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

Logo LENOCEF™-250 CAPSULES
LENOCEF™-500 CAPSULES
LENOCEF™-125 SUSPENSION
LENOCEF™-250 SUSPENSION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

LENOCEF™-250 CAPSULES
LENOCEF™-500 CAPSULES
LENOCEF™-125 SUSPENSION
LENOCEF™-250 SUSPENSION

COMPOSITION:
(a) Capsules Capsules containing cephalexin monohydrate equivalent to 250 mg cephalexin.
Capsules containing cephalexin monohydrate equivalent to 500 mg cephalexin.
(b) Suspension Powder for preparing flavoured suspension. When dispensed as directed, each 5 mL contains cephalexin monohydrate equivalent to 125 mg or 250 mg cephalexin. The suspension contains 0,1% m/v sodium benzoate as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Cephalexin is an acid-stable cephalosporin and is well absorbed from the gastro-intestinal tract. Peak plasma concentrations, reached at about 1 hour after ingestion of the drug, are approximately 9 and 18 ug/mL after oral doses of 250 and 500 mg, respectively.
Cephalexin inhibits bacterial cell-wall synthesis in a manner similar to that of penicillin. In-vitro sensitivity does not necessarily indicate in-vivo efficacy. Cephalexin is active in vitro against both gram-positive and gram-negative micro-organisms. Group A Strep. pyogenes, the viridans group, and non-hemolytic streptococci, Strep. (D.) pneumoniae, penicillin-resistant and penicillin-sensitive Staph. aureus, Staph. epidermis, Cl. perfringens, List.  monocytogenes, B. subtilis, C. diphtheriae, N. gonorrhoeae, N. meningitides, and A. israelii 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 para-colon 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. influenza are also insensitive to the drug.
The ingestion of food may delay absorption.

INDICATIONS:
Infections caused by susceptible organisms.

CONTRA-INDICATIONS:
Patients who are known or suspected to be allergic to other cephalosporins should not be treated with cephalexin.

DOSAGE AND DIRECTIONS FOR USE:
The usual adult dose is 250-500 mg every 6 hours and for children 25 to 50 mg per kg body mass daily in divided doses.
When high doses are required the use of a parenteral cephalosporin should be considered. In patients with impaired kidney function smaller doses should be employed: with creatinine clearances of 5, 20 and 50 mL per minute, daily doses should not exceed 0,5, 1,5 and 3 g respectively and 8, 25 and 50 mg per kg respectively in children.
Suspension
To make up to 100 mL, add 54 mL of water, invert bottle and shake until all powder is dispersed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects include nausea, vomiting, diarrhoea and abdominal discomfort. Skin rashes occur in about 1% of patients treated with cephalexin and rises in serum transaminases have been noted. Eosinophilia and neutropenia have occurred in a few patients. Supra-infection with resistant micro-organisms, particularly Candida, may follow treatment.
Care is necessary in treating patients known to be hypersensitive to penicillin or with known histories of allergy. Reduced dosage is necessary in patients with impaired kidney function.
The urine of patients taking cephalexin may give a false positive reaction for glucose with copper-reduction reagents. Positive results to the Coomb's test have been reported with cephalexin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See under "Side-effects and Special Precautions". Serious acute hypersensitivity reactions may require epinephrine, aminophylline and corticosteroids.

CONDITIONS OF REGISTRATION:
Advertise to the professions only.

IDENTIFICATION:
250 mg Capsules:
A No. 1 capsule with a white body and green cap, imprinted with a Lennon Logo and "LENNON" on one part of the capsule and "LENOCEF-250" on the other part.
500 mg Capsules: A No. 00 elongated capsule with an orange body and cap, imprinted with a Lennon Logo and "LENNON" on one part of the capsule and "LENOCEF-500" on the other part.
Powder for Suspension: An off white powder with characteristic odour.
Reconstituted Suspension: A pale yellow homogenous suspension with characteristic odour.

PRESENTATION:
Capsules:
Securitainers of 20 and 100 capsules.
Suspension: Bottles containing powder for reconstitution to 100 mL of 125 mg or 250 mg/5 mL cephalexin.

STORAGE INSTRUCTIONS:
Capsules:
Store below 25°C. Protect from light.
Suspension: Containers should be kept tightly closed, stored below 25°C and in a dry place. Protect from light. Once dispensed, the syrup must be used within 14 days if stored in a refrigerator. If stored at room temperature, use within 7 days. Shake the bottle before use.
KEEP OUT OF REACH OF CHILDREN:

REGISTRATION NUMBERS:.
Lenocef-250 Capsules N/20.1.1/128
Lenocef-500 Capsules N/20.1.1/129.
Lenocef-125 Suspension N/20.1.1/134.
Lenocef-250 Suspension N/20.1.1/135.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18/07/1980
       
011125/11-01
        ILEN011

Updated on this site: May 2003
Source: Community Pharmacy

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