Flynn Pharma Ltd
Summary of Product Characteristics last updated on medicines.ie: 12/3/2018
Distaclor LA Tablets 375mg
Distaclor LA 375 mg prolonged-release tablets.
Each prolonged release tablet contains cefaclor monohydrate equivalent to 375 mg of cefaclor as active ingredient.
For a full list of excipients, see section 6.1.
Prolonged-release film-coated tablet.
Blue, capsule-shaped, film-coated tablets, engraved with GP5.
4.1 Therapeutic indications
Distaclor LA is indicated in the treatment of the following infections when caused by susceptible strains of the designated organisms:
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae, Moraxella catarrhalis (including beta-lactamase producing strains) and Staphylococcus aureus.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A streptococci).
Pneumonia caused by S. pneumoniae, H. influenzae (including beta-lactamase producing strains) and M. catarrhalis (including beta-lactamase producing strains).
Uncomplicated lower urinary tract infections, including cystitis and asymptomatic bacteriuria, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Staphylococcus saprophyticus.
Skin and skin structure infections caused by S. pyogenes (group A streptococci), S. aureus (including beta-lactamase producing strains) and Staphylococcus epidermidis (including beta-lactamase producing strains).
Bacteriological studies, to determine the causative organism and its susceptibility to cefaclor, should be performed. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.
Distaclor LA is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of this antibiotic in the subsequent prevention of rheumatic fever are not available.
4.2 Posology and method of administration
Adults, including the elderly:
Pharyngitis, bronchitis, tonsillitis, lower urinary tract infections, skin and skin structure infections: 375 mg twice daily.
750 mg twice daily.
If prolonged therapy is required, it should be noted that in clinical trials doses of 1.5 g/day of Distaclor LA have been administered safely for 14 days, and doses of 4 g/day of cefaclor have been administered safely to normal subjects for 28 days.
Cefaclor should be administered with caution in the presence of markedly impaired renal function. Since the half-life of cefaclor in anuric patients is 2.3 to 2.8 hours, dosage adjustments for patients with moderate or severe renal impairment are not usually required. Clinical experience with cefaclor under such conditions is limited, therefore, careful clinical observation and laboratory studies should be made.
If regular haemodialysis is required for renal failure, a loading dose of 250 to 1000 mg of cefaclor can be given prior to dialysis and 250 to 500 mg every 6 to 8 hours during the intervals between dialysis.
In the treatment of infections caused by S. pyogenes (group A streptococci), a therapeutic dosage should be administered for at least 10 days.
Elderly subjects with normal renal function do not require dosage adjustment.
The safety and effectiveness of Distaclor LA have not been established. Cefaclor suspensions are available (see Distaclor Summary of Product Characteristics for dosages).
Method of administration
Distaclor LA is administered orally.
Distaclor LA is well absorbed from the gastro-intestinal tract and may be given orally without regard to meals. However, absorption is enhanced when administered with food. The tablets should not be cut, crushed or chewed.
Hypersensitivity to cephalosporins.
4.4 Special warnings and precautions for use
Before instituting therapy with cefaclor, every effort should be made to determine whether the patient has had previous hypersensitivity reactions to the cephalosporins, penicillins or other drugs. Cefaclor should be given cautiously to penicillin-sensitive patients and to any patient who has demonstrated some form of allergy, particularly to drugs.
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-spectrum antibiotics, including macrolides, semi-synthetic penicillins and cephalosporins. It is important, therefore, to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Such colitis may range in severity from mild to life-threatening. Mild cases usually respond to drug discontinuance alone. In moderate to severe cases, appropriate measures should be taken.
Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
A false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets.
A positive Coombs' test may occur with cephalosporins.
Cross-sensitisation and cross-resistance may exist between penicillins and cephalosporins.
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 necessary.
The extent of absorption of Distaclor LA is diminished if magnesium hydroxide or aluminium hydroxide containing antacids are taken within 1 hour of administration.
H2-blockers do not alter either the rate or extent of absorption.
The renal excretion of cefaclor is inhibited by probenecid.
4.6 Fertility, pregnancy and lactation
Although animal studies have shown no evidence of impaired fertility or harm to the foetus due to cefaclor, there are no adequate and well-controlled studies in pregnant women. Distaclor LA should be used during pregnancy only if clearly needed.
Small amounts of cefaclor have been detected in breast milk following administration of single 500 mg 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. No studies have been done with Distaclor LA.
Labour and Delivery
Treatment should be given only if clearly needed.
4.7 Effects on ability to drive and use machines
Distaclor has no known influence on the ability to drive and use machines.
