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Logo ADCO-CEFACLOR 250 Capsules

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form) :

ADCO-CEFACLOR 250 Capsules

COMPOSITION:
Each ADCO-CEFACLOR 250 Capsule contains 250 mg
cefaclor.
Cefaclor is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and Medium Spectrum Antibiotics

PHARMACOLOGICAL ACTION:
Cefaclor is a semi-synthetic cephalosporin antibiotic with a broad spectrum of bactericidal activity against certain Gram-positive and Gram-negative micro-organisms.
Human pharmacology: Cefacloris absorbed after oral administration whether taken with food or while fasting. Following single doses of 250 mg, 500 mg, and 1g, to fasting subjects, average peak serum levels of approximately 7 ug/mL, 13 ug/mL, and 23 ug/mL respectively, were obtained at 30 to 60 minutes.  Approximately 60% of the agent is excreted unchanged in the urine within 8 hours. Peak urine concentrations following the 250 mg, 500 mg, and 1g doses were approximately 600 ug/mL, 900 ug/mL, and 1 900 ug/mL respectively during the first 2 hours after a single dose. Cefacloris not appreciably metabolised. The presence of food in the gastro-intestinal tract delays absorption and lowers peak serum levels, but does not alter the total amount of cefaclorabsorbed.
Microbiology: In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis.
Cefaclor is active against the following organisms in vitro:
Strains of staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains, are moderately sensitive.
Streptococcus pyogenes (group A beta-haemolytic streptococci).
Streptococcus pneumoniae.
Escherichia coli.
Proteus mirabilis.
Klebsiella
sp.
Haemophilus influenzae, including ampicillin-resistant strains.
Moraxella (Branhamella) catarrhalis.
Note: Cefaclor has no activity against Pseudomonas species, enterococci (E. faecalis), Enterobacter sp., indole-positive Proteus and Serratia. Some strains of staphylococci are resistant to cefaclor.

INDICATIONS:
Cefacloris indicated for the treatment of the following infections due to susceptible micro-organisms:
Pneumonia, bronchitis, acute exacerbations of chronic bronchitis, streptococcal pharyngitis and tonsillitis.
Otitis media.
Skin and soft-tissue infections.
Urinary tract infections, including pyelonephritis and cystitis.
Note: Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

CONTRA-INDICATIONS:
Cefaclor is contra-indicated in patients with a known hypersensitivity to the cephalosporin group of antibiotics.
Cefaclorshould not be used in critically ill patients because parenteral antibiotic therapy is more appropriate in such patients.
Usage in pregnancy: Safety of cefaclorfor use during pregnancy has not been established.
Paediatric use: Safety and effectiveness of cefaclorfor use in infants less than 1 month of age have not been established.

WARNINGS:
BEFORE CEFACLORTHERAPY 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, the medicine should be discontinued and the patient treated with the appropriate agents, e.g. adrenaline, corticosteroids, aminophylline, and antihistamines.
Pseudomembranous colitis has been reported with many broad-spectrum antibiotics; therefore, it is important to consider its diagnosis in patients who develop diarrhoea in association with their use. Such colitis may be life-threatening and appropriate measures should be taken, including the immediate discontinuation of the antibiotic.
Efficacy of cefaclorin the prophylaxis of rheumatic fever has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Cefacloris administered orally.
Adults: The adult dosage is 250 mg every 8 hours. For skin and soft-tissue infections and mild to moderate cystitis, 250 mg every 12 hours has been used successfully. For more severe infections, such as pneumonia, or those caused by less susceptible organisms, doses may be doubled.
Children: The recommended dosage for children is 20 mg/kg/day in divided doses every eight hours.
For skin and soft-tissue infections and streptococcal pharyngitis, 10 mg/kg every 12 hours has been used successfully.
In more severe infections and those caused by less susceptible organisms, 40 mg/kg/day in divided doses every 8 hours is recommended, but not to exceed a dosage of 1 g per day.
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dosage of cefaclorshould be administered for at least 10 days.
The dosage recommendations for cefaclorin the presence of impaired renal function are undernoted:
CREATININE CLEARANCE
(mL/min/1,73m²)
24 HOUR DOSE
        >40 No modification necessary
        40 to 10 50% of the usual 24 hour dose
        <10 25% of the usual 24 hour dose

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 and 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 reverseible 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 cefacloroccurs, the medicine should be discontinued and the patient treated with the appropriate agents.
Prolonged use of cefaclormay 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.
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.
As a result of administration of cefaclor, a false-positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution or with Clinitest tablets, but not with the glucose oxidase test, eg Tes-Tape.
There have been rare reports of increased anticoagulant effect when cefaclor and oral anticoagulants were administered concomitantly.
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. (See 'DOSAGE AND DIRECTIONS FOR USE'.)
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 cefaclormay 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.

IDENTIFICATION:
ADCO-CEFACLOR 250
Capsules have an opaque purple cap and an opaque violet body, imprinted with ADCO 250 in black.

PRESENTATION:
ADCO-CEFACLOR 250
Capsules are supplied in blister packs containing 15.

STORAGE INSTRUCTIONS:
Store below 30°C in blister packs. Keep out of reach of children.

REGISTRATION NUMBERS:
ADCO-CEFACLOR 250
Capsules: 29/20.1.1/0463

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext 77
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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