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

Logo A-LENNON AMOXYCILLIN 250 mg CAPSULES
A-LENNON AMOXYCILLIN 500 mg CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

A-LENNON AMOXYCILLIN 250 mg CAPSULES
A-LENNON AMOXYCILLIN 500 mg CAPSULES

COMPOSITION:
A-Lennon Amoxycillin 250 mg Capsules:
Each hard gelatin capsule contains Amoxycillin Trihydrate equivalent to 250 mg
Amoxycillin.
A-Lennon Amoxycillin 500 mg Capsules: Each hard gelatin capsule contains Amoxycillin Trihydrate equivalent to 500 mg Amoxycillin.


PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
A-Lennon Amoxycillin Capsules
is a semisynthetic aminopenicillin with an in vitro bactericidal action against a broad spectrum of gram-positive and gram-negative pathogens. The presence of the enzyme penicillinase has a major influence on the degree and extent of its activity against organisms. Being acid stable it is well absorbed when given orally.
The in vitro antibacterial spectrum of A-Lennon Amoxycillin Capsules is as follows (care must however be exercised when extrapolating this to the clinical situation):
A-Lennon Amoxycillin Capsules is particularly active against the following organisms:
Gram-positive organisms:
Streptococcus pneumoniae*, Streptococcus faecalis* (enterococci), Streptococcus agalactiae (group B), penicillin-sensitive Neisseria gonorrhoeae, Listeria monocytogenes.
A-Lennon Amoxycillin Capsules is also active against the following organisms:
Gram-positive organisms:
Staphylococcus aureus* (penilcillin sensitive), Streptococcus pyogenes, Streptococcus viridans*, Streptococcus bovis, Neiserria meningitidis (except the carrier state), Bacillus anthracis*, Corynebacterium species*, Clostridium species*;
A-Lennon Amoxycillin Capsules also has in vitro activity against the following gram-negative organisms (these organisms may produce beta-lactamase):
Escherichia coli*, Haemophilus influenzae*, (except the type beta-strains causing meningitis in children), Salmonella*, and Shigella* species.
A-Lennon Amoxycillin Capsules may also have some effect against the following organisms:
Bacteroides fragilis*, Proteus mirabilis* and Nocardia.
* sensitivity tests must be performed.
Most species of the following organisms are reistant to A-Lennon Amoxycillin Capsules:
Enterobacter, Pseudomonas, Klebsiella, Serratia, Acinetobacter and indole-positive Proteus.

INDICATIONS:
Infections caused by susceptible (non-penicillinase-producing) organisms:
Respiratory tract infections: Sinusitus, pharyngitis, otitis media, epiglottitis, acute and chronic bronchitis and acute typical pneumonias.
Urinary tract infections:
Uncomplicated gonococcal infections:
Meningitis (sensitivity tests must be performed):
Gastro-intestinal infections: Uncomplicated gastro-enteritis and enteric fever including Salmonella, Shigella, and typhoid.
Skin and soft tissue infections, bacteraemia, and in combination with aminoglycosides against sepsis caused by gram negative bacteria.

CONTRA-INDICATIONS:
Allergy to penicillins. Patients with infectious mononucleosis are susceptible to skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
One 250 mg capsule three times a day.
500 mg A-Lennon Amoxycillin Capsules may be required in some severe infections. In gonorrhoea the usual dose is the equivalent of 3 g given as a single dose concomitantly with 1 g probenecid.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Allergic reactions may occur. Skin rashes (pruritic skin rash, and erythrematous skin reaction or urticaria) are the most common side-effects.
Fever, eosinophilia, joint pains, angioneurotic oedema, erythema multiforme and anaphylaxis may occur.
If a serious anaphylactic reaction occurs, A-Lennon Amoxycillin Capsules should be discontinued and the patient treated with the usual agents: adrenaline, corticosteroids and antihistamines.
Treatment with A-Lennon Amoxycillin Capsules may give rise to maculopapular eruptions which often appear about 5 days after treatment has finished. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis. Diarrhoea, nausea, vomiting have occurred and raised serum aminotransferase concentrations have been reported. Severe pseudomembranous colitis has also been reported. Super-infections with Pseudomonas and Candida have also occurred. Care must be taken in treating patients with dehydration or oliguria because of the possibility of crystalluria. The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should, therefore, be carried out wherever possible to ensure the appropriateness of the therapy.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastro-intestinal symptoms such as transient diarrhoea, nausea and colic are dose-related and a result of local irritation and not toxicity. Treatment is symptomatic and supportive.

IDENTIFICATION:
A-Lennon Amoxycillin 250 mg Capsules
: A hard gelatine capsule (size 2) with an opaque dark green cap and an opaque flesh body, containing white granules.
A-Lennon Amoxycillin 500 mg Capsules: A hard gelatine capsule (size 0 EL) with an opaque dark green cap and an opaque flesh body, containing white granules.

PRESENTATION:
A-Lennon Amoxycillin 250 mg Capsules
: White securitainers of 15, 100 and 500 x 250 mg amoxycillin capsules.
A-Lennon Amoxycillin 500 mg Capsules: White securitainers of 15, 100 and 500 x 500 mg amoxycillin capsules.

STORAGE INSTRUCTIONS:
Containers should be kept tightly closed and stored in a cool place (below 25°C), protected from light and moisture.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
A-Lennon Amoxycillin 250 mg Capsules:
        27/20.1.2/0325
A-Lennon Amoxycillin 500 mg Capsules:         27/20.1.2/0326

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1994

New addition to this site: December 2004
Source: Pharmaceutical Industry

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