4.8 Undesirable effects
The majority of adverse reactions observed in clinical trials of Distaclor LA were mild and transient. Drug-related adverse reactions requiring discontinuation of therapy occurred in 1.7% of patients. The following adverse reactions were reported in clinical trials. Incidence rates were less than 1 in 100 (less than 1%), except as stated:
Diarrhoea (3.4%), nausea (2.5%), vomiting and dyspepsia.
Rash, urticaria or pruritus occurred in approximately 1.7% of patients. One serum sickness-like reaction (0.03%) was reported among the 3,272 patients treated with Distaclor LA during the controlled clinical trials.
Serum sickness-like reactions (Erythema multiforme minor, rashes or other skin manifestations accompanied by arthritis/arthralgia, with or without fever) have been reported with cefaclor. Lymphadenopathy and proteinuria are infrequent, there are no circulating immune complexes and no evidence of sequelae.
Occasionally, solitary symptoms may occur, but do not represent a serum sickness-like reaction. Serum sickness-like reactions are apparently due to hypersensitivity and have usually occurred during or following a second (or subsequent) course of therapy with cefaclor. Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and usually subside within a few days of cessation of therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome. No serious sequelae have been reported.
Haematological and lymphatic systems: Eosinophilia.
Genitourinary: Vaginal moniliasis (2.5%) and vaginitis (1.7%).
The following adverse effects have been reported, but causal relationship is uncertain:
Central nervous system: Headache, dizziness and somnolence.
Hepatic: Transient elevations in AST, ALT and alkaline phosphatase.
Renal: Transient increase in BUN or creatinine.
Laboratory tests: Transient thrombocytopenia, leucopenia, lymphocytosis, neutropenia and abnormal urinalysis.
In addition to the adverse reactions listed above that have been observed in patients taking Distaclor LA, the following have been reported in patients treated with cefaclor:
Erythema multiforme, fever, anaphylaxis (may be more common in patients with a history of penicillin allergy), Stevens-Johnson syndrome, positive direct Coombs' test and genital pruritus. Symptoms of pseudomembranous colitis may appear either during or after antibiotic treatment.
Anaphylactoid events may present as solitary symptoms, including angioedema, asthenia, oedema (including face and limbs), dyspnoea, paraesthesias, syncope, or vasodilatation.
Rarely, hypersensitivity symptoms may persist for several months.
The following reactions have been reported rarely in patients treated with cefaclor:
Toxic epidermal necrolysis, reversible interstitial nephritis, hepatic dysfunction, including cholestasis, increased prothrombin time in patients receiving cefaclor and warfarin concomitantly, reversible hyperactivity, nervousness, insomnia, confusion, hallucinations, hypertonia, aplastic anaemia, agranulocytosis and haemolytic anaemia.
The following adverse reactions have been reported in patients treated with other beta-lactam antibiotics:
Colitis, renal dysfunction and toxic nephropathy.
Several beta-lactam antibiotics have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.
General management consists of supportive therapy.
Consider activated charcoal instead of, or in addition to, gastric emptying.
Forced diuresis, peritoneal dialysis, haemodialysis or charcoal haemoperfusion have not been established as beneficial.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Second generation cephalosporins, ATC code: J01DC04
Distaclor LA has been shown to be active in vitro against most strains of the following organisms, although clinical efficacy has not been established:
Bacteroides species (excluding Bacteroides fragilis)
Note: Pseudomonas sp., Acinetobacter calcoaceticus, most strains of enterococci, Enterobacter sp., indole-positive Proteus and Serratia sp. are resistant to cefaclor. Cefaclor is inactive against methicillin-resistant staphylococci.
Cefaclor is a broad spectrum semi-synthetic cephalosporin antibiotic.
5.2 Pharmacokinetic properties
'Long Acting' (sustained release) cefaclor differs from cefaclor in its rate of dissolution, producing a lower peak serum concentration, but retaining sustained measurable serum concentrations, which provides the advantage of twice daily dosing. It is well absorbed, giving peak levels after 2.5-3 hours. It is excreted without metabolism in urine. Plasma half-life in healthy subjects is independent of dosage form and ranges from 0.6 to 1.2 hours. Elderly subjects with normal, or mildly diminished renal function, do not require dosage adjustment.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber in addition to that summarised in other sections of the Summary of Product Characteristics.
6.1 List of excipients
Methacrylic acid copolymer, Type C
Magnesium stearate (E572)
Colour mixture - Dark blue (includes Hyromellose (E464), Titanium dioxide (E171), Macrogol, Indigo carmine Aluminium lake (E132))
6.3 Shelf life
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original container
6.5 Nature and contents of container
The product is packaged in PVC/Aclar/Aluminium foil blister packs of 2 or 14.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements
Flynn Pharma Limited
Date of first authorisation: 16 June 1994
Date of last renewal: 16 June 2008
9 March 2018