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Logo MEGAPEN 500 (capsules)
MEGAPEN S (syrup)
SCHEDULING STATUS:
S4

PROPRIETARY NAMES
(and dosage form):

MEGAPEN 500 (capsules)
MEGAPEN S (syrup)

COMPOSITION:
MEGAPEN 500 Gelatin capsule containing amoxycillin trihydrate equivalent to 250 mg amoxycillin and flucloxacillin sodium equivalent to 250 mg flucloxacillin.
MEGAPEN S Powder for preparing a fruit-flavoured syrup. When dispensed as directed each 5 mL contains amoxycillin trihydrate equivalent to 125 mg amoxycillin and flucloxacillin -sodium equivalent to 125 mg flucloxacillin.. The powder contains 0,13% m/m sodium benzoate as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
(a) Bacteriology
  MEGAPEN exhibits in vitro and in experimental animals in vivo, bactericidal activity against some Gram-positive and Gram-negative bacteria. In vitro sensitivity does not necessarily imply in vivo efficacy.
(b) Absorption
  MEGAPEN is well absorbed orally. Peak serum levels are achieved 1 to 2 hours after dosing.
(c) Excretion
  Approximately 50% of the dose is excreted unchanged into the urine within 6 hours, resulting in high urine levels of active drug.

INDICATIONS:
MEGAPEN is indicated for the treatment of bacterial infections, caused by susceptible organisms; in particular infections of mixed origin where penicillin-resistant staphylococci may be implicated.

CONTRA-INDICATIONS'
MEGAPEN should not be given to those subjects hypersensitive to penicillin. As there is currently no neonatal formulation, MEGAPEN should not be given to neonates.

DOSAGE AND DIRECTIONS FOR USE:
Adults: One 500 mg capsule three times a day.
Children 2-12: 5 mL of syrup (containing 250 mg MEGAPEN) three times a day.
Children under 2: 2,5 mL of syrup (containing 125 mg MEGAPEN) three times a day.
Neonates: No formulation is available at present.
In severe infections these dosages may be increased.
To ensure maximal absorption MEGAPEN should be given in the fasting state, i.e. approximately 1 hour before a meal.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Amoxycillin
The most common adverse effects associated with penicillins are allergic reactions. Of these skin rashes occur most frequently and are either urticarial or maculopapular. The incidence of this occurring is especially high in patients suffering from mononucleosis. Patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at increased risk of developing skin rashes.
Administration of penicillins to a hypersensitive patient may occasionally result in anaphylactic shock with collapse and sometimes death. Angioedema or bronchospasm may also occur.
Gastro-intestinal adverse effects particularly diarrhoea, nausea and vomiting occur quite frequently.
Pseudomembranous colitis has also been reported. Suprainfections with non-susceptible organisms may occur particularly with prolonged use. Renal and haematological systems should be monitored during prolonged high dose therapy. Jarisch-Herscheimer reaction may :occur when treating patients with syphilis.
Amoxycillin may decrease the efficacy of oestrogen containing oral contraceptives and it may also effect the absorption of other drugs due to its effect on gastrointestinal flora. 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.
Flucloxacillin
As for amoxycillin see above.
Cholestatic hepatitis has been reported rarely.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms of overdosage,
As with all penicillins, oral administration can cause gastrointestinal symptoms such as transient diarrhoea, nausea and colic which are dose related and a result of local irritation not toxicity.

IDENTIFICATION:
MEGAPEN 500 - Light grey/standard grey capsules imprinted "Garec 500"
MEGAPEN S - Free-flowing off-white powder. Yellow syrup.

PRESENTATION:
MEGAPEN 500 - Glass bottles containing 15 or 100 capsules.
MEGAPEN S - Glass bottles containing powder for the preparation of 100 mL of 250 mg/5 mL syrup.

STORAGE INSTRUCTIONS:
Containers should be kept tightly closed in a cool (below 25 °C), dry place. Once dispensed MEGAPEN S must be used within 7 days if stored in a cool place (below 25 °C), or 14 days if stored in a refrigerator (5°C).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
MEGAPEN 500        Z/20.1.2/353
MEGAPEN S        Z/20.1.2/354

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GAREC (Pty) Ltd.
43 Richards Drive
Halfway House
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
16 February 1993

PZ353-354/1

Current: January 2004
Source: Community Pharmacy

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