Ceframax

Composition
Ceframax capsule: Each capsule contains Cephradine USP 500 mg.

Pharmacology
Ceframax is a cephalosporin antibiotic with broad spectrum bactericidal activity against both gram-positive and gram-negative bacteria. Cephradine interferes with the synthesis of bacterial cell wall by inhibiting transpeptidase enzyme, as a result the bacterial cell wall is weakened, the cell swells and then ruptures.

Indication
Ceframax is used in the treatment of infections caused by sensitive organisms. Upper respiratory tract infections: Pharyngitis, sinusitis, otitis media, tonsilitis, laryngotracheo-bronchitis; Lower respiratory tract infections: Acute and chronic bronchitis, lobar and bronchopneumonia. Urinary tract infections: Cystitis, urethritis, pyelonephritis; Skin and soft tissue infections: Abscess, cellulitis, furunculosis, impetigo; Gastrointestinal tract infections: Bacillary dysentery, enteritis, peritonitis. Bone and joint infection; Surgical prophylaxis: It is also used in perioperative prophylactic administration (pre-operatively, intra-operatively and post-operatively). In cesarean section, intra-operative (after clamping the umbilical cord) and post-operative use may reduce the incidence of certain postoperative infections.

Dosage & administration
The dosage may be given without regard to meals.
Adult: Oral: The usual dose is 1-2 gm daily in 2 to 4 divided doses. In severe and prolonged infection, the dose can be increased up to 4 gm daily which should be taken in equally divided doses. Skin and skin structures and respiratory tract infection: Usual dose is 250 mg every 6 hours or 500 mg every 12 hours. Lobar pneumonia: 500 mg every 6 hours or 1 gm every 12 hours. Urinary tract infection: Usual dose is 500 mg every 12 hours. Gastro-intestinal tract infection: 500 mg three to four times daily.

Children: Oral: The usual total dose is 25 to 50 mg/kg/day given in 2 to 4 equally divided doses.

Dosage in renal impairment: In patients with impaired renal function, doses and frequency of administration of cephradine must be modified according to the degree of impairment, severity of infection, susceptibility of the causative organism and serum concentration of the drug. For adults, a loading dose of 750 mg should be given subsequently followed by 500 mg with the mentioned time interval.

Creatinine clearance (ml/min)

Time interval (hrs)

> 20

6-12

15-19

12-24

10-14

24-40

5-9

40-50

<5

50-70

For children, dosage schedule may need to be adjusted.
or as directed by the physician.

Contra-indication
Cephradine is contraindicated in patients with known hypersensitivity to the cephalosporin group of antibiotics.

Warning & precaution
Cephradine should be used with caution with those patients who are known hypersensitive to penicillins.

Side effects
Side effects include nausea, vomiting, diarrhea and abdominal discomfort. Allergic reactions including skin rashes, urticaria, eosinophilia, angioedema and anaphylaxis may occur and elevation of hepatic enzyme values have been noted. Neutropenia has been reported. Super-infection with resistant microorganisms, particularly candia, may follows the treatment There is also possibility of development of pseudomembranous colitis.

Use in pregnancy & lactation
Although there have been no reports of adverse effect on the fetus, safety of use during pregnancy has not been definitely established. The drug should be used during pregnancy only when clearly indicated. Cephalosporins are distributed into breast milk and the drug should be used with caution in nursing mother.

Use in children & adolescents
Children: Oral: The usual total dose is 25 to 50 mg/kg/day given in 2 to 4 equally divided doses.

Drug interaction
The cephalosporins are potentially nephrotoxic (particularly Cefaloridine) and may enhance the nephrotoxicity of aminoglycoside antibiotics such as Gentamycin and Tobramycin. One should be cautious about the use of any cephalosporin with Frusemide and Ethacrynic acid.

Overdose
In the case of an overdose, supportive measures should be instituted.

Storage
Keep out of the reach of children. Keep below 30°C, protect from light.

Packing
Ceframax capsule: Each box contains 5x6's capsules in blister pack.