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Cephradine BP

SEFRAD
Presentation
SEFRAD 250 mg Capsules: Light caramel and dark brown capsules imprinted with company logo and ‘SEFRAD 250 mg’; each capsule contains cephradine BP 250 mg. SEFRAD 500 mg Capsules: Caramel and black capsules imprinted with company logo and ‘SEFRAD 500 mg’; each capsule contains cephradine BP 500 mg. SEFRAD Syrup: Bottles containing powder for preparation of 100 ml of yellow coloured, banana flavoured syrup; when reconstituted each 5 ml contains cephradine BP 125 mg. SEFRAD 250 mg Injection: Powder in vials containing cephradine with arginine equivalent to 250 mg cephradine USP. SEFRAD 500 mg Injection: Powder in vials containing cephradine with arginine equivalent to 500 mg cephradine USP.
Microbiology
The wide range of micro-organisms that have shown ‘in vitro’ sensitivity to cephradine include:
Gram-positive
Gram-negative
Staphylococcus aureus
Escherichia coli
Staphylococcus epidermidis
Proteus mirabilis
Streptococcus pyogenes
Klebsiella spp
Streptococcus pneumoniae
Neisseria gonorrhoeae
Streptococcus viridans
Haemophilus influenzae
Streptococcus faecalis
Shigella spp
Peptococcus
Salmonella spp.
Peptostreptococcus
Gardnerella vaginalis

Cephradine is relatively more resistant to hydrolysis by beta-lactamases and hence many strains of both Gram-positive and Gram-negative bacteria capable of producing beta-lactamase are susceptible to cephradine but resistant to many other broad spectrum antibiotics.

Uses
SEFRAD is a broad spectrum bactericidal antibiotic of the cephalosporin group active against a wide range of infections caused by susceptible Gram-positive and Gram-negative organisms. SEFRAD is indicated for the treatment of the following bacterial infections: Upper respiratory tract, ENT infections: Pharyngitis, Tonsillitis, Laryngo-Tracheitis, Sinusitis, Otitis media. Lower respiratory tract infections: Acute and chronic bronchitis, Lobar and broncho-pneumonia. Urinary tract infections: Cystitis, Urethritis, Pyelonephritis, Prostatitis, Epididymitis. Skin and soft tissue infections: Abscess, Cellulitis, Furunculosis, lmpetigo. Gastro-intestinal tract infections: Bacillary dysentery, Enteritis, Peritonitis. Infections in the bones and joints. Septicaemia Endocarditis SEFRAD is also of value for the prophylaxis of post-operative infections, in patients undergoing surgical procedures associated with a high risk of infection. As in the case of any antimicrobial agent, before instituting therapy with cephradine, necessary bacteriological studies should be performed to identify the causative organisms and their sensitivity to cephradine.

Dosage and administration
Adults:
Oral: The usual dosage range is 1-2 gm daily in two or four equally divided doses. Severe or chronic infectiuns rnay require larger doses upto 4 gm daily in divided doses or as advised by the physician. Specific dosage recommendations: Respiratory tract infections: 250 mg to 500 mg four times daily or 500 mg to 1 g twice daily Urinary tract infections 500 mg four times daily or 1 g twice daily. Skin and soft tissue infections: 250 mg four times daily or 500 mg to 1 g twice daily. Gastro-intestinal tract infections 500 mg three to four times daily. Parenteral: 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:
Oral: The usual dose is 25 to 50 mg/kg/day, given in two or four equally divided doses. The oral dosages should be taken before meals. Parenteral The usual dose is 50-100 mg/kg/ day, given in four equally divided doses. More serious infections may require 200-300 mg/kg/ day. Elderly: There are no specific dosage recommendations or precautions for use in the elderly except, as with other drugs, to monitor those patients with impaired renal or hepatic functions. Larger oral doses (upto 1 gm four times daily) may be given to all patients, irrespective of age and weight, for chronic infections or depending on the severity or site of infections. Therapy should be continued for a minimum of 48-72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In infections caused by beta-haemolytic strains of streptococci, a minimum of 10 days treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis. In the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisal is necessary during therapy and may be necessary for several months afterwards.Persistent infections may require treatment for several weeks. Doses for children should not exceed doses recommended for adults.
Dosage in renal impairment:
A modified dosage schedule in patients with decreased renal function is necessary. Each patient should be considered individually; the following reduced dosage schedule is recommended as a guideline, based on the creatinine clearance (m/min/1.73 m2). In adults, the initial loading dose is 750 mg of SEFRAD and the maintenance dose is 500 mg at the following time intervals:

