INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
ADCO-CEFACLOR BD 187 Granules for Suspension
ADCO-CEFACLOR BD FORTE 375 Granules for Suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ADCO-CEFACLOR BD 187 Granules for Suspension
ADCO-CEFACLOR BD FORTE 375 Granules for Suspension

COMPOSITION:
After mixing, each 5 mL ADCO-CEFACLOR BD 187 suspension contains 187 mg cefaclor.
After mixing, each 5 mL ADCO-CEFACLOR BD FORTE 375 suspension contains 375 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: Cefaclor is absorbed after oral administration whether taken with food or while fasting. Approximately 60% of the agent is excreted unchanged in the urine within 8 hours. Cefaclor is 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 cefaclor absorbed.
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:
Cefaclor is indicated for the treatment of the following infections due to susceptible micro-organisms:
Pneumonia, bronchitis, acute exacerbations of chronic bronchitis, streptococcal pharyngitis and tonsillitis.
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.
Cefaclor should not be used in critically ill patients because parenteral antibiotic therapy is more appropriate in such patients.
Usage in pregnancy: Safety of cefaclor for use during pregnancy has not been established.
Paediatric use: Safety and effectiveness of cefaclor for use in infants less than 1 month of age have not been established.

WARNINGS:
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 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 immediate discontinuation of the antibiotic.
Efficacy of cefaclor in the prophylaxis of rheumatic fever has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Cefaclor is administered orally.
Adults: The adult dosage is 375 mg every 12 hours. 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 two divided doses.
        20 mg/kg/day

Child's mass	187 mg/5 mL	375 mg/5 mL
9 kg	2,5 mL every 12 hours	-
18 kg	5 mL every 12 hours	2,5 mL every 12 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 two divided doses is recommended, but not to exceed a dosage of 1g per day.
In the treatment of beta-haemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.
The dosage recommendations for cefaclor in 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

Reconstitution of the suspensions: Invert the bottle and tap to loosen powder. Add 31 mL of water, divided into 2 portions, to granules. Shake well after each addition.

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 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 patient 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.
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, e g 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 Cefaclor is 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.

IDENTIFICATION:
ADCO-CEFACLOR BD 187 (187 mg/5 mL suspension) - pink coloured granules yielding a light pink coloured suspension with a strawberry flavour, when suspended in water.
ADCO-CEFACLOR BD FORTE 375 (375 mg/5 mL suspension) - pale pink coloured granules yielding a light pink coloured suspension with a strawberry flavour, when suspended in water.

PRESENTATION:
ADCO-CEFACLOR BD 187 (187 mg/5 mL suspension) and ADCO-CEFACLOR BD FORTE 375 (375 mg/5 mL suspension) are supplied in bottles containing 50 mL when mixed.

STORAGE INSTRUCTIONS:
Before reconstitution: Store below 30°C in tightly closed containers.
After reconstitution: Suspension is stable for 14 days if stored in a refrigerator (4-8°C). Keep tightly closed and shake well before using.
Keep out of reach of children.

REGISTRATION NUMBERS:
ADCO-CEFACLOR BD 187 (187 mg/5 mL suspension): 29/20.1.1/0468
ADCO-CEFACLOR BD FORTE 375 (375 mg/5 mL suspension): 29/20.1.1/0469

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: May 2004
Source: Pharmaceutical Industry
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