INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
AMOXICILLIN HEXAL® 500

MOXCP1

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

Amoxicillin Hexal^® 500 (film coated tablets)

COMPOSITION
Each film coated tablet contains 500 mg Amoxicillin as the trihydrate.

PHARMACOLOGICAL CLASSIFICATION
A 20.1.2 Penicillins

PHARMACOLOGICAL ACTION
Amoxicillin is a semi-synthetic penicillinase susceptible penicillin, inhibiting bacterial cell wall synthesis. It has a broad spectrum of in-vitro bactericidal activity against both gram positive and gram negative organisms. In vitro sensitivity does not necessarily imply in vivo efficacy.
Amoxicillin is acid stable and is rapidly and completely absorbed from the gastro-intestinal tract (75-90%). Peak plasma concentrations of about 5 mcg per mL are achieved 1 to 2 hours after a 250 mg dose. Presence of food does not affect the total absorption of the medicine. Amoxicillin is widely distributed in body tissues and fluids. It crosses the placenta and appears in the breast milk. Distribution into the cerebrospinal fluid is low in subjects with non inflamed meninges. Amoxicillin is about 20% protein bound and has a half life of 1 to 1,5 hours.
Amoxicillin is metabolised to a limited extent and about 60% is excreted in urine in six hours by glomerular filtration and tubular secretion. High concentrations may be reached in bile and some amount may be excreted in the faeces.

INDICATIONS
Amoxicillin Hexal 500 is indicated in the treatment of infections caused by susceptible non penicillinase producing strains :

-	Genitourinary tract infections caused by Escherichia coli, Proteus mirabilis and Enterococcus faecalis.
-	Acute uncomplicated anogenital and urethral gonorrhoea in males and females, caused by Neisseria gonorrhoeae.
-	Infections of the nose, ear and throat caused by Streptococci, Pneumococci, non penicillinase producing Staphylococci and Haemophilus influenzae.

Skin and soft tissue infections caused by Streptococci, non penicillinase producing Staphylococci, E. coli and Proteus mirabilis.
In the therapy of duodenal ulcer associated with Helicobacter pylori, amoxicillin used in conjunction with another appropriate antibiotic and a proton pump inhibitor may be useful.

CONTRA-INDICATIONS
Penicillin hypersensitivity or hypersensitivity to any of the ingredients of this preparation.
A history of allergic reaction to any of the penicillins / cephalosporins.
A history of antibiotic associated colitis.
Infectious mononucleosis.
Patients with lymphatic leukaemia as well as patients suffering from hyperuricaemia, who are being treated with allopurinol, may be at increased risk of developing skin rashes.
Babies, born to hypersensitive mothers, who are still in the neonatal period.

WARNINGS
Before initiating therapy with amoxicillin or any other penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or cephamycins. There is clinical and laboratory evidence of partial cross allergenicity of the penicillins and cephalosporins.
Care should be taken when treating patients with syphilis as the Jarisch-Herxheimer reaction may occur. This reaction, manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a risk of increased local damage as with optic atrophy.
Patients with a history of gastro-intestinal disease, especially antibiotic associated colitis should be treated with amoxicillin with caution since penicillins may cause pseudomembranous colitis.

DOSAGE AND DIRECTIONS FOR USE
Adults:
The average adult dose is 750 mg to 1,5g per day.
ie a half to one Amoxicillin Hexal 500 tablet every 8 hours.
Higher doses have been administered in severe infections.

For Gonorrhoea
Adults - 3g as a single dose together with probenecid 1g
Children over 2 years - 50 mg/kg amoxicillin with 25 mg/kg probenecid as a single dose.

In the treatment of beta haemolytic streptococcal infections a therapeutic dose must be administered for at least 10 days.

Eradication of H. pylori : to decrease the recurrence of duodenal ulcer in combination with a proton pump inhibitor and another antibiotic:
Amoxicillin 1000 mg twice daily in combination with clarithromycin 500 mg twice daily and omeprazole 20 mg daily for 7 to 10 days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Skin rashes are the most common side effects and vary from maculopapular to urticarial.
Urticarial reactions are typical of penicillin hypersensitivity reactions.
If serious anaphylactic reaction occurs, Amoxicillin Hexal 500 should be discontinued and the patient treated with adrenalin, corticosteriods and antihistamines.
Most patients with infectious mononucleosis develop a maculopapular rash, and patients with other lymphoid disorders seem to be more at risk. Avoid using Amoxicillin Hexal 500 in these instances.
Gastro-intestinal side effects including diahrroea, nausea and vomiting may occur quite frequently.
Pseudomembranous colitis has also been reported.
Super-infection is relatively common.
Doses should be reduced in severe renal failure.
Use in pregnancy : animal reproduction studies have failed to demonstrate a risk to the foetus. However, there are no adequate and well controlled studies in pregnant women.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “Side-effects and Special Precautions”. Should a serious allergic reaction occur the medicine should be discontinued.
Treatment is supportive and symptomatic.

IDENTIFICATION
Amoxicillin Hexal 500 - white, round, biconvex, film coated tablets, with a score notch.
13,1-13,2mm (d) X 5,0-5,4mm (h)

PRESENTATION
Amoxicillin Hexal 500 –Opaque white securitainers containing 100 tablets

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN
Do not remove the tablets from the container until required for use.

REGISTRATION NUMBER
Amoxicillin Hexal 500 –32/20.1.2.0091

NAME AND ADDRESS OF THE APPLICANT:
Hexal Pharma (SA) (PTY) Ltd
Unit A, 10 Fangio road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 April 2000                MOXCP1

AMOXICILLIN HEXAL^® 500

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