Creatinine clearance
Time interval
More than 20 m/min
6-12 hours
15-19 ml/min
12-24 hours
10-14 mlmin
40-50 hours
5-9 ml/min
50-70 hours
Less than 5 mlmin


Further modification of the dosage schedule may be necessary in children. Surgical prophylaxis: The recommended dose for surgical prophylaxis is a single pre-operative 1-2 im or iv dose.Subsequent parenteral or oral doses can be administered as appropriate.

Administration:
Oral: Using capsule or syrup.
Intramuscular:
250 mg: add 1.2 mi Water for Injection BP and shake vigorously.
500 mg : Add 2,0 ml Water for lnjection BP and shake vigorously.
Intravenous:
250 mg: Dissolve in 5 ml of Water for Injection BP.
500 mg: Dissolve in 5 ml of Water for Injection BP.
The solution may be slowly injected directly into a vein over a 3 to 5 minute period. Solutions should be used within 2 hours when kept at room temperature. When stored at 5° C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however this does not affect the potency.

Contra-indications, warnings, etc.
Contra-indications: SEFRAD is contra-indicated in patients with known hypersensitivity to the cephalosporin antibiotics. Precautions: There is evidence of partial cross allergenicity between the penicillins and the cephalosporins. Therefore cephradine should be used with caution in those patients with known hypersensitivity to penicillins. As with all antibiotics, prolonged use may result in overgrowth of non-susceptible organisms. A false positive reaction for glucose in the urine may occur with reducing substances but not with enzyme-based tests.Administration in renal failure : A modified dosage schedule in patients with decreased renal function is necessary (see dosage). Pregnancy and breast feeding: Animal studies with cephradine have shown no teratogenicity. When antibiotic therapy is indicated during pregnancy SEFRAD may be considered appropriate. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Side-effects: Side-effects are limited essentially to gastro-intestinal disturbances and on occasion to hypersensitivity phenomena. The latter are more likely to occur in individuals who have previously demonstrated hypersensitivity and those with a history of allergy, asthma, hay fever or urticarias. The majority of reported side-effects have been mild. Skin reactions have occasionally been reported. Adverse reaction reports are rare, but includeglossitis, heart burn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candidal overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains and oedema. As with other cephalosporins, mild transient eosinophilia, eucopenia and neutropenia, positive direct Coombs test and pseudomembraneous colitis have been reported. Rarely have these side effects been severe enough to warrant cessation of therapy. As with other parenterally administered antibiotics, transient pain may be experienced at the injection site, but is seldom the cause for discontinuing treatment. Thrombophlebitis has been reported following intravenous injection. Since sterile abscesses have been reported following accidental subcutaneous injection, the preparation should be administered by deep intramuscular injection. Clinical chemistry: Isolated instances of mild elevations of BUN, SGOT, SGPT, total bilirubin and alkaline phosphatase have been observed, but in most cases, the values tend to return to normal at the end of the therapy. No consistent pattern was observed that would suggest hepatocellular damage.

Pharmaceutical precautions
Storage: SEFRAD capsules and dry powder for syrups should be stored in a cool place. SEFRAD syrup should be freshly prepared. Reconstituted syrup should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Solutions of cephradine should be protected from concentrated light or direct sunlight.

Package quantities
SEFRAD 250 mg capsules: cartons of 20 capsules in strip. Capsules SEFRAD 500 mg Capsules: cartons of 20 in strip. SEFRAD Syrup: Bottles containing powder to produce 100 ml of syrup when reconstituted. SEFRAD 250 mg injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 250 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.SEFRAD 500 mg Injection: Cartons of 10 combipacks. Each combipack contains 1 vial of 500 mg and 1 ampoule of 5 ml Water for Injection BP for dilution.

Ref. FISONS (BANGLADESH) LIMITED