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

Logo MOXAN 250 CAPSULES
MOXAN 500 CAPSULES
MOXAN S SUSPENSION
MOXAN SF SUSPENSION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MOXAN 250 CAPSULES
MOXAN 500 CAPSULES
MOXAN S SUSPENSION
MOXAN SF SUSPENSION

COMPOSITION:
Amoxycillin trihydrate BP available as:
Moxan 250 Gelatin capsules containing the equivalent of 250 mg amoxycillin.
Moxan 500 Gelatin capsules containing the equivalent of 500 mg amoxycillin.
Moxan S Each 5 mL of the reconstituted suspension contains the equivalent of 125 mg amoxycillin.
Moxan 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 ** Except type b-strains
performed 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 Moxan 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 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 Moxan 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 the powder is dispersed.
  Children 2 –10 years: 125 mg (5 mL of 125 mg/5 mL suspension)
    three times a day.
  Children six months –2 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 Duration 
  Adults Children 
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 Moxan is necessary.
Should a serious anaphylactic reaction occur Moxan should be discontinued and the patient treated with: Adrenalin, corticosteroids and antihistamines.
Treatment with Moxan 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 Moxan to patients with syphillis, as the Jarisch-Herxheimer reaction may occur in these patients. Moxan may decrease the efficacy of oestrogen-containing oral contraceptives. Due to Moxan’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:
Moxan 250 Yellow-black capsules overprinted "GS or Garec 250".
Moxan 500 Yellow-black capsules overprinted "GS or Garec 500".
Moxan S Free-flowing, slightly pink powder, light mauve suspension.
Moxan SF Free-flowing, slightly pink powder, light mauve suspension.
PRESENTATION:
Moxan 250 Canisters containing 15 or 100 x 250 mg amoxycillin capsules.
Moxan 500 Canisters containing 15 or 100 x 500 mg amoxycillin capsules.
Moxan S Bottles containing powder for reconstitution to 100 mL of 125 mg/5 mL suspension.
Moxan SF 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 NUMBERS
Moxan 250 Y/20.1.2/123
Moxan 500 Y/20.1.2/124
Moxan S Y/20.1.2/125
Moxan SF Y/20.1.2/126
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Garec Limited
6 Old Pretoria Road
Halfway House 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1992

Davbar Dbn.
Mox. 1.1 P 11/92

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