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

Logo PETERCILLIN® S-125
PETERCILLIN® SF-250
PETERCILLIN®–250 CAPSULES
PETERCILLIN®–500 CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PETERCILLIN® S-125
PETERCILLIN® SF-250
PETERCILLIN®–250 CAPSULES
PETERCILLIN®–500 CAPSULES

COMPOSITION:
Syrup: when reconstituted each 5 mL contains
Ampicillin Trihydrate equivalent to 125 mg or 250 mg Ampicillin.
Preservative:
Sodium benzoate 0,1% m/v
Capsules containing Ampicillin Trihydrate equivalent to 250 mg or 500 mg Ampicillin.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Petercillin is bactericidal with a broad spectrum of activity.

INDICATIONS:
Petercillin is effective in conditions caused by the Gram-positive non-penicillinase producing staphylococci, haemolytic and non-haemolytic streptococci, Diplococcus pneumoniae, Clostridia sp. and Streptococcus faecalis. Also the Gram-negative cocci (Neisseria sp.), H. influenzae, E. Coli, Proteus mirabilis and many strains of brucellae, salmonellae and shigellae.

CONTRA-INDICATIONS:
Petercillin should not be given to subjects known to be sensitive to penicillin or any cephalosporin, in the neo-natal period or to babies born of sensitive mothers. Should not be given to patients with infectious mononucleosis, since they are especially susceptible to ampicillin - induced skin rashes; patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol, may be at increased risk of developing skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
Powder for reconstitution
To make up to 100 mL, add 57 mL of water, invert bottle and shake until all powder is dispersed. Once dispensed, the syrup must be used within 7 days if stored in a cool room or 14 days if stored in a refrigerator.

Adults                 250 to 750 mg every 6 hours.
Children 0-6 years One quarter the adult dose.
  6-10 years Half the adults dose every 6 hours.
  Over 10 years Adult dosage
Much higher doses (up to 12 g daily in adults) may be safely given. In severe infections doses may be safely increased or high doses given by injection. Oral preparations should be taken ½ to 1 hour before meals.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common adverse effects are allergic reactions and of these skin rashes occur most frequently. Administration of ampicillin to a hypersensitive patient may result in anaphylactic shock with collapse which may be fatal; angioedema or bronchospasm may also occur.
A generalised sensitivity reaction with urticaria, fever, joint pains and eosinophilia can develop within a few hours to several weeks after starting ampicillin treatment. Other allergic reactions include exfoliative dermatitis and other skin reactions, interstitial nephritis, and vasculitis.
Ampicillin may produce diarrhoea, nausea and heartburn, usually following administration! by mouth.
Supra-infections with non-susceptible organisms may occur particularly with prolonged use.
Ampicillin should be given with caution to patients with a history of allergy especially to other medicine. Care is necessary if very high doses of ampicillin are given especially if renal function is poor because of the risk of neurotoxicity.
These reactions may occur after administration of any penicillin derivative in persons who have become hypersensitised after a previous course of treatment.
The onset of symptoms varies; it may occur within a few hours or days of the beginning of treatment or not until therapy with a penicillin derivative is resumed on a subsequent occasion.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions.
Should a serious allergic reaction occur, treatment should be discontinued and the patient treated specifically (antihistamines, pressor amines or corticosteroids).
Treatment is supportive and symptomatic.

IDENTIFICATION:
Petercillin S-125 While to slightly pink fruit-flavoured powder.
Petercillin SF-250 Pink fruit-flavoured powder.
Capsules Black/Blue printed in while ink with a Lennon logo and "Lennon" and "Petercillin 250" or "500".

PRESENTATION:
Petercillin S-125 100 mL bottles.
Petercillin SF-250 100 mL bottles.
Capsules 
250 mg & 500 mg Packs of 20, 100 and 500.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from moisture.
Shake the bottle before use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Petercillin S-125 H/20.1.2/20
Petercillin SF-250 H/20.1.2/21
Petercillin-250 Capsules H/20.1.2/22
Petercillin-500 Capsules H/20.1.2/23

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
600l

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11.6.75

Code 308252                LH&SEL-K 13809 A94

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