EXTRACEF

Cephradine

Description:

Extracef is a preparation of Cefradine, which is the most stable first generation Cephalosporin antibiotic active against all types of beta-lactamases. Extracef is a broad spectrum bactericidal antibiotic active against a wide range of infections caused by susceptible Gram-negative and Gram-positive organisms.

Composition:

Extracef-250 Capsule: Each capsule contains Cefradine BP 250 mg.

Extracef-500 Capsule: Each capsule contains Cefradine BP 500 mg.

Extracef Powder for Suspension: After reconstitution each 5 ml contains Cefradine BP 125 mg.

Extracef DS powder for Suspension: After reconstitution each 5 ml contains Cefradine BP 250 mg.

Extracef Paediatric Drops: After reconstitution each 1.25 ml contains Cefradine BP 125 mg.

Extracef-250 Injection: Each vial contains dry powder equivalent to 250 mg Cefradine USP and 1 ampoule contains 5 ml Water for Injection BP.

Extracef-500 Injection: Each vial contains dry powder equivalent to 500 mg Cefradine USP and 1 ampoule contains 5 ml Water for Injection BP.

Extracef-1 g Injection: Each vial contains dry powder equivalent to 1 g Cefradine USP and 1 ampoule contains 10 ml Water for Injection BP. 

Indications:

Extracef is indicated for the treatment of the following bacterial infections: Respiratory tract infections: Tonsillitis, pharyngitis, sinusitis, laryngo-trachitis, acute and chronic bronchitis, lobar and broncho-pneumonia caused by group-A beta-hemolytic Streptococci and Streptococcus pneumoniae. Otitis media; caused by group-A beta-hemolytic Streptococci, S. pneumoniae, Haemophilus influenzae and Staphylococci. Skin and soft tissue infections: Cellulitis, abscess, furunculosis, and impetigo caused by Staphylococci and beta-hemolytic Streptococci. Urinary tract infections: Cystitis, urethritis, pyelonephritis, and prostatitis caused by E. Coli, Proteus mirabilis, and Klebsiella species. Extracef is also used in the treatment of some enterococci (S. faecalis) infections confined to the urinary tract. Perioperative prophylaxis: Extracef may reduce the incidence of certain postoperative infections in patients undergoing surgical procedures. 

Dosage & Administration:

Oral:

The oral dosages may be given without regard to meals.

Adults: The usual dosage range is 1-2 g daily in two or four equally divided doses. Severe or chronic infections may require large doses up to 4 g daily in divided doses or as advised by the physician. Specific dosage recommendation: Respiratory tract infections (other than lobar pneumonia): 250 mg, 6 hourly or 500 mg, 12 hourly. Lobar pneumonia: 500 mg, 6 hourly or 1 g, 12 hourly. Skin & soft tissue infections: 250 mg, 6 hourly or 500 mg, 12 hourly. Urinary tract infections: 500 mg, 6 hourly or 1 g, 12 hourly. Severe or chronic infection may require larger doses (up to 1 g, 6 hourly). Peritonitis: 500 mg 4 times daily Osteomyelitis: Single dose pre-operatively and single dose post-operatively is the simplest regimen. GIT infections: 500 mg 3-4 times daily. Prophylaxis of wound infections: 1-2 g pre-operatively, post-operative dose is adjusted as required.

Children: For children over 9 months, the usual dose is 25-50 mg/kg body weight per day, in equally divided doses, 6 or 12 hourly. For otitis media due to H. influenzae, 75-100 mg/kg body weight per day in equally divided doses, 6 or 12 hourly is recommended.

Parenteral:

Adults: The usual dosage range is 2-4 g daily, IM or IV in four equally divided doses. This may be increased up to 8 g a day for severe infections e.g., septicaemia and endocarditis.

Children: The usual dose is 50-100 mg/kg body weight per day, given in four equally divided doses. More serious infections may require 300 mg/kg body weight per day. 

Preparation of solution for intramuscular/intravenous injections:

For IM injection: Add 1.2 ml, 2 ml & 4 ml Water for Injection BP to Extracef 250, 500 & 1 g respectively. Then shake gently to disperse. For IV injection: Add 5 ml Water for Injection BP to both Extracef 250 & 500 mg and add 10 ml Water for Injection BP to Extracef 1 g to make solution. The injection should be administered by deep intramuscular or by slow intravenous injection over 3-5 minutes. The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 2 hours if kept at room temperature & for 12 hours if kept below 5⁰ C. 

Contraindications:

Cefradine is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics. 

Precautions:

Administer cautiously to penicillin-sensitive patient because there were evidences of partial cross-allergenicity between the penicillins and cephalosporins. A modified dosage schedule in patients with impaired renal function is necessary. In patients not on dialysis, the following initial dosage should be as a guideline based on creatinine clearance (Ccr ml/min): 500 mg 6 hourly; when Ccr is >20, 250 mg 6 hourly; when Ccr is 5-20 & 250 mg 12 hourly; when Ccr is <5. For patients on chronic, intermittent hemodialysis 250 mg initially, & repeated at 12 hours and after 36-48 hours. Children may require dosage modification proportional to their weight and severity of infection.

Use in Pregnancy & Lactation:

Animal studies with Cefradine have shown no teratogenicity. But the safety in pregnancy has not been established. Cefradine is excreted in breast milk and should be used with caution in lactating mothers.

Drug Interaction:

Potentially hazardous interactions: The cephalosporins are potentially nephrotoxic (particularly cephaloridine) and may enhance the nephrotoxicity of aminoglycoside antibiotics such as gentamicin and tobramycin. The nephrotoxicity of cephaloridine is increased by frusemide and one should be cautious about the use of any cephalosporin with frusemide and ethacrynic acid.

Potentially useful interactions: Combinations with aminoglycosides may exert more potent bactericidal action against some organisms than agent alone.

Adverse Reactions:

Adverse reaction reports are rare but include glossitis, heart burn, dizziness, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candidial overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes and edema. As with other cephalosporins mild transient eosinophilia, leukopenia, neutropenia and pseudomembranous colitis may be reported.

Incompatibilities:

The admixture of beta-lactam antibacterials (Penicillins and Cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If they are administered concurrently, they should be administered in separate sites. Do not mix them in the same intravenous bag or bottle. 

Packaging:

Extracef-250 Capsule: Box containing 3x10's capsules in blister pack.

Extracef-500 Capsule: Box containing 7x4's capsules in blister pack.

Extracef Powder for Suspension: Bottle containing dry powder for the reconstitution of 100 ml suspension.

Extracef DS Powder for Suspension: Bottle containing dry powder for the reconstitution of 100 ml suspension.

Extracef Paediatric Drops: Bottle containing dry powder for the reconstitution of 15 ml drops.

Extracef-250 Injection: Box containing 5 combipacks each having 1 vial of 250 mg Cefradine (as sterile Cefradine USP) and 1 ampoule of 5 ml Water for Injection BP.

Extracef-500 Injection: Box containing 5 combipacks each having 1 vial of 500 mg Cefradine (as sterile Cefradine USP) and 1 ampoule of 5 ml Water for Injection BP.

Extracef-1g Injection: Box containing 1 combipacks having 1 vial of 1 g Cefradine (as sterile Cefradine USP) and 1 ampoule of 10 ml Water for Injection BP.