JAMP CEFUROXIME

1 Dosing Considerations The dose of cefuroxime that is selected to treat an individual infection should take into account: • The expected pathogens and their likely susceptibility to cefuroxime axetil • The site of the infection • The age, weight and renal function of the patient.

The duration of therapy should be determined by the type of infection and the response of the patient and should generally not be longer than recommended. 2 Recommended Dose and Dosage Adjustment Adults and Children 12 Years of Age and Older The usual recommended dosage is 250 mg twice a day.

g. pneumonia 500 mg twice daily Infants and Children less than 12 Years of Age JAMP Cefuroxime tablets are not recommended for infants and children less than 12 years of age. The usual duration of treatment for JAMP Cefuroxime tablets is 7 to 10 days.

For β-hemolytic streptococcal infections, therapy should be continued for at least 10 days. Renal Impairment Cefuroxime axetil is primarily excreted by the kidneys. In patients with markedly impaired renal function, it is recommended that the dosage of JAMP Cefuroxime be reduced to compensate for its slower excretion (see the table 2 below).

8 Standard individual dose given every 48 hours During haemodialysis 2 - 4 A single additional standard individual dose should be given at the end of each dialysis The safety and efficacy of the proposed dosing adjustment has not been established.

4 Administration For optimal absorption, JAMP Cefuroxime should be taken with food. 5 Missed Dose If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

The following adverse reactions have been reported:

Blood and lymphatic system disorders: Eosinophilia, very rarely hemolytic anemia. See 7 WARNINGS and PRECAUTIONS, Hemolytic Anemia. 3%). Reports of abdominal pain have occurred. 3% of patients): As with other cephalosporins, there have been rare reports of drug fever.

3% of patients): Hypersensitivity reactions to cefuroxime axetil may occur in patients who report delayed hypersensitivity to penicillins. See 7 WARNINGS AND PRECAUTIONS, Immune.

Investigations:

Increased erythrocyte sedimentation rate, decreased hemoglobin, positive Coomb’s test. Transient increases of hepatic enzyme levels [ALT, AST, LDH] (3% of patients). The following adverse reactions have been observed to occur, although infrequently, in association with parenteral cefuroxime sodium and may be potential adverse effects of oral JAMP Cefuroxime (Cefuroxime Axetil Tablets) Page 12 of 33 cefuroxime axetil: Transient increases in serum bilirubin, creatinine, alkaline phosphatase, and urea nitrogen (BUN).

2% of patients): Headache and dizziness. The following adverse reactions have been observed to occur, although infrequently, in association with parenteral cefuroxime sodium and may be potential adverse effects of oral cefuroxime axetil: drowsiness Reproductive system and breast disorders: The following adverse reactions have been observed to occur, although infrequently, in association with parenteral cefuroxime sodium and may be potential adverse effects of oral cefuroxime axetil: Vaginitis.

, General 06/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .........................................................................................

2 TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................

4 1 INDICATIONS............................................................................................................ 1 Pediatrics ..................................................................................................................

2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ..............................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 1 Dosing Considerations ..............................................................................................

2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration .......................................................................................................... 5 Missed Dose .............................................................................................................

7 5 OVERDOSAGE .......................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 7 7 WARNINGS AND PRECAUTIONS ................................................................................

JAMP

Cefuroxime (cefuroxime axetil tablets) is contraindicated for patients who have shown Type 1 hypersensitivity to cefuroxime, to any of its components, or to any of the cephalosporin group of antibiotics. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.