Indications of Sefril 500

Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-

• Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngotracheobronchitis, and otitis media, and also
• Lower respiratory tract infections: bronchitis (acute and chronic), 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 susceptible, in vitro to Cephradine:

• Gram-positive: Staphylococci (both penicillin-sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta-hemolytic), Streptococcus pneumonia.
• Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin-resistant, are susceptible to Cephradine which is unaffected by this enzyme.

Pharmaceutical Name of Sefril 500

ACME Laboratories Ltd.

Pharmacology

Cephradine could be a semisynthetic wide range bactericidal anti-microbial, it is dynamic against contaminations caused by both gram-positive and gram-negative microorganisms. Both penicillinases creating and nonproducing staphylococci are delicate to Cephradine. The most location of activity of Cephradine is the cell divider of microscopic organisms. Cell divider of touchy living being contains peptidoglycan. Cephradine restrains cross-linking handle and as a result cell divider with numerous pores is shaped, hence lysis of microbes happen due to outside osmotic pressure.

Dosage & Administration

For oral administration-Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections that 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 size 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 size and severity of the infection.

Children:

• A total daily dose of 25 to 50mg/kg is 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 Sefril 500

The concomitant utilizes of nephrotoxic drugs such as aminoglycosides with Cefradine may increment the chance of kidney harm. Diuretics (e.g., frusemide, ethacrynic corrosive) and probenecid upgraded the plausibility of renal harmfulness.

Contraindications

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

Side Effect of Sefril 500

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter is more likely to occur in individuals, who have previously demonstrated hypersensitivity and those with a history of allergy, asthma, hay fever, or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, edema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anemia and hemolytic anemia)
• Immune system disorders- Unknown: Fever, serum sickness-like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Pregnancy & Lactation

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Precautions & Warnings

• Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
• Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
• Cephalosporin antibiotics may cause a positive result in Combs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labor, it should be noted that a positive result may be due to the drug.
• Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clingiest are used in the testing. This does not occur with enzyme-based tests (e.g., Clinistix, Diastix).
• Dosage adjustment is necessary for renal impairment.
• This product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Therapeutic Class

First-generation Cephalosporins.

Storage Conditions

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days if kept in a refrigerator. Cephradine Injection 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 color from light to straw yellow; however, this does not affect the potency. Do not use it later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Generic of Sefril 500

Cephradine.