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

Logo BELEX 250 (tablet)
BELEX 500 (capsule)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

BELEX 250 (tablet)
BELEX 500 (capsule)

COMPOSITION:
BELEX 250:
Each tablet contains:
Cephalexin (as monohydrate) 250 mg
BELEX 500:
Each capsule contains: Cephalexin (as monohydrate) 500 mg

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION:
Cephalexin inhibits bacterial cell wall synthesis, probably by acylation of the membrane-bound enzyme transpeptidase. This prevents cross-linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity. Cell division and growth are also inhibited and lysis of susceptible bacteria frequently occurs.
Cephalexin is almost completely absorbed from the gastrointestinal tract and produces peak plasma concentrations about 1 hour after oral administration. A dose of 500 mg produces a peak plasma concentration of about 16 micrograms/mL: doubling the dose doubles the peak plasma concentration.
Absorption may be delayed with the intake of food. About 90% or more of the dose is excreted unchanged in the urine within 8 hours.
Cephalexin is active in vitro against both Gram-positive and Gram-negative micro-organisms. (in vitro sensitivity does not necessarily imply in vivo efficacy). Group A Streptococcus pyogenes, the viridans group, and non-haemolytic streptococci, Streptococcus (D) pneumoniae, penicillin-resistant and penicillin-sensitive Staphylococcus aureus, Staphylococcus epidermis, Clostridium perfringes, B. subtilis, C. diphtheriae, N. gonorrhoeae, N. meningitides, and A israeli are highly sensitive to this agent, many being suppressed by concentrations of 0,004 to 1 ug/mL.
Gram-negative bacteria are generally less susceptible, but the majority strains of Salmonella, including S. typhi, most Shigella, all Pr mirabilis, and about 75% of E. coli, 60% of paracolon strains are inhibited by 1 to 6 ug/mL. Indole, producing strains of Proteus Enterobacter (Aerobacter), Pseudomonas, and an occasional strain of Klebsiella are highly resistant to cephalexin. Enterococci and H. influenzae are also insensitive to the drug.

INDICATIONS:
Belex is indicated for the treatment of the following infections due to susceptible micro-organisms:
Respiratory tract infections caused by Streptococcus pneumoniae and group A beta-haemolytic streptococci.
Otitis media due to Streptococcus pneumonia, H.influenza, staphylococci, streptococci and N.catarrhalis.
Dental infections caused by staphylococci and/or streptococci.
Skin and soft tissue infections caused by staphylococci and/or streptococci.
Genito-urinary tract infections, including acute prostitis caused by E.coli, P.mirabilis and Klebsiella sp.
Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cephalexin. Renal function studies should be performed when indicated.

CONTRA-INDICATIONS:
Patients with known or suspected hypersensitivity to cephalexin, penicillin and other cephalosporins should not be treated with Belex tablets/capsules.
Pregnancy and lactation. (See Pregnancy and lactation heading).

WARNINGS:
It should be used with caution in patients with history of gastrointestinal disease, especially ulcerative colitis, regional enteritis or antibiotic-associated colitis.
The diagnosis of pseudomembranous colitis must be considered in patients who develop diarrhoea in association with its use. Such colitis may be life-threatening and appropriate measures should be taken, including discontinuation of Belex tablets.
Care is necessary in treating patients known to be hypersensitive to cephalosporins and penicillin or with known histories of allergy. Cephalosporin C derivatives should be given cautiously to penicillin-sensitive patients.

INTERACTIONS:
Probenecid may decrease renal tubular secretion of cephalexin when used concurrently, resulting in increased and more prolonged Belex serum concentration and toxicity. There have been reports of Belex decreasing the efficacy of oestrogen containing oral contraceptives. The potential for increased nephrotoxicity exists when Belex is used with other nephrotoxic medications, such as potent loop diuretics (e.g. frusemide, ethacrynic acid) and aminoglycoside (Gentamycin) especially in patients with pre-existing renal function impairment.

PREGNANCY AND LACTATION:
Pregnancy: Belex crosses placenta. Safety of this product for use during pregnancy has not been established.
Breast feeding: Belex is excreted in breast milk.

DOSAGE AND DIRECTIONS FOR USE:
Belex is administered orally.
Adults:
The adult dosage ranges from 1 g to 4 g daily in equally divided doses. The usual adult dosage is 250 mg every 6 hours. For skin and soft-tissue infections, streptococcal pharyngitis or tonsillitis and mild, uncomplicated urinary tract infections, a dosage of 500 mg may be administered every 12 hours. For more severe infections or those caused by less susceptible organisms, larger doses may be needed. Parenteral cephalosporin therapy, in appropriate doses, should be considered if daily doses higher than 4 g of Belex are required.
In the treatment of beta-haemolytic streptococcal infections, antibiotic therapy should continue for at least 10 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Common Gastro-intestinal Effects: Diarrhoea has been reported. Nausea, vomiting, dyspepsia and abdominal pain may occur. Colitis, including instances of pseudomembranous colitis, has been reported in conjunction with therapy with Belex - (See Warnings).
Hypersensitivity: Allergic reactions such as skin rashes are common (in about 1% of patients). Urticaria and angio-oedema, anaphylaxis and drug fever occur less frequently. Reactions resembling serum-sickness also occurs less frequently.
Other less frequent side-effects that have occurred are as follows:
Genito-urinary Tract:- genital and anal pruritis, genital moniliasis, vaginitis and vaginal discharge.
Central Nervous System:- dizziness, fatigue and headache.
Blood:- Eosinophilia, neutropenia, thrombocytopenia and elevations in AST (aspartate-transaminase) and ALT (alanine-transaminase) have been reported. Convulsions and toxic psychosis may occur. Hepatitis and cholestatic jaundice have occurred less frequently.
Special precautions:
Patients should be carefully observed, so that any side-effects or unusual manifestations of medicine idiosyncrasy may be detected. If an allergic reaction to Belex occurs, the medicine should be discontinued and the patient treated with usual agents, eg adrenaline, aminophylline, corticosteroids and/or antihistamines.
Prolonged use of Belex may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is therefore essential. If superinfection occurs during therapy, appropriate measures should be taken.
Belex should be administered with caution in the presence of impaired renal function. Under such conditions, careful clinical observation and laboratory studies should be made because safe dosage may be lower than that usually recommended.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See under side effects and special precautions.
Serious acute hypersensitivity reactions may require adrenaline, aminophylline and corticosteroids, including other emergency measures.

IDENTIFICATION:
BELEX 250:
Round orange film-coated tablet, bevel-edged, convex faces.
BELEX 500:
Dark green and light green capsule with "CEX 500" printed on one end and "HD" printed on the other end

PRESENTATION:
BELEX 250:
Opaque plastic bottle containers with 100 or 500 tablets
BELEX 500:
Opaque plastic bottle containers with 100 capsules

STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from light and moisture. Keep well closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER (OR REFERENCE NUMBER):
BELEX 250:        37/20.1.1/0617
BELEX 500:        37/20.1.1/0618

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300

DATE OF PUBLICATION:
07 April 2006

New addition to this site: July 2010
Source: Pharmaceutical Industry

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