INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
AMOXYFIZZ 125 EFFERVESCENT TABLETS
AMOXYFIZZ 250 EFFERVESCENT TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

AMOXYFIZZ 125 EFFERVESCENT TABLETS
AMOXYFIZZ 250 EFFERVESCENT TABLETS

COMPOSITION:
AMOXYFIZZ 125 –Each effervescent tablet contains amoxycillin trihydrate equivalent to 125 mg amoxycillin.
AMOXYFIZZ 250 –Each effervescent tablet contains amoxycillin trihydrate equivalent to 250 mg amoxycillin.
Each tablet (both strengths) contains 100 mg ASPARTAME (PHENYLALANINE) (a non-nutritive, permitted sweetener)
CONTAINS NO SUGAR.

PHARMACOLOGICAL CLASSIFICATION:
A20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Amoxycillin is a penicillinase-susceptible semi-synthetic aminopenicillin. Amoxycillin exhibits in vitro bactericidal activity against a wide range of Gram-negative and Gram-positive organisms including:

Gram-positive bacteria:
* Staphylococcus aureus (penicillin-sensitive)
Streptococcus pyogenes
* Streptococcus viridans
* Streptococcus faecalis
* Streptococcus pneumoniae
* Corynebacterium species
* Clostridium species
* Bacillus anthracis

Gram-negative bacteria:
Neisseria gonorrhoeae
Neisseria meningitidis
Haemophilus influenzae
(except type b-strains causing meningitis in children).
Bordetella pertussis
* Escherichia coli
Salmonella typhi
Salmonella species
Shigella species
Brucella species
Proteus mirabilis

* Sensitivity tests must be performed.

Note: In vitro sensitivity does not necessarily imply in vivo efficacy.

Amoxycillin is well absorbed orally. After oral administration, there is no significant difference between the peak serum levels in fasting and non-fasting subjects. The presence of food does not interfere with the absorption of amoxycillin. Amoxycillin may, therefore, be taken with meals.
There is insufficient evidence at present to show that amoxycillin penetrates into the cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections.
Approximately 60% of an oral dose of amoxycillin is excreted unchanged in the active form into the urine within six hours.

INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:
Upper respiratory tract infections
Lower respiratory tract infections
Otitis media
Upper urinary tract infections
Lower urinary tract infections
Skin and soft tissue infections
Gonorrhoea
Non-specific urethritis
Typhoid Fever
Gastro-intestinal tract infections

CONTRA-INDICATIONS:
Allergy to penicillins or any of the cephalosporins. Patients with infectious mononucleosis, since they are especially susceptible to amoxycillin-induced skin rashes; patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at increased risk of developing skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for amoxycillin is 750 mg to 1,5 gram per day.

a) GENERAL DOSAGES:
Adults: 250 mg three times a day.
viz.: 1 x 250 mg tablet or 2 x 125 mg tablets in about 100 mL of water (half a glass) three times a day.

Children 1 to 10 Yrs: 125 mg three times a day
viz.: 1 x 125 mg tablet in about 30 mL to 100 mL (about a quarter to half a glass) of water three times a day.

NOTE: In order to ensure that the patient consumes the correct amount of amoxycillin at each dosage, use that minimum amount of water which the patient is able to drink at one time. The tablet will effervesce in the water and a foam layer will be formed on the surface. Allow the tablet to dissolve completely (approximately 5 - 10 minutes) and disperse the foam by swirling or stirring before drinking.

b) SPECIFIC DOSAGES:

Indications	Daily Dosages Adults	Daily Dosages Children	Duration
Gastro-intestinal tract infections	1 - 2 g		4 - 5 days
Acute Typhoid Fever	4 g	-	14 days
	-	100 mg/kg	21 days
Gonorrhoea	2 - 3 g	-	stat

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances, including diarrhoea, nausea and vomiting occur frequently. Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event withdrawal of amoxycillin is necessary.
Should a serious anaphylactic reaction occur, amoxycillin should be discontinued and the patient treated with adrenalin, corticosteroids and antihistamines.
Treatment with amoxycillin may give rise to a macupapular rash during therapy or within a few days after completion thereof. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
Pseudomembranous colitis has been reported. Super-infections with non-susceptible organisms may occur. Caution must be exercised 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 whenever possible, to ensure the appropriateness of the therapy.

Special Precautions:
The dose should be reduced in patients with renal failure. Caution is needed when administering amoxycillin to patients with syphillis, as the Jarisch-Herxheimer reaction may occur in these patients. Amoxycillin may decrease the efficacy of oestrogen-containing oral contraceptives. Due to amoxycillin's effect on the intestinal flora, the absorption of other medicines may be affected.

PHENYLKETONURICS - CONTAINS PHENYLALANINE

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and Special Precautions”.
Treatment is symptomatic and supportive.

IDENTIFICATION:
AMOXYFIZZ 125 - Coin shaped tablets (round with flat surfaces) of pinkish colour
AMOXYFIZZ 250 - Coin shaped tablets (round with flat surfaces) of greenish colour

PRESENTATION:
AMOXYFIZZ 125 - Canisters of 15 tablets in foil wrap.
AMOXYFIZZ 250 - Canisters of 15 tablets in foil wrap.

STORAGE INSTRUCTION:
Store below 25°C in dry place.
Due to the effervescent nature of the tablets, protect against undue exposure to moisture during use by re-wrapping the tablets in the foil and replacing the lid and desiccant each time.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
AMOXYFIZZ 125 TABLETS - 27/20.1.2/382
AMOXYFIZZ 250 TABLETS - 27/20.1.2/383

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo. Schwulst Laboratories Limited,
1 Manchester Road,
WADEVILLE
1407

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
FEBRUARY 1993

PSO - 72 - 2/93
PSO - 73 - 2/93
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