INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
SUPRAPEN 500 (capsules)
SUPRAPEN S (syrup)

SCHEDULING STATUS:
S4

PROPRIETARY NAMES
(and dosage form):

SUPRAPEN 500 (capsules)
SUPRAPEN S (syrup)

COMPOSITION:

Suprapen 500	–	Gelatin capsules containing 250 mg amoxycillin (as amoxycillin trihydrate B.P.) and 250 mg flucloxacillin (as flucloxacillin sodium).
Suprapen-S	–	Powder for preparing a fruit-flavoured syrup. When dispensed as directed each 5 mL contains the equivalent of 125 mg amoxycillin and 125 mg flucloxacillin.
		The powder contains 0,13 % m/m sodium benzoate B.P. as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins

PHARMACOLOGICAL ACTION:

a)	Bacteriology
(i)	Spectrum

Suprapen exhibits in vitro and in experimental animals in vivo, bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. The following are among the more commonly encountered sensitive organisms:

Gram-positive bacteria			Gram-negative bacteria
Streptococcus pyogenes			Neisseria gonorrhoeae
Strep. faecalis			Neisseria meningitidis
Strep. viridans			Haemophilus influenzae
Dip. pneumoniae			Ischerichia coli
Staphylococcus aureus			Salmonella typhi
(penicillin sensitive)			Salmonella species
Staphylococcus aureus			Proteus mirabilis
(penicillinase producing)			Bordetella pertussis
Corynebacterium species			Shigella species
Clostridium species			Brucella species
Bacillus anthracis
(ii)	Synergism

Suprapen exhibits synergistic bactericidal activity in vitro, and in experimental animals in vivo against some ampicillin-resistant organisms.

(iii)

Additive effects

The two components of Suprapen –amoxycillin and flucloxacillin – generally exhibit an additive effect against sensitive bacteria and bacteria that are sensitive to amoxycillin or to flucloxacillin remain sensitive to the combination, showing that antagonism does not occur when the two components are combined.

(b)	Absorption

Suprapen is well absorbed orally. Peak serum levels are achieved 1 to 2 hours after dosing.

(c)ExcretionApproximately 50% of the dose is excreted unchanged into the urine within 6 hours, resulting in high urine levels of active drug.

INDICATIONS:
Suprapen is indicated for the treatment of a wide range of bacterial infections, caused by susceptible organisms; in particular infections of mixed origin where penicillin-resistant staphylococci may be implicated or where the causative organism is unknown.

Typical indications include:

Acute and chronic bronchitis	Pelvic inflammatory disease
Pneumonia	Urinary tract infections
Ear, nose and throat infections	Skin and soft tissue infections
Gynaecological infections

CONTRA-INDICATIONS:
Suprapen should not be given to those subjects hypersensitive to penicillin. As there is currently no neonatal formulation Suprapen 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 Suprapen) three times a day.
Children under 2: 2,5 mL of syrup (containing 125 mg Suprapen) three times a day.
Neonates: No formulation is available at present.

In severe infections these dosages may safely be increased.
To ensure maximal absorption Suprapen should be given in the fasting state, i.e. approximately 1 hour before a meal.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
As with other penicillins, side-effects are rare and usually of a mild and transitory nature. Allergic reactions may occur, and these are normally mild in nature, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event withdrawal of Suprapen and administration of an antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, the drug should be discontinued and the patient treated with the usual agents: (adrenaline, corticosteroids and antihistamines). Treatment with Suprapen may give rise to a maculopapular 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.

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.

Hepatitis and cholestatic jaundice have 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 gastro-intestinal symptoms such as transient diarrhoea, nausea and colic which are dose related and a result of local irritation not toxicity.

IDENTIFICATION:

Suprapen 500	–	Maroon/caramel capsules overprinted with the trade name "Suprapen".
Suprapen S	–	Free-flowing off-white powder. Yellow syrup.

PRESENTATION:

Suprapen 500	–	Glass bottles containing 15 or 100 capsules.
Suprapen S	–	Glass bottles containing powder for the preparation of 100 mL of 250 mg/5mL syrup.

STORAGE INSTRUCTIONS:
Containers should be kept tightly closed in a cool (below 25°C), dry place.
Once dispensed, Suprapen 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).

REGISTRATION NUMBERS:

Suprapen 500	–	J/20.1.2/437
Suprapen S	–	J/20.1.2/438

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Ltd.
6 Carey Street Wynberg Ext. 6, Johannesburg 2090.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12.11.1985.

Suprapen and the SB logo are trademarks.

        P0730
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