INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo VERCEF GRANULES for Oral Suspension 125 mg/5 mL
VERCEF GRANULES for Oral Suspension 187 mg/5 mL
VERCEF GRANULES for Oral Suspension 250 mg/5 mL
VERCEF GRANULES for Oral Suspension 375 mg/5 mL
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

VERCEF GRANULES for Oral Suspension 125 mg/5 mL
VERCEF GRANULES for Oral Suspension 187 mg/5 mL
VERCEF GRANULES for Oral Suspension 250 mg/5 mL
VERCEF GRANULES for Oral Suspension 375 mg/5 mL

COMPOSITION:
VERCEF Granules for Oral Suspension 125 mg/5 mL
Each 5 mL of the reconstituted suspension contains:
Cefaclor USP equivalent to
Cefaclor anhydrous 125,0 mg
Sodium Benzoate USNF 0,1% m/v (as preservative)
VERCEF Granules for Oral Suspension 187 mg/5 mL
Each 5 mL of the reconstituted suspension contains:
Cefaclor USP equivalent to
Cefaclor anhydrous 187,0 mg
Sodium Benzoate USNF 0,1% m/v (as preservative)
VERCEF Granules for Oral Suspension 250 mg/5 mL
Each 5 mL of the reconstituted suspension contains:
Cefaclor USP equivalent to
Cefaclor anhydrous 250,0 mg
Sodium Benzoate USNF 0,1% m/v (as preservative)
VERCEF Granules for Oral Suspension 375 mg/5 mL
Each 5 mL of the reconstituted suspension contains:
Cefaclor USP equivalent to
Cefaclor anhydrous 375,0 mg
Sodium Benzoate USNF 0,1% m/v (as preservative)

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) 
Staphylococci sp. Proteus mirabilis
  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:
Cefaclor is well absorbed after oral administration. The presence of food may delay the absorption of cefaclor but the total amount absorbed remains unchanged. Serum levels of 6 mcg per mL and 13 mcg per mL are obtained after 250 mg and 500 mg oral dose of cefaclor. Peak serum concentrations are obtained in 0,5 to 1 hour. About 25% of the medicine is protein bound.
Cefaclor is widely distributed in the body. It is rapidly excreted by the kidneys and up to 60% of a dose appears unchanged in the urine within 8 hours. Probenecid delays the excretion of cefaclor. Some cefaclor is removed by haemodialysis.

INDICATIONS:
VERCEF is indicated in the treatment of following infections:
* 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.

CONTRA-INDICATIONS:
Previous allergic reaction (anaphylaxis) to penicillins, penicillin derivatives, penicillamine or cephalosporins.
Safety in pregnancy, lactation and children under 1 month of age 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 and adolescents:
VERCEF 125 mg/5 mL and 250 mg/5 mL: Usual dosage 250 mg every eight hours.
VERCEF 187 mg/5 mL and 375 mg/5 mL: Usual dosage 375 mg every twelve hours.
For more severe infections the dosage may be doubled.

Children:
Infants up to 1 month of age: Dosage has not been established.
Infants 1 month of age and older: The recommended dosage is 20 mg/kg/day in divided doses. In more severe infections and those caused by less susceptible organisms, 40 mg/kg/day in divided doses 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 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 necessary
40 to 10 50% of usual 24 hour dose
< 10 25% of usual 24 hour dose

Directions for mixing: Add 35 mL & 70 mL water for 50 mL and 100 mL pack respectively in 2 portions to dry mixture in the bottle. Shake well after each addition.
Add 53 mL & 105 mL water for 75 mL & 150 mL pack respectively in 2 portions to dry mixture in the bottle. Shake well after each addition.
May be kept for 14 days without significant loss of potency.

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, hypotension, erythema multiforme, Stevens-Johnson Syndrome.
Haematological – Haemolytic anaemia, hypoprothrombinemia.
Other side/adverse effects include seizures, oral and vaginal candidiasis.
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:
VERCEF Granules for Oral Suspension 125 mg/5 mL
White to off-white granules forming a red suspension on constitution with water. The resulting suspension has a sweet taste and strawberry like flavour.
VERCEF Granules for Oral Suspension 187 mg/5 mL
White to off-white granules forming a red suspension on constitution with water. The resulting suspension has a sweet taste and strawberry like flavour.
VERCEF Granules for Oral Suspension 250 mg/5 mL
White to off-white granules forming a red suspension on constitution with water. The resulting suspension has a sweet taste and strawberry like flavour.
VERCEF Granules for Oral Suspension 375 mg/5 mL
White to off-white granules forming a red suspension on constitution with water. The resulting suspension has a sweet taste and strawberry like flavour.

PRESENTATION:
VERCEF Granules for Oral Suspension 125 mg/5 mL –HDPE Bottle of 75 mL and 150 mL
VERCEF Granules for Oral Suspension 187 mg/5 mL –HDPE bottle of 50 mL and 100 mL
VERCEF Granules for Oral Suspension 250 mg/5 mL –HDPE bottle of 75 mL and 150 mL
VERCEF Granules for Oral Suspension 375 mg/5 mL –HDPE bottle of 50 mL and 100 mL

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture.
After constitution the product must be stored at 2-8°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
VERCEF Granules for Oral Suspension 125 mg/5 mL: 30/20.1.1/0435
VERCEF Granules for Oral Suspension 187 mg/5 mL: 30/20.1.1/0436
VERCEF Granules for Oral Suspension 250 mg/5 mL: 30/20.1.1/0437
VERCEF Granules for Oral Suspension 375 mg/5 mL: 30/20.1.1/0451

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:
VERCEF Granules for Oral Suspension 125 mg/5 mL: 22 May 1996
VERCEF Granules for Oral Suspension 187 mg/5 mL: 22 May 1996
VERCEF Granules for Oral Suspension 250 mg/5 mL: 22 May 1996
VERCEF Granules for Oral Suspension 375 mg/5 mL: 22 May 1996

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