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

Logo AMPIMAX 250 (250 mg capsule)
AMPIMAX S (125 mg powder for suspension)
AMPIMAX SF (250 mg powder for suspension)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

AMPIMAX 250 (250 mg capsule)
AMPIMAX S (125 mg powder for suspension)
AMPIMAX SF (250 mg powder for suspension)

COMPOSITION:
Each capsule contains
ampicillin trihydrate equivalent to 250 mg ampicillin.
The reconsituted suspension contains ampicillin trihydrate equivalent to 125 mg or 250 mg ampicillin per 5 mL medicine measure and 0,5% m/v sodium benzoate as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A: 20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
Ampimax
is a bactericidal broad spectrum penicillin.

INDICATIONS:
Infections due to susceptible organisms.

CONTRA-INDICATIONS:
Ampimax
should not be given to patients known to be allergic to penicillin nor, in the neo-natal period, to babies born of hypersensitive mothers.
Ampimax should not be given to patients with infectious mononucleosis since they are especially susceptible to ampicillin-induced rashes, patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol, since they may be at increased risk of developing ampicillin-induced skin rashes.

WARNINGS:
Ampimax
may cause reactions typical of penicillin allergy. In patients with a history of penicillin or cephalosporin allergy Ampimax should be used with caution.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 250 mg to 750 mg every 6 hours.
Children 0 - 6 years: 62,5 mg to 187,5 mg every 6 hours.
A half to three quarters of a medicine measureful of
Ampimax S (125 mg/5 mL) every 6 hours.
Children 7 - 10 years: 125 mg to 375 mg every 6 hours.
One to three medicine measuresful of Ampimax S
(125 mg/5 mL) or a half to one and a half medicine
measuresful of Ampimax SF (250 mg/5 mL), every 6
hours.
Children over 10 years: 250 mg to 750 mg every 6 hours.
One to three medicine measureful of Ampimax SF
(250 mg/5 mL) or one to three capsules of Ampimax
250 mg every 6 hours.
In severe infections doses may be increased or high doses administered parenterally. Ampimax should be taken 30 minutes to 1 hour before meals. In patients with renal impairment dosage may be reduced if required.

Reconstitution of powder for suspension 125 mg:
Add 70 mL water to make up 100 mL and shake well.
Reconstitution of powder for suspension 250 mg:
Add 50 mL water to make up 100 mL and shake well.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Overgrowth of non-susceptible organisms (Aerobacter aerogenes, Pseudomonas, Candida, etc.) may occur and under these circumstances, Ampimax treatment should be discontinued and specific or supportive therapy instituted. Diarrhoea, nausea, vomiting, heartburn and pruritis ani may occur. When Ampimax is administered to a hypersensitive patient, allergic reactions may occur. Urticaria and maculopapular skin rashes are common, exfoliative dermatitis, eosinophilia, angioneurotic oedema, erythema multiforme, fever and swollen joints may occur.
Allergic reactions which may be fatal such as anaphylaxis may occur. These reactions may be common after parenteral use but may also occur after oral administration. If serious anaphylactic reaction occurs, Ampimax should be discontinued and the patient treated with adrenalin, corticosteriods and antihistamines. The onset of the symptoms varies: it may occur within a few days of the beginning of treatment or not until therapy with a penicillin derivative is resumed on a subsequent occasion. In cases of ampicillin treatment of mononucleosis a rash usually appears. Severe pseudomembranous colitis may occur. Raised serum aminotransferase concentrations have been reported.
Use with caution in patients with syphylis as the Jarish-Herxheimer reaction may occur.

INTERACTIONS:
Ampimax
may decrease the efficacy of oestrogen containing oral contraceptives.
Due to ampicillin’s effect on the gastro-intestinal flora, the absorption of other medicines may be affected.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT’S TREATMENT:
See “Side-effects and Special Precautions”. Should a serious allergic reaction occur the medicine should be discontinued.
Treatment is supportive and symptomatic.

IDENTIFICATION:
Ampimax 250: Maroon and orange, opaque capsules
Ampimax S and SF: White powder forming a white suspension when reconstituted.

PRESENTATION:
Ampimax 250: Containers of 20, 100 or 500 capsules.
Ampimax S and SF: Glass bottles containing 125 mg and 250 mg powder for suspension, producing 100 mL of suspension when reconstituted.

STORAGE INSTRUCTIONS:
Ampimax 250: Store below 25°C. Protect from light and moisture.
Ampimax S and SF: Store in a dry place below 25°C. Protect from light and moisture.
Reconstituted suspension:
Keep in refrigerator. Remains stable for 14 days when stored in refrigerator. Discard after 7 days if kept at room temperature.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
Ampimax 250: 28/20.1.2/0408
Ampimax S: 28/20.1.2/0409
Ampimax SF: 28/20.1.2/0410

NAME AND ADDRESS OF THE APPLICANT:
HEXAL PHARMA (SA) (PTY) LTD
UNIT A
10 FANGIO ROAD
MAHOGANY RIDGE
WESTMEAD
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 November 1993

Updated on this site: February 2000

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