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

Logo PENRITE 250 CAPSULES
PENRITE 500 CAPSULES
PENRITE 125S SUSPENSION
PENRITE 250S SUSPENSION
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PENRITE 250 CAPSULES
PENRITE 500 CAPSULES
PENRITE 125S SUSPENSION
PENRITE 250S SUSPENSION

COMPOSITION :
PENRITE 250 – each capsule contains ampicillin trihydrate equivalent to 250 mg ampicillin base.
PENRITE 500 – each capsule contains ampicillin trihydrate equivalent to 500 mg ampicillin base.
PENRITE 125S – each 5 mL of the reconstituted suspension contains ampicillin trihydrate equivalent to 125 mg ampicillin base.
Preservative - 0,125% (m/v) sodium benzoate.
PENRITE 250S – each 5 mL of the reconstituted suspension contains ampicillin trihydrate equivalent to 250 mg ampicillin base.
Preservative - 0,125% (m/v) sodium benzoate.
PHARMACOLOGICAL CLASSIFICATION:
A20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Ampicillin is bactericidal with a broad spectrum of activity in vitro against Gram-positive non-penicillinase producing staphylococci, haemolytic and non-haemolytic streptococci, Diplococcus pneumoniae, Clostridia sp. and Streptococcus faecalis. Also the Gram-negative cocci, Neissera sp., H. influenzae, E. coli, Proteus mirabalis and many strains of brucellae, salmonellae and shigellae. It has been determined that certain organisms which were previously sensitive are already showing resistance.

INDICATIONS:
Indicated in infections due to susceptible organisms.

CONTRA-INDICATIONS:
Penrite should not be given to patients known to be sensitive to penicillin or in the neonatal period, to babies born of hypersensitive mothers. Penrite should not be given to patients with infectious mononucleosis since they are susceptible to ampicillin-induced skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 250 mg to 750 mg every six hours.
Children:
0 - 6 years – quarter the adult dose six hourly.
6 - 12 years – half the adult dose six hourly.
over 12 years – adult dose six hourly.
Much higher doses (up to 12 g daily in adults) may be given safely. Oral preparations should be taken half an hour before meals.

Directions for reconstituting suspension :
PENRITE 125S –add 75 mL distilled water to dry powder in the bottle and shake well.
PENRITE 250S –add 68 mL distilled water to dry powder in the bottle and shake well.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
If symptoms due to overgrowth of non-susceptible organisms (Aerobacter aerogenes, Pseudomonas, Candida, etc.), appear, the medicine should be discontinued and specific or supportive therapy instituted. Side effects are usually mild, transitory and are similar to those found with other penicillins. Transient diarrhoea, nausea, heartburn and pruritis ani may occur. When ampicillin is administered to a hypersensitive patient allergic reactions may occur.
Urticaria and skin rashes are common. Exfoliative dermatitis, eosinophilia, angio neurotic oedema, fever and swollen joints may occur. Severe allergic reactions which may be fatal occur. These reactions are more common after a previous course of treatment. The onset of the symptoms varies, it may occur within a few hours or days of the onset of the treatment or not until therapy with a penicillin derivative is resumed on a subsequent occasion.
Should a serious anaphylactic reaction occur, Penrite should be discontinued and the patient treated with the usual agents (adrenalin, corticosteroids and antihistamines). Reduced doses may be required in patients with impaired renal function. In cases of ampicillin treatment of mononucleosis, a rash usually appears.

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

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
PENRITE 250 – size 2, blue and pink capsule.
PENRITE 500 – size 0, blue and pink elongated capsule.
PENRITE 125S – amber glass bottle containing a white powder which on reconstitution produces a white, vanilla flavoured suspension
PENRITE 250S – amber glass bottle containing a buff-coloured powder which on reconstitution produces a yellow to slightly orange, pineapple flavoured suspension.
PRESENTATION:
PENRITE 250 – securitainers with 20, 100 and 500 capsules.
PENRITE 500 – securitainers with 20 and 100 capsules.
PENRITE 125S – 150 mL amber glass bottles containing powder for reconstitution of 100 mL suspension.
PENRITE 250S – 150 mL amber glass bottles containing powder for reconstitution of 100 mL suspension.
STORAGE INSTRUCTIONS:
Keep in a dry place below 25°C.
Keep out of reach of children.
Potency of the reconstituted suspension will be maintained for one week at a temperature below 25°C and two weeks at 2-8°C.

REGISTRATION NUMBERS:
PENRITE 250 – Q/20.1.2/239
PENRITE 500 – V/20.1.2/116
PENRITE 125S – V/20.1.2/353
PENRITE 250S – Q/20.1.2/240
NAME AND ADDRESS OF APPLICANT:
Columbia Pharmaceuticals (Pty) Ltd
Tempelhof South
Bonaero Park

DATE OF PUBLICATION:
18/05/1989.

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