Composition
Each vial contains:
Sterilized cephradine            500 mg or 1 g
(as cephradine with L - arginine)

Properties and Mode of Action
CEPHRADINE is a first generation cephalosporin . It is bactericidal inhibiting bacterial septum and cell wall synthesis.
CEPHRADINE is effective against G+ve and G-ve bacteria such as Staphylococci including beta - lactamase - producing Staphylococcus aureus, beta-hemolytic Streptococci, Streptococcus pneumoniae; E.coli, Haemophilus influenzae, Klebsiella sp. and Proteus mirabilis.
CEPHRADINE is widely distributed to body tissues and fluids. It is excreted unchanged in urine with 60-80% of an intramuscular dose being recovered within 6 hours.

Indications
Treatment of infections due to susceptible microorganisms:
Respiratory tract infections.
Urinary tract infections.
Skin and Skin structure infections.
Bone infections.
Septicemia.
Perioperative prophylaxis.

Dosage and Administration
Deep I.M. injection or I.V. by slow injection over 3 - 5 minutes or by infusion.
Adults:
0.5 - 1 g every 6 hours.
In severe infections, dose may be given every 4 hours or by increasing dose up to a maximum of 8 g/day.
Perioperative Prophylaxis:
1 g IV or IM administered 30 - 90 minutes prior to start of surgery, followed by 1 g every 4 - 6 hours after the first dose for 1 or 2 doses, or for up to 24 hours postoperatively.
Cesarian section:
1 g IV as soon as the umbilical cord is clamped, and 1 g IM or IV at 6 and 12 hours after the first dose.

Children:
Infants and Children 1 year of age and over:
50 - 100 mg/kg/day in 4 equally divided doses.
Up to 300 mg/kg/day may be given in severe infections.
The maximum daily dose should not exceed 8 gms.

Renal Impairment Dosage:
Adults with impaired renal function may require a reduction in dose as follows:
Creatinine Clearance > 20 ml/min. : 500 mg every 6 hours.
Creatinine Clearance 5 - 20 ml/min. : 250 mg every 6 hours.
Creatinine Clearance < 5 ml/min. : 250 mg every 12 hours.
Patients on chronic, intermittent hemodialysis:
250 mg initially, repeat at 12 hours and after 36 - 42 hours.
Children may require dosage modification proportional to their weight and severity of infection.

Administration
IM:
Add 2 ml of diluent to each 500 mg vial or
4 ml of diluent to each 1 g vial.
Diluents for IM injection :
Sterile water for Injection or Bacteriostatic Water for Injection.
IV:
Direct IV:
Add 5 ml of diluent to each 500 mg vial or
10 ml of diluent to each 1 g vial.
Inject slowly over 3 - 5 minutes or give through tubing.
Diluents for direct IV Injection :
Sterile Water for Injection; 5% Dextrose Injection; Sodium Chloride Injection.
Continuous or Intermittent IV infusion :
Add 10 - 20 ml of Sterile Water for Injection or a suitable infusion fluid to each 1 g vial, to prepare solution. Withdraw entire contents; transfer to an IV infusion container.
Use Sterile water for Injection at a concentration of 30 - 50 mg / ml . Infusion solutions :
5% and 10% Dextrose Injection; Sodium Chloride Injection; Dextrose and Sodium Chloride Injection; M/6 Sodium Lactate; 10% Invert Sugar in Water, Normosol-R and lonosol B with 5% Dextrose.
Admixture Incompatibility
Do not mix CEPHRADINE with beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides. If they are administered concurrently they should be administered in separated sites. Do not mix them in the same intravenous bag or bottle.
Do not mix CEPHRADINE with other antibiotics.
Do not use with Lactated Ringer’s Injection.

Precautions
Patients intolerant of one cephalosporin may be intolerant of other cephalosporins.
Patients allergic to penicillins, penicillin derivatives, or penicillamine may be allergic to cephalosporins. Caution is recommended when cephalosporins are administered to patients with a history of penicillin anaphylaxis.
Pregnancy:
Adequate and well-controlled studies in humans have not been done. However, studies in animals have not shown that cephalosporins cause adverse effects on the fetus. Use only when potential benefits outweigh potential hazards to the fetus.
Lactation:
CEPHRADINE is excreted in breast milk, usually in low concentrations. However, problems in humans have not been documented.
CEPHRADINE may give false - positive or falsely elevated test results with Benedict’s or Fehling’s tests. Direct Coomb’s test may become positive in neonates whose mothers receive CEPHRADINE before delivery.
As with all cephalosporins, prolonged or repeated CEPHRADINE therapy may result in bacterial or fungal overgrowth of nonsusceptible organisms, in which case appropriate measures should be taken.

Drug Interactions
Probencid delays excretion of CEPHRADINE.

Contra_indications
Hypersensitivity to cephalosporins or related antibiotics.

Side effects
As with all cephalosporins, gastrointestinal disturbances or hypersensitivity phenomena may occasionally occur.
IM administration may result in pain, temperature elevation or tenderness while IV or IM administration may produce local swelling, inflammation, burning, paresthesia, phlebitis or thrombophlebitis.
Transient increase in BUN, ALT (SGPT), AST (SGOT), serum alkaline phosphatase, or serum bilirubin may occasionally occur.
Serum LDH may transiently increase with parenteral administration.

Presentation
CEPHRADINE 500 mg Vials : Box of 1 vial + 1 ampoule solvent.
CEPHRADINE 1 g Vials : Box of 1 vial + 1(5 ml) ampoule solvent.