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

Logo ZOXIL 250 (capsules)
ZOXIL 500 (capsules)
ZOXIL S (syrup)
ZOXIL SF (syrup)

SCHEDULING STATUS:
S4

PROPRIETARY NAMES
(and dosage form):

ZOXIL 250 (capsules)
ZOXIL 500 (capsules)
ZOXIL S (syrup)
ZOXIL SF (syrup)

COMPOSITION:
Amoxycillin trihydrate available as :
ZOXIL 250 - Gelatin capsules containing the equivalent of 250 mg Amoxycillin.
ZOXIL 500 - Gelatin capsules containing the equivalent of 500 mg Amoxycillin.
ZOXIL S - Powder for preparing a fruit-flavoured syrup. When reconstituted as directed, each 5 mL of the suspension contains the equivalent of 125 mg Amoxycillin. The powder contains 0,295% m/m sodium benzoate B.P. as a preservative.
ZOXIL SF - Powder for preparing a fruit-flavoured syrup. When reconstituted as directed, each 5 mL of the suspension contains the equivalent of 250 mg Amoxycillin. The powder contains 0,295% m/m sodium benzoate B.P. as a preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins

PHARMACOLOGICAL ACTION:
(a) Bacteriology
  (i) Spectrum - Amoxycillin is a penicillinase-susceptible penicillin. Amoxycillin exhibits in vitro, bactericidal activity against a wide range of Gram-negative and Gram-positive organisms including:
  Gram-positive bacteria: Gram-negative bacteria:
  Staphylococcus aureus (penicillin-sensitive) * Neisseria gonorrhoeae *
  Streptococcus pyogenes Neisseria meningitidis
  Streptococcus viridans * Haemophilus influenzae **
  Streptococcus faecalis * Bordetella pertussis
  Diplococcus pneumoniae * Escherichia coli *
  Corynebacterium-species * Salmonella typhi
  Clostridium species * Salmonella species
  Bacillus anthracis * Shigella species
    Proteus mirabilis
    Brucella species
* Sensitivity tests must be performed,
** except type b-strains causing meningitis in children.

  (ii) Bactericidal Action
Amoxycillin exerts a rapid bactericidal activity at normal dosage levels against all susceptible organisms.
(b) Absorption
Amoxycillin is rapidly and well absorbed orally. A single 250 mg oral dose achieves an average peak serum level virtually equal to that achieved by IM injection viz. 5,3 micrograms/mL oral and 5,6 micrograms/mL IM. The peak serum level is achieved within 1,5 - 2 hours after oral and 15 minutes after IM or IV (18,2 micrograms/mL) administration.
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 Zoxil. Zoxil may, therefore, be taken with meals.
There is a linear/dose response in peak serum levels after both oral and parenteral administration.
(c) Distribution
(i) Sputum:
The concentration of Amoxycillin in sputum does not decrease as occurs with ampicillin as purulence subsides.
(ii) Bile: Zoxil is present in bile obtained from a common bile duct drain of a healthy gall-bladder, however, biliary levels are lower when the gall-bladder is diseased and absent in the presence of biliary tract obstruction.
(iii) Urine: The average concentration of Zoxil in urine collected during the first six hours after 250 mg oral dose, is 580 mg/mL.
(d) Excretion
(i) Renal:
Approximately 60% of an oral dose of Amoxycillin is excreted unchanged in the active form into the urine within six hours. Approximately 70%-80% of an intramuscular dose and 90% of an intravenous dose is excreted unchanged in the active form, into the urine within 12 hours.
(ii) Biliary: A variable percentage of Zoxil is excreted into the bile.
(e) Probenecid
Even higher Zoxil serum levels may be achieved after oral administration to patients with normal renal function, by the simultaneous administration of a renal blocking agent such as probenecid. Probenecid should not be given in the presence of abnormal renal function. No data on the effect of probenecid on parenteral Amoxycillin are yet available.

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

CONTRA-INDICATIONS:
Allergy to penicillins or any of the cephalosporins is an absolute contra-indication to the use of Zoxil.

WARNINGS:
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. Before commencing therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergies.
If an allergic reaction occurs, appropriate therapy should be instituted and Amoxycillin therapy discontinued.
There is insufficient evidence at present to show that Zoxil penetrates into the cerebro-spinal fluid in therapeutic quantities and it should, therefore, not be used in the treatment of cerebro-spinal infections.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for Zoxil is 750 mg - 1,5 g/day, but in serious infections up to 6 g daily has been administered.

(a) General dosages:
(i) Oral
  Adults 250 mg (1 X 250 mg capsule or 5 mL of 250 mg/5 mL syrup) three times a day.
  Children 2 - 10 years: 125 mg (5 mL of 125 mg/5 mL syrup) three times a day.
  Children 6 months - 2 years: 125 mg (5 mL of 125 mg/5 mL syrup) three times a day.
  Infants 0 - 6 months: 62,5 mg (2,5 mL of 125 mg/5 mL syrup) three times a day.
  Premature infants 1,0 - 2,5 kg: 30,0 - 62,5 mg (quarter to half medicine measureful of 125 mg/5 mL syrup) once daily for the first 1 - 2 weeks depending on the size and maturity of the infant, thereafter dose may be given 2 - 3 times daily.
  In severe infections these dosages may be increased.

NOTE: (1) Patients with renal insufficiency may possibly require a reduced dose.
  (2) During treatment with high doses of Zoxil, an adequate fluid intake and urinary output must be maintained. Indwelling catheters should be checked regularly for potency since at room temperature high urinary concentration of Zoxil may precipitate out of solution.

Specific Dosages:
  DAILY DOSAGES 
Indications Adults Children Duration 
Gastro-intestinal tract infections 1 - 2 g - 4 - 5 days 
Acute typhoid fever 4 g
-
100 mg/kg
14 days
21 days
 
Gonorrhoea 2 - 3 g - stat 

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Precautions:
Allergic reactions presenting as a skin rash, pruritus and urticaria have been reported less frequently. Other reactions including angio-oedema anaphylaxis, erythema multiforma, Stevens-Johnson syndrome and exfoliative dermatitis may occur in exceptional cases. If a skin rash occurs, treatment should be discontinued. In the event of an anaphylactic reaction, immediate treatment with adrenalin, oxygen, corticosteroids and antihistamines should be initiated.
Blood:
Blood dyscrasias have been reported less frequently. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Liver:
A moderate rise in SGOT and for SGPT has been reported in exceptional cases.
At high doses of parenteral Amoxycillin, caution must be exercised in treating patients with dehydration or oliguria because of the possibility of cristalluria.
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.
Gastro-intestinal disturbances including diarrhoea, nausea and vomiting have been reported. Pseudo-membranous colitis has been reported if this condition occurs, treatment should be discontinued and appropriate therapy, e.g. vancomycin, should be initiated.
The dose should be reduced in patients with renal failure. Periodic assessment of renal, hepatic, and haematopoietic function should be made during prolonged therapy. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.
Amoxycillin should preferably not be used in patients with infectious mononucleosis and should also be used with caution in patients with glandular fever, lymphatic leukaemia, and patients treated with allopurinol since they are especially susceptible to ampicillin-induced skin rashes.
Due to Amoxycillin's effect on intestinal flora, the absorption of other medicine may be affected. Amoxycillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
The absorption of concurrently administered digoxin may be increased during treatment with Amoxycillin.
Caution is needed when administering Amoxycillin to patients with syphilis, as the Jarisch-Herxheimer reaction may occur in these patients.
Pregnancy and Lactation:
Animal reproduction studies have failed to demonstrate a risk to the foetus. There are no adequate and well controlled studies in pregnant women.
Zoxil is excreted in breast milk, and should be used with caution when administered to lactating women.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If encountered gastro-intestinal symptoms and disturbance of the fluid and electrolyte balance may be evident. They may be treated symptomatically and supportive with attention to the water/electrolyte balance. In the absence of an adequate fluid intake and urinary output, crystalluria is a possibility, the antibiotic may be removed from the circulation by haemodialysis.
Oral administration can cause gastro-intestinal symptoms such as transient diarrhoea, nausea and colic which are dose-related and a result of local irritation not toxicity.

IDENTIFICATION:
Zoxil 250 - Dark Grey/Pink Opaque capsules overprinted "Zoxil 250" in white.
Zoxil 500 - Dark Grey/Pink Opaque capsules overprinted "Zoxil 500" in white.
Zoxil S - Free-flowing, pink powder. Pink suspension.
Zoxil SF - Free-flowing, pink powder. Pink suspension.

PRESENTATION:
Zoxil 250 - Securitainers containing 15, 100 or 500 X 250 mg Amoxycillin capsules.
Zoxil 500 - Securitainers containing 15 or 100 X 500 mg Amoxycillin capsules.
Zoxil S - Bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL syrup.
Zoxil SF - Bottles containing powder for reconstitution to 100 mL of 250 mg/5 mL syrup.

STORAGE INSTRUCTIONS:
Containers of Zoxil 250 and Zoxil 500 should be kept tightly closed in a cool (below 25°C) dry place.
Once dispensed, Zoxil S and Zoxil SF must be used within 14 days and stored in a cool place (below 25°C), preferably in a refrigerator (5°C).

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Zoxil 250 - 28/20.1.2/0124
Zoxil 500 - 28/20.1.2/0125
Zoxil S - 28/20.1.2/0126
Zoxil SF - 28/20.1.2/0127

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
Sandton
P.O. Box 2080, Gallo Manor, 2052

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
04.06.1993

Good Old Printing        P1305/1

Current: April 2005
Source: Community Pharmacy

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