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

Logo XERACIL 250 capsules
XERACIL 500 capsules
XERACIL S Powder for suspension
XERACIL SF Powder for suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

XERACIL 250 capsules
XERACIL 500 capsules
XERACIL S Powder for suspension
XERACIL SF Powder for suspension

COMPOSITION:
Amoxycillin trihydrate BP available as:
XERACIL 250 capsules Gelatin capsules containing the equivalent of 250 mg amoxycillin.
XERACIL 500 capsules Gelatin capsules containing the equivalent of 500 mg amoxycillin.
XERACIL S Each 5 mL of the reconstituted suspension contains the equivalent of 125 mg amoxycillin.
XERACIL 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 gonorrhoeae
(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 XERACIL penetrates into the cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebral-spinal infections.
Approximately 60% of an oral dose of amoxycillin is excluded unchanged in the active form into the urine within six hours.

INDICATIONS:
Infections caused by susceptible, non-penicillinase-producing organisms including:
Upper respiratory tract infections Skin & soft tissue infections
Lower respiratory tract infections Gonorrhoea
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 XERACIL is 750 mg-1,5 g per day.
(a) General dosages:                
  Adults: 250 mg (1x250 mg capsules 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. 
  To reconstitute 75 mL suspension, add 43 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
ADULT
DOSAGES
        CHILDREN
DURATION
Gastro-intestinal tract infections 1-2g         - 4-5 days
Acute Typhoid Fever 4g         - 14 days
          - 100 mg/kg 21 days
Gonorrhoea 2-3g         - 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 reactions or urticaria. In this event withdrawal of XERACIL is necessary.
Should a serious anaphylactic reaction occur, XERACIL should be discontinued and the patient treated with: Adrenalin, corticosteroids and antihistamines.
Treatment with XERACIL 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 whenever 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 XERACIL to patients with syphilis, as the Jarisch-Herxheimer a reaction may occur in these patients. XERACIL may decrease the efficacy of oestrogen-containing oral contraceptives. Due to XERACIL's effects 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:
XERACIL 250 capsules - Flesh/maroon capsules
XERACIL 500 capsules - Flesh/maroon capsules
XERACIL S powder for suspension Free-flowing, slightly pink powder, light mauve suspension.
XERACIL SF powder for suspension Free-flowing, slightly pink powder, light mauve suspension.

PRESENTATION:
XERACIL 250 capsules Canisters containing 15, 100 or 500 x 250 mg amoxycillin capsules or cartons containing 15 blister packed capsules.
XERACIL 500 capsules Canisters containing 15, 100 or 500 x 500 mg amoxycillin capsules or cartons containing 15 blister packed capsules.
XERACIL S powder for suspension Bottles containing powder for reconstitution to 100 mL or 75 mL of 125 mg/5 mL suspensions.
XERACIL SF powder for suspension Bottles containing powder for reconstitution to 100 mL of 250 mg/5 mL suspensions.

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

REGISTRATION NUMBERS:
XERACIL 250 Capsules:        28/20.1.2/0392
XERACIL 500 Capsules:        28/20.1.2/0393
XERACIL S Suspension:        28/20.1.2/0394
XERACIL SF Suspension:        28/20.1.2/0395

NAME AND ADDRESS OF THE APPLICANT:
Xeragen Laboratories (Pty) Ltd
1 Highdale Road
GLEN ANIL
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 August 2003

        PENC0052

Updated on this site:October 2005
Source: Hospital Pharmacy

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