Cephradine is indicated for the treatment of infections caused by susceptible Gram-positive and Gram-negative organisms. These include:

• Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngotracheobronchitis, and otitis media
• Lower respiratory tract infections: acute and chronic bronchitis, lobar pneumonia, and bronchopneumonia
• Urinary tract infections: cystitis, urethritis, and pyelonephritis
• Skin and soft tissue infections: abscess, cellulitis, furunculosis, and impetigo

The following microorganisms are generally susceptible to Cephradine (in vitro):

• Gram-positive: Staphylococci (including penicillin-sensitive and resistant strains, and penicillinase-producing species), Streptococci, Streptococcus pyogenes (beta-hemolytic), Streptococcus pneumoniae
• Gram-negative: Escherichia coli, Klebsiella spp., Proteus mirabilis, Haemophilus influenzae, Shigella spp., Salmonella spp. (including Salmonella typhi), Neisseria spp. Many strains of E. coli and Staphylococcus aureus that produce penicillinase (and are resistant to ampicillin) remain susceptible to Cephradine

Cephradine is a semisynthetic, broad-spectrum, bactericidal antibiotic that is active against infections caused by both Gram-positive and Gram-negative microorganisms. Both penicillinase-producing and non-penicillinase-producing staphylococci are sensitive to cephradine. Its principal site of action is the bacterial cell wall. The cell wall of susceptible organisms contains peptidoglycan, and cephradine inhibits the cross-linking process of this structure. As a result, the bacterial cell wall becomes defective and porous, leading to bacterial lysis under external osmotic pressure.

For oral administration-

Adults:

• Urinary tract infections: 500 mg four times daily or 1 g twice daily. Severe or chronic infections may require higher doses. In complicated cases (e.g., prostatitis, epididymitis), prolonged intensive therapy is needed.
• Respiratory tract infections: 250–500 mg four times daily or 500 mg–1 g twice daily, depending on the site and severity of infection.
• Skin and soft tissue infections: 250–500 mg four times daily or 500 mg–1 g twice daily, depending on the site and severity of infection.

Children:

• Total daily dose: 25–50 mg/kg in two or four divided doses
• Otitis media: 75–100 mg/kg/day in divided doses every 6–12 hours
• Maximum daily dose: 4 g

Elderly: Usual adult dose is recommended. Patients with impaired renal or hepatic function should be monitored during therapy.

For injectable administration-

Adult: Usual dose: 2–4 g daily in four equally divided doses; may be increased up to 8 g daily.For prophylaxis: a single preoperative dose of 1–2 g IM or IV

Children: 50–100 mg/kg/day in four equally divided doses. In severe infections: up to 300 mg/kg/day

Concomitant use of cephradine with nephrotoxic drugs such as aminoglycosides may increase the risk of renal damage. Diuretics such as frusemide and ethacrynic acid, as well as probenecid, may further increase the possibility of nephrotoxicity.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

Generally limited to gastrointestinal disturbances and occasional hypersensitivity reactions. These reactions are more likely in individuals with a prior history of hypersensitivity, allergy, asthma, hay fever, or urticaria. Skin reactions have occasionally been reported.Rare: Glossitis, heartburn, dizziness, chest tightness, nausea, vomiting, diarrhea, abdominal pain, vaginitis, and candida overgrowth. Skin and hypersensitivity reactions may include urticaria, rash, joint pain, and edema.

• Blood and lymphatic system disorders – Frequency unknown: Blood disorders such as thrombocytopenia, leucopenia, agranulocytosis, aplastic anemia, and hemolytic anemia
• Immune system disorders – Frequency unknown: Fever, serum sickness-like reactions, anaphylaxis
• Psychiatric disorders – Frequency unknown: Confusion, sleep disturbances
• Nervous system disorders – Frequency unknown: Hyperactivity, hypertonia, dizziness, nervousness
• Rare: Headache
• Hepatobiliary disorders – Frequency unknown: Liver enzyme abnormalities, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders – Frequency unknown: Reversible interstitial nephritis
• Investigations – Frequency unknown: Increased blood urea nitrogen, serum creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and alkaline phosphatase

Although animal studies have not shown any teratogenic effects, the safety of cephradine during pregnancy has not been established. Cephradine is excreted in breast milk and should therefore be used with caution in breastfeeding mothers. As this medicine may cause dizziness, patients should be advised to exercise caution when driving or operating hazardous machinery, including automobiles.

• Long-term use of anti-infective agents may lead to superinfection due to the emergence of resistant organisms
• Cephradine should be used cautiously in patients with penicillin hypersensitivity due to possible cross-reactivity among beta-lactam antibiotics
• Cephalosporins may cause a positive Coombs’ test; in neonates whose mothers received cephalosporins before delivery, a positive result may be drug-related
• Cephradine may produce false-positive urine glucose results with Benedict’s or Fehling’s solutions or Clinitest tablets; this does not occur with enzyme-based tests (e.g., Clinistix, Diastix)
• Dose adjustment is required in patients with renal impairment
• This product contains lactose; patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine

Renal Impairment:
The following doses are recommended for patients not on haemodialysis, based on a standard dose of 500 mg every 6 hours:

• CrCl >20 ml/min: 500 mg every 6 hours
• CrCl 5–20 ml/min: 250 mg every 6 hours
• CrCl <5 ml/min: 250 mg every 50–70 hours

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose

Additional Information for all patients. Regardless of age or body weight, higher doses of up to 1 g four times daily may be required for chronic or severe infections. Treatment should be continued for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the risk of rheumatic fever or glomerulonephritis following haemolytic streptococcal infections, therapy should continue for at least 10 days.

During treatment of chronic urinary tract infections and for several months afterward, regular bacteriological and clinical monitoring is necessary.
Doses lower than those recommended above should not be prescribed. Pediatric doses should not exceed the recommended adult doses, regardless of infection severity. In persistent infections, cephradine therapy may need to be continued for several weeks. Patients receiving intramuscular or intravenous cephradine may be switched to oral treatment at the same dosage level.

Symptoms of cephradine overdose are generally nonspecific and may include nausea, vomiting, diarrhea, and gastrointestinal upset. Treatment is mainly supportive, although gastric lavage may be necessary if a large amount has been ingested.

First-generation cephalosporin antibiotic.

Cephradine suspension should be prepared freshly. The reconstituted suspension should be used within 7 days if stored at room temperature, or within 14 days if refrigerated. Cephradine injection solutions should be used within 2 hours when kept at room temperature. If stored at 5°C, the solutions remain potent for up to 12 hours. Reconstituted solutions may vary in color from light yellow to straw yellow; however, this does not affect their potency. Do not use after the expiry date. Keep all medicines out of the reach of children. Dispense only on the prescription of a registered physician.