Roxicef
Cephradine 500 mg
 
   
      Description

Cephradine is a semisynthetic Cephalosporin antibiotic. This semi-synthetic Cephalosporin is very similar to Cephalexin. Cephradine is marketed in both oral and parenteral form. Cephradine is active against the following organisms in vitro: Group A beta-hemolytic Streptococci, Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains Streptococcus pneumoniae (formerly Diplococcus pneumoniae), Escherichia coli, Proteus mirabilis, Klebsiella species, Hemophilus influenzae.

Indications

Cephradine is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory Tract Infections, like- tonsillitis, pharyngitis and lobar pneumonia (caused by group A beta-hemolytic Streptococci and S. pneumoniae), Otitis Media (caused by group A beta-hemolytic Streptococci, S. pneumoniae, H. influenzae, and Staphylococci), Skin and Skin Structure Infections (caused by Staphylococci and beta-hemolytic Streptococci. Urinary Tract Infections including prostatitis (caused by E. coli, P. mirabilis, Klebsiella species, and Enterococci (S. faecalis). The high concentrations of Cephradine achievable in the urinary tract will be effective against many strains of Enterococci for which disc susceptibility studies indicate relative resistance.

Dosage and Administrations

Cephradine may be given without regard to meals. Adults: For respiratory tract infections and skin and skin structure infections, the usual dose is 250 mg every 6 hours or 500 mg every 12 hours. For lobar pneumonia, the usual dose is 500 mg every 6 hours or 1 g every 12 hours. For uncomplicated urinary tract infections, the usual dose is 500 mg every 12 hours. In more serious urinary tract infections, including prostatitis, 500 mg every 6 hours or 1 g every 12 hours may be administered. Larger doses (up to 1 g every 6 hours) may be given for severe or chronic infections. Children: No adequate information is available on the efficacy of b.i.d. regimens in children under nine months of age. The usual dose in children over nine months of age is 25 to 50 mg/kg/day administered in equally divided doses every 6 or 12 hours. For otitis media due to H. influenzae, doses are from 75 to 100 mg/kg/day administered in equally divided doses every 6 or 12 hours, but should not exceed 4 g per day. Dosage for children should not exceed dosage recommended for adults. All patients, regardless of age and weight, larger doses (up to 1 g q.i.d.) may be given for severe or chronic infections.

Side Effects

As with other Cephalosporins, untoward reactions are limited essentially to gastrointestinal 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 urticaria. The following adverse reactions have been reported following the use of Cephradine: Gastrointestinal: Symptoms of pseudomembranous colitis can appear during antibiotic treatment. Nausea and vomiting have been reported rarely. Skin and hypersensitivity reactions: Mild urticaria or skin rash, pruritus, and joint pains were reported by very few patients. Hematologic: Mild, transient eosinophilia, leukopenia, and neutropenia have been reported. Liver: Transient mild rise of SGOT, SGPT, and total bilirubin have been observed with no evidence of hepatocellular damage. Renal: Transitory rises in BUN have been observed in some patients treated with Cephalosporins; their frequency increases in patients over 50 years old. In adults for whom serum creatinine determinations were performed, the rise in BUN was not accompanied by a rise in serum creatinine. Others: Other adverse reactions have included dizziness and tightness in the chest and candidal vaginitis.


Contraindications

Cephradine is contraindicated in patients with known hypersensitivity to the Cephalosporin group of antibiotics.

Drug Interactions

When administered concurrently, the following drugs may interact with Cephalosporins. Other Antibacterial Agents - Bacteriostats may interfere with the bactericidal action of Cephalosporins in acute infection; other agents, e.g., Aminoglycosides, Colistin, Polymyxins and Vancomycin may increase the possibility of nephrotoxicity. Diuretics (potent "loop diuretics," e.g., Furosemide and Ethacrynic acid) - Enhanced possibility for renal toxicity. Probenecid - Increased and prolonged blood levels of Cephalosporins, resulting in increased risk of nephrotoxicity.

Precautions

Patients should be followed carefully so that any side effects or unusual manifestations of drug idiosyncrasy may be detected. If a hypersensitivity reaction occurs, the drug should be discontinued and the patient treated with the usual agents, e.g., pressor amines, antihistamines, or corticosteroids. Administer Cephradine with caution in the presence of markedly impaired renal function. In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy as Cephradine accumulates in the serum and tissues. Cephradine should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms.

Overdosage
The risk of adverse reactions is increased.

Pharmaceutical Precautions
Store in a cool dry place protected from light. Keep out of reach of children.

Commercial Pack
Roxicef ® 500 capsule: Each capsule contains Cephradine USP equivalent to 500 mg Anhydrous Cephradine and each box contains 5X4 capsules in Alu-Alu blister pack.