1. Name Of The Medicinal Product
Distaclor/cefaclor 500mg capsules.
Distaclor/cefaclor 125mg/5ml.
Distaclor/cefaclor 250mg/5ml.
2. Qualitative And Quantitative Composition
Each capsule contains, as the active ingredient, cefaclor monohydrate PhEur, equivalent to 500mg of cefaclor base.
Each 5ml of reconstituted 125mg/5ml suspension contains, as the active ingredient, cefaclor monohydrate PhEur, equivalent to 125mg of cefaclor base.
Each 5ml of reconstituted 250mg/5ml suspension contains, as the active ingredient, cefaclor monohydrate PhEur, equivalent to 250mg of cefaclor base.
3. Pharmaceutical Form
500mg capsule, size 0, with opaque purple cap and opaque grey body
Granules for oral suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
Distaclor is indicated for the treatment of the following infections due to susceptible micro
Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of sinusitis
Otitis media
Skin and soft tissue infections
Urinary tract infections, including pyelonephritis and cystitis
Distaclor has been found to be effective in both acute and chronic urinary tract infections.
Cefaclor is generally effective in the eradication of streptococci from the nasopharynx, however, data establishing efficacy in the subsequent prevention of either rheumatic fever or bacterial endocarditis are not available.
4.2 Posology And Method Of Administration
Distaclor is administered orally.
Adults: The usual adult dosage is 250mg every eight hours. For more severe infections or those caused by less susceptible organisms, doses may be doubled. Doses of 4g per day have been administered safely to normal subjects for 28 days, but the total daily dosage should not exceed this amount.
Distaclor may be administered in the presence of impaired renal function. Under such conditions, dosage is usually unchanged (see 'Special warnings and special precautions for use').
Patients undergoing haemodialysis: Haemodialysis shortens serum half
The elderly: As for adults.
Children: The usual recommended daily dosage for children is 20mg/kg/day in divided doses, every eight hours, as indicated. For bronchitis and pneumonia, the dosage is 20mg/kg/day in divided doses, administered 3 times daily. For otitis media and pharyngitis, the total daily dosage may be divided and administered every 12 hours. Safety and efficacy have not been established for use in infants aged less than one month.
Distaclor Suspension
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In more serious infections, otitis media, sinusitis and infections caused by less susceptible organisms, 40mg/kg/day in divided doses is recommended, up to a daily maximum of 1g.
In the treatment of beta
4.3 Contraindications
Hypersensitivity to cephalosporins.
4.4 Special Warnings And Precautions For Use
Warnings
Before instituting therapy with cefaclor, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins or other drugs. Cefaclor should be given cautiously to penicillin
If an allergic reaction to cefaclor occurs, the drug should be discontinued and the patient treated with the appropriate agents.
Pseudomembranous colitis has been reported with virtually all broad
Precautions
Cefaclor should be administered with caution in the presence of markedly impaired renal function. Since the half
Broad
Prolonged use of cefaclor may result in the overgrowth of non
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In haematological studies or in transfusion cross
A false
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There have been rare reports of increased prothrombin time, with or without clinical bleeding, in patients receiving cefaclor and warfarin concomitantly. It is recommended that in such patients, regular monitoring of prothrombin time should be considered, with adjustment of dosage if necessary.
The renal excretion of cefaclor is inhibited by probenecid.
4.6 Pregnancy And Lactation
Usage in pregnancy: Animal studies have shown no evidence of impaired fertility or teratogenicity. However, since there are no adequate or well
Usage in nursing mothers: Small amounts of cefaclor have been detected in breast milk following administration of single 500mg doses. Average levels of about 0.2 micrograms/ml or less were detected up to 5 hours later. Trace amounts were detected at one hour. As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to a nursing woman.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Gastro The most frequent side
Hypersensitivity: Allergic reactions such as morbilliform eruptions, pruritus and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness
There are rare reports of erythema multiforme major (Stevens
Rarely, hypersensitivity symptoms may persist for several months.
Haematological: Eosinophilia, positive Coombs' tests and, rarely, thrombocytopenia. Transient lymphocytosis, leucopenia and, rarely, haemolytic anaemia, aplastic anaemia, agranulocytosis and reversible neutropenia of possible clinical significance. See 'Interactions with other medicaments and other forms of interaction'.
Hepatic: Transient hepatitis and cholestatic jaundice have been reported rarely, slight elevations in AST, ALT or alkaline phosphatase values.
Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis.
Central nervous system: Reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Miscellaneous: Genital pruritus, vaginitis and vaginal moniliasis.
4.9 Overdose
Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
Treatment: Unless 5 times the normal total daily dose has been ingested, gastro
General management may consist of supportive therapy.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Cefaclor is active against the following organisms in vitro:
Alpha
Staphylococci; including coagulase
Streptococcus pneumoniae
Streptococcus pyogenes (group A beta
Branhamella catarrhalis
Escherichia coli
Proteus mirabilis
Klebsiella species
Haemophilus influenzae, including ampicillin
Cefaclor has no activity against Pseudomonas species or Acinetobacter species. MethicillinStr. faecalis) are resistant to cefaclor. Cefaclor is not active against most strains of Enterobacter spp, Serratia spp, Morganella morganii, Proteus vulgaris and Providencia rettgeri.
5.2 Pharmacokinetic Properties
Cefaclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration achieved is 50
5.3 Preclinical Safety Data
There are no preclinical 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
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6.2 Incompatibilities
None Known.
6.3 Shelf Life
Capsule: 3 years.
Suspensions: 24 months.
6.4 Special Precautions For Storage
Capsule: Store below 25°C. Keep containers tightly closed and protect from light.
Suspensions: Store at room temperature (15
6.5 Nature And Contents Of Container
Capsule: High
Suspensions: The product is filled into high
6.6 Special Precautions For Disposal And Other Handling
Capsule: None.
Suspensions: When dilution is unavoidable, syrup BP should be used after the suspension has been prepared according to the manufacturer's instruction.
7. Marketing Authorisation Holder
Flynn Pharma Limited
Alton House
4 Herbert Street
Dublin
Ireland
8. Marketing Authorisation Number(S)
500 mg capsule: PL 13621/0008
125mg/5ml suspension: PL 13621/0009
250mg/5ml suspension: PL 13621/0010
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 21 August 1978
Date of last renewal of authorisation: Capsule: 4 October 1994
Suspensions: 29 July 1994
10. Date Of Revision Of The Text
Capsule: Nov 2005
Suspensions: April 1999
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