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Logo VERCEF MR Tablets
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

VERCEF MR Tablets

COMPOSITION:
Each modified release film coated tablet contains:
Cefaclor monohydrate
equivalent to cefaclor anhydrous 375 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION:
Mechanism of Action
Cefaclor is a semi-synthetic cephalosporin antibiotic and inhibits bacterial septum and cell-wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. The cell division and cell growth are inhibited by cefaclor.
Antibacterial Activity
Cefaclor is bactericidal and has in vitro antibacterial activity both against Gram-positive and Gram-negative organisms.
(in vitro sensitivity does not necessarily imply in vivo efficacy)
Gram-positive organisms Gram-negative organisms
Streptococcus pyogenes E. Coli
Streptococcus pneumoniae Klebsiella pneumonia
(Penicillin Sensitive) Proteus mirabilis
Staphylococci sp. H. influenzae
  M. catarrhalis
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.
Pharmacokinetics:
Following an oral dose of VERCEF MR, the medicine is well absorbed from the gastro-intestinal tract. The peak plasma concentration (Cmax ) following oral administration of 375 mg VERCEF MR is about 4,75 mcg/mL achieved in about 2 hours and area under curve (AUC0-12) is 12,13 + 3,5 mcg.h/mL. After a standard meal Cmax and AUC0-12, were not significantly different but time to achieve Cmax was increased to about 3 hours.
About 25% of cefaclor is bound to plasma proteins. Cefaclor is widely distributed in the body. The medicine crosses the Placenta and is excreted in very low concentrations in breast milk.
Cefaclor is not metabolised in the liver. About 60% of the medicine is excreted unchanged in urine. Decreased renal function is reported to result in elevated plasma concentrations and significantly prolonged elimination half-life.

INDICATIONS:
VERCEF MR is indicated in the treatment of the following infections caused by susceptible strains:
* Upper and lower respiratory tract infections caused by Gram-positive organisms: M. catarrhalis and H. influenzae: pneumonia, bronchitis, acute exacerbation of chronic bronchitis, streptococcal pharyngitis, tonsillitis.
* Otitis media.
* Skin and soft tissue infections caused by Gram-positive organisms.
* Urinary tract infections including pyelonephritis and cystitis.
* 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 known hypersensitivity to the penicillins, penicillin derivatives, penicillamine or cephalosporins. Safety in pregnancy, lactation and children has not been established.

WARNINGS:
Hypersensitivity –serum-sickness like reactions may be more common with cefaclor than several other oral antibiotics. A relatively high incidence of anaphylactic reaction has been reported.
Before cefaclor therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins and penicillins. Cefaclor should be administered with caution to penicillin-sensitive patients. There is evidence of partial cross-allergenicity between the cephalosporins and penicillins. Patients have been reported to have had severe reactions including anaphylaxis, to both penicillins and cephalosporins.
If such severe reactions should occur, the medicine should be discontinued and the patient treated with appropriate medicine, e.g. adrenaline, corticosteroids, aminophylline and antihistamines.
Pseudomembranous colitis has been reported with many broad-spectrum antibiotics such as cefaclor, 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 discontinuation of the antibiotic.
Efficacy of cefaclor in the prophylaxis of rheumatic fever has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Adults:                         For mild to moderate infections: One tablet of Vercef MR twice a day.
For severe infections: Two tablets of Vercef MR twice a day.
The tablets should not be cut, crushed or chewed.
In the treatment of ß-haemolytic streptococcal infections, a therapeutic dosage of cefaclor should be administered for at least 10 days.

        Dosage recommendation in presence of impaired renal function:
        Creatinine clearance
        (mL/min/1,73 m²)		         24 Hour dose 
        > 40         No modification 
        40 to 10         50% of usual 24 hour dose 
        < 0         25% of usual 24 hour dose 
The duration of treatment depends upon the type of infection and may range from 7 to 10 days. VERCEF MR should be taken on an empty stomach.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Gastrointestinal reactions:
Nausea, vomiting, abdominal cramps, mild diarrhoea, pseudomembranous colitis.
Allergic reactions, resembling serum sickness: Skin rash, itching, redness, swelling, bronchospasm, serum sickness, hypotension, erythema multiforme, Stevens-Johnson Syndrome
Haematological: Haemolytic anaemia, hypoprothrombinemia.
Other side/adverse effects include seizures, oral and vaginal candidiasis.
Risk-benefits should be considered when a history of bleeding disorder, ulcerative colitis, regional enteritis or pseudomembranous colitis exist.
Special Precautions:
Renal
Cefaclor is excreted primarily by the kidneys. It should be administered with caution in the presence of markedly impaired renal function.
Geriatrics
Elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment of dosage and/or dosing interval in patients receiving cefaclor.
Dental
Long-term therapy with cefaclor may lead to overgrowth of Candida albicans, resulting in oral candidiasis.
Interactions and/or related problems
Anticoagulants, coumarin or indandione-derivative, or Heparin or Thrombolytic agents: Cefaclor can inhibit vitamin K synthesis by suppressing gut flora. Prophylactic vitamin K therapy is recommended when any of these medications is used for prolonged periods in malnourished or seriously ill patients.
Probenecid: Probenecid delays the excretion of cefaclor.
Laboratory value alterations:
Coombs' (antiglobulin) tests
A positive Coombs reaction frequently appears in patients who receive large doses of cefaclor; hemolysis rarely occurs, but has been reported; test may become positive in neonates whose mothers received cephalosporins before delivery.
Urine Glucose
Cefaclor may produce false-positive or falsely elevated test results with copper sulfate tests [Benedict's, Fehling's, or Clinitest tablets]. Glucose enzymatic tests, such as Clinistix and Tes-Tape are not affected.
Prothrombin time (PT)
Cefaclor may inhibit vitamin K synthesis by suppressing gut flora. As a result prothrombin time may be prolonged.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects. Treatment is symptomatic and supportive.

IDENTIFICATION:
Capsule shaped, biconvex, peach coloured, film coated tablets imprinted with "VERCEF MR" above "375 mg" in red edible ink.

PRESENTATION:
VERCEF MR Tablets: Carton containing 10 tablets in blister strips.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
31/20.1.1/0651

NAME AND BUSINESS ADDRESS OF APPLICANT:
RANBAXY (SA) (PTY) LTD.
Lincoln House
Epsom Downs Office Park
13 Sloane Street
Epsom Downs
Bryanston

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
???

60821dd.pm6                1                28/11/97. 10:59

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