Procef Suspension

Indications

Procef is prescribed for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. Its indications include:

• Upper Respiratory Tract Infections: Such as sinusitis, pharyngitis, tonsillitis, laryngotracheobronchitis, and otitis media.
• Lower Respiratory Tract Infections: Including acute and chronic bronchitis, lobar pneumonia, and bronchopneumonia.
• Urinary Tract Infections: Such as cystitis, urethritis, and pyelonephritis.
• Skin and Soft Tissue Infections: Including abscesses, cellulitis, furunculosis, and impetigo.

Susceptible Microorganisms
Procef has demonstrated in vitro efficacy against the following microorganisms:

• Gram-positive Bacteria: Staphylococci (both penicillin-sensitive and resistant strains, including penicillinase-producing species), Streptococci, beta-hemolytic Streptococcus pyogenes, and Streptococcus pneumoniae.
• Gram-negative Bacteria: Escherichia coli, Klebsiella species, Proteus mirabilis, Haemophilus influenzae, Shigella species, Salmonella species (including Salmonella typhi), and Neisseria species. Notably, many E. coli strains and Staphylococcus aureus that produce penicillinase, which typically confer ampicillin resistance, remain susceptible to Procef, as this antibiotic is unaffected by that enzyme.

Usage should follow the guidance of a registered healthcare professional.

Pharmacology

Cephradine, the active ingredient in Procef, is a semisynthetic, broad-spectrum bactericidal antibiotic. It effectively targets infections caused by both Gram-positive and Gram-negative microorganisms, including both penicillinase-producing and non-producing strains of staphylococci. The primary action of Cephradine occurs at the bacterial cell wall, where it interferes with the cross-linking of peptidoglycan. This disruption results in a weakened cell wall with multiple pores, leading to bacterial lysis due to osmotic pressure.

Dosage & Administration

For Oral Administration
Adults:

• Urinary Tract Infections: 500 mg four times daily or 1 g twice daily. Higher doses may be necessary for severe or chronic infections, including prostatitis and epididymitis.
• Respiratory Tract Infections: 250 to 500 mg four times daily or 500 mg to 1 g twice daily, depending on the infection’s site and severity.
• Skin and Soft Tissue Infections: 250 to 500 mg four times daily or 500 mg to 1 g twice daily, as indicated.

Children:

• Total daily dose of 25 to 50 mg/kg, divided into two to four doses.
• For otitis media: Total daily dose of 75 to 100 mg/kg, divided every 6 to 12 hours.
• Maximum daily dosage: 4 g.

Elderly: Standard adult dosages apply. Close monitoring is essential for patients with renal or hepatic impairments.

For Injectable Administration
Adults: Typically, 2-4 g daily in four divided doses, with a maximum of 8 g daily. For prophylaxis, a single preoperative dose of 1-2 g may be administered intramuscularly or intravenously.
Children: Dosage ranges from 50 to 100 mg/kg daily, given in four divided doses, with a maximum of 300 mg/kg daily for severe infections.

Usage should follow the guidance of a registered healthcare professional.

Interactions

Concurrent use of nephrotoxic agents such as aminoglycosides with Cephradine may heighten the risk of renal impairment. Additionally, diuretics (e.g., furosemide, ethacrynic acid) and probenecid may increase the potential for renal toxicity.

Contraindications

Cephradine is contraindicated in individuals with known or suspected hypersensitivity to cephalosporins.

Side Effects

Side effects are primarily limited to gastrointestinal disturbances, with occasional hypersensitivity reactions. Those with a history of allergies, asthma, hay fever, or urticaria are more susceptible. Skin reactions, while rare, may occur. Other uncommon side effects include glossitis, heartburn, dizziness, chest tightness, nausea, vomiting, diarrhea, abdominal pain, vaginitis, and candidiasis.

Blood and Lymphatic System Disorders: Unknown occurrences of blood disorders (thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia).

Immune System Disorders: Unknown reactions like fever, serum sickness-like symptoms, and anaphylaxis.

Nervous System Disorders: Unknown symptoms include hyperactivity, hypertonia, dizziness, and occasionally headaches.

Hepatobiliary Disorders: Unknown frequencies of liver enzyme disturbances, transient hepatitis, and cholestatic jaundice.

Renal and Urinary Disorders: Unknown incidences of reversible interstitial nephritis.

Investigations: Unknown elevations in blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, and alkaline phosphatase.

Pregnancy & Lactation

While animal studies have not indicated teratogenic effects, the safety of Cephradine during pregnancy has not been established. Cephradine is excreted in breast milk, and caution is advised for nursing mothers. Patients should be warned about the potential for dizziness, affecting the operation of machinery or driving.

Precautions & Warnings

• Extended use of antibacterial agents may lead to superinfection from resistant organisms.
• Caution is warranted for patients with a known hypersensitivity to penicillins due to potential cross-reactivity between beta-lactam antibiotics.
• Cephalosporins may yield a positive Coombs’ test result. Neonates whose mothers received cephalosporins before labor should be evaluated accordingly.
• Procef can produce a false positive urine glucose result using Benedict’s or Fehling’s solutions; however, this does not apply to enzyme-based tests (e.g., Clinistix, Diastix).
• Dose adjustments are necessary for patients with renal impairment.
• Procef contains lactose; those with rare hereditary galactose intolerance or lactase deficiency should avoid this medication.

Use in Special Populations

Renal Impairment: Adjusted doses for patients not on hemodialysis include:

• 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.

For patients on chronic, intermittent hemodialysis:

• 250 mg at the start of hemodialysis
• 250 mg 6 to 12 hours after initiation
• 250 mg 36 to 48 hours after starting
• 250 mg at the start of the next session if over 30 hours since the last dose.

Regardless of age or weight, higher doses of up to 1 g four times daily may be required for severe or chronic infections. Treatment should persist for at least 2 to 3 days after symptom resolution or bacterial eradication. To prevent rheumatic fever or glomerulonephritis from hemolytic streptococci infections, therapy should last for a minimum of 10 days. Regular bacteriological and clinical monitoring is recommended during chronic urinary tract infection treatment and for several months afterward.

Overdose Effects

Overdose symptoms may include non-specific issues such as nausea, vomiting, diarrhea, and gastrointestinal discomfort. Supportive care is primarily recommended, although gastric lavage may be necessary in cases of significant ingestion.

Therapeutic Class

First Generation Cephalosporins

Storage Conditions

Procef Suspension should be prepared fresh. The reconstituted suspension must be used within 7 days at room temperature or within 14 days if refrigerated. Procef Injection solutions should be administered within 2 hours at room temperature. When stored at 5°C, solutions remain potent for up to 12 hours. Variations in the color of reconstituted solutions from light to straw yellow do not affect potency. Avoid using beyond the expiration date. Keep all medications out of reach of children. Dispense only with a registered physician’s prescription.