose being excreted unchanged in the urine following IV administration.
Indications/Uses
Infections caused by cefuroxime-sensitive organisms eg, bone and joint infections; osteomyelitis, septic arthritis; bronchitis (and other lower respiratory tract infections); gonorrhea; meningitis; otitis media; peritonitis; pharyngitis; sinusitis; skin disorder (including soft tissue infections); surgical infections (prophylaxis); urinary tract infections; cystitis.
Dosage/Direction for Use
Patients with Normal Kidney Function: Adults: Usual Dose: 750 mg every 8 hrs. Severe Infections: 1.5 g IV every 6 or 8 hrs.
Children and Infants: 30-60 mg/kg body weight daily, increased to 100 mg/kg daily in 3 or 4 divided doses.
Neonates: 30-60 mg/kg body weight daily, increased to 100 mg/kg daily in 2-3 divided doses.
Meningitis: Only recommended in bacterial meningitis, due to sensitive microorganisms.
Adults: 3 g IV every 8 hrs.
Children and Infants: 200-240 mg/kg daily IV in 3-4 divided doses, which may be decreased to 100 mg/kg daily after 3 days.
Neonates: 100 mg/kg daily, decreased to 50 mg/kg daily.
Gonorrhea: A unique dosage of 1.5 g (2 IM injections of 750 mg in different parts of the body).
Surgical Infection Prophylaxis: Usual Dose: 1.5 g IV prior to procedure followed by 750 mg IV or IM every 8 hrs for up to 24-48 hrs.
In total joint replacement, 1.5 g of cefuroxime powder may be mixed with the methyl-methacrylate cement.
Dosage in Special Groups: Cefuroxime is excreted almost entirely by the kidneys and patients with renal failure require a modified dosage schedule.
Patients with Renal Impairment: In case of kidney failure, dosages shall be adjusted to the presence of creatinine in the blood of the creatinine clearance. (See table.)

Click on icon to see table/diagram/image

Administration: IM: Dissolve the powder in 3 mL of water for injection.
The solution can be used within 6 hrs at 25°C ± 2°C and within 48 hrs when stored at a temperature between +2°C and +8°C.
IV: Dissolve the powder in 6 mL of water for injection. The solution can be used within 6 hrs at 25°C ± 2°C and within 48 hrs when stored at a temperature between +2°C and +8°C.
IV Infusion: 1.5 g of cefuroxime is diluted in 50 mL of water for injection. The solution can be used within 24 hrs at 25°C ± 2°C and within 72 hrs when the solution is stored at a temperature between +2°C and +8°C.
Cefuroxime is also compatible with fluids commonly used for infusion and more particularly sodium chloride 0.9% solution or dextrose solution 5%. In these cases, the preparation must be immediately used after reconstitution and dilution.
Overdosage
Administering high dosage of β-lactams, more particularly to patients suffering from kidney failure may lead to metabolic encephalopathies (consciousness disorders, abnormal motions, convulsive crises).
Contraindications
Patients with allergy to penicillins and cephalosporins.
Special Precautions
As with other antibiotics, a continued administration of cefuroxime sodium may lead to the susceptible strains selection (ie, Enterococci, Clostridium difficile, Candida); in this case, the treatment must be stopped.
Glycosuria: On a biochemical dosage using reducing substances, a falsely positive reaction may occur. This is not the case with dosage methods using enzymes of the "glucose-oxydase" or "hexokinase" types.
Use in Pregnancy: Cefuroxime shall be administered to pregnant women only if necessary.
Use in Lactation: In nursing mothers, cefuroxime crossing into the mothers milk is light (<5%); swallowed quantities are very inferior to the therapeutic doses. Nursing is therefore possible while receiving this drug. Nevertheless, should diarrhea, candidiasis or skin rash occur, nursing or treatment with Panaxim should be discontinued.
Use In Pregnancy & Lactation
Use in Pregnancy: Cefuroxime shall be administered to pregnant women only if necessary.
Use in Lactation: In nursing mothers, cefuroxime crossing into the mothers milk is light (<5%); swallowed quantities are very inferior to the therapeutic doses. Nursing is therefore possible while receiving this drug. Nevertheless, should diarrhea, candidiasis or skin rash occur, nursing or treatment with Panaxim should be discontinued.
Side Effects
Digestive Disorders: Diarrhea, nausea, vomiting. As with some other wide-spectrum antibiotics, some rare cases of pseudomembranous colitis have been reported.
Allergic Reactions: Maculopapulous rashes, urticaria, pruritus, fever, seric disease, some very rare cases of anaphylaxis, polymorphous erythema and on exceptional occasions, the Stevens-Johnson syndrome, the Lyell syndrome may occur.
Hematologic Reactions: Hypereosinophilia, leukopenia, neutropenia (sometimes severe), thrombocytopenia (sometimes severe) may also occur.
Hepatic Reactions: Transient increase in SGOT and SGPT transaminases as well as LDH can occur.
Nephrotoxicity: Alterations of the kidney function have been reported with antibiotics of the same family, or particularly when combined with aminoglycosides or powerful diuretics.
Rare cases of headaches may occur. Thrombophlebitis after IV administration. Pains, discomfort, induration at the site of injection site when administered through IM route.
Drug Interactions
A false-positive reaction to Coombs' test was noticed on administering cephalosporins. This may also occur in patients receiving cefuroxime.
Glycosuria: On a biochemical dosage using reducing substances, a false-positive reaction may occur. This is not the case with dosage method using enzymes of the 'glucose-oxydase' or 'hexokinase' types.
Storage
Store at temperatures not exceeding 25°C.
Shelf-Life: 3 years.
MIMS Class
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Powd for inj (vial) 750 mg x 10's, 50's.
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