PETERCILLIN INJECTION 100 mg Powder for Injection; PETERCILLIN INJECTION 250 mg Powder for Injection; PETERCILLIN INJECTION 500 mg Powder for Injection; PETERCILLIN INJECTION 1 g Powder for Injection; PETERCILLIN INJECTION 5 g Powder for Injection

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

PETERCILLIN INJECTION 100 mg Powder for Injection
PETERCILLIN INJECTION 250 mg Powder for Injection
PETERCILLIN INJECTION 500 mg Powder for Injection
PETERCILLIN INJECTION 1 g Powder for Injection
PETERCILLIN INJECTION 5 g Powder for Injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PETERCILLIN INJECTION 100 mg Powder for Injection
PETERCILLIN INJECTION 250 mg Powder for Injection
PETERCILLIN INJECTION 500 mg Powder for Injection
PETERCILLIN INJECTION 1 g Powder for Injection
PETERCILLIN INJECTION 5 g Powder for Injection

COMPOSITION:
Vial containing 100 mg, 250 mg, 500 mg, 1 g or 5 g ampicillin as ampicillin sodium.

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 hypersensitive to penicillin nor, in the neo-natal period, to babies born of hypersensitive mothers.

WARNINGS:
None.

DOSAGE AND DIRECTIONS FOR USE:
The usual dose for adults is 500 mg, 6 hourly. In severe infections this dose may be given up to 6 times in one day.
The recommended intravenous and intramuscular dosages for children are ¼ to ¾ of the adult dose and are increased in relation to the age from infants to 15 years.

Intramuscular: 100 mg –add 0,5 mL Water for Injections. 250 mg, 500 mg, 1 g –add 1,5 to 2,0 mL Water for Injections.

Intravenous: Dissolve the contents of a vial in the specified volume of Water for Injections.
250 mg –5,0 mL; 500 mg –10,0 mL; 1 g or 5 g –20,0 to 30,0 mL.
Administer by slow injection over a period of 3 –4 minutes.
Alternatively, if fluids are being given by intravenous infusion, the solution may be injected slowly into the drip tubing –refer to table under "Stability".

Intrathecal: Infants 0 to 2 years, 5 to 10 mg daily –dissolve in 0,5 mL.
* Single injections daily.
Children 2 to 12 years, 10 to 20 mg daily –dissolve in 0,5 mL to 1 mL.
* Single injection daily.
Adults, up to 40 mg daily –dissolve in up to 2 mL.
* Single injection daily.
* (Only sterile solutions should be used i.e. Water for Injections, sterile normal saline or C.S.F.)

Intravenous infusions:

	Intraperitoneal: Dialysis: 50 mg per litre of dialysate.
	Therapeutic: Dissolve 500 mg in 5 to 10 mL Water for Injections.
	Intrapleural: Dissolve 500 mg in 5 to 10 mL Water for Injections.
	Intra-Articular: 50 –100 mg/mL using Water for Injections or 0,5% lignocaine hydrochloride to make up to volume of 2,5 mL.

Subconjunctival: Dissolve 100 mg in 0,5 mL Water for Injections.

Topical: Sprinkle 500 mg to 1 g dry powder extraperitoneally before closure and suturing.

Stability and Compatibility: Injectable solution: Only freshly prepared solutions should be used.
Intravenous infusion: PETERCILLIN is compatible with the following intravenous fluids, but solutions must be used within the periods shown below:
Table: Period of stability of Petercillin intravenous infusion solutions at room temperature.

N. Saline	6-8 hours
5% Dextrose	1 hour
Dextrose saline	1 hour
M/6 Sodium lactate	4 hours
Ringers solution	6-8 hours
1,4% Sodium bicarbonate	4 hours

PETERCILLIN should not be added to infusion bottles containing Dextran 40 Injection but may be injected into the drip tubing of such an infusion.

Blood and Plasma: A dilute solution (i.e. 500 mg dissolved in 20 mL Water for Injections) should be injected slowly into the drip tubing rather than added to the infusion bottle.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
If symptoms due to overgrowth of non-susceptible organisms (Aerobacter aerogenes, Pseudomonas, Candida, etc.) appear, the drug should be discontinued and specific or supportive therapy instituted. Side-effects are usually mild, transitory and infrequent and are similar to those found with other penicillins, however the administration of high doses to children may cause cerebral irritation and convulsions. Transient diarrhoea, nausea, heartburn and pruritus ani may occur. When ampicillin is administered to a hypersensitive patient, allergic reactions may occur; urticaria and skin rashes are common; exfoliative dermatitis, eosinophilia, angioneurotic oedema, fever and swollen joints are less frequent; occasionally severe allergic reactions, which may be fatal, occur.
These reactions are more common after parenteral use but may occur after oral 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.
Occasionally an erythema multiforme type of rash may occur up to 15 days after stopping administration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosing is virtually impossible. However, in patients with renal impairment, because serum levels increase, dosage may be reduced if required. Should a serious allergic reaction occur, the drug should be discontinued and the patient treated specifically (antihistamines, pressor amines or corticosteroids).

IDENTIFICATION:
A while powder in sealed vials.

PRESENTATION:
In boxes of 100 vials of sterile powder containing 100 mg, 250 mg, 500 mg, 1 g or 5 g ampicillin as ampicillin sodium

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:

Petercillin Injection 100 mg	–H/20.1.2/24
Petercillin Injection 250 mg	–H/20.1.2/25
Petercillin Injection 500 mg	–H/20.1.2/26
Petercillin Injection 1 g	–H/20.1.2/27
Petercillin Injection 5 g	–H/20.1.2/28

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD
6 Gibaud Road
Port Elizabeth, 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

09/09/1975	12-489/5-94
	Tradepak P.E.