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

Logo ACUPILLIN 250 Capsules
ACUPILLIN S Powder for suspension
ACUPILLIN SF Powder for suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ACUPILLIN 250 Capsules
ACUPILLIN S Powder for suspension
ACUPILLIN SF Powder for suspension

COMPOSITION:
Each capsule contains
ampicillin trihydrate equivalent to 250 mg ampicillin.
The reconstituted suspension contains ampicillin trihydrate equivalent to either 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:
ACUPILLIN is a bactericidal broad spectrum penicillin.

INDICATIONS:
Infections due to susceptible organisms.

CONTRA-INDICATIONS:
ACUPILLINshould not be given to patients known to be sensitive to penicillin nor, in the neo-natal period, to babies born of sensitive mothers. ACUPILLIN should not be given to patients with infectious mononucleosis; patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may be at increased risk of developing ampicillin-induced skin rashes.

WARNINGS:
The capsule shell contains tartrazine which may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals. Though the overall incidence of tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who also have aspirin sensitivity. ACUPILLIN may cause reactions typical of penicillin allergy. In patients with a history of penicillin or cephalosporin allergy ACUPILLIN 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/mL (half to one and a half medicine measures of 125 mg/5 mL suspension) every 6 hours.
Children 7 - 10 years: 125 mg to 375 mg (one to three medicine measures of 125 mg/5 mL suspension) every 6 hours.
Children over 10 years: Adult dose
In severe infections doses may be increased or bigger doses can be given parenterally. ACUPILLIN should be taken half an hour to 1 hour before meals. In patients with renal impairment dosage may be reduced if required.
Reconstitution of powder for suspension:
S: Add 70 mL water to make up 100 mL and shake well.
SF: 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, ACUPILLIN treatment should be discontinued and specific or supportive therapy instituted. Diarrhoea, nausea, vomiting, heartburn and pruritis ani may occur. When ACUPILLIN 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, ACUPILLIN should be discontinued and the patient treated with adrenalin, corticosteroids and antihistamines. The onset of the 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. If a serious anaphylactic reaction occurs ACUPILLIN should be discontinued and the patient treated with adrenalin, corticosteroids and antihistamines. 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 syphillis as the Jarish-Herxheimer reaction may occur.
ACUPILLIN may decrease the efficacy of oestrogen containing oral contraceptives. Due to ACUPILLIN’s effect on the gastrointestinal 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:
ACUPILLIN 250: Red and black opaque capsules.
ACUPILLIN S: White powder forming a white suspension when reconstituted.
ACUPILLIN SF: White powder forming a white suspension when reconstituted.

PRESENTATION:
ACUPILLIN 250 capsules: 20 or 100 capsules in amber glass bottles or white plastic bottles. 500 capsules in amber plastic jars or white plastic bottles..
ACUPILLIN S: Powder for suspension, producing 100 mL of suspension when reconstituted in PVC or glass bottles.
ACUPILLIN SF: Powder for suspension, producing 100 mL of suspension when reconstituted in PVC or glass bottles.

STORAGE INSTRUCTIONS:
ACUPILLIN 250: Store below 25°C. Protect from light and moisture.
ACUPILLIN S powder for suspension: Store in a dry place below 25°C. Protect from light and moisture.
ACUPILLIN SF powder for suspension: 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:
ACUPILLIN 250: 27/20.1.2/0133
ACUPILLIN S: 27/20.1.2/0134
ACUPILLIN SF: 27/20.1.2/0135

NAME AND ADDRESS OF THE APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
Apotex SA (Pty) Ltd
Corner Watt & Fleming Streets
Meadowdale Ext. 1.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1993

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