ADCO-CEFACLOR BD TABLETS 375 mg
SCHEDULING STATUS :
(and dosage form):
ADCO-CEFACLOR BD TABLETS 375 mg
Each ADCO-CEFACLOR BD TABLET 375 mg (convenient dose) contains 375 mg cefaclor.
Cefaclor is chemically 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate.
A 20.1.1 Broad and Medium Spectrum Antibiotics
ADCO-CEFACLOR BD TABLETS 375 mg is a pharmaceutically-modified form of the orally active cephalosporin, cefaclor. It is a semi-synthetic cephalosporin antibiotic for oral administration.
Human pharmacology: ADCO-CEFACLOR BD TABLETS 375 mg 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.
ADCO-CEFACLOR BD TABLETS 375 mg is well absorbed from the gastro-intestinal tract after oral administration. Although ADCO-CEFACLOR BD TABLETS 375 mg can be taken with or without food, absorption is enhanced with food. When it was given within 1 hour after a meal, the bioavailability of ADCO-CEFACLOR BD TABLETS 375 mg was greater than 90%, using cefaclor as a reference. When taken in the fasting state, the bioavailability of ADCO-CEFACLOR BD TABLETS 375 mg was 77% that of cefaclor. Compared to cefaclor (fasted state), mean peak plasma concentrations of ADCO-CEFACLOR BD TABLETS 375 mg (both fed and fasted states) were delayed by 40 to 90 minutes and were approximately 25% lower. Concomitant administration of H2 blockers does not affect the rate or extent of absorption. Administration of magnesium- or aluminium hydroxide-containing antacids 1 hour after ADCO-CEFACLOR BD TABLETS 375 mg had no effect on the rate of absorption, but resulted in a 17% decrease in the extent of absorption.
Following administration of 375 mg tablets to fed subjects, an average peak serum concentration of 4 micrograms/mL, was obtained within 2,5 to 3 hours. No accumulation was noted when it was given twice daily.
The plasma half-life in healthy subjects is independent of dosage form and averages approximately 1 hour. In elderly subjects (over age 65) with normal serum creatinine values, a higher peak plasma concentration and AUC are effects resulting from mildly diminished renal function and have no apparent clinical significance. Therefore, dosage changes are not necessary in elderly subjects with normal renal function. There is no evidence of metabolism of cefaclor in humans.
Microbiology: In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis.
Cefaclor is active against strains of the following organisms in vitro (in vitro activity does not necessarily imply in vivo efficacy):
Strains of staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, are moderately sensitive.
Streptococcus pyogenes (group A beta-haemolytic streptococci).
Haemophilus influenzae, including beta-lactamase-producing strains.
Moraxella (Branhamella) catarrhalis.
Note: Cefaclor has no activity against Pseudomonas species, Acinetobacter calcoaceticus enterococci (E. faecalis), Enterobacter sp., indole-positive Proteus and Serratia. Cefaclor is inactive against methicillin-resistant staphylococci.
ADCO-CEFACLOR BD TABLETS 375 mg is indicated in the treatment of the following mild to moderately severe infections when caused by susceptible strains of the designated organisms:
Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis and Haemophilus parainfluenzae.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A-streptococci).
Uncomplicated lower urinary tract infections, e.g. cystitis and asymptomatic bacteriuria caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Staphylococcus saprophyticus.
Skin and soft-tissue infections caused by Streptococcus pyogenes, Staphylococcus aureus and Staphylococcus epidermidis.
Note: Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.
ADCO-CEFACLOR BD TABLETS 375 mg is contra-indicated in patients with a known hypersensitivity to cefaclor and other cephalosporins.
Safety in pregnancy, lactation and children has not been established.
BEFORE CEFACLOR THERAPY IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO CEPHALOSPORINS AND PENICILLIN. CEFACLOR SHOULD BE ADMINISTERED WITH CAUTION TO PENICILLIN-SENSITIVE PATIENTS.
THERE IS EVIDENCE OF PARTIAL CROSS-ALLERGENICITY BETWEEN THE PENICILLINS AND THE CEPHALOSPORINS. PATIENTS HAVE BEEN REPORTED TO HAVE HAD SEVERE REACTIONS, INCLUDING ANAPHYLAXIS, TO BOTH MEDICINES. IF SUCH SEVERE REACTIONS SHOULD OCCUR, CEFACLOR SHOULD BE DISCONTINUED AND THE PATIENT TREATED WITH THE APPROPRIATE AGENTS, E.G. ADRENALINE, CORTICOSTEROIDS, AMINOPHYLLINE AND ANTIHISTAMINES.
Pseudomembranous colitis may occur with broad-spectrum antibiotics, therefore it is important to consider its diagnosis in patients who develop diarrhoea in association with the use of cefaclor. Such colitis may be life-threatening and appropriate measures should be taken, including immediate discontinuation of the antibiotic.
Efficacy of cefaclor in the prophylaxis of rheumatic fever has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Since absorption is enhanced by administration with food, ADCO-CEFACLOR BD TABLETS 375 mg should be taken with meals. The tablets should not be cut, crushed or chewed.
Adults: The recommended dosage for pharyngitis, tonsillitis, skin and soft-tissue infections, lower urinary tract infections and acute bronchitis is 375 mg twice daily.
In the treatment of infections caused by S. pyogenes (group A streptococci), a therapeutic dosage of cefaclor should be administered for at least 10 days.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity: Allergic reactions such as urticaria and morbilliform eruptions have been observed as have pruritus and positive Coombs' tests. These reactions usually subside upon discontinuation of the medicine. Eosinophilia, genital pruritus, vaginal moniliasis or vaginitis, have also occurred.
Cases of serum-sickness-like reactions (erythema multiforme, rashes or the above skin manifestations accompanied by arthritis/arthralgia and, frequently, fever) have been reported. These reactions are apparently due to hypersensitivity and have usually occurred during or following a second 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 subside within a few days after cessation of therapy. Antihistamines and corticosteroids appear to enhance resolution of the syndrome.
More severe hypersensitivity reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis and angioedema have been reported.
Gastro-intestinal: Side effects are diarrhoea, nausea, vomiting, dyspepsia and cholestatic jaundice. Colitis, including instances of pseudomembranous colitis, has been reported in conjunction with therapy with cefaclor.
Central nervous system: Headache, dizziness, somnolence and reversible hyperactivity, nervousness, insomnia, confusion and hypertonia.
Other: Infrequently, thrombocytopenia and reversible interstitial nephritis.
Laboratory tests: Abnormalities in clinical laboratory test results have been reported, i.e. elevations in AST, ALT or alkaline phosphatase values; lymphocytosis, leucopenia, neutropenia and, infrequently, haemolytic anaemia, aplastic anaemia and agranulocytosis; and elevations in BUN or serum creatinine or abnormal urinalysis.
Precautions: If an allergic reaction to cefaclor occurs, the medicine should be discontinued and the patients treated with the appropriate agents.
Prolonged use of cefaclor may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If super-infection occurs during therapy, appropriate measures should be taken.
Medicine interactions: The extent of absorption of cefaclor is diminished if magnesium- or aluminium hydroxide-containing antacids are taken within 1 hour of administration: H2 blockers do not alter either the rate or the extent of absorption of cefaclor. The renal excretion of cefaclor (and presumably Adco-cefaclor BD tablets 375 mg) is inhibited by probenecid.
There have been rare reports of increased anticoagulant effect when cefaclor and oral anticoagulants were administered concomitantly.
Laboratory test interactions: Administration of cefaclor may result in a false-positive reaction for glucose in the urine. This phenomenon has been seen in patients taking cephalosporin antibiotics when the test is performed using Benedict's and Fehling's solutions and also with Clinitest tablets, but not with the glucose oxidase test, e.g. Tes-Tape.
Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the medicine.
Since cefaclor is eliminated primarily by the kidneys, it should be administered with caution in the presence of markedly impaired renal function. Under such conditions, safe dosage may be lower than that usually recommended.
As with other beta-lactam antibiotics, the renal excretion of cefacloris inhibited by probenecid.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Signs and symptoms: The toxic symptoms following an overdose of cefaclor may include nausea, vomiting, epigastric distress and diarrhoea. The severity of the epigastric distress and the diarrhoea are dose-related. If other symptoms are present, it is probable that they are secondary to an underlying disease state, an allergic reaction, or the effects of other intoxication.
Treatment: In managing overdosage, consider the possibility of multiple drug overdoses, interaction among medicines and unusual medicine kinetics in your patient.
The treatment is symptomatic and supportive.
ADCO-CEFACLOR BD TABLETS 375 mg are blue paracapsule-shaped, dual radii, film-coated tablets.
ADCO-CEFACLOR BD TABLETS 375 mg are supplied in blister packs containing 10.
Store below 30°C in blister packs.
Keep out of reach of children.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park, 17 Harrison Avenue,
Private Bag X69, Bryanston 2021.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
22 December 1994
New addition to this site: April 2004
Source: Pharmaceutical Industry
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