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

Logo ACUCIL 250 Capsules
ACUCIL 500 Capsules
ACUCIL S Suspension
ACUCIL SF Suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ACUCIL 250 Capsules
ACUCIL 500 Capsules
ACUCIL S Suspension
ACUCIL SF Suspension

COMPOSITION:
Amoxycillin trihydrate BP available as :
ACUCIL 250 Gelatin capsules containing the equivalent of 250 mg amoxycillin
ACUCIL 500 Gelatin capsules containing the equivalent of 500 mg amoxycillin
ACUCIL S Each 5 mL of the reconstituted suspension contains the equivalent of 125 mg amoxycillin.
ACUCIL SF Each 5 mL of the reconstituted suspension contains the equivalent of 250 mg amoxycillin.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins.

PHARMACOLOGICAL ACTION:
Amoxycillin is a penicillinase-susceptible penicillin. Amoxycillin exhibits in vitro bactericidal activity against a wide range of Gram- negative and Gram-positive organisms including.
(In vitro sensitivity does not necessarily imply in vivo efficacy):
Gram-positive bacteria: Gram-negative bacteria:
Staphylococcus aureus* Neisseria gonorrhoea
(penicillin sensitive) Neisseria meningitidis**
Streptococcus pyogenes Haemophilus influenzae
Streptococcus viridans* Bordetella pertussis
Streptococcus faecalis* Escherichia coli
Streptococcus pneumoniae* Salmonella typhi
Corynebacterium species* Salmonella species
Clostridium species* Shigella species
Bacillus anthracis* Brucella species
  Proteus mirabilis
* Sensitivity tests must be performed.
** Except type b-strains causing meningitis in children

Amoxycillin is well absorbed orally. After oral administration there is no significant difference between the peak serum levels in fasting and non-fasting subjects.
The presence of food does not interfere with the absorption of amoxycillin. Amoxycillin may, therefore, be taken with meals.
There is a linear/dose response in peak serum levels after oral administration.
There is insufficient evidence at present to show that ACUCIL penetrates into the cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections.
Approximately 60% of an oral dose of amoxycillin is excreted unchanged in the active form into the urine within 6 hours.

INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:
Upper respiratory tract infections Skin and soft tissue infections
Lower respiratory tract infections Gonorrhea
Otitis media Non-specific urethritis
Upper urinary tract infections Typhoid fever
Lower urinary tract infections Gastro-intestinal tract infections

CONTRA-INDICATIONS:
Allergy to penicillins or any of the cephalosporins.
Patients with infectious mononucleosis, since they are especially susceptible to amoxycillin induced skin rashes; patients with lymphatic leukaemia and patients with hyperuricaemia being treated with allopurinol may also be at increased risk of developing skin rashes.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for ACUCIL is 750 mg - 1,5 g per day.
(a)        General dosages
  Adults 250 mg (1 x 250 mg capsule or 5 mL of 250 mg/5 mL suspension) three times a day.
To reconstitute 100 mL suspension, add 57 mL of water, invert the bottle and shake until all powder is dispersed.
  Children 2-10 years: 125 mg (5 mL of 125 mg/5 mL suspension) three times a day.
  Children six months - two years: 125 mg (5 mL of 125 mg/5 mL suspension) three times a day.
  Infants 0-6 months: 62,5 mg (2,5 mL of 125 mg/5 mL suspension) three times a day.

(b)        Specific Dosages
Indications Daily Dosages Adults Daily Dosages Children         Duration
Gastro-intestinal tract infections         1-2 g         --         4-5 days
Acute Typhoid fever         4 g         --         14 days
          --         100 mg/kg         21 days
Gonorrhoea         2-3 g --         stat

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances including diarrhoea, nausea and vomiting occur frequently.
Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction or urticaria. In this event withdrawal of ACUCIL is necessary.
Should a serious anaphylactic reaction occur, ACUCIL should be discontinued and the patient treated with adrenaline, corticosteroids and antihistamines.
Treatment with ACUCIL may give rise to a maculopapular rash during therapy or within a few days after completion thereof. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis.
Pseudomembranous colitis has been reported. Super-infections with non-susceptible organisms may occur.
Caution must be exercised in treating patients with dehydration or oliguria because of the possibility of crystalluria.
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity testing should, therefore, be carried out wherever possible, to ensure the appropriateness of the therapy.

SPECIAL PRECAUTIONS:
The dose should be reduced in patients with renal failure.
Caution is needed when administering ACUCIL to patients with syphilis, as the Jarisch-Herxheimer reaction may occur in these patients. ACUCIL may decrease the efficacy of oestrogen-containing oral contraceptives. Due to ACUCIL’s effect on intestinal flora the absorption of other medicines may be affected.

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

IDENTIFICATION:
ACUCIL 250 Opaque blue/pink capsules
ACUCIL 500 Opaque blue/pink capsules
ACUCIL S Free-flowing, off-white powder, off-white suspension.
ACUCIL SF Free-flowing, off-white powder, off-white suspension.

PRESENTATION:
ACUCIL 250 White plastic bottles containing 15, 100 or 500 x 250 mg amoxycillin capsules.
ACUCIL 500 White plastic bottles containing 15, 50, 100 or 250 x 500 mg amoxycillin capsules.
ACUCIL S PVC or glass bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL suspension.
ACUCIL SF PVC or glass bottles containing powder for reconstitution to 100 mL of 250 mg/5 mL suspension.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
The reconstituted suspension must be used within 14 days if stored in a refrigerator between 2 and 8°C or within 7 days if stored at room temperature below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ACUCIL 250 - 27/20.1.2/0196
ACUCIL 500 - 27/20.1.2/0197
ACUCIL S - 27/20.1.2/0198
ACUCIL SF - 27/20.1.2/0199

NAME AND BUSINESS ADDRESS OF APPLICANT:
Apotex S.A. (Pty) Ltd.
78 Fleming Street
Meadowdale Ext. 1
Isando
1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
{undated}

Updated on this site: September 2004
Source: Pharmaceutical Industry

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