Indications of SK-Cef 500

Cephradine is used to treat infections caused by

• Gram-positive and Gram-negative bacteria that are susceptible to antibiotics. Undesirable is one of them. Lower respiratory tract infections include bronchitis (acute and chronic), lobar pneumonia, and bronchopneumonia. Upper respiratory tract infections include sinusitis, pharyngitis, tonsillitis, laryngo-tracheobronchitis, and otitis media.
• Infections in the urinary system include cystitis, urethritis, and pyelonephritis.
• Abscess, cellulitis, furunculosis, and impetigo are all skin and soft tissue infections.
• Cephradine is sensitive to the following bacteria in vitro:
• Gram-positive bacteria include Staphylococci (including penicillin-sensitive and resistant strains, as well as species that produce penicillinase), Streptococci, Streptococci pyogenes (beta haemolytic), and Streptococcus pneumonia.

Gram-negative organisms include E. coli, Klebsiella spp., Proteus mirabilis, Haemophilus influenzae, Shigella spp., Salmonella spp. (including Salmonella typhi), and Neisseria spp. Many E. coli and Staphylococcus aureus strains that generate the enzyme penicillinase and are consequently ampicillin resistant are sensitive to Cephradine, which is not affected by this enzyme.

Pharmaceutical Name of SK-Cef 500

Eskayef Pharmaceuticals Ltd.

Pharmacology

Cephradine is a semisynthetic broad range bactericidal antibiotic that is effective against both gram-positive and gram-negative bacteria. Cephradine is toxic to both penicillinase-producing and non-producing staphylococci. Cephradine’s principal site of action is the bacterial cell wall. Peptidoglycan is found in the cell wall of sensitive organisms. Cephradine inhibits cross-linking, resulting in the formation of a cell wall with numerous holes, resulting in bacterial lysis owing to external osmotic pressure.

Dosage & Administration

For oral administration–
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration–

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Interaction of SK-Cef 500

When nephrotoxic medicines like aminoglycosides are used with Cefradine, the risk of kidney damage increases. Renal toxicity was increased by diuretics (e.g., frusemide, ethacrynic acid) and probenecid.

Contraindications

Cephradine should not be administered in individuals who have a known or suspected cephalosporin hypersensitivity.

Side Effect of SK-Cef 500

Mostly limited to gastrointestinal issues and, on rare cases, hypersensitivity reactions. Individuals who have previously exhibited hypersensitivity, as well as those with a history of allergy, asthma, hay fever, or urticaria, are more prone to develop the latter. Skin responses have been observed on occasion. Glossitis, heartburn, dizziness, chest tightness, nausea, vomiting, diarrhoea, stomach discomfort, vaginitis, candida overgrowth are all uncommon symptoms. Urticaria, skin rashes, joint aches, and oedema are examples of skin and hypersensitivity responses.

• Disorders of the blood and lymphatic system- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Fever, serum sickness-like responses, and anaphylaxis are examples of immune system diseases that are unknown.
• Unknown psychiatric disorders: confusion, sleep problems, etc.
• Hyperactivity, hypertonia, dizziness, and anxiety are examples of nervous system diseases that are unknown. Headache is a rare occurrence.
• Liver, enzyme abnormalities, transitory hepatitis, and cholestatic jaundice are examples of hepatobiliary diseases with an unknown frequency.
• Unknown: reversible interstitial nephritis Renal and urinary diseases.
• Unknown: Increased blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, and alkaline phosphatase levels.

Pregnancy & Lactation

Although there has been no evidence of teratogenicity in animal tests, safety in pregnancy has not been proven. Cephradine is secreted in breast milk, thus it should be avoided by nursing women. Patients should be advised about driving dangerous machinery, such as vehicles, because the medication may produce dizziness.

Precautions & Warnings

• Disorders of the blood and lymphatic system- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Fever, serum sickness-like responses, and anaphylaxis are examples of immune system diseases that are unknown.
• Unknown psychiatric disorders: confusion, sleep problems, etc.
• Hyperactivity, hypertonia, dizziness, and anxiety are examples of nervous system diseases that are unknown. Headache is a rare occurrence.
• Liver, enzyme abnormalities, transitory hepatitis, and cholestatic jaundice are examples of hepatobiliary diseases with an unknown frequency.
• Unknown: reversible interstitial nephritis Renal and urinary diseases.
• When Benedict’s or Fehling’s solutions or Clinitest tablets are employed in the testing, cephradine may induce a false positive urine glucose result. With enzyme-based testing, this does not happen (e.g. Clinistix, Diastix).
• Renal insufficiency necessitates dosage adjustments.
• Lactose is included in this product. This drug should not be used by those who have a rare inherited issue with galactose intolerance, Lapp lactase insufficiency, or glucose-galactose malabsorption.

Therapeutic Class

First generation Cephalosporins

Storage Conditions

Cephradine Suspension should be made as soon as possible. If maintained at room temperature, the reconstituted suspension should be used within 7 days; if kept in the refrigerator, it should be used within 14 days. When stored at room temperature, Cephradine Injection solutions should be used within 2 hours. Solutions keep their potency for 12 hours when kept at 5°C. The color of reconstituted solutions can range from pale to straw yellow, although this has no bearing on their effectiveness. Do not use beyond the expiration date. All medications should be kept out of the reach of youngsters. Only on a qualified physician’s prescription can it be dispensed.

Generic of SK-Cef 500

Cephradine