| SPC | Cefradine 500mg Capsules |
1. Name of the medicinal product
| Cefradine 500mg Capsules |
2. Qualitative and quantitative composition
| Each capsule contains 500mg cefradine anhydrous For excipients, see section 6.1. |
3. Pharmaceutical form
| Capsule, hard. |
4. Clinical particulars
4.1 Therapeutic indications
| Cefradine
500mg Capsules are used in the treatment of bacterial infections of the
respiratory and urinary tracts and of the skin and soft tissues. These
include the following: Upper respiratory tract infections - sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media. Lower respiratory tract infections - acute and chronic bronchitis, lobar and bronchopneumonia. Urinary tract infections - cystitis, urethritis and pyelonephritis. Skin and soft tissue infections - impetigo, abscess, cellulitis, furunculosis. Cefradine 500mg Capsules are also used in the prophylaxis of postoperative infections following surgical procedures associated with a high risk of infection and for patients with a reduced host resistance to bacterial infection. Cefradine should be administered immediately prior to surgery in order to ensure sufficient local tissue concentrations at the time that contamination is likely to occur. Treatment should be continued during the post operative period. Laboratory testing should be carried out to determine the causative agents and their sensitivity to cefradine. However, therapy may commence prior to receipt of the sensitivity test results. |
4.2 Posology and method of administration
| Adults Respiratory tract infections and skin and soft tissue infections - the usual dose is 250mg or 500mg four times daily or 500mg or 1g twice daily depending on the severity and site of infection. Urinary tract infections - the usual dose is 500mg four times daily or 1g twice daily. This may need to be increased for severe or chronic infections. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. Elderly As for adults. Patients with impaired renal or hepatic function should be monitored as modifications of the dosage schedule may be required. Children The usual dose is 25 to 50 mg/kg/day total, given in two or four equally divided doses. For otitis media daily doses from 75 to 100mg/kg in divided doses every 6 to 12 hours are recommended. Maximum dose 4g per day. Cefradine may be taken without regard to meals. In the case of severe or chronic infection larger doses of up to 1g four times daily may be given. Administration should be continued for a minimum of 48-72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. For infections caused by haemolytic strains of streptococci, a minimum of 10 days treatment is recommended to guard against the risk of rheumatic fever or glomerulo-nephritis. For the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Persistent infections may require treatment for several weeks. Smaller doses than those indicated above should not be used. Doses for children should not exceed those recommended for adults. As cefradine is available in both injectable and oral forms, patients may be changed from injection to capsules at the same dosage level. Dosage in renal impairment: For patients not on dialysis: The following dosage schedule guideline is based on a dosage of 500mg 6 hourly and on creatinine clearance:
For patients on chronic, intermittent haemodialysis:
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4.3 Contraindications
| Use in patients with a history of hypersensitivity to the cephalosporin antibiotics or to any component of the formulation. |
4.4 Special warnings and precautions for use
| Following
administration of cefradine, a false positive reaction for glucose in
the urine may occur with Benedict's or Fehling's solution or with
reagent tablets such as Clinitest. This does not occur with enzyme based
tests such as Clinistix or Diastix. Prolonged use of antibiotics may result in overgrowth of non-susceptible organisms. There is evidence of partial allergenicity between the penicillins and the cephalosporins. Therefore, cefradine should be used with caution in those patients with known hypersensitivity to penicillins. There have been instances of patients who have had reactions to both drug classes (including anaphylaxis). Dosage should be reduced in renal failure (see section 4.2). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. |
4.5 Interaction with other medicinal products and other forms of interaction
| Loop diuretics may increase nephrotoxicity of cephalosporins. Probenecid has been seen to raise serum concentrations of cefradine, by reducing renal clearance of the cephalosporins. |
4.6 Pregnancy and lactation
| Although animal studies have shown no teratogenic effects, safety in pregnancy has not been established. As with all medicines, use should be avoided in pregnancy especially in the first trimester, unless considered essential by the physician. Cefradine is excreted in breast milk and therefore should be used with caution in lactating mothers. |
4.7 Effects on ability to drive and use machines
| Since this medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles. |
4.8 Undesirable effects
Undesirable
effects are uncommon and mainly mild in nature. They are limited
essentially to gastrointestinal disturbances and on occasion to
hypersensitivity phenomena.
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4.9 Overdose
| None known. |
5. Pharmacological properties
5.1 Pharmacodynamic properties
| Cefradine
is an antibiotic agent with a broad spectrum of activity against both
Gram-positive and Gram-negative bacteria. It is also highly active
against most strains of penicillinase-producing Staphylococci. Microbiology The following organisms have shown in vitro sensitivity to cefradine: Gram-positive Staphylococci (both penicillin sensitive and resistant strains), Streptococci, Streptococcus pyogenes (beta haemolytic) and Streptococcus pneumoniae. Gram-negative Escherichia coli, Klebsiella spp., Proteus mirabilis, Haemophilus influenza, Shigella spp., Salmonella spp. (including Salmonella typhi) and Neisseria spp. Because cefradine is unaffected by penicillinase, many strains of Escherichia coli and Staphylococcus aureus which produce this enzyme are susceptible to cefradine but resistant to ampicillin. |
5.2 Pharmacokinetic properties
| Cefradine
has a high degree of stability to many beta-lactamases. It has a low
degree of protein binding and a large volume of distribution. Therefore,
tissue levels are generally found to be high. Oral cefradine can be given twice or four times daily and is well absorbed. Cefradine is acid stable and is rapidly absorbed following oral administration in the fasting state. Following doses of 250mg, 500mg and 1000mg average peak serum levels of approximately 9, 16.5, and 24.2 micrograms/ml, respectively, were obtained at one hour. The presence of food in the gastrointestinal tract delays the absorption but does not affect the total amount of cefradine absorbed. Measurable serum levels are present six hours after administration. Over 90% of the drug is excreted unchanged in the urine within 6 hours. Peak urine concentrations are approximately 1600 micrograms/ml following a 250mg dose, 3200 micrograms/ml following a 500mg dose, and 4000 micrograms/ml following a 1000mg dose. After 48 hours administration of 100mg/kg/day of cefradine for the treatment of otitis media, cefradine has been measured in the middle ear exudate at an average level of 3.6 microgram/ml. |
5.3 Preclinical safety data
| There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SPC. |
6. Pharmaceutical particulars
6.1 List of excipients
| Magnesium stearate Lactose monohydrate The capsule shell contains: Gelatin Titanium dioxide (E171) Indigo carmine (E132) |
6.2 Incompatibilities
| None. |
6.3 Shelf life
| 24 months. |
6.4 Special precautions for storage
| Do not store above 25°C. |
6.5 Nature and contents of container
| PVC/PVDC blister foil, 0.25 +/- 5% mm thick with an aluminium lidding foil 0.025 mm thick containing 10, 20 or 100 capsules. |
6.6 Special precautions for disposal and other handling
| No special instructions. |